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Intraoperative Transducers

An intraoperative transducer is used during surgery to help the surgeon locate and visualize
anatomical structures, to visualize blood flow patterns and quantify velocities, and to image
and measure anatomical and physiological parameters of interest to the surgeon.
The system supports the L15-7io transducer for use in intraoperative applications.

WARNING
All intraoperative transducers are designed to be defibrillator safe in accordance with IEC
60601-1. Nevertheless, always remove the transducer from the patient before defibrillation.

NOTE
Intraoperative transducers will be unavailable in the US and Canada until regulatory clearance is
received.

Operators of Intraoperative Transducers

Philips intraoperative transducers are designed to be used under the guidance of physicians
who are properly trained in intraoperative ultrasound imaging techniques according to
currently approved relevant medical practices. Philips recommends that physicians operating
any Philips intraoperative transducer have the following qualifications:
• Proficiency in recognizing and interpreting imaging patterns.
• Thorough familiarity with the safe operation, care, and maintenance of the ultrasound

system and the intraoperative transducers.

• Thorough familiarity with the latest intraoperative methods through literature and

seminars.

9

Operators of Intraoperative Transducers

Intraoperative Transducers

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Summary of Contents for epiq 7

Page 1: ...EPIQ 7 Ultrasound System User Manual Release 1 0 4535 617 25341 Rev B August 2013 2013 Koninklijke Philips N V All rights reserved Published in USA ...

Page 2: ... the implied warranties of merchantability and fitness for a particular purpose Philips has taken care to ensure the accuracy of this document However Philips assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability function or design Philips may make improvements or changes in the products or programs ...

Page 3: ...758 508 7 771 354 7 859 170 8 030 824 8 038 618 8 096 947 8 137 272 8 161 817 8 169 125 8 177 718 8 257 260 Re43 048 Re36 564 Chroma Color Power Angio High Q PercuNav QLAB SonoCT xMATRIX and XRES are trademarks of Koninklijke Philips N V Non Philips product names may be trademarks of their respective owners EPIQ 7 User Manual 4535 617 25341 3 ...

Page 4: ...4 EPIQ 7 User Manual 4535 617 25341 ...

Page 5: ...d Disposal 22 2 Safety 27 Basic Safety 27 Electrical Safety 29 Defibrillators 33 Fire Safety 34 Mechanical Safety 34 Equipment Protection 36 Product Compatibility 37 Symbols 38 Biological Safety 46 FDA Medical Alert on Latex 49 ALARA Education Program 50 Output Display 54 Control Effects 58 Related Guidance Documents 60 Acoustic Output and Measurement 60 Acoustic Output Tables 63 Acoustic Measurem...

Page 6: ...munity 74 Electromagnetic Interference 77 Recommended Separation Distance 79 Avoiding Electromagnetic Interference 81 Use Restrictions Due to Interference 81 3 System Overview 83 System Capabilities 83 Measurements 83 Transducer Types 84 Image Acquisition and Review 84 Patient Data Protection 84 System Options 84 Imaging Options 85 Connectivity Capabilities 85 Clinical Analysis Applications 86 QLA...

Page 7: ...Moving the System 106 Preparing and Moving the System 108 Positioning the System in Confined Spaces 111 Setting Up After Moving 112 5 Using the System 113 Turning the System On and Off 113 Setting the System Time and Date 114 Using the Brakes and Steering Locks 115 Monitor Adjustments 116 Positioning the Monitor 117 Changing the Monitor Tint 117 Changing the Default Monitor Brightness 118 Automati...

Page 8: ...g Your Password 134 Imaging Display 135 Patient Bar 136 Image Area 136 Tools and Icons Area 138 Emergency Studies 138 Temporary ID 139 Starting Emergency Studies 139 Setting the Auto Freeze Function 140 Transducer Receptacles and Cable Management 140 Selecting a Transducer 142 Selecting a Preset 143 ECG Feature 143 DVD CD and USB Devices 143 Media Compatibility 143 DVD Drive 144 Loading and Ejecti...

Page 9: ...52 Creating a Custom Procedure 152 Selecting a Custom Procedure 153 7 Performing an Exam 155 New Patient Exams 155 Entering Patient Data 156 Selecting in the Worklist 156 Searching in the Worklist 157 Hiding Patient Name and ID on Images 157 Imaging Modes 158 Selecting a Transducer 158 Annotation 159 Adding Labels 159 Adding Labels Using the Keyboard 161 Adding an Image Title 161 Displaying Body M...

Page 10: ...ption 178 Transducer Maintenance 178 Acoustic Artifacts 179 Acoustic Artifacts in 3D Imaging 181 Transducer Covers 183 Ultrasound Transmission Gels 184 Transducer Storage 185 Storage for Transport 185 Daily and Long Term Storage 186 9 Intraoperative Transducers 187 Operators of Intraoperative Transducers 187 Intended Uses for Intraoperative Transducers 188 Patient Safety During Intraoperative Stud...

Page 11: ...ng the X7 2t TEE Transducer 210 X7 2t Deflection Controls 211 Manipulating the X7 2t Tip 213 Rotating the X7 2t Image Plane 215 S7 3t TEE Transducer Description 216 Using the S7 3t TEE Transducer 217 S7 3t TEE Controls 218 Manipulating the S7 3t TEE Tip 220 S7 3t TEE Array Rotation 221 Rotating the S7 3t TEE Array 222 Checking the TEE Transducer 223 TEE Transducer Inspection 223 TEE Transducer Con...

Page 12: ...Endocavity Transducers 239 Operators of Endocavity Transducers 239 Patient Safety During Endocavity Studies 239 Preparing Transducers for Endocavity Use 240 C10 3v Description 241 C10 4ec Description 241 Patient Contact Parts 242 Biopsy with Endocavity Transducers 243 12 Biopsy Guides 245 Attaching and Removing a Biopsy Guide 245 Biopsy Guideline Display 246 Displaying the Biopsy Guideline 247 Mov...

Page 13: ...nsducers by Immersion 270 Disinfecting TEE Transducers with an AER 273 Transducer Sterilization 273 Sterilizing Transducers by Immersion 275 Disinfectants Compatibility 276 Disinfectant Types 277 Factors Affecting Disinfectant Efficiency 278 Disinfectants and Cleaning Solutions Compatibility Table 278 14 System Maintenance 287 Cleaning and Maintaining the System 287 Cleaning the System and ECG Equ...

Page 14: ...ansferring the Test Patterns 296 Using the Test Patterns 296 Testing the System 297 For Assistance 297 15 Specifications 299 Safety and Regulatory Requirements 302 16 Index 303 Contents 14 EPIQ 7 User Manual 4535 617 25341 ...

Page 15: ...nded Use This product is intended to be installed used and operated only in accordance with the safety procedures and operating instructions given in the product user information and only for the purposes for which it was designed For indications for use see Indications for Use and Supporting Transducers on page 176 However nothing stated in the user information reduces your responsibility for sou...

Page 16: ...made by a qualified Philips Ultrasound field service engineer WARNING To avoid electrical shock use only supplied power cords and connect only to properly grounded wall wall mains outlets WARNING Do not operate this system in the presence of flammable gases or anesthetics Explosion can result The system is not compliant in AP APG environments as defined by IEC 60601 1 WARNING Medical equipment mus...

Page 17: ...nformation Components The user information provided with your product includes the following components User Information CD Includes all of the user information except the Operating Notes The instructions for using the CD are included with the CD Operating Notes Contains information that clarifies certain product responses that might be misunderstood or cause user difficulty User Manual Provided w...

Page 18: ...d with the trackball The two buttons on either side of the trackball are called the left and right trackball buttons and they operate somewhat similarly to PC mouse buttons The button above the trackball is called the middle trackball button and it is used to update the imaging display complete measurements and other operations as specified in procedures The trackball arbitration icon at the botto...

Page 19: ...teps in the sequence they are presented to ensure success Bulleted lists indicate general information about a particular function or procedure They do not imply a sequential procedure Control names and menu items or titles are spelled as they are on the system and they appear in bold text Exceptions are the trackball the buttons adjacent to it and the TGC slide controls all of which are unlabeled ...

Page 20: ... your left as you stand in front of the system facing the system The front of the system is nearest to you as you operate it Transducers and pencil probes both are referred to as transducers unless the distinction is important to the meaning of the text Information that is essential for the safe and effective use of your product appears throughout your user information as follows WARNING Warnings ...

Page 21: ...r covers bite guards biopsy guides and other supplies and accessories contact CIVCO Medical Solutions CIVCO Medical Solutions 102 First Street South Kalona IA 52247 9589 Telephone 800 445 6741 USA and Canada 1 319 248 6757 International Fax 877 329 2482 USA and Canada 1 319 248 6660 International E mail info civco com Internet www civco com To order the items listed in the following table see the ...

Page 22: ...atural environment and helping ensure continued safe and effective use of this system through proper support maintenance and training Philips designs and manufactures equipment in compliance with relevant guidelines for environmental protection As long as the equipment is properly operated and maintained it presents no risk to the environment However the equipment may contain materials that could ...

Page 23: ...member that passing on medical electrical equipment to new users may present serious technical medical privacy and legal risks The original user may remain liable even if the equipment is given away Philips strongly advises you to seek advice from your local Philips representative before agreeing to pass on any equipment After you pass the system to a new user you might still receive important saf...

Page 24: ...and information contact your Philips service organization or see the following website www healthcare philips com us about sustainability recycling Perchlorate Material In this system perchlorate material is present in lithium coin cells or batteries Special handling may apply to those items For more information see this website www dtsc ca gov hazardouswaste perchlorate Discarding Batteries Batte...

Page 25: ...e apply reverse polarity expose to high temperatures or disassemble Misuse or abuse could cause physical injury NOTE Wash skin with large amounts of water in the event of electrolyte leakage to prevent skin irritation and inflammation Recycling Reuse and Disposal Read This First EPIQ 7 User Manual 4535 617 25341 25 ...

Page 26: ...Read This First Recycling Reuse and Disposal 26 EPIQ 7 User Manual 4535 617 25341 ...

Page 27: ...e device WARNING Warnings highlight information vital to the safety of you the operator and the patient CAUTION Cautions highlight ways that you could damage the product and consequently void your warranty or service contract or ways that you could lose patient or system data Basic Safety WARNING Do not use the system for any application until you have read understood and know all the safety infor...

Page 28: ...jury WARNING Do not operate the system with patients unless you have an adequate understanding of its capabilities and functions Using the system without such understanding may compromise the system s effectiveness and the safety of the patient you and others WARNING Never attempt to remove modify override or frustrate any safety device on the system Interfering with safety devices could lead to f...

Page 29: ...ed WARNING To avoid the risk of electrical shock never connect the system power cord to a power strip or an extension cord When using the power cord always connect it directly to a grounded wall outlet WARNING Use only Type CF transducers for invasive procedures Type B transducers are insufficiently electrically isolated for invasive use WARNING Do not remove the protective covers on the system ha...

Page 30: ...EE procedures either remove the TEE transducer from the patient or disconnect the TEE transducer from the system immediately following image acquisition WARNING Ultrasound equipment in normal operation as with other medical electronic diagnostic equipment uses high frequency electrical signals that can interfere with pacemaker operation Though the possibility of interference is slight be alert to ...

Page 31: ... optional devices are connected to your ultrasound system ensure that the total system earth leakage current does not exceed 500 µA WARNING To avoid risk of electrical shock do not use any transducer that has been immersed beyond the specified cleaning or disinfection level WARNING To avoid risks of electrical shock and fire hazards inspect the system power cord and plug regularly Ensure that they...

Page 32: ...ult from a defect in the high frequency surgical neutral electrode connection WARNING Using cables transducers and accessories other than those specified for use with the system may result in increased emissions from or decreased immunity of the system CAUTION Although your system has been manufactured in compliance with existing EMI EMC requirements use of this system in the presence of an electr...

