Users Manual
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ZIEHM QUANTUM USER’S MANUAL
Table of Contents
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Table of Contents
TABLE OF CONTENTS ABOUT THIS MANUAL ...11 1.0
SAFETY & RESPONSIBILITIES ...13
1.1 INTENDED USE...13 1.2 OPERATION (U.S.A.) ...13 1.3 AUTHORIZED PERSONNEL ... 13 1.4 EQUIPMENT OWNER RESPONSIBILITIES... 14 1.5 HOSPITAL ADMINISTRATION ... 14 1.6 MANUFACTURER ...14 1.7 EXCLUSION OF LIABILITY ... 14 1.8 USA REGULATORY RESPONSIBILITIES ... 15 1.8.1 SERVICE ENGINEERS/TECHNICIAN ... 15 1.8.2 SYSTEM USERS ...15 1.9 CDRH REPORT ...15 1.10 PROBLEMS ...15 1.11 REGULATORY /NOTIFIED BODY ... 15 1.12 RECORD KEEPING USA ... 15 2.0
SYSTEM OVERVIEW SECTION ...17
2.1 FIELDS OF APPLICATION ...17 2.2 FEATURES ...17 2.2.1 MOBILITY ...17 2.2.2 ORGAN PROGRAMS ...17 2.2.3 RADIATION REDUCTION ... 17 2.2.4 IMAGE QUALITY ...17 2.2.5 IMAGE ADJUSTMENT ...17 2.2.6 IMAGE MANAGEMENT ... 18 2.2.7 DOCUMENTATION AND OUTPUT ... 18 2.2.8 NETWORKABILITY ...18 2.3 OPTIONS ...18 2.4 OPTIONAL ACCESSORIES ... 19 2.5 PARTS OF THE SYSTEM ...20 2.5.1 C-ARM STAND ...20 2.5.2 TWIN FLAT PANEL MONITORS ... 20 2.5.3 MONITOR POSITION ...21 2.5.4 DUAL FLAT PANEL LCD MONITORS ... 23 2.5.5 CHANGING THE MONITOR SETTINGS ... 24 2.5.6 ZIEHM QUANTUM FP MONITORS ADJUSTMENTS ... 24 2.5.6.1. MONITOR SETTINGS ... 24 2.5.6.2. INTEGRATED BUTTON PANEL ... 24 2.5.6.3. SETTING THE BRIGHTNESS, CONTRAST AND BACKLIGHT BRIGHTNESS ... 24 2.5.6.4. SETTING THE MENU LANGUAGE ... 26 2.5.6.5. RESTORING THE FACTORY SETTINGS ... 27 2.5.7 BNC SOCKET VIDEO OUTPUT ... 28 3.0
SAFETY INSTRUCTIONS ...29
3.1 GENERAL SAFETY INSTRUCTIONS ... 29 3.1.1 OPERATION ...29 3.1.2 OPERATION (U.S.A.) ASSEMBLY AND SERVICE ... 29 3.1.3 WARRANTY VOIDED ...29 3.2 X-RAY AND ELECTRICAL SAFETY ... 29
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Table of Contents 3.2.1 GENERAL RADIATION SAFETY ... 29 3.2.2 HAZARDS...30 3.2.2.1. X-RAY TUBE HOUSING... 30 3.2.2.2. X-RAY TUBE ...30 3.2.2.3. RADIATION WARNING ... 30 3.2.2.4. PROTECTION-OF STAFF ... 30 3.2.2.5. FLAMMABLE GAS ...31 3.3 MECHANICAL AND ELECTRICAL WARNINGS... 31 3.3.1 ELECTRICAL SAFETY ...31 3.3.2 GROUNDING ...31 3.3.3 HIGH VOLTAGE COMPONENTS ... 31 3.3.4 PERFORMING INTERNAL SERVICE... 32 3.4 GENERAL SAFETY ...32 3.4.1 GETTERING ...33 3.4.2 BONDING ...33 3.5 PROTECTION OF THE PATIENT... 33 3.5.1 ELECTROMAGNETIC COMPATIBILITY ... 34 3.5.2 PROTECTIVE EARTHING (PE) ... 34 3.5.3 EQUIPOTENTIAL EARTHING HEART AND BRAIN EXAMINATIONS ... 34 3.6 LASER RADIATION...34 3.6.1 LASER TARGETING DEVICE ... 34 3.6.2 MAINTENANCE ...35 3.6.3 LASER RADIATION ...35 3.7 ENVIRONMENTAL COMPATIBILITY ... 36 4.0
UNPACKING INSTALLATION ...37
4.1 INSTALLATION PROCEDURE... 37 4.1.1 AUDIENCE ...37 4.1.2 DETAILED INFORMATION ... 37 4.1.3 ROOM TEMPERATURE ... 37 4.1.4 SHIPPING CONTAINER UNPACKING ... 37 4.1.5 UNPACKING ...37 4.2 MOUNTING MONITORS ...39 4.2.1 MOUNTING STANDARD MONITORS ... 40 4.2.2 MOUNTING QUICK RELEASE MONITORS ... 40 4.3 POWER CABLE CONNECTIONS... 42 4.4 PREPARING THE SYSTEM ... 42 4.4.1 TO PREPARE THE UNIT, DO THE FOLLOWING:... 42 4.5 SWITCHING ON THE SYSTEM ... 43 4.5.1 CUSTOMER-SPECIFIC INITIAL SETTINGS... 43 4.5.2 CONFIGURATION ...44 4.5.3 ENTERING THE HOSPITAL DATA ... 44 4.6 TEST OPERATION ...44 4.6.1 CHECK LEAKAGE CURRENT ... 44 4.6.2 C-ARM OPERATION...44 4.6.3 FLUOROSCOPY IS SELECTED; ... 44 4.6.4 PERFORM THE FOLLOWING OPERATIONAL TESTS & VERIFY THAT THE FOLLOWING RESULTS OCCUR:..45 4.7 ACCESSORIES ...46 5.0
MECHANICAL HANDLING...47
5.1 TRANSPORT POSITION ...47 5.1.1 TRANSPORT POSITION OF THE C-ARM MOBILE STAND... 47 5.1.2 TRANSPORT POSITION FOR ZIEHM QUANTUM ... 51
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Table of Contents 5.2 BRAKING AND STEERING THE C-ARM STAND... 52 5.2.1 STEERING & BRAKING ... 52 5.2.1.1. PARKING BRAKE ...52 5.2.1.2. STEERING ...52 5.3 MOVEMENT OF THE C-ARM, MECHANICAL BRAKES ... 53 5.3.1 ORBITAL ROTATION ...54 5.3.2 ANGULATION ...55 5.3.3 SWIVELING (PANNING) ... 55 5.3.4 HORIZONTAL MOVEMENT ... 56 5.3.5 VERTICAL MOVEMENT... 57 5.3.5.1. VERTICAL OVERRIDE: ... 57 6.0
USER TOUCH AND CONSOLE KEYBOARDS ...59
6.1 DESKVIEW TM CONTROL PANEL ... 59 6.2 DESKVIEW CONTROL PANEL ... 59 6.2.1 ELEMENTS OF THE CONTROL PANEL ... 59 6.3 DESKVIEW MAIN SCREEN BUTTONS... 60 6.4 MAIN SCREEN BUTTON IDENTIFICATION TABLE: ... 61 6.5 CONTROLS IN FLUOROSCOPIC OPERATION MAIN SCREEN ... 72 6.6 TOUCH CONTROL KEYBOARD ... 72 6.6.1 ALPHANUMERIC KEYPAD ... 73 6.6.2 UPPERCASE LETTERS AND SPECIAL CHARACTERS... 73 6.7 MOBILE STAND CONTROL KEYBOARD ... 74 6.7.1 MAIN KEYBOARD ELEMENT GROUPS ... 74 6.8 MOBILE STAND CONTROL KEYBOARD TABLE ... 75 6.9 SWITCHING ON THE ZIEHM QUANTUM ... 81 6.10 SWITCHING OFF THE ZIEHM QUANTUM ... 82 6.11 VERTICAL LIFT ...83 6.11.1 VERTICAL OVERRIDE: ... 83 6.12 HAND SWITCH AND FOOT SWITCH ... 83 7.0
STANDARD FLUOROSCOPIC OPERATIONS ...85
7.1 GENERAL DESCRIPTION ...85 7.2 SPECIAL FEATURES...85 7.3 IMAGE SYSTEM DESIGN...85 7.4 IMAGING PROCESSING ...85 7.5 THUMBNAIL IMAGE DISPLAY ... 86 7.6 LIVE IMAGES ...86 7.7 FLUOROSCOPY...86 7.8 BASIC OPERATION ...87 7.8.1 STEPS AND SETTINGS ...87 7.8.2 ADJUSTMENTS THAT CAN BE MADE:... 87 7.9 FLUOROSCOPY MODES...88 7.9.1 CONTINUOUS AND PULSE FLUOROSCOPY... 88 7.9.1.1. CONTINUOUS FLUOROSCOPY ... 89 7.9.1.2. PULSE FLUOROSCOPY ... 89 7.9.2 SNAPSHOT ...90 7.10 FLUOROSCOPY ANATOMICAL PROGRAMS ... 90 7.10.1 ACTIVATING ANATOMICAL/ORGAN PROGRAM ... 90 7.10.2 BONE/EXTREMITY ...91 7.10.3 PELVIS/ABDOMEN ... 91 7.10.4 HEART/THORAX ...91 7.10.5 LPD LARGE PATIENT ADIPOSE PATIENT FUNCTION ... 91