Page 33: ...WARNING Before defibrillation always remove all patient applied parts from the patient WARNING Before defibrillation always disconnect invasive transducers that remain in contact with the patient from the system WARNING A disposable transducer cover provides no protective electrical insulation against defibrillation WARNING A small hole in the outer layer of the transducer opens a conductive path ...

Page 34: ... in an environment for which they were not designed can lead to fire or explosion Fire regulations for the type of medical area being used should be fully applied observed and enforced Fire extinguishers should be available for both electrical and nonelectrical fires Mechanical Safety A list of precautions related to mechanical safety follows observe these precautions when using the system WARNING...

Page 35: ...e system is parked WARNING If system operation is abnormal after you move or transport the system contact Philips Ultrasound Customer Service immediately System components are installed securely and can withstand considerable shock but excessive shock can cause a system failure WARNING To avoid injury Philips recommends against lifting the system cart WARNING If you park the system on a floor that...

Page 36: ...ot roll the system over transducer cables or power cables Equipment Protection Follow these precautions to protect your system CAUTION Excessive bending or twisting of cables on patient applied parts may cause failure or intermittent operation of the system Do not roll the system over cables which may damage them CAUTION Improper cleaning or sterilization of a patient applied part may cause perman...

Page 37: ...hen the time required for the device to return to room temperature could be significantly less than 24 hours CAUTION To avoid damaging the flat panel display in the monitor do not store the system where the ambient temperature exceeds 65 C 149 F Product Compatibility Do not use your system in combination with other products or components unless Philips expressly recognizes those other products or ...

Page 38: ...nection or warn of potential hazards Of those symbols the following may be used on your Philips product and its accessories and packaging USA federal law restricts this device to sale by or on the order of a physician Isolated patient connection Type BF applied part Defibrillation proof patient connection Type BF applied part Non isolated patient connection Type B applied part Isolated patient con...

Page 39: ...the user should see the instructions for use for safety information Identifies equipotential ground Identifies earth ground Identifies protective earth ground Nonionizing electromagnetic radiation Indicates that interference may occur in the vicinity of equipment marked with this symbol Indicates conformance with European Council Directive 93 42 EEC The radio component contained in this device is ...

Page 40: ...t the effects of immersion This degree of protection can apply to transducers and foot operated devices Indicates that the device is protected against the effects of immersion for up to 60 minutes This degree of protection can apply to foot operated devices or transducers Indicates the need for separate collection for electrical and electronic equipment in compliance with the Waste Electrical and ...

Page 41: ... the temperature range noncondensing for transport and storage Does not apply to media Indicates the atmospheric pressure range for transport and storage Indicates the relative humidity range noncondensing for transport and storage Indicates that a connector receives alternating current Identifies fuse boxes or their locations For continued protection from fire and shock replace fuses only with fu...

Page 42: ...be kept dry Indicates that the device is fragile handle with care Do not use if damaged Warns of system over balance due to external force Do not push on the monitor or the transducer holders to move the system Keep away from sunlight Non sterile Sterilized using ethylene oxide Catalog number Batch code Safety Symbols 42 EPIQ 7 User Manual 4535 617 25341 ...

Page 43: ...Do not place field generator within 200 mm 8 in of a patient with a pacemaker Connection for a pencil probe Connection for a pencil probe Connection for a transducer Connection for ECG and physio leads Connection for ECG and physio leads Print remote output Input port for audio left right VHS S VHS microphone CD or DVD Symbols Safety EPIQ 7 User Manual 4535 617 25341 43 ...

Page 44: ...ort VGA or parallel output port DVI video output receptacle USB input output port FireWire IEEE 1394 input output port Ethernet connection RS 232 serial port System microphone Isolated auxiliary power provided for connection of Philips approved remote accessories Foot switch Safety Symbols 44 EPIQ 7 User Manual 4535 617 25341 ...

Page 45: ...B W Composite video output connection Color composite video output connection Video print trigger connection EU Authorized Representative Russian approval GOST Chinese Environmentally Friendly Use Period symbol Symbols Safety EPIQ 7 User Manual 4535 617 25341 45 ...

Page 46: ...the system A list of precautions related to biological safety follows observe these precautions when using the system For more information refer to Medical Ultrasound Safety on your User Information CD WARNING Do not use the system if an error message on the video display indicates that a hazardous condition exists Note the error code turn off power to the system and call your customer service rep...

Page 47: ... on page 49 WARNING The M2203A bite guard strap contains natural rubber latex which may cause allergic reactions See FDA Medical Alert on Latex on page 49 WARNING In contrast studies using a high MI acoustic field capillary rupture due to microbubble expansion within a capillary in an acoustic field can cause extravasation References 1 Skyba D M Price R J Linka A Z Skalak T C Kaul S Direct in vivo...

Page 48: ... this document from the World Health Organization WHO CDS APH 2000 3 WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies The transducers for your system cannot be decontaminated using a heat process WARNING If the system becomes contaminated internally with bodily fluids carrying pathogens you must immediately notify your Philips service representative Components inside ...

Page 49: ...itive Proteins in the latex itself appear to be the primary source of the allergic reactions Although it is not now known how much protein is likely to cause severe reactions the FDA is working with manufacturers of latex containing medical devices to make protein levels in their products as low as possible FDA s recommendations to health professionals in regard to this problem are as follows When...

Page 50: ... Natural rubber latex is not used on any Philips ultrasound transducer It also is not used on Philips ECG cables for the products described in this document ALARA Education Program The guiding principle for the use of diagnostic ultrasound is defined by the as low as reasonably achievable ALARA principle The decision as to what is reasonable has been left to the judgment and insight of qualified p...

Page 51: ...allows the sonographer to apply the ALARA principle with informed judgment Additionally the transducer frequency system setup values scanning techniques and operator experience allow the sonographer to meet the definition of the ALARA principle The decision as to the amount of acoustic output is in the final analysis up to the system operator This decision must be based on the following factors ty...

Page 52: ...peripheral vascular intensity levels are not recommended for fetal exams Some systems automatically select the proper range for a particular application while others require manual selection Ultimately the user has the responsibility for proper clinical use The ultrasound system provides both automatic default settings and manual user selectable settings Output power has direct impact on acoustic ...

Page 53: ... is turned on The longer the pulse the greater the time average intensity value The greater the time average intensity the greater the likelihood of temperature increase and cavitation Pulse length burst length or pulse duration is the output pulse duration in PW Doppler Increasing the Doppler sample volume size increases the pulse length Transducer selection indirectly affects intensity Tissue at...

Page 54: ... Before increasing output adjust velocity range or scale and Doppler gain to obtain an optimal Doppler trace Only if maximum Doppler gain does not create an acceptable image do you increase output In summary Select the correct transducer frequency and application for the job start with a low output level and optimize the image by using focus receiver gain and other imaging controls If the image is...

Page 55: ...rough bone near the surface as in a cranial exam Mitigating factors that might create artificially high or low thermal index readings location of fluid or bone or blood flow For example is there a highly attenuating tissue path so that the actual potential for local zone heating is less than the thermal index displays Scanned modes versus unscanned modes of operation affect the thermal index For s...

Page 56: ... within soft homogeneous tissue You can choose to display TIS TIC or TIB For details on changing the TI display see the system Help On systems with transcranial applications TIC is displayed when you select a transcranial preset Mechanical and Thermal Indices Display Precision and Accuracy The MI and TI precision is 0 1 unit on the system The MI and TI display accuracy estimates for the system are...

Page 57: ...rol and efficiencies is also a contributor to variability There are inherent uncertainties in the algorithms used to estimate acoustic output values over the range of possible system operating conditions and pulser voltages Inaccuracies in laboratory measurements are related to among others differences in hydrophone calibration and performance positioning alignment and digitization tolerances and ...

Page 58: ...ith software controls to keep the TI below the system maximums A decrease in pulser voltage will decrease MI Zoom Increasing the zoom magnification by pressing Zoom may increase frame rate This action will increase the TI The number of focal zones may also increase automatically to improve resolution This action may change the MI because the peak MI can occur at a different depth Number of Focal Z...

Page 59: ...will change little if at all If PW Doppler is also enabled then PW Doppler will remain the dominant mode and the TI change will be small M Mode and Doppler Controls Simultaneous and Update Methods Use of combination modes affects both the TI and MI through the combination of pulse types During simultaneous mode the TI is additive During Duplex the TI will display the dominant pulse type The displa...

Page 60: ...nsus Report Journal of Ultrasound in Medicine Vol 27 Issue 4 April 2008 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment AIUM NEMA 2004 Second Edition of the AIUM Medical Ultrasound Safety brochure 2009 A copy of this document is provided with each system Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers FDA September...

Page 61: ...f Diagnostic Ultrasound Systems and Transducers In Situ Derated and Water Value Intensities All intensity parameters are measured in water Since water absorbs very little acoustic energy these water measurements represent a worst case value Biological tissue does absorb acoustic energy The true value of the intensity at any point depends on the amount and type of tissue and the frequency of the ul...

Page 62: ...erated intensity in one of its shallowest focal zones Conclusions Regarding Tissue Models and Equipment Survey Tissue models are necessary to estimate attenuation and acoustic exposure levels in situ from measurements of acoustic output made in water Presently available models may be limited in their accuracy because of varying tissue paths during diagnostic ultrasound exposures and uncertainties ...

Page 63: ...ure elevations during transabdominal scans were obtained in a survey of 1988 and 1990 PW Doppler equipment The vast majority of models yielded upper limits less than 1 C and 4 C for exposures of first trimester fetal tissue and second trimester fetal bone respectively The largest values obtained were approximately 1 5 C for first trimester fetal tissue and 7 C for second trimester fetal bone Estim...

Page 64: ... frequency in megahertz MHz NEMA UD 2 definition 1 PII 3 is the derated spatial peak pulse intensity integral in joules per square centimeter J cm2 P11 3 3 2 Acoustic Measurement Uncertainty Quantity Measurement Uncertainty Percentage 95 Confidence Value Pr is the underated peak rarefactional pressure measured in megapascals MPa Pr 11 3 Wo is the ultrasonic power in milliwatts mW 10 fc is the cent...

Page 65: ...nt breaks to give soft tissue a chance to recuperate from awkward positions and repetitive movement Avoid gripping the transducer with excessive force Repetitive Strain References Pike I et al Prevalence of Musculoskeletal Disorders and Related Work and Personal Factors Among Diagnostic Medical Sonographers Journal of Diagnostic Medical Sonographers Vol 13 No 5 219 227 September 1997 Necas M Muscu...

Page 66: ...ures To reduce the presence of glutaraldehyde fumes in the air be sure to use a covered or ventilated soaking basin Such systems are commercially available The most current information about disinfection products and Philips transducers can be found on the Philips Transducer Care website www healthcare philips com us_en products ultrasound Transducers transducer_care index wpd Infection Control Is...

Page 67: ...ilable for transducers For more information see the Transducer Care section For more information about removing blood and other infectious material from the system see Disinfecting System Surfaces on page 290 ECG Cables and Lead Sets For information on cleaning ECG cables and lead sets see Cleaning the System and ECG Equipment on page 287 Disposable Drape If you believe contamination of the system...

Page 68: ...ssible sources of radiated emissions These emissions could be from other electrical devices used within the same room or an adjacent room or from portable and mobile RF communications equipment such as cellular phones and pagers or from the existence of radio TV or microwave transmission equipment located nearby In cases where electromagnetic interference EMI is causing disturbances it may be nece...

Page 69: ...pectral display Measurements Acoustic output ECG triggering Recording and playback on a VCR or DVD recorder Printing using system printers Patient information Date and time information Radio Frequency Emissions The following information applies to the system and any radio frequency device included in or with the system For information on related labeling see Symbols on page 38 FCC and Industry Can...

Page 70: ...ing when the system is used in the presence of the electromagnetic phenomena described in this section and elsewhere in your system user information Electrostatic Discharge Precautions Electrostatic discharge ESD commonly referred to as a static shock is a naturally occurring phenomenon that results in the flow of an electrical charge from a higher charged object or person to a lower charged objec...