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Table of Contents 7.11 7.11.1 7.12 7.13 7.14 7.15 7.15.1 7.15.2 8.0
DIGITAL NOISE FILTERS ... 92 NOISE FILTER FACTORS ... 92 LAST IMAGE HOLD NOISE FILTER ... 92 METAL ARTIFACT CORRECTION ... 92 MANUAL EXPOSURE RATE SETTING ... 92 SCREEN DISPLAY DURING RADIATION ... 94 FLUOROSCOPIC ...94 FLUOROSCOPY FACTORS ... 94
USER FUNCTIONALITY ...97
8.1 SPECIAL FUNCTIONALITY ... 97 8.1.1 METAL...97 8.1.2 1/2 DOSE...97 8.2 MAGNIFICATION ELECTRO-OPTICAL IMAGE INTENSIFIER ... 97 8.1.3 MOBILE STAND CONTROL PANEL: ... 97 8.1.4 DESKVIEW TOUCH PANEL: ... 97 8.3 IMAGE ROTATION ...98 8.4 IMAGE REVERSAL / IMAGE MIRROR... 98 8.5 IRIS COLLIMATOR ...98 8.6 SLOT COLLIMATOR ...98 8.7 MARK IMAGE ...99 8.8 LIVE SWAP ...99 8.9 MONITOR L TO R ...100 8.10 MONITOR R TO L...100 8.11 INV VIDEO ...100 8.12 STORING/SAVING ...101 8.13 STORE USB IMAGE ...102 8.14 MOBILE STAND AND TOUCH INFORMATION DISPLAYS... 103 8.14.1. KV DISPLAY ...104 8.14.2. MA DISPLAY ...104 8.14.3. EXPOSURE TIME(S)... 104 8.14.4. CGYCM2 / ERROR ... 104 8.14.5. MIN FLUOROSCOPY TIME DISPLAY ... 104 8.14.5.1. AUDIBLE ALARM ...104 8.14.6. GENERATOR OVERHEATING ... 105 8.14.7. RADIATION EXPOSURE INDICATOR ... 105 8.15 DESKVIEW DISPLAYS FOR KV/MA, TIME AND DOSE ... 106 8.15.1. KV: ... 106 8.15.2. MA: ... 106 8.15.3. S OR SECONDS: ...106 8.15.4. MIN: ...106 8.15.5. MGY / MGY/MIN: (ACTIVE ONLY ON SYSTEM MANUFACTURED AFTER JUNE 10, 2006) ... 107 8.16 LASER AIMING DEVICE ... 107 8.16.1. RANGE OF APPLICATIONS ... 107 8.16.2. POSITIONING AID ... 108 8.17 DOSE DISPLAY FOR AKR AND ACCUMULATED AIR KERMA... 108 8.17.1. AKR /CUMULATIVE AIR KERMA DOSE DISPLAY (ACTIVE ONLY ON SYSTEM MANUFACTURED AFTER JUNE 10, 2006) ..108 8.17.2. DISPLAY FUNCTIONS: ... 108 8.17.3. DOSE DISPLAY USER/OPERATOR... 108 8.17.4. RESET DOSE DISPLAY...109 8.18 IMAGE FILTERS: ...110 8.18.1. RTE (REAL-TIME EDGE ENHANCEMENT) ... 110 8.18.2. NOISE REDUCTION ... 110
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Table of Contents 8.18.3. LIH NOISE (LAST IMAGE HOLD NOISE) ... 111 8.19 AUTO FUNCTIONS...111 8.19.1. SETTING AUTO STORE: ... 111 8.19.2. AUTO OFF...112 8.19.3. AUTO STORE ...112 8.19.4. AUTO TRANSFER ...112 8.19.5. EXIT AUTO ...112 8.20 POST PROCESSING FUNCTIONS ... 112 8.20.1. W/L (WINDOW LEVEL) ... 113 8.20.1.1. ADJUSTING WINDOW ... 113 8.20.1.2. ADJUSTING LEVEL ... 113 8.20.1.3. USING THE WINDOW/LEVEL FUNCTION ... 113 8.20.2. INVERT ...114 8.20.3. IMAGE CROP ...115 8.20.4. ZOOM (DIGITAL MAGNIFICATION) ... 116 8.21 SELECTING THUMBNAIL IMAGES... 118 8.21.1. THUMBNAILS ...118 8.21.2. TO VIEW OR SELECT A SPECIFIC IMAGES ... 118 8.21.3. DELETE IMAGE (ACTIVE ONLY WITH SYSTEMS HAVING SOFTWARE VERSION 2.5.0 OR ABOVE) ...119 8.21.4. STORE TO OR MAKE A COPY OF AN IMAGE ... 119 8.22 MONITOR IMAGE DISPLAYS... 121 8.23 DIRECT RADIOGRAPHY OPTION ... 122 8.23.1. OVERVIEW: ...122 8.23.2. FITTING THE FILM CASSETTE HOLDER ... 122 8.23.3. MANUAL SETTINGS ... 122 8.24 MAKING A DIRECT RADIOGRAPHIC EXPOSURE (OPTIONAL) ... 122 8.24.1. SET TECHNIQUE FACTORS:... 124 9.0
CINE & DIGITAL SUBTRACTION MODE ... 125
9.1 DSA/CINE FUNCTIONS ...125 9.2 CINE AND DSA NAVIGATION BUTTONS ... 127 9.3 PERFORMING DSA ...127 9.4 STORING OF DSA/CINE IMAGES ... 128 9.5 STORING INDIVIDUAL IMAGES TO THE PATIENT FILE DIRECTORY ... 129 9.6 CINE FUNCTIONS ...129 9.6.1. CINE MESSAGES ...129 9.6.2. IMAGE STOP/PLAY AND STEP ... 130 9.7 PERFORMING CINE ACQUISITION ... 130 9.7.1. ACQUIRING A NEW CINE RUN ... 131 9.7.2. IMAGE STEP ...131 10.0
PATIENT FILE OPERATIONS... 133
10.1 10.2 10.3 10.3.1. 10.3.2. 10.3.3. 10.4 10.4.1. 10.4.2. 10.5 10.6
PATIENT FILE OVERVIEW ... 133 NEW PAT (NEW PATIENT) ... 135 NEW PATIENT ENTRY ... 135 PATIENT NAME ...135 FACILITY NAME ...136 ESCAPE ( ESC) ...136 NO NAME FOLDER ...136 FUNCTION ...136 STORAGE CAPACITY ... 136 EDIT PATIENT RECORDS ... 137 DELETING PATIENT RECORDS ... 139
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Table of Contents 10.7 DELETING PATIENTS TO FREE UP SPACE ... 140 10.8 PROTECTING A PATIENT FILE ... 141 10.9 LOG IN SECURITY PERMISSION ... 142 10.10 IMAGE EXPORT ...143 10.10.1. OVERVIEW OF THE USB AND DVD EXPORT FUNCTIONS:... 144 10.10.2. ENTER ARCHIVE ...146 10.10.3. IMAGE ARCHIVE SCREEN BUTTON DESCRIPTION: ... 147 10.10.4. SELECTING IMAGE FORMAT: ... 151 10.10.5. SELECT PATIENT IMAGES FOR EXPORT: ... 152 10.10.6. USB MEMORY DEVICE PROBLEMS (THUMB DRIVE)... 153 10.10.7. OPTIONAL: SEND DICOM IMAGES TO THE PAC’S SERVER ... 154 10.11 PATIENT FOLDERS: ...155 10.12 CONFIGURING SYSTEM: (CONFIG) ... 156 10.12.1. ERASING DISK AND ACTIVATING DATABASE AFTER ERASE DISK OPERATION ... 156 10.13 SETTING USER/ADMINISTRATIVE LOG IN PERMISSIONS ... 161 10.13.1. RESTRICTIONS: ...161 10.13.2. SETTING USER PERMISSIONS ... 163 10.13.2.1. DELETE SINGLE LOG IN PERMISSION:... 163 10.13.2.2. DELETE ALL PERMISSIONS: ... 164 10.13.2.3. SAVE AND CLEAR EXPORT LOG FILES: ... 164 10.13.2.4. SETTING TIME AND DATE: ... 166 10.13.3. SETUP SERVICE KEY AND SERVICE LOG IN ... 167 10.13.4. SETUP SERVICE KEY AND SERVICE LOG IN ... 168 11.0
ZIEHM QUANTUM OPTIONAL TRANSPORT BRACKETS ... 169
11.1 11.2 11.3 11.4 11.5 12.0
FLOOR MOUNTED INSTALLATION ... 169 SHIPPING LOCKS INSTALLATION ... 174 SHIPPING LOCKS REMOVAL ... 178 FLOOR MOUNTED REMOVAL ... 178 MONITOR TRANSPORT CONTAINER ... 179 TECHNICAL DATA ... 181