Page 71: ...onnector pins and always observe the preceding ESD precautions when handling or connecting transducers NOTE Electrostatic discharges ESDs may cause the ECG heart rate display to increase by 10 to 15 for a few seconds after the discharge However the ECG heart rate display will return to normal within 4 seconds Electromagnetic Emissions The system is intended for use in the electromagnetic environme...

Page 72: ...ents and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class B Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Approved Cables for Electromagnetic Compliance Cables connected to the system may affect its emissions Use only the cable types and lengths listed here WARNING Using...

Page 73: ...nly those transducers WARNING Using cables transducers and accessories other than those specified for use with the system may result in increased emissions from or decreased immunity of the system NOTE The use of an Intracardiac Echocardiography ICE Probe or an Transesophageal Echocardiogram TEE probe results in Class A Radiated Emissions and should be used in a hospitable environment only Approve...

Page 74: ...e the device s documentation to determine whether it is Class B compliant Approved Accessories Accessory Manufacturer Model Number Ultrasonic imaging transducer Philips Use only the transducers listed in Clinical Applications and Transducers on page 174 DVD recorder Sony DVO 1000MD Black and white printer Sony UP D897MD Color printer Sony UP D25MD Electromagnetic Immunity The system is intended fo...

Page 75: ...pply lines 1 kV for input output lines Same as IEC 60601 test level Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Same as IEC 60601 test level Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input...

Page 76: ...er supplied equipment such as a local area network LAN or a remote printer Philips cannot guarantee that the remote equipment will work correctly in the presence of electromagnetic phenomena Although most remote devices comply with their applicable standards for immunity those device requirements may not be as stringent as those required for medical equipment It is the responsibility of the instal...

Page 77: ...re It may be extremely difficult to identify the source of the interference NOTE The following table describes a few typical interferences seen in imaging systems It is impossible to describe all manifestations of interference because it depends on many parameters of the transmitting device such as the type of modulation used by the signal carrier the source type and the transmitted level It is al...

Page 78: ...tem reset Brief flashes in the displayed or recorded image Horizontal lines in the spectral display or tones abnormal noise in the audio or both Vertical lines in the spectral display popping noise in the audio or both M mode Change of operating mode system settings or system reset Brief flashes in the displayed or recorded image Increase in the image background noise or white M mode lines White d...

Page 79: ...rdless 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 fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level in the table ...

Page 80: ...1700 m 34800 ft 12 m 39 4 ft 24 m 78 7 ft The conducted RF test level is 3 V and the system has a compliance level of 3 mV For the system this means that the imaging system is extremely sensitive to RF interference in the transducer passband For example for a 5 MHz imaging transducer the frequency range of interference from a 3 V m field may be from 2 to 10 MHz and manifest itself as described in ...

Page 81: ...are medical devices information technology products and radio and television transmission towers Tracing the source of radiated interference can be a difficult task Customers should consider the following in an attempt to locate the source Is the interference intermittent or constant Does the interference show up only with one transducer or with several transducers Do two different transducers ope...

Page 82: ... is accurate Tracking in an untested environment or a location known to cause electromagnetic interference can contribute to inaccurate information and possible personal injury Safety Electromagnetic Compatibility 82 EPIQ 7 User Manual 4535 617 25341 ...

Page 83: ...Software Q Apps are available as options The system supports a wide range of transducers The system provides measurement tools analysis options and DICOM network capabilities Measurements The system provides tools and controls for measuring distance area and volume Additionally the following application specific tools are available Aliasing Velocity 3D Volume Generic Angle Heart Rate High Q automa...

Page 84: ... report printer Patient Data Protection The data security feature if enabled on your system limits access to previously stored patient data and images To gain access to such data you must first log on to the system using a password When you are finished using the system you can log off manually or you can simply shut down the system which logs you off automatically The system stores a record of ea...

Page 85: ...anoramic 3D imaging Physio Sleep Portability Mode Battery Option Stress Echo protocols Tissue Doppler Imaging TDI NOTE The elastography feature is available only in selected regions For information specific to your region contact your local Philips representative Connectivity Capabilities The following features are standard Image and waveform export to removable media Printing to DICOM printers Pr...

Page 86: ...ications Clinical applications are available on the system as separate purchasable options The following clinical applications and their presets for example small parts superficial are associated with specific transducers Abdominal Adult Echo Fetal Echo General GYN Intervention CV Intervention GI Musculoskeletal OB Pediatric Echo Pediatric GI Small Parts TCD Urology Vascular QLAB Advanced Quantifi...

Page 87: ...Media Thickness IMT MicroVascular Imaging MVI Mitral Valve Navigator MVN Region of Interest Quantification ROI Strain Quantification SQ Stress Echocardiography Stress Echocardiography Stress Echo is a protocol driven study that allows a cardiologist to assess cardiac wall motion at various heart rates by acquiring views of the heart at different stages of the study Stress Echo includes these Phili...

Page 88: ...ltiple applications and can be used for ablations biopsies and other diagnostic and guidance procedures Multiple modalities The PercuNav option works with images from multiple modalities including but not limited to CT MR PET ultrasound and rotational fluoroscopy Instructions for using PercuNav are in the PercuNav User Manual NOTE PercuNav is a purchasable licensed option Its user interface is ava...

Page 89: ... On Off switch 3 Control module 4 Transducer receptacle locks 5 Transducer receptacles 6 Side panel 7 Brake steering lock pedal 8 Touch screen 9 Peripheral bays System Components System Overview EPIQ 7 User Manual 4535 617 25341 89 ...

Page 90: ...information on the control module refer to System Controls on page 119 The control panel contains the main imaging controls These controls include buttons knobs and a trackball The control module also allows you to select transducers enter patient data review and annotate images perform measurements and calculations and change setups The touch screen located above the control panel displays contro...

Page 91: ...osition of the control module vertically and side to side You can also swivel the control module Beneath the control panel is a retractable keyboard The keyboard is used to enter patient data comments and text annotation on images System Components System Overview EPIQ 7 User Manual 4535 617 25341 91 ...

Page 92: ...f control is located on the control panel When the system is off pushing this control brings the system into a fully operational state Pushing this control again turns off the system System Overview System Components 92 EPIQ 7 User Manual 4535 617 25341 ...

Page 93: ...ages onto removable media Removable media includes USB storage devices and the DVDs and CDs The DVD RW drive is located on the right side of the control panel behind the transducer holders System Components System Overview EPIQ 7 User Manual 4535 617 25341 93 ...

Page 94: ...DVD RW Drive System Overview System Components 94 EPIQ 7 User Manual 4535 617 25341 ...

Page 95: ...erals The peripheral bays at the back of the system provide space for up to two peripheral devices Those devices can be any combination of the following devices a black and white printer a color printer and a DVD recorder System Components System Overview EPIQ 7 User Manual 4535 617 25341 95 ...

Page 96: ...stalled in the bay Peripheral Bays Transducer Receptacles and Cable Management The system includes four receptacles for imaging transducers one receptacle for a pulsed or continuous wave Doppler probe and one receptacle for physio if physio is included in your system s configuration All receptacles can be occupied simultaneously but only one transducer at a time can be active System Overview Syste...

Page 97: ...receptacle When a transducer is not in use store it in one of the transducer holders on the system cart Always loop transducer cables over the cable hangers to prevent cables from being stepped on or run over by the cart wheels System Components System Overview EPIQ 7 User Manual 4535 617 25341 97 ...

Page 98: ... Receptacles For physio support your system includes input receptacles for ECG for the connector location see the figure in Transducer Receptacles and Cable Management on page 140 pulse phono and auxiliary signals System Overview System Components 98 EPIQ 7 User Manual 4535 617 25341 ...

Page 99: ...teering locks on the front wheels to aid in steering while moving the system or you can release all locks which allows all wheels to move freely When the pedal is fully pressed down all brakes are engaged To release all brakes move the pedal to the middle position To engage the steering locks pull the pedal fully up For more information see Using the Brakes and Steering Locks on page 115 System Co...

Page 100: ...Brake Steering Lock Pedal System Overview System Components 100 EPIQ 7 User Manual 4535 617 25341 ...

Page 101: ...esentative WARNING When using additional peripheral equipment powered from an electrical source other than the ultrasound system the combination is considered to be a medical system It is your responsibility to comply with IEC 60601 1 and test the system to those requirements If you have questions contact your Philips representative WARNING Do not use nonmedical peripherals such as report printers...

Page 102: ...below 10 C 50 F allow them to reach room temperature before connecting or turning them on Philips recommends allowing 24 hours for complete normalization Otherwise condensation inside the devices could cause damage If the device was only briefly exposed to temperatures below 10 C 50 F then the time required for the device to return to room temperature could be significantly less than 24 hours NOTE...

Page 103: ...m an electrical source other than the ultrasound system the combination is considered to be a medical system It is your responsibility to comply with IEC 60601 1 and test the system to those requirements If you have questions contact your Philips representative WARNING Do not use nonmedical peripherals such as report printers within 1 5 m 5 ft of a patient unless the nonmedical peripherals receive...

Page 104: ...Multi image prints made on small size paper are intended only for reference and should not be used for diagnostic purposes Text annotation and scaling markers may not be visible on such prints NOTE Before adding a local printer connect the printer to the ultrasound system 1 Touch Utilities 2 On the System tab touch Setups 3 Click Acquisition Capture 4 Click the Archive Printer tab 5 To assign a pr...

Page 105: ...ol the external DVD recorder 1 Turn off the system and unplug the power cord from the power source 2 Connect an S Video cable between the S Video input on the DVD recorder and the S Video output on the ultrasound system 3 Connect the DVD recorder s power cord into the back of the DVD recorder and plug the other end into an appropriate power source 4 Turn on the DVD recorder and then turn on the ul...

Page 106: ...he S Video connector in NTSC or PAL format depending on the system setting Connecting the System to a Network For information on changing the network configuration for the system see System Administration in the Help To display the Help touch To close the Help touch again or touch Close 1 Turn off system power 2 Connect one end of the provided network connection cable to the wall receptacle for yo...

Page 107: ...a bed rail WARNING Never park the system on an incline WARNING The brakes are intended as a convenience To increase cart security use wheel chocks when the system is parked WARNING Before moving the system ensure that the keyboard is retracted the control panel is centered and the monitor is locked When extended the keyboard might be damaged if it hits another object and the video monitor could sw...

Page 108: ...ransporting the system in a vehicle avoid exposing the monitor to direct sunlight and do not let the inside temperature of the vehicle exceed 65 C 149 F Either of these conditions can permanently damage the monitor Preparing and Moving the System CAUTION When shipping the system make sure the batteries are inserted upside down to prevent electrical discharge 1 Press On Off to turn off the system 2...

Page 109: ...k and external devices Secure all cables transducers and accessories so that they do not interfere with the wheels 5 Retract the keyboard 6 Lock the monitor arm by pressing the articulating sections of the arm together Moving the System Preparing the System EPIQ 7 User Manual 4535 617 25341 109 ...

Page 110: ... locks engaged and the wheels pointing in the direction you are moving the system To avoid system instability while moving it engage the steering lock only after you have moved the system a short distance in the intended direction This engages the steering locks with the wheels correctly aligned Preparing the System Moving the System 110 EPIQ 7 User Manual 4535 617 25341 ...

Page 111: ...ase the steering lock and wheel brakes by moving the pedal to its middle position 2 Move the system in any direction using the front handle 3 When the system is in position set the wheel brakes by pushing the pedal down fully Moving the System Preparing the System EPIQ 7 User Manual 4535 617 25341 111 ...

Page 112: ...lure 1 With the system in position set the brakes connect the power network and other cables from the system to the appropriate wall receptacles 2 Release the monitor from its locked transport position 3 Position the monitor where you want it 4 Squeeze the release button on the front handle and position the control module to the position you want 5 Press the On Off control to turn on the system Pr...

Page 113: ...nnected Lighted green Lighted white Sleep Mode on Disconnected Blinking amber Unlighted Sleep Mode on Connected Blinking green Unlighted CAUTION If you press and hold the On Off control to force the system to shut down you will have to wait longer than usual to use your system the next time you turn it on You may also corrupt files which can result in an inoperative system or the loss of patient d...

Page 114: ...to 10 seconds to force the system to turn off 4 To break the connection from the main power supply remove the ultrasound system plug from the wall outlet Setting the System Time and Date The system includes a clock calendar function which maintains accurate time and date even when the system is turned off and disconnected from power The system uses the clock calendar function to display the time a...

Page 115: ...TP server 1 Touch Utilities 2 On the System tab touch Setups 3 Click System Settings and then Header 4 In Set Time select a Format 12 hours or 24 hours click the time in the Time box to select it and then use the number keys to enter the correct setting Select Am or Pm if necessary 5 In Set Date select a Format click the Date to select it and then use the number keys to enter the correct setting U...

Page 116: ...fully 2 To release both the steering locks and the brakes move the pedal to its middle position 3 To engage the brakes and release the steering locks press the pedal fully Monitor Adjustments CAUTION To avoid damaging the flat panel display in the monitor do not operate it in direct sunlight Also do not operate or store the system where the ambient temperature exceeds 65 C 149 F Using the System M...

Page 117: ...nel to release the monitor from its locked transport position Monitor Articulation Arm Button 2 Grasp the monitor firmly and do one of the following Tilt the monitor up and down Swivel the monitor left and right Move the monitor side to side Changing the Monitor Tint In the setups you can change the tint of the system display The Monitor Tint setting affects only the appearance of images on the mo...

Page 118: ...tor Brightness to 1 You can also change the monitor tint temporarily 1 Touch Utilities 2 On the System tab touch Monitor Tint to choose from sRGB 1 or 2 Changing the Default Monitor Brightness You can change the default brightness of the monitor image in the setups The system uses this default value to set monitor brightness each time the system is turned on 1 Touch Utilities 2 On the System tab t...

Page 119: ...creen and the keyboard Control Panel The control panel contains the main imaging controls These controls include buttons knobs TGC slide controls and a trackball The control module also allows you to select imaging modes review and annotate images perform measurements and calculations and access Philips SupportConnect The touch screen located above the control panel displays controls used to selec...

Page 120: ...el 1 Touch screen 2 Power and Sleep Mode controls 3 TGC slide controls 4 Trackball 5 Soft key knobs and mode controls 6 Philips SupportConnect Using the System System Controls 120 EPIQ 7 User Manual 4535 617 25341 ...

Page 121: ...ouch Setups 3 Do one of the following Select System Settings and click Display Select a setting for Control Panel Brightness Turn the CP Brightness knob or touch CP Brightness until your preferred brightness is selected Positioning the Control Panel You can swivel the control panel move it side to side and move it up and down to improve ergonomics 1 Press the On Off control to turn on the system 2...

Page 122: ...w the Depth control responds when you turn it 1 Touch Utilities 2 On the System tab touch Setups 3 Click System Settings and then click the Mode tab 4 Under Depth Control do one of the following Select Increase Clockwise to increase depth when the control is turned clockwise Select Increase Counter Clockwise to increase depth when the control is turned counter clockwise 5 Click Close Touch Screen ...

Page 123: ... Touch Screen A Workflow area Contains tools that enable the major workflow activities for starting performing and completing an exam 1 Transducer selection controls 2 Tools B Tabs Contains mode specific or application specific controls in different tabs C Controls The main area of the touch screen which shows the controls for the currently selected tab in the current mode or application 3 Sub mod...

Page 124: ... the backlight on the soft key controls and their labels indicates the status of controls and modes White backlight available but inactive Amber backlight active Gray off backlight unavailable For multi use controls such as Res Spd or Compress touch the control to change the active function Types of Touch Screen Controls For this type of control Do this Touch a tab to display a different set of co...

Page 125: ... to the system For details about the System controls see System Tab Touch Screen Controls on page 125 System Tab Touch Screen Controls This topic describes the touch screen controls for the System tab on the Utilities touch screen Some of the controls are visible immediately and others may be visible only when particular transducers or presets are active To use a touch screen control or change its...

Page 126: ...monitor brightness setting in the setups Touch Monitor Brightness to select a setting from 1 darkest to 5 lightest Monitor Tint A control used to adjust the tint of the system display This control affects only the appearance of images on the monitor it does not affect saved or exported images Print Screen A control used to save an image of the full screen to the system hard drive and a copy to the...

Page 127: ...me available only after you press Measure Also you can configure the left and right trackball buttons by using the Left Select Key and Right Select Key settings in the Tools Results tab of the Analysis setups Soft Key Controls Soft key controls knobs that can be pressed and turned are located along the top of the control panel Two rows of labels for soft key functions and settings appear along the...

Page 128: ...also touch the page indicator located above the soft keys to display the next available page of soft keys Soft Key Page Indicator Using the Keyboards The system has two keyboards which you can use to enter patient data exam comments image annotation and your logon password Touch Screen Keyboard One keyboard is located on the touch screen That keyboard may appear automatically during certain activi...

Page 129: ...est is active Displayed when remote access is enabled but there is no active remote session Displayed when a remote session is active Displayed when the system is acquiring an image or an image is opening in the Review pane Indicates the status of a remote session No dot Remote session is enabled but not active Green dot Remote session is enabled and active Red X Remote session is disabled Indicat...

Page 130: ...us dialog box You can cancel pause or resume any data transfer job listed Indicates the status of the DVD recorder if installed Green dot DVD recorder is recording Pause symbol DVD recording is paused Icon is hidden DVD recorder is not recording Indicates the status of the current print job Icon is displayed a print job is being sent Icon is hidden a print job has been sent Green dot a print job i...

Page 131: ...ly NOTE The batteries may need to be replaced For information on replacing the batteries see the system Service Manual Sleep Mode Sleep Mode uses battery power and allows quick startup of the system It does not eliminate power consumption and should be used only for short periods of time such as when you transport the system between exam locations The Sleep Mode control is in the upper left corner...

Page 132: ...ion on the Sleep Mode status indicators see Turning the System On and Off on page 113 NOTE When the system is in Sleep Mode and is connected to AC power the system remains in Sleep Mode until it is awakened Battery Indicators The battery charge level is indicated by icons on the system display CAUTION The batteries are used to ensure quick system startup and easy movement of the system only You ca...

Page 133: ... limits access to previously stored patient data and images To gain access to such data you must first log on to the system using an ID and a password When you are finished using the system you can log off manually or simply shut down the system which logs you off automatically Only a registered user can change the password The data security feature is set up by your system administrator For infor...

Page 134: ...he Data Security setups 1 Click Log Off at the bottom of the imaging display 2 In the LogOff dialog box click Yes Changing Your Password If the data security feature is enabled on your system you must log on to the system to gain access to patient data and images Once the system administrator has given you a password for the system you can change it as needed A password must be 6 to 10 characters ...

Page 135: ... then press the Tab key 6 For New Password type the new password you want to use and then press the Tab key 7 For Confirm Password type your new password again 8 Click OK 9 To exit setups click Close Imaging Display The imaging display contains three distinct regions Imaging Display Imaging Display Using the System EPIQ 7 User Manual 4535 617 25341 135 ...

Page 136: ...ing an exam Image Area The image area is approximately in the center of the display and includes the following Image tabs The left tab displays the live image Additional tabs provide quick access to acquired images from the current exam retrieved images from previous exams images acquired in other modalities or analysis summary results for example fetal trending graphs Left pane Lists available ca...

Page 137: ...thumbnail images from the current exam For general imaging a scan plane orientation marker appears at the top left of the image For cardiac exams the orientation marker appears at the top right of the image The marker corresponds to the orientation marker on the transducer The marker always follows the orientation of the image When you invert the image by using Left Right or Top Bottom the marker ...

Page 138: ...under the trackball icon indicate the functions that are available for the entire trackball For details see Trackball on page 126 System management icons Provide status and can be selected When you click a system management icon a dialog box displays additional information or available actions For definitions of status and system management icons see Status Icons on page 129 Tools and Icons Area 1...

Page 139: ...r an exam started with a temporary ID edit patient data before ending the exam After the exam is ended you cannot change patient data When the patient data is changed all images are automatically resent to any local printers that they were previously sent to If your system is connected to a DICOM Worklist Server you can load patient data to replace the temporary ID data NOTE If you have configured...

Page 140: ...ing 1 Touch Utilities 2 On the System tab touch Setups 3 Click System Settings 4 Click the Display tab 5 Under Auto Freeze select On and then select the Wait time 6 Click Done Transducer Receptacles and Cable Management The system includes four receptacles for imaging transducers one receptacle for a pulsed or continuous wave Doppler probe and one receptacle for physio if physio is included in you...

Page 141: ...n a transducer is not in use store it in one of the transducer holders on the system cart Always loop transducer cables over the cable hangers to prevent cables from being stepped on or run over by the cart wheels Transducer Receptacles and Cable Management Using the System EPIQ 7 User Manual 4535 617 25341 141 ...

Page 142: ...e Default Transducer and Preset on page 148 If multiple transducers are connected when the system is turned on the system selects the transducer that was in use when the system shut down You can select among the connected transducers during system operation If the system does not recognize a transducer it will switch back to the original transducer Disconnect and reconnect the unrecognized transdu...

Page 143: ...nd auxiliary signals Low level ECG comes from leads connected to the patient high level ECG comes from a patient monitor or other similar equipment Heart rate derived from the ECG signal is displayed on the screen whenever ECG is connected and displayed DVD CD and USB Devices The system supports a variety of removable media including DVD CD and USB storage devices For additional information on spe...

Page 144: ... only for writing logs and setup data DVD Drive The system includes a DVD drive located on the right side of the control module You can use this drive to store and transfer patient files including full exams 3D data sets and reports In addition you can save restore and distribute configuration data You do not need to format a disc before storing data on it Loading and Ejecting a Disc Do one of the...

Page 145: ...The system supports the following USB devices Single partition USB flash memory drives USB flash memory drives that do not use or contain any antivirus or other executable software USB hard disk devices that require 500 mA or less per USB port USB 2 0 compliant devices USB 3 0 compliant devices Some portable hard drives do not work when connected to a single USB port on the system Connect a dual p...

Page 146: ...sound system see Shared Roles for System and Data Security included on your User Information CD CAUTION Use only Class B compliant USB storage devices with the system USB devices that are not Class B compliant may cause RF emissions that exceed Class B limits See the device s documentation to determine whether it is Class B compliant DICOM Viewer When you export patient data in DICOM format and se...

Page 147: ...em the default preset is active Before you begin an exam be sure that the appropriate preset is active You can choose from several default presets You cannot delete these default presets However they provide a starting point from which you can create your own presets You can create and store up to 45 presets per transducer application combination depending on the space available on the touch scree...

Page 148: ...er You specify how the system will be set up for operation by selecting a clinical application preset Quick Save Presets Quick Save presets provide a quick way to set imaging parameters to the values you prefer for a specific exam type Using the Quick Save feature you can define presets for any combination of clinical application preset and transducer A Quick Save preset stores the primary imaging...

Page 149: ...a name For Calculation Package select a calculation package For Annotation Body Marks select the annotation and body mark you want as the defaults 6 Click OK Deleting Quick Save Presets You can delete any Quick Save preset on the system except the active preset 1 If a preset you want to delete is active deactivate it by touching the associated transducer name and a different preset 2 Swipe the tou...

Page 150: ...r the backup is complete click Close 9 Click Done Loading Quick Save Presets from Removable Media 1 Load the DVD containing the data into the DVD drive or connect the USB device containing the data to a USB port on the system 2 On the control panel press Support 3 Click System Management 4 Click Backup Restore 5 From the Select the Media menu select the media type that you are using 6 Deselect the...