12.1 12.1.1 12.1.2 12.2 12.3 12.4 12.5 12.5.1. 12.6 12.7 12.8 12.8.1. 12.8.2. 12.8.3. 12.8.4. 12.8.5. 12.8.6. 12.9 12.10 13.0
SAFETY CLASSIFICATION ... 181 STATEMENT OF COMPLIANCE IEC STANDARDS: ... 181 FDA PRODUCT CLASSIFICATION NAME / CODE: ... 181 TECHNICAL SPECIFICATION... 181 X-RAY GENERATOR X-RAY GENERATOR, HOUSING AND TUBE WITH BEAM-LIMITING DEVICE ...183 MECHANICS ...184 C-ARM OVERALL DIMENSION ... 186 CONVERSION TABLE MM TO INCHES ... 186 SCATTERED RADIATION IN THE SIGNIFICANT ZONE OF OCCUPANCY ... 187 LASER ALIGNMENT ...188 DOSE AKR AND CUMULATIVE AIR KERMA MEASUREMENT ... 188 CALIBRATION OF CALCULATED DOSE MEASUREMENT 21CFR 1020.33 (K) (4) (II) ... 188 AKR / CUMULATIVE DOSE DISPLAY CALCULATION ... 188 TEST INTERVAL: ...189 OPERATOR MONTHLY TEST PROCEDURE: ... 189 TEST RESULTS: ...190 DOSE CALIBRATION POINT: ... 190 HEAT/COOLING CAPACITY ... 192 ANATOMICAL PROGRAM KV/MA DOSE CURVES ... 192
INSPECTION & MAINTENANCE ... 197
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Table of Contents 13.1 ROUTINE CHECKS TO BE PERFORMED BY THE USER ... 197 13.1.1 SYSTEM INSPECTION ... 197 13.1.2 TABLE OF REGULAR CHECKS ... 197 13.2 TEST RECORDING ...197 13.3 VERIFY AUTOMATIC DOSE RATE CONTROL ... 198 13.4 CHECKING THE USEFUL BEAM ... 198 13.4.1. INSPECTION INTERVAL ... 198 13.4.2. CENTERING ...198 13.5 COLLIMATOR DIAMETER ACCURACY ... 198 13.5.1. GETTERING THE IMAGE INTENSIFIER TUBE ... 199 13.5.1.1. TO GETTER THE IMAGE INTENSIFIER TUBE, DO THE FOLLOWING: ... 199 13.6 PREVENTATIVE MAINTENANCE ... 199 13.7 CDRH MAINTENANCE ... 200 14.0
CLEANING, DISINFECTION, STERILIZATION... 201
14.1 PREPARATION ...201 14.2 CLEANING ...201 14.2.1. RECOMMENDED DETERGENTS ... 201 14.2.2. CLEANING THE MONITOR SCREENS ... 201 14.3 DISINFECTION STERILIZATION ... 201 14.3.1. RECOMMENDED DISINFECTANTS ... 201 14.3.2. NO ALCOHOL OR SAGROTAN ... 201 14.3.3. NO DISINFECTING SPRAYS ... 201 15.0
APPENDIX LABELS ... 203
16.0
APPENDIX ERROR CODES ... 215
16.1 16.2 16.3 17.0
ERROR AND ALERT MESSAGES ... 215 ERRORS DURING NORMAL USE ... 215 TABLE 4: LIST OF C-ARM STAND ERROR CODES ... 215 GLOSSARY ... 217
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About this Manual
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About this Manual
ABOUT THIS MANUAL This manual is designed to enable owners and operators of a ZIEHM QUANTUM c-arm to operate the systems described herein safely and efficiently. This manual is written for Service Engineers, System Users, Equipment Owners, and Hospital Administrators, and all other individuals responsible for the safe operation of x-ray equipment. All are responsible for carefully reading this manual, paying special attention to Warnings, Cautions, and Notes. Operator must read and be familiar with this material before operating this equipment.