Page 151: ...gory on the left side of the setups display 4 Click a tab or sub tab at the top of the setups display 5 Enter text or make selections necessary to set up your system 6 Click Close Hiding the Doppler Velocity Minus Sign You can choose to include only the numeric value of the Doppler velocity measurements Doppler velocity is marked as negative when the flow is moving away from the transducer When re...

Page 152: ...ndard features available in the system other features are available as purchasable licensed options The types of options available include clinical applications protocols imaging capabilities QLAB Advanced Quantification Software Q Apps PercuNav Image Fusion and Interventional Navigation and connectivity capabilities To add licensed options to your system you purchase them from your Philips repres...

Page 153: ...e study in which the new or modified procedure is used Transducer Select a transducer from a list of all of the transducers that are supported by the system Preset Select a preset from a list of all of the presets that are available for the selected transducer 7 Click Save and then click Close To use the new custom procedure see Selecting a Custom Procedure on page 153 Selecting a Custom Procedure...

Page 154: ...Customizing the System Custom Procedures 154 EPIQ 7 User Manual 4535 617 25341 ...

Page 155: ...bled you can select an exam to load patient data instead of entering that information manually See Selecting in the Worklist on page 156 If you want to start an exam without first entering patient data you can select Use Temporary ID after you acquire an image The system uses a unique ID to identify each patient You can enter an ID or you can have the system create one automatically Stored images ...

Page 156: ...ve the cursor from field to field 4 For Study Type select the study you will be performing It is important to select the correct study type at this time Selecting a study type after you have entered patient data and exited the Patient Data form does not update the report with the correct study type 5 Enter the pertinent study information for the patient 6 If you have created a custom procedure for...

Page 157: ...Search 5 Select the patient from the worklist 6 Click Done Hiding Patient Name and ID on Images WARNING Images printed without the patient name and ID could be incorrectly associated with another patient One way to alleviate this risk is to configure the DICOM printer so that the patient data that is included in the header of the image file is printed along with the image However some printers do ...

Page 158: ...e modes display a live grayscale image Others are Doppler modes to evaluate the amplitude or the direction of the blood flow and the spectral information Special modes are also available for 3D imaging and Panoramic imaging NOTE Some modes are available on your system only if the corresponding option has been purchased and installed Selecting a Transducer When the system is turned on the system in...

Page 159: ...us to reflect the transducer type and the preset you selected Annotation You can place text labels and arrows on an image to identify anatomical structures and locations You can also annotate an image with a body marker graphic that indicates the part of the anatomy that you are scanning Trackball Functionality in Annotation Use the touch screen to select annotation labels and body markers and use...

Page 160: ...uch a label control to display its text To display an arrow press the Arrow soft key position the arrow with the trackball and then click to fix the position To erase an arrow touch Erase Last To erase the last word typed touch Erase Last to erase all arrows and then erase words one at a time To erase all text touch Erase All To move the text cursor to the home position touch Home To set a new hom...

Page 161: ...7 To remove text press ABC Label and then touch Erase Last Word or Erase All Text Adding an Image Title You can add a title to the image display 1 Press ABC Label 2 Touch ABC Labels 3 Touch Keyboard 4 Touch Title on the keyboard touch screen 5 Type the text that you want to add for the title 6 To erase text touch Backspace 7 When finished touch Title again Displaying Body Markers NOTE During Revie...

Page 162: ...the Body Markers touch screen touch another tab title or press ABC Label Recording You can record live imaging to a local DVD recorder and simultaneously record comments You can play back recordings on other DVD players Playback is not supported on the system Using the DVD Recorder NOTE Use only DVD RW media in the DVD recorder NOTE Always format a new disc before using it with the DVD recorder Al...

Page 163: ...ols also have print capabilities associated with them In the setups you can assign each of these controls separately to one or more image printers In addition you can select whether the controls print the entire display or just the image area NOTE If you print a monochrome image while a Chroma map is selected the system sends the image to the color printer Also if you export a monochrome image whi...

Page 164: ...one patient In Review you can look at the images or cineloop sequences that you stored You can view send print and back up your stored images You can also perform analysis on images in Review Images that are in image memory can be stored on the ultrasound system hard drive on removable media or on DICOM compatible devices on a network You can display images within an exam in several layouts and yo...

Page 165: ...ages at a time Click a thumbnail to jump to the page that contains the corresponding image To view a thumbnail full screen double click it If the image represents a 3D data set it opens in 3D review mode To return to the review screen double click the full screen image or set Layout to 4 up Drag the scroll bar to move up or down through available thumbnails quickly Turn Page to move backward or fo...

Page 166: ...rospective capture captures a specified loop length that was acquired previously A retrospective capture captures a loop that ends when you press Acquire 1 or Acquire 2 Capturing while reviewing a cineloop sequence saves all retrospective frames in the cineloop sequence You can configure the Acquire 1 Acquire 2 and touch screen print controls in the Acquisition Capture setups The default setting i...

Page 167: ...e your own calc lists including collections groups measurements and calculations In addition the measurements and calculations can be associated with system and custom tables and equations The ultrasound system supports a number of measurement and quantification methods The basic measurements report the size speed or duration of image data The image data may be contained in a 2D ultrasound image a...

Page 168: ...medical references See the References section in the Help NOTE Ensure that you follow current medical practices when identifying specific measurement points on an image Performing a 2D Distance Measurement A 2D distance measurement uses two calipers to measure the length of a straight line between the two points You can set the display of the line in the setups NOTE The left and right trackball bu...

Page 169: ...isplay The measurements that appear depend on the settings for Doppler in the Tools and Results setups You can measure Doppler velocity on a live image 1 Press PW 2 Press the middle trackball button to update the Doppler display 3 Obtain the Doppler image you want to measure spectral waveform 4 Touch Measure 5 Use the trackball to position the horizontal cursor 6 There are no measurement values in...

Page 170: ...asuring Then Labeling The measure then label method of obtaining results uses caliper controls for making measurements without first having to select measurement labels These measurements are not explicitly associated with a report region and do not appear in the report unless associated with a measurement You can assign these measurements to labels on an as needed basis After making a measurement...

Page 171: ...he next exam WARNING Failing to end the current exam before starting a new exam can result in data being acquired and stored under the wrong patient name If you turn off the system without ending the exam the system pauses the exam before shutting down When the exam is complete do one of the following Touch End Exam Click End Exam in the Patient Data display Ending an Exam Performing an Exam EPIQ ...

Page 172: ...Performing an Exam Ending an Exam 172 EPIQ 7 User Manual 4535 617 25341 ...

Page 173: ...nder normal system operation Non TEE transducers are rated minimum IPX7 in accordance with IEC 60529 Transesophageal transducers are rated minimum IPX1 control area and IPX7 endoscope area in accordance with IEC 60529 WARNING All TEE transducers are designed to be defibrillator safe in accordance with IEC 60601 1 Nevertheless always remove the transducer from the patient before defibrillation WARN...

Page 174: ... operation and updates system status to reflect the transducer type and the preset you selected Setting the Default Transducer and Preset You can set a default transducer and preset so that each time the system is turned on that transducer and preset are initiated automatically The system selects the default transducer regardless of which receptacle it is connected to If the default transducer is ...

Page 175: ...usculoskeletal Small Parts Vascular L12 5 50 Abdominal Musculoskeletal OB Pediatric Abdomen Pediatric Hip Small Parts Vascular L15 7io Epiaortic Musculoskeletal Vascular L18 5 Musculoskeletal Pediatric Abdomen Pediatric Hip Small Parts Vascular S5 1 Adult Echo Pediatric TCD S7 3t Adult Echo Pediatric S8 3 Adult Echo Pediatric S12 4 Adult Echo Neonatal Head Pediatric V6 2 Fetal Echo OB X5 1 Abdomen...

Page 176: ...S8 3 S12 4 X5 1 Cerebral Vascular C8 5 D2tcd D5cwc L12 3 L12 5 50 L15 7io L18 5 X6 1 Cephalic Adult D2tcd S5 1 X5 1 Cephalic Neonatal C8 5 L12 3 S8 3 S12 4 Fetal Obstetric C5 1 C9 2 C10 3v C10 4ec L12 5 50 L18 5 S5 1 S8 3 V6 2 X6 1 Gynecological C5 1 C9 2 C10 3v C10 4ec X6 1 Intraoperative Vascular L15 7io Intraoperative Cardiac L15 7io Musculoskeletal Conventional L12 3 L12 5 50 L15 7io L18 5 Mus...

Page 177: ...on on page 209 Use Live xPlane imaging to simultaneously create two full resolution planes Use Live Volume imaging to acquire and render full volume data at true real time frame rates X5 1 Description Features of the X5 1 transducer include Operating range 1 3 to 4 2 MHz 2D xMATRIX phased array with 3 000 elements 2D imaging provides a 90 degree field of view while volumetric imaging is 90 x 90 de...

Page 178: ...erilization as necessary Inspect the transducer cable case and lens before each use Check for cracks or other damage that jeopardizes the integrity of the transducer Report any damage to your Philips customer service representative and discontinue use of the transducer For all information on transducer cleaning and disinfection see the Transducer Care section For all information about the use of a...

Page 179: ...ges in beam intensity Artifacts and their manifestations are listed below and following are some definitions of various artifacts Added objects displayed as speckle section thickness reverberation mirror image comet tail or ring down Missing objects due to poor resolution Incorrect object brightness due to shadowing or enhancement Incorrect object location due to refraction multi path reflections ...

Page 180: ...reased range Refraction and multi path positioning errors are normally relatively small and contribute to general degradation of the image rather than to gross errors in object location Propagation speed errors occur when the assumed value for propagation speed by the ultrasound system is incorrect If the actual speed is greater than that assumed the calculated distance to a reflector is too small...

Page 181: ...rs as tissue texture close to the transducer but does not correspond to scatterers in tissue It is produced by ultrasound wave interference and results in general image degradation Spectral broadening is a display phenomenon that occurs when the number of energy bearing Fourier frequency components increases at any given point in time As a consequence the spectral display is broadened Spectral bro...

Page 182: ...lt to recognize due to different and unfamiliar displays Acoustic shadowing and other artifacts look very different when displayed in 3D volumes and may be more difficult to recognize than on standard 2D imaging Those artifacts may produce apparent defects such as limb abnormalities or facial clefts where they are not present Acquiring data from multiple orientations may avoid artifacts of this ty...

Page 183: ...overs For procedures for using transducer covers see the instructions provided with the covers WARNING Latex and talc are commonly used in sheaths marketed to help with infection control in transesophageal endocavity and intraoperative imaging applications and during biopsies Examine the packaging to confirm latex and talc content Studies have shown that patients can experience allergic reactions ...

Page 184: ...n of the acoustic beam use the ultrasound transmission gel supplied by or recommended by Philips or another glycol glycerol or water based acoustic coupling medium Products that do not contain mineral oil are acceptable for use Never use lotion based products WARNING Do not apply the transducer gel until you are ready to perform the procedure Transducers should not be left soaking in gel WARNING F...

Page 185: ...sport the transducer from one site to another Follow these guidelines to properly store transducers for transport Make sure that the transducer is clean and disinfected before placing it in the case to avoid contaminating the foam that lines the carrying case Place the transducer in the case carefully to prevent kinking of the cable Before closing the lid make sure no part of the transducer is pro...

Page 186: ... transducers in areas of temperature extremes or in direct sunlight Store transducers separately from other instruments to avoid inadvertent transducer damage When storing transducers use the cable management clips to secure the transducer cable Before storing transducers make sure they are thoroughly dry For TEE transducers be sure the distal tip is straight and protected before storing the trans...

Page 187: ...e US and Canada until regulatory clearance is received Operators of Intraoperative Transducers Philips intraoperative transducers are designed to be used under the guidance of physicians who are properly trained in intraoperative ultrasound imaging techniques according to currently approved relevant medical practices Philips recommends that physicians operating any Philips intraoperative transduce...

Page 188: ...te an intraoperative transducer you must be under the guidance of a physician who is properly trained in intraoperative ultrasound imaging techniques according to currently approved relevant medical practices You also must be thoroughly familiar with the safe operation care and maintenance of the ultrasound system used with the transducer as well as proficient at interpreting the images generated ...

Page 189: ... the transducer from the patient before defibrillation Patient Contact Parts Latex is commonly used in sheaths marketed to help with infection control in transesophageal endocavity and intraoperative imaging applications and during biopsies Examine the packaging to confirm latex content Studies have shown that patients can experience allergic reactions with natural rubber latex See FDA Medical Ale...

Page 190: ...sducer There are three primary areas of transducer misuse Cuts and abrasions on the transducer insulation and lens from sharp instruments such as scalpels scissors and clamps Improper disinfection techniques causing fluid to enter the transducer or damage transducer materials Damage caused by dropping the transducer on a hard surface To minimize the chance of damage Philips strongly recommends tha...

Page 191: ...sing Used for evaluating blood vessels musculoskeletal exams small parts breast testicles thyroid imaging and epicardiac imaging Phased linear array with 128 elements 8 degrees of trapezoidal imaging 23 mm 0 9 in effective aperture length Frequency Operating range 15 to 7 MHz Biopsy Capable No Specifications Lens footprint elevation 10 mm 0 4 in scan plane 32 mm 1 25 in Transducer length 89 mm 3 5...

Page 192: ...etation confusion NOTE To achieve good acoustic contact make sure that the imaging surface is moist NOTE Imaging improves with adequate coupling between the patient surface and the transducer cover surface Sterile water is a good acoustic coupling agent during surgery Disposable Drapes During studies in which you believe contamination of the ultrasound system can occur Philips recommends that you ...

Page 193: ... Leakage current tests should be performed by a technically qualified person any time that the transducer is dropped or if cracks or cuts are found on the transducer Normal leakage current testing frequency should be based on the procedures established by the hospital for operating room based equipment Regularly perform the electrical safety check to ensure that IEC 60601 1 Type CF leakage limits ...

Page 194: ...d in the bucket of saline solution about 850 kΩ with an intact outer insulating layer 500 Ω with a hole in the layer A Microammeter to measure leakage current from the transducer to the earth lift ground through Z to the test electrode e Line power source either 110 Vac or 220 Vac I Current caused by e and stray capacitance and optionally Z S1 Open earth lift ground switch S2 Line polarity switch ...

Page 195: ... between the metal parts of the transducer and a test electrode placed in the bucket of saline solution about 850 kΩ with an intact outer insulating layer 500 Ω with a hole in the layer A Microammeter to measure leakage current from a line supply to the transducer and back to earth ground through electrode Z and the equipment chassis e Line power source either 110 Vac or 220 Vac Leakage Current Te...

Page 196: ...y analyzer 3 Connect the transducer being tested to the ultrasound system 4 Immerse 5 cm 2 in of the transducer in saline solution 5 Set the safety analyzer Mode switch to the ECG position 6 Set the safety analyzer Leads switch to the ALL all ECG leads position 7 Connect a lead to any ECG terminal on the safety analyzer and immerse the other end into the saline solution 8 Set the safety analyzer L...

Page 197: ...ing tested to the ultrasound system 4 Immerse 5 cm 2 in of the transducer in saline solution 5 Set the safety analyzer Mode switch to the ECG position 6 Set the safety analyzer Leads switch to the Isolation Test position 7 Connect a lead to any ECG terminal on the safety analyzer Leave the other end of the lead disconnected for now 8 Press and hold the Isolation Test button and note the leakage re...

Page 198: ...Intraoperative Transducers Leakage Current Testing for Intraoperative Transducers 198 EPIQ 7 User Manual 4535 617 25341 ...

Page 199: ... panel WARNING All TEE transducers are designed to be defibrillator safe in accordance with IEC 60601 1 Nevertheless always remove the transducer from the patient before defibrillation Operators of TEE Transducers Philips TEE transducers are designed for use under the guidance of physicians who are properly trained in esophagogastroscopic techniques according to currently approved relevant medical...

Page 200: ...he TEE transducer into the patient s esophagus See Checking the TEE Transducer on page 223 Insert remove and operate the transducer properly Ensure that the transducer handle does not rest on or touch the patient Use protective equipment such as a bite guard and a market approved sterile transducer cover during a TEE study See TEE Accessories and Supplies on page 233 Do not allow water or other li...

Page 201: ...draw the transducer from the patient In the neutral position the tip is straight when the indicators on the control wheels are aligned and point toward the center of the array rotation button WARNING Bite guards are mandatory protective transducer covers are recommended for TEE transducers but in China and Japan the covers are mandatory See Electrical Safety and TEE Transducers on page 205 CAUTION...

Page 202: ...EE Studies Problem Effect on Patient Prevention See Mechanical damage Severe trauma cuts bleeding perforations Inspect the transducer using both sight and touch before the study Checking the TEE Transducer on page 223 Electrical damage Esophageal burns Check the transducer for frayed insulation kinks or other abnormalities Follow procedures for checking electrical safety Electrical Safety and TEE ...

Page 203: ...25 Increased transducer temperature Esophageal burns Use the TEE preset that has been established to minimize the effects of temperature For febrile patients use the Auto Cool feature Entering Patient Temperature on page 231 Improper patient position Transient unilateral vocal cord paralysis Never use the transducer during any procedure requiring extreme neck flexion such as sitting craniotomies T...

Page 204: ...ervice contract Transducer repairs necessitated by misuse of the transducer are not covered and can be very costly often requiring complete disassembly and rebuilding of the transducer There are three primary areas of transducer misuse Cuts and abrasions on the transducer and insulation from teeth or sharp instruments such as scalpels scissors and clamps Improper disinfection techniques including ...

Page 205: ...ls on page 211 and S7 3t TEE Controls on page 218 Incorrect storage Possible damage to highly sensitive elements cuts in flexible shaft Suspend the transducer from a wall mounted rack and the distal tip with a tip protector when not in use Transducer Storage on page 185 Internal exposure to liquids Severe transducer damage that affects the image quality the steering mechanism and electrical safety...

Page 206: ...d system is plugged into an isolated power outlet which is standard in most operating rooms Reducing Risks of Using TEE Transducers WARNING Before defibrillation if you cannot remove the transducer from the patient always disconnect invasive transducers that remain in contact with the patient from the system To reduce the possibility of electrical risks associated with use of TEE transducers follo...

Page 207: ...ducer move the deflection area located between the distal tip and flexible shaft The deflection area bends when you operate the controls permitting anterior posterior and lateral positioning Deflection Control Movement To prevent tissue damage such as pressure necrosis gastroesophageal lacerations bleeding tearing of adhesions ligament damage and perforation observe the following warnings See TEE ...

Page 208: ...the patient In the neutral position the tip is straight when the indicators on the control wheels are aligned and point toward the center of the array rotation button WARNING Bite guards are mandatory protective covers are recommended for TEE transducers except in China and Japan where protective transducer covers are mandatory for TEE transducers WARNING To avoid damaging gastroscope cables be su...

Page 209: ... mode and PW Doppler mode frequency agility and electrocautery suppression Tip surface constantly monitored for patient safety Convenient hanging ring Specifications Tip 1 5 cm 0 6 in wide 3 5 cm 1 4 in long Shaft 1 0 cm 0 4 in wide 1 0 m 3 3 ft long NOTE Philips recommends that you use the X7 2t transducer only on patients weighing at least 30 kg 66 lb to ensure that the esophagus can comfortably...

Page 210: ...g yourself with the controls and parts of the TEE transducer before using it in a study TEE Transducer Components Component Description Distal tip Transducer connector Transesophageal Transducers Using the X7 2t TEE Transducer 210 EPIQ 7 User Manual 4535 617 25341 ...

Page 211: ...he knobs can be controlled by a detent brake that holds the tip position without locking it in place This allows the tip to straighten if it meets additional resistance When the detent brake actuator is rotated to the right as shown both knobs are in the freewheeling mode When the detent brake actuator is centered the small knob medial lateral movement is in the detent mode and when the actuator i...

Page 212: ...Transducer Controls Control Description Medial lateral control Anterior posterior control Detent brake actuator Transesophageal Transducers Using the X7 2t TEE Transducer 212 EPIQ 7 User Manual 4535 617 25341 ...

Page 213: ...on buttons to put both knobs into freewheeling mode 2 Turn the large knob to deflect the tip in the anterior posterior plane 3 Turn the small knob to deflect the tip in the medial lateral plane 4 When the tip is positioned properly do one of the following Turn the detent brake actuator fully toward the image plane rotation buttons to put both knobs in detent mode Center the detent brake actuator t...

Page 214: ...Transducer Controls Control Description Medial lateral control Anterior posterior control Detent brake actuator Transesophageal Transducers Using the X7 2t TEE Transducer 214 EPIQ 7 User Manual 4535 617 25341 ...

Page 215: ...ntation Because the center of the image array is the pivot point you can achieve a 360 degree view To rotate the X7 2t transducer image plane do either of the following To rotate the imaging plane toward the 180 degree position press the image plane rotation button that is distal to the system To rotate the imaging plane toward the 0 degree position press the button that is proximal to the system ...

Page 216: ... the handle of the transducer Another control on the handle sets the deflection of the tip This transducer is capable of color flow imaging steerable CW and PW Doppler and frequency agility Tip surface temperature is constantly monitored for patient safety Specifications Tip 10 9 mm x 8 3 mm 27 mm long 0 43 in x 0 33 in 1 1 in long Shaft 7 5 mm diameter 70 cm long 0 3 in diameter 27 5 in long Tran...

Page 217: ...f the TEE transducer before using it in an exam For more information on transducer controls see S7 3t TEE Controls on page 218 S7 3t TEE Transducer Parts 1 Distal tip 2 Flexible shaft 3 Transducer connector Using the S7 3t TEE Transducer Transesophageal Transducers EPIQ 7 User Manual 4535 617 25341 217 ...

Page 218: ... can be rotated continuously from 0 degrees transversal plane through 90 degrees longitudinal plane to 180 degrees transversal plane left right inverted WARNING Verify that the maximum deflection of the tip is 120 degrees up and 90 degrees down If the up down deflection shows an unwanted amount of free play or exceeds the maximal deflection angles do not use the transducer Contact Philips to readj...

Page 219: ...icator 2 Array control 3 Deflection control 4 Deflection lock 5 Neutral position indicators no deflection Unlocked freewheeling white Locked red Using the S7 3t TEE Transducer Transesophageal Transducers EPIQ 7 User Manual 4535 617 25341 219 ...

Page 220: ...turn the smaller knob clockwise To deflect the tip toward the anterior turn the smaller knob counterclockwise To set the tip in the neutral position no deflection turn the smaller knob so that its white bar is in line with the center of the proximal end of the transducer handle 3 Once the tip is positioned properly lock the deflection control knob by sliding the deflection lock so that the indicat...

Page 221: ...r allows you to select all planes between 0 degrees and 180 degrees you can scan a conical imaging volume An icon shows the current degree of rotation Depending on image orientation the icon appears in the upper or lower part of the display S7 3t Array Rotation Short axis Angle 0 Long axis Angle 90 Short axis Angle 180 Using the S7 3t TEE Transducer Transesophageal Transducers EPIQ 7 User Manual 4...

Page 222: ...bar on the side of the array control with the center of the proximal end of the transducer handle 3 To rotate the array to a specific setting align a setting on the top of the array control with the center of the proximal end of the transducer handle Rotating the S7 3t Imaging Array 1 Array control 2 Align settings on the control with the proximal end of the transducer handle 90 setting as shown T...

Page 223: ... in every possible direction both to ensure that the controls work properly and to get used to the feel of the TEE transducer Make sure that the controls operate smoothly without binding and that you can achieve all possible positions easily before introducing the TEE transducer into the patient Test the detent brakes and freewheeling mode Remember that the controls must be in freewheeling mode no...

Page 224: ...nsidering TEE for a particular patient Patient Selection for TEE Transducer Use Although the TEE transducers can provide clinical data not available from other instruments you should consider which patients can safely use the TEE transducers WARNING The ability of a patient to swallow or accommodate the transducer should be considered WARNING You must consider any history of gastroesophageal disea...