Purpose of this manual
ZIEHM QUANTUM Software Package
Scope of validity of this manual
• • • • •
Software and Optional modules Options: Image formats, laser alignment device External storage DICOM, USB and DVD Option: Sequential Imager Capture (CINE) Option: Digital Subtraction Angiography (DSA)
For several system options, separate operating instructions are available. They are supplied with the system, provided that the system configuration includes the respective option. You will find a corresponding reference in the relevant sections of the manual.
Separate operating instructions
Quality Standards
Copyright Copyright © 2005 Ziehm Imaging, Inc. of All rights reserved. Transmission or reproduction of this manual, exploitation and disclosure of its contents to third persons is not permitted without express written consent of the manufacturer. Infringements shall entitle to damage claims.
This manual was produced in compliance with the quality principles ISO 13485:2003, IEC 60601, and UL:60601. The information provided in this manual may be updated at regular intervals and is subject to change without prior notice.
Registered Trademarks
Manufactured by:
This manual may contain the names of registered trademarks or brands, the use of which by third persons for their purposes may infringe the rights of their respective owners.
In the U.S.A.: Ziehm Imaging, Inc. 4181 Latham Street Riverside, CA 92501 E-mail: [email protected]
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Section 1.0
1.0 SAFETY & RESPONSIBILITIES This manual does not constitute a complete catalog of all safety and responsibility measures necessary for the operation of the respective medical equipment, since special operating conditions may require further measures. However, it does contain an overview of responsibilities and instructions that must be observed in order to ensure the personal safety of operating staff and patients as well as avoiding damage to property when operating the ZIEHM QUANTUM Mobile C-Arm. These are highlighted as follows: WARNING This is the highest level of risk. Personal injury or damage to property may occur if the operator does not observe the instructions provided here.
CAUTION This means that a situation exists which may require a decision or action on the part of the user for optimum equipment performance or to avoid a minor hazard. NOTE Notes are informative. Additional useful information and hints are provided for the operator here. 1.1
INTENDED USE The ZIEHM QUANTUM Mobile C-arm, is a medical device intended for fluoroscopic imaging in the field of surgical procedures, e.g. trauma, orthopedics, neurology, urology, pain management, gastroenterology, ERCP, simple peripheral vascular and limited interventional procedures such as pacemakers. Third-party devices and components used in combination with the system must comply with the safety requirements according to IEC 60601-1 and/or IEC60601-1-1 or furnish proof of an equivalent degree of safety before use. Proper and safe operation of the system requires adequate transportation, storage, assembly and installation as well as appropriate use and maintenance. The limiting values indicated in this user manual must not be exceeded; this applies also when putting the system into service.
1.2
OPERATION (U.S.A.) In the U.S.A., Federal law restricts use of this device to trained personnel on the order of a physician.
1.3
AUTHORIZED PERSONNEL Only authorized personnel are allowed to assemble and/or repair the medical equipment described in this manual. Authorized personnel are persons who have attended an appropriate training course provided by the manufacturer.
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1.4
EQUIPMENT OWNER RESPONSIBILITIES The Equipment Owner is responsible for ensuring that the x-ray system complies with the applicable sections of CFR 21, Subchapter J - Radiological Health. Compliance is periodically verified by subjecting the system to various test procedures defined by the Center for Disease and Radiological Health (CDRH). The Equipment Owner is responsible for ensuring that only persons who are trained and qualified are allowed to operate the x-ray system. When required, System Users must obtain credentials from local, state, and federal authorities before operations of the device. If the system fails to operate correctly, or fails to respond to system controls as outlined in this manual, notify the local, authorized Ziehm Imaging, Inc. dealer representative.