Page 225: ... sure that a recent ECG CBC and SMA6 are available as a baselines TEE Study Guidelines During a TEE study an assistant can provide oral and pharyngeal suctioning of the patient and can monitor the patient s blood pressure and general responses For unexpected occurrences an emergency cart with basic life support equipment should be ready Throughout the study it is important to carefully monitor the...

Page 226: ...ceful insertion manipulation or withdrawal of a transducer can result in lacerations bleeding perforation tearing of adhesions and ligament damage Also be aware that the tip can fold over causing similar damage Refrain from handling the distal tip whenever possible If you must handle the distal tip grasp it on the sides Do not touch the top or bottom Support the transducer s proximal head either b...

Page 227: ...rtion Technique You may find transducer insertion easier if you guide the transducer into the patient s mouth with your fingers You also may want to lock medial lateral tip movement WARNING All patients should wear a bite guard during a TEE exam A bite guard protects against dangerous transducer mechanical and electrical malfunction caused by involuntary biting Even anesthetized patients require b...

Page 228: ...mperature is 37 C 98 6 F You must manually enter the actual patient temperature if it is above 37 C 98 6 F The Auto Cool feature provides warning messages at two points At 41 0 C 105 8 F the TEE Auto Cool Imminent message appears At 42 5 C 108 5 F the TEE Auto Cool In Progress message appears and the system automatically stops scanning WARNING If the patient temperature is above 37 C 98 6 F and th...

Page 229: ...s When the temperature display is enabled you can see both the patient temperature and the distal tip temperature while scanning NOTE The patient temperature shown on the ultrasound display is always either 37 C 98 6 F or the temperature that you manually enter The system does not monitor or report the actual patient temperature If the distal tip temperature reaches 41 C 105 8 F a warning message ...

Page 230: ... of the display when enabled On the display the patient temperature is labeled PAT T and the transducer temperature is labeled TEE T A less than sign after TEE T indicates that the transducer s distal tip temperature is below the patient temperature PAT T assumed by the system which is either 37 C 98 6 F or the temperature you entered NOTE If you want the temperature display enabled by default tur...

Page 231: ...sophagus by direct measurement or by monitoring the temperature of blood returning from the bypass pump heat exchanger For closed chest situations rectal temperature is the best estimate of core temperature You can also use oral temperatures even though they can be one degree lower than the core temperature If you measure an auxiliary temperature which can be two degrees lower than the core temper...

Page 232: ...or in the receptacle and move the locking lever to the locked position 3 Select the transducer and preset 4 If the system does not resume imaging after the transducer has initialized shut down the system and then restart it Patient Care After a TEE Study Follow your institutional guidelines for post TEE studies Additionally you might want to include the following recommendations in your guidelines...

Page 233: ...ntract Use bite guards to help prevent such accidents All patients must wear a bite guard during a TEE study A bite guard prevents dangerous transducer mechanical and electrical malfunctions caused by involuntary biting Even anesthetized patients require bite guards to prevent damage to their teeth and to the transducer Philips supplies disposable bite guards that are suitable for both awake and a...

Page 234: ...rmed regularly to determine if there is a hole in a transducer s outer insulating layer This procedure detects liquid pathways to the interior parts of the transducer shaft and tip by measuring third wire leakage current This procedure can be performed with any commercially available safety analyzer that is designed for hospital use WARNING Only a technically qualified person should perform the le...

Page 235: ...ucer and a test electrode placed in the bucket of saline solution about 850 kΩ with an intact outer insulating layer 500 Ω with a hole in the layer A Microammeter to measure third wire current either directly from the chassis or through Z to the test electrode e Line power source either 110 Vac or 220 Vac I Current caused by e and stray capacitance and optionally Z TEE Leakage Current Test Transes...

Page 236: ...e generally presents an impedance of about 500 Ω so Z will vary between 850 kΩ and 500 Ω depending on whether or not there is a conductive pathway caused by a hole in the transducer s insulating layer CAUTION Do not make a DC measurement of impedance This could set up a voltaic cell with the metal of the transducer and a test electrode in the salt bath forming the two electrodes and an electrolyte...

Page 237: ...y analyzer to the Case Leakage Ground Conductor position Press the Lift Ground switch S1 on the safety analyzer and record the chassis leakage current 10 Set the Mode switch S3 on the safety analyzer to the ECG position Press the Lift Ground switch S1 on the safety analyzer and record the patient leakage current The transducer fails the test if the patient leakage current recorded in step 10 is gr...

Page 238: ...al Echocardiography Its Role in Solving Clinical Problems Journal of the American College of Cardiology 975 979 1986 Radwin Martin et al Transesophageal Echocardiography Intubation Techniques Philips Application Note 5091 2804E 1992 Urbanowitz John H et al Transesophageal Echocardiography and Its Potential for Esophageal Damage Anesthesiology Vol 72 No 1 1990 Transesophageal Transducers TEE Transd...

Page 239: ...cognizing and interpreting imaging patterns Thorough familiarity with the safe operation care and maintenance of the system and endocavity transducers Thorough familiarity with the latest endocavity methods through literature and seminars Patient Safety During Endocavity Studies To operate an endocavity transducer you must be under the guidance of a physician who is properly trained in endocavity ...

Page 240: ...ear the patient or the transducer may have been contaminated 3 Insert the transducer into the transducer cover and unfurl the transducer cover until it covers the transducer and its cable The cover must be unfurled far enough to maintain the sterile field 4 Use a sterile elastic band or clip to hold the proximal end of the transducer cover in place 5 Ensure that wrinkles and bubbles over the face ...

Page 241: ...t Enables high resolution and contrast for gynecological obstetrical urological and fetal echo procedures Frequency Operating range 3 to 10 MHz Biopsy capable Yes Specifications Length transducer cable and connector 2 5 m 8 17 ft Length handle to tip 30 cm 12 in Radius of curvature 11 5 mm 0 45 in C10 4ec Description The C10 4ec transducer is described here For more information on connecting activ...

Page 242: ... 4 in Patient Contact Parts Latex and talc are commonly used in transducer covers marketed to help with infection control in transesophageal endocavity and intraoperative imaging applications and during biopsies Examine the packaging to confirm latex and talc content Studies have shown that patients can experience allergic reactions with natural rubber latex See the FDA Medical Alert on Latex on p...

Page 243: ...ure see the Biopsy Guides section NOTE CIVCO Medical Solutions supplies biopsy kits for Philips transducers that are biopsy capable For information on proper attachment of a biopsy bracket consult the manufacturer s instructions Biopsy with Endocavity Transducers Endocavity Transducers EPIQ 7 User Manual 4535 617 25341 243 ...

Page 244: ...Endocavity Transducers Biopsy with Endocavity Transducers 244 EPIQ 7 User Manual 4535 617 25341 ...

Page 245: ...0 mm and L18 5 transducers have infinite angle capability and can be installed on either side of the transducer they do not constrain the biopsy needle to a particular path Because the needle path is unpredictable the Biopsy control is unavailable and the biopsy graphics do not appear on the display when you are using these transducers A biopsy with these transducers is a manual action The C5 1 an...

Page 246: ...G Some biopsy guides must be installed over a sterile transducer cover WARNING After each use biopsy guides must be either sterilized or disposed of depending upon the type See the instructions included with the biopsy guide WARNING Most transducers can only be disinfected they cannot be sterilized Only the transducer cover provides the sterile barrier Biopsy Guideline Display WARNING Do not attem...

Page 247: ...tation is defined by the location of the orientation marker When depth is changed the biopsy display redraws to reflect the new relationships at the new depth setting Displaying the Biopsy Guideline WARNING When using a transducer with an infinite angle biopsy guide do not display a fixed angle biopsy guideline The biopsy guideline can have a single fixed path or multiple paths The system determin...

Page 248: ...h cursor appears at the bottom of the imaging screen Rotate the trackball to move the depth cursor along the guideline The Bx measurement value changes to reflect the distance between the biopsy guide reference point origin and the depth cursor Biopsy Depth Biopsy Guides Moving the Biopsy Depth Cursor 248 EPIQ 7 User Manual 4535 617 25341 ...

Page 249: ... needle for each biopsy procedure WARNING To assist in an accurate projection of the needle use a straight new needle for each alignment procedure Preparation for Alignment Verification Assemble the following items before performing the alignment verification Transducer Biopsy guide or bracket The bracket is not disposable The type of bracket you use depends upon the transducer you are using For t...

Page 250: ...h the biopsy guide Although some transducers require the use of a second transducer cover for biopsy procedures a second transducer cover is unnecessary for this alignment verification 2 Connect the transducer to the system and select the appropriate applications and preset 3 Set the system depth for the procedure to be performed 4 Display the biopsy guideline 5 Without changing the position of th...

Page 251: ...video display 10 Verify that the needle as seen on the video display falls along the guideline along the entire depth of the guideline display The biopsy guideline is intended only to provide an indication of the expected path of the needle Actual position must be verified by identifying the echoes from the needle 11 Remove the needle from the biopsy guide 12 From the tip of the needle measure a d...

Page 252: ... is properly aligned Performing a Biopsy Procedure WARNING Before the biopsy procedure perform alignment verification at the selected depth to ensure that the biopsy guide and the needle have been installed properly WARNING Use a straight new sterile needle for each procedure WARNING Do not perform the biopsy guide procedure if the needle is not visible WARNING The biopsy guideline is intended onl...

Page 253: ...biopsy guide according to the instructions provided with the biopsy guide 2 Select a new straight needle that matches the needle gauge size on the biopsy guide clip you are using if applicable and select the guide channel on the biopsy guide 3 Set the system imaging controls for the biopsy procedure 4 Touch a preset 5 Touch the 2D tab 6 Touch Biopsy 7 Orient the transducer to match image presentat...

Page 254: ...ed in the patient Separate the needle from the biopsy guide by pulling the tab up so that the clip snaps out of the needle guide allowing the clip still attached to the needle and needle to separate from the biopsy guide still attached to the transducer 13 Remove the biopsy guide after use Biopsy Guide Maintenance WARNING The biopsy procedure kit components are disposable and must not be reused Fo...

Page 255: ...ectants listed in this manual are recommended because of their chemical compatibility with product materials not their biological effectiveness For the biological effectiveness of a disinfectant see the guidelines and recommendations of the disinfectant manufacturer the U S Food and Drug Administration and the U S Centers for Disease Control WARNING The level of disinfection required for a device ...

Page 256: ...dering transducer covers contact CIVCO Medical Solutions see Supplies and Accessories on page 21 Latex Product Alert Philips ultrasound systems and transducers do not contain natural rubber latex that contacts humans Natural rubber latex is not used on any ultrasound transducer including transthoracic intraoperative and transesophageal echocardiography TEE transducers It also is not used on Philip...

Page 257: ...ing the Correct Transducer Care Method To choose an appropriate care method for your transducer you first must determine the transducer s classification based on its use Care Methods by Transducer Type Transducer Use Example Classification Care Method Contacts intact skin Curved linear xMatrix and sector transducers Noncritical Low level disinfection see Transducer Cable and Connector Cleaning on ...

Page 258: ... and disinfecting any equipment WARNING If a premixed solution is used be sure to observe the solution expiration date WARNING Transducers must be cleaned after each use Cleaning the transducer is an essential step before effective disinfection or sterilization Be sure to follow the manufacturer s instructions when using disinfectants CAUTION Attempting to disinfect a cable or connector by using a...

Page 259: ...he transducer CAUTION Do not allow any type of fluid to enter the connector Ensure that fluid does not enter through the strain relief through the connector through the electrical contacts or through the areas surrounding the locking lever shaft and the strain relief Fluid in the connector may void the device warranty CAUTION You can use an alcohol solution for disinfection on the connector only E...