1.5
HOSPITAL ADMINISTRATION Hospital Administration is responsible for verifying that the equipment continues to operate within the correct calibration of mA, kV, time/mAs, and alignment of the useful beam. Hospital Administration is responsible for ensuring that the system complies with applicable local, federal, statutory, and regulatory requirements. Hospital administration is responsible for consulting with local, state, and federal agencies regarding requirements and regulations applicable to the system’s use. Ziehm Imaging, Inc. assumes no responsibility or liability for after-sale operating and safety practices and is not responsible for personal injury or damage resulting from the misuse of its systems. If you have any safety-related questions, contact your authorized Ziehm Imaging, Inc. dealer representative.
1.6
MANUFACTURER The manufacturer is responsible for the safety, reliability and efficiency of the equipment only when:
1.7
•
Installation, alterations or repairs are carried out by persons authorized by the manufacturer.
•
The electrical installation in the room in which the ZIEHM QUANTUM is used corresponds to the power requirements listed in Appendix A.
•
The equipment is used in accordance with this manual and the operator follows said manual.
EXCLUSION OF LIABILITY The manufacturer accepts responsibility for the safety, reliability and performance of the system only if; •
Any installation, modification or repair work is carried out exclusively by persons authorized by the manufacturer;
•
The electrical installation of the room where the system is operated complies with the requirements of VDE 0107, or the corresponding national regulations of the respective
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Section 1.0
country; •
The system is used in accordance with the User Manual.
The warranty becomes invalid when any repair, modification, or installation work is carried out by unauthorized personnel. No consequential damages will be accepted either. The equipment conforms to Class IIb according to the Council Directive 93/42/EEC. This User Manual has been written and reviewed originally in German and translated.
1.8
USA REGULATORY RESPONSIBILITIES
1.8.1
SERVICE ENGINEERS/TECHNICIAN Service Engineers/Technicians are responsible for installing, calibrating, and maintaining the CArm system. In order to be qualified to perform the procedures described in the Service Manual, Service Engineers must attend formal training provided by Ziehm Imaging, Inc. (hereafter referred to as the manufacturer).
1.8.2
SYSTEM USERS System Users are responsible for reading and following each section of this manual that applies to them. The user should not attempt any procedures in this manual that are described as a service task. USERS shall contact manufacturer to perform service related tasks described in this manual.
1.9
CDRH REPORT The CDRH Maintenance Manual contains or may refer to test procedures that the Center of Disease and Radiological Health (CDRH) requires to be performed as the system is installed and prior to customer acceptance. A list of the equipment required to conduct these tests is included. Use only this equipment, or approved substitutes. This manual includes reference to forms for recording required tests. Make copies of these forms and safeguard the original. As tests are conducted, record the results onto a blank copy of the form. Keep the original, and send a copy to the manufacturer at the following address: Ziehm Imaging, Inc.; 4181 Latham Street; Riverside, CA 92501. If you have any questions concerning testing, call the manufacturer at: 951-781-2020, and ask for the Service department. Maintain original copies of completed forms for future reference.
1.10
PROBLEMS If System Users have an equipment-related problem, they must immediately stop using the system and notify a Service Engineer. The system must not be operated until repairs have been made and the proper functioning of the system is verified.
1.11
REGULATORY /NOTIFIED BODY Ziehm Imaging, Inc. USA 1. The Food and Drug Administration (FDA) is our Regulatory Body.
1.12
RECORD KEEPING USA Service Engineers are responsible for:
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Section 1.0
1. Completing the records listed below, 2. Filing the original, and for 3. Forwarding copies to the indicated recipient. Record
When Required
Recipient
Service log
Whenever any service is performed on the system
• Original to Service files. • Copy to Manufacturer for DHR
FDA Form 2579, Report Of Assembly Diagnosis X-Ray System
Whenever the system is installed, or when any of the following certified components are replaced or added: • New system • X-ray tube housing, highvoltage generator • Beam-limiting assembly • Image receptor • X-ray control unit
Original to Service files. Copies to: •FDA • Manufacturer • State • Hospital
When system installation is complete
• Original to Service files. • Copy to Manufacturer for DHR
Equipment Locator Card
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Section 2.0
2.0
SYSTEM OVERVIEW SECTION
2.1
FIELDS OF APPLICATION The ZIEHM QUANTUM is a Mobile C-Arm X-Ray System with Image Intensifier which is suitable for all surgical applications, pain management, traumatology, orthopedics, neurology, urology, gastroenterology, ERCP, simple peripheral vascular and simple interventional procedures such as pacemaker.
2.2
FEATURES
2.2.1
MOBILITY With its compact design and combined steering & braking system, the ZIEHM QUANTUM offers the operator unrestricted mobility in positioning at the operating table, even if space is scarce. The easy adjustability and accurate counterbalancing of the ample C-Arm profile and stand makes it possible to access even the most difficult positions.
2.2.2
ORGAN PROGRAMS Computer-controlled anatomical programs ensure optimal exposure rate and image quality control as well as high operating comfort. A “LP”’ program for visualization of larger adipose patients and a ‘Metal’ program for suppressing image flare resulting from the use of metal implants and surgical instruments complete the automatic functions.
2.2.3
RADIATION REDUCTION The superior penetration capabilities of the ZIEHM QUANTUM High-Frequency Generator enable a significant reduction in the patient skin dose. Radiation-free digital image rotation is provided by the system’s state of the art image processing. LPD operation allows larger adipose patient penetration without incorporating boost or high mA modes of radiation.
2.2.4
IMAGE QUALITY 18" flat-panel LCD Monitors with anti-reflection coating guarantee clear flicker-free images. The advanced LCD TFT Technology, CCD camera, 16 bit image processing, and 1K x 1K up-scan image system matrix, provides the operator with higher resolution images.
2.2.5
IMAGE ADJUSTMENT Comprehensive real-time image processing functions, customizable noise and area filtering, electronic contrast and brightness adjustment, zooming, radiation-free horizontal and vertical image reversal, digital image rotation ensure perfect adaptation of the image quality and orientation on the screen to the surgeon’s needs. Further image processing functions are available for saved images by means of Post-processing.
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2.2.6
IMAGE MANAGEMENT A patient-based image management system providing an image Mosaic (thumbnails) view and menu-controlled user guidance guaranties efficient image data handling.
2.2.7
DOCUMENTATION AND OUTPUT For documentation purposes, optional USB image port is available, as well as an optional DVD re-writer allowing film less archiving in PC compatible full resolution digital BMP image format. You also have the option to save your images in DICOM format and/or other optional image formats depending on system configurations. Patient-related data, data (e.g. the fluoroscopy parameters) are included in the stored image. In addition, all systems have a video BNC output.
2.2.8
NETWORKABILITY The optional DICOM 3.0 interface (Quantum FlexNet) enables integration into any network supporting DICOM 3.0, e.g. PACS. Thanks to “Primary Capture” support, the original fluoroscopic images can be archived without changes to the image that may have been applied to them later. The following DICOM Classes are available: -
Storage
-
Work list
-
Print WARNING Do not touch the USB or DICOM ports and the patient at the same time. Failure to observe this warning may result in serious injury to patient or operator.
WARNING Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment.) Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical services department of your local representative. 2.3
OPTIONS This manual describes a system with maximum configuration. The system configuration chosen by you may not contain all options and functions described here. The following options can be integrated into the system upon request: -
The DICOM 3.0 interface ZIEHM QUANTUM FlexNet (Primary Capture) Depending on the system configuration chosen, the following functions, features and DICOM Classes are supported:
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Section 2.0
-
DICOM Print Class Storage Class including multi-frame capability Media Class (images for DSA and Cine sequences) Worklist Class Laser targeting device on the generator and/or image intensifier USB DVD writer CINE with 5/10/15 frames per second (15 frames per second only with DSA option) DSA with final Max Opacification (MSA) image on reference monitor. Additional image storage: 1000/5,000/10,000/20,000 images (20,000 images only with DSA option) USB Port using certified USB 2.0 USB Memory storage device Image export of AVI image format for motion studies (Cine) JEG, BMP and DIOCM 3.0 media image formats. (Available image formats vary depending on system configurations)
WARNING Do not touch the USB or DICOM ports and the patient at the same time. Failure to observe this warning may result in serious injury to patient or operator.
WARNING The Optional USB port does not support externally powered USB devices.
WARNING Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical services department of your local representative.
2.4
OPTIONAL ACCESSORIES The following accessories are optionally available for the ZIEHM QUANTUM: -
Sterile disposable covers
-
Radiographic Cassette holder
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Section 2.0
2.5
PARTS OF THE SYSTEM
2.5.1
C-ARM STAND Fig 2.1: ZIEHM QUANTUM Mobile Stand
2.5.2
TWIN FLAT PANEL MONITORS ON
OFF
On the rear side of each flat-screen monitor, there is an ON/OFF switch. NOTE Newer models may not have the Power Switch.
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