Page 260: ...a minimum IPX7 in accordance with IEC529 This rating indicates that the device is protected against the effects of immersion Continuous wave nonimaging transducers are rated IPX1 This rating indicates that the device is protected against the effects of vertically falling water For all TEE transducers the control module is rated IPX1 while the endoscope is rated IPX7 in accordance with IEC529 Befor...

Page 261: ...the lens use a soft cloth and a blotting motion instead of a wiping motion NOTE If you use cleaning wipes it may be unnecessary to rinse the transducer with water Always follow the product label recommendations Cleaning and Disinfecting Cables and Connectors Before cleaning the cables and connectors read the warnings and cautions in Transducer Cable and Connector Cleaning on page 258 and Transduce...

Page 262: ...ns for wipe durations solution strengths and duration of disinfectant contact with the cable Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device Ensure that the disinfectant solution does not enter the device or the connector or come into contact with the connector label 7 Air dry or towel dry with a sterile cloth according to the i...

Page 263: ...immersion method or a wipe method with a disinfectant recommended by Philips Ultrasound Use the method that is biologically appropriate as described in Choosing the Correct Transducer Care Method on page 257 WARNING Always use protective eyewear and gloves when cleaning and disinfecting any equipment Transducer Disinfection Transducer Care EPIQ 7 User Manual 4535 617 25341 263 ...

Page 264: ...E transducers except for the handle Disinfecting Transducers Using a Wipe or Spray Method This topic provides instructions on using the wipe or spray method CAUTION The use of 70 isopropyl alcohol rubbing alcohol on transducers is restricted Wipe only the distal tip of the transducer up to 2 5 cm 1 in from the strain relief housing joint with an isopropyl alcohol solution Do not use isopropyl alco...

Page 265: ...rain relief housing joint 6 You can use alcohol in this area of non TEE transducers 7 Do not use alcohol in this area 1 Clean the transducer and cable according to the procedures in Transducer Cable and Connector Cleaning on page 258 2 After cleaning wipe or spray the transducer and cable with a low level disinfectant Allow for the manufacturer s recommended contact time For a list of compatible d...

Page 266: ...n on page 270 or Disinfecting TEE Transducers with an AER on page 273 WARNING If a premixed disinfectant is used be sure to observe the expiration date NOTE All imaging transducers are rated at a minimum IPX7 in accordance with IEC529 This rating indicates that the device is protected against the effects of immersion Continuous wave nonimaging transducers are rated IPX1 This rating indicates that ...

Page 267: ...ary staining of the mouth and lip area and irritation or chemical burns of the mouth throat esophagus and stomach To minimize the effects from residual OPA or any other disinfectant Philips recommends the following WARNING Follow the disinfectant manufacturer s instructions very carefully For example the manufacturer of Cidex OPA recommends soaking transducers three times in fresh water WARNING Us...

Page 268: ...ansducer Cable and Connector Cleaning on page 258 2 Mix the disinfection solution compatible with your transducer see Disinfectants and Cleaning Solutions Compatibility Table on page 278 according to label instructions for solution strength 3 Immerse the transducer into the appropriate disinfectant for your transducer as shown in the illustration Follow the instructions on the disinfectant label f...

Page 269: ...cautions when disinfecting TEE transducers CAUTION Never sterilize the transducer with autoclave gamma radiation gas steam or heat sterilization techniques Severe damage will result Avoidable transducer damage is not covered by the warranty or service contract CAUTION Do not bend the shaft into a circle with a diameter of less than 0 30 m 1 ft CAUTION Do not use bleach on the transducer and shaft ...

Page 270: ...er steering mechanism is unsealed If disinfectant or other fluid enters the steering mechanism it corrodes the gears and electrical connections Avoidable transducer damage is not covered by the warranty or service contract Disinfecting TEE Transducers by Immersion Before performing this procedure read the cautions and warnings in Transducer Disinfection by Immersion on page 266 Transducer Care Saf...

Page 271: ...3 Use water to rinse the distal tip and flexible shaft thoroughly 4 Immerse the distal tip and flexible shaft into the appropriate disinfectant as shown in the illustration 5 Remove the tip and shaft from the disinfectant and thoroughly rinse with water according to the instructions from the disinfectant manufacturer 6 Check the transducer for any residual organic material If any is present remove...

Page 272: ...section only up to 5 1 cm 2 in from the handle s strain relief 2 Maximum allowable immersion depth you are not required to immerse to this depth if it is unnecessary Transducer Care Transducer Disinfection 272 EPIQ 7 User Manual 4535 617 25341 ...

Page 273: ... wpd Methods for disinfecting transesophageal TEE and non TEE transducers differ For non TEE transducers see Disinfecting Non TEE Transducers by Immersion on page 268 1 Disconnect the transducer from the system 2 Follow the manufacturers instructions for disinfection Transducer Sterilization Sterilization is required if the transducer enters otherwise sterile tissue without a sterile cover If you ...

Page 274: ...UTION Use only liquid solutions to sterilize transducers Using autoclave gas EtO or other methods not approved by Philips will damage your transducer and void your warranty CAUTION Do not allow sharp objects such as scalpels and cauterizing knives to touch transducers or cables CAUTION When handling a transducer do not bump the transducer on hard surfaces CAUTION Ensure the solution strength and d...

Page 275: ...erse the transducer in the sterilization solution as shown in the illustration 4 Follow the instructions on the sterilization label for the duration of transducer immersion required for sterilization 5 Remove the transducer from the sterilization solution after the recommended sterilization time has elapsed 6 Using the instructions on the sterilization label rinse the transducer in sterile water u...

Page 276: ...sterilization procedures It discusses recommended disinfectants and choosing an appropriate disinfectant for the required level of disinfection You must check Disinfectants and Cleaning Solutions Compatibility Table on page 278 for the chemical compatibility of disinfectants and cleaners with specific transducers In addition the table indicates if a device can be sprayed or wiped only or if it can...

Page 277: ...inistration and the U S Centers for Disease Control WARNING If a premixed solution is used be sure to observe the solution expiration date WARNING Always use protective eyewear and gloves when cleaning and disinfecting any equipment CAUTION Using a non recommended disinfection solution using an incorrect solution strength or immersing a transducer deeper or longer than recommended can damage the d...

Page 278: ...n disinfection for information that can help you choose an appropriate disinfectant for the required level of disinfection and for transducer specific instructions Factors Affecting Disinfectant Efficiency The following factors will affect the efficiency of a disinfectant solution Number and location of microorganisms Innate resistance of microorganisms Concentration and potency of disinfectants P...

Page 279: ...loride solution where x can be any organic functional group such as ethyl and methyl and so on concentration at use should be less than 0 5 total for all QUATs listed Accelerated hydrogen peroxide based except on Doppler transducers D2cwc D2tcd and D5cwc Activated hydrogen peroxide based except on Doppler transducers D2cwc D2tcd and D5cwc Alcohol or alcohol plus QUAT based product alcohol content ...

Page 280: ...Isopropyl Alcohol All Spray Wipe Alcohol T T T T H T T T H AbcoCide US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T AbcoCide 28 US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Accel Wipes CA Wipe Hydrogen Peroxide T C N T C T C N T C T C T C T C H Aidal AU Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Aidal Plus AU Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Alkaspray FR Sp...

Page 281: ...T C T Cidex PAE 14J FR Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Cidex Plus US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Cleanisept Wipes DE Spray Wipe Quat Ammonia T C T C T C T C T C H T C T C T C T C H Descoton Extra DE Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Dispatch US Spray Wipe Sodium Hypochlorite T C T C T C T C C T C T C T C C Endo FC FR Soak1 Glutaraldehyde T...

Page 282: ... C T T C T C T C T Korsolex Extra FR Soak1 Aldehydes Quaternary Ammonium T C N T C T C T T C T C T C T Korsolex PAE FR Soak1 Glutaraldehyde T C N T C T C T T C T C T C T MaxiCide Plus US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T MedDis UK Soak1 Quat Ammonia Sulfamic Acid T C N T C T C T T C T C T C T Medistel UK Soak1 Quat Ammonia Sulfamic Acid T C N T C T C T T C T C T C T MetriCide US S...

Page 283: ...T T C T C T C T Omnicide 28 US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Opti Cide 3 US Spray Wipe Alcohol Quat Ammonia T T T T H T T T H Oxivir US Wipe Hydrogen Peroxide T C N T C T C N T C T C T C T C H Peracetic Acid OCS UK Soak1 Peracetic Acid T C N T C T C N T C T C T C T PeraSafe Powder UK Soak1 Peracetic Acid T C N T C T C T T C T C T C T Perastel formerly Perascope UK Soak1 Perace...

Page 284: ... C T C T T C T C T C T PSS Select 28 Day US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T PSS Select Plus US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Quaternary Ammonium All Spray Wipe Quat Ammonia T C T C T C T C C T C T C T C C Rapicide US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Resert XL HLD US Soak Hydrogen Peroxide T C N T C T C N T C T C T C N Rivascop FR Spray Wipe...

Page 285: ...acetic Acid T C N T C T C T T C T C T C T Sekusept Plus DE Soak1 Glucoprotamin T C N T C N T T C N T C T Steranios 2 FR Soak1 Glutaraldehyde T C N T C T C T T C T C T C T TD 5 US TD 100 Reproces sor Glutaraldehyde N N N N T N N N T T Spray US Spray Wipe Quat Ammonia T C T C T C T C T C H T C T C T C T C H T Spray II US Spray Wipe Quat Ammonia T C T C T C T C T C H T C T C T C T C H Tristel Duo UK ...

Page 286: ...ray Wipe Alcohol Biguanide T T T T H T T T H Vespore US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Virox 5 RTU CA Wipe Hydrogen Peroxide T C N T C T C T C H T C T C T C T C H Wavicide 01 US Soak1 Glutaraldehyde T C N T C T C T T C T C T C T Wip Anios FR Wipe Alohol Quat Ammonia T T T T H T T T H Transducer Care Disinfectants Compatibility 286 EPIQ 7 User Manual 4535 617 25341 ...

Page 287: ...rocedures vary for the different types of transducers and their uses For detailed instructions on how to clean and maintain each type of transducer used with the system including disinfectant compatibility see the Transducer Care section Cleaning the System and ECG Equipment Use this method to clean the system and the ECG cables leads and electrodes You can use a mild soap solution If the equipmen...

Page 288: ...ood or other infectious material comes in contact with the system or any cable other than a transducer cable wipe with a 70 solution of isopropyl alcohol CAUTION If blood or other infectious material comes in contact with a transducer or transducer cable do not wipe with isopropyl alcohol until you have read the Transducer Care section for specific cleaning guidelines Isopropyl alcohol should not ...

Page 289: ... residue with a cloth moistened with sterile water 7 Be sure to dry the equipment to prevent potential corrosion Disinfectants for System Surfaces The exterior surfaces of the system can be disinfected using a compatible disinfectant with a wipe method System surfaces include the monitor screen the touch screens and plastic and painted surfaces The following products can be used on system surfaces...

Page 290: ...an exterior surfaces on the system 3 Mix the disinfection solution compatible with your system according to label instructions for solution strength CAUTION Do not spray disinfectant directly on system surfaces When wiping do not allow disinfectant to pool or run on system surfaces In either case disinfectant may leak into the system damaging the system and voiding the warranty Wipe only with a cl...

Page 291: ...G Equipment on page 287 Cleaning the Trackball Cleaning the trackball regularly prolongs its useful life and prevents service calls 1 With your fingers unscrew the ring around the trackball 2 Lift the trackball out of the mounting area 3 Clean the trackball and the mounting area with a lint free cloth or a small brush 4 Place the ball back on the mounting area 5 With your fingers screw the ring ba...

Page 292: ... of the system 2 Pull the air filter handle straight out until the filter is completely removed from the system 3 Inspect the filter Depending on the condition of the air filter vacuum or rinse the filter with water to clean it If the filter is worn out or cannot be cleaned replace it with a spare 4 To reinstall the filter slide the filter into place at the bottom of the left side of the system Sy...

Page 293: ...under Filter Cleaning type the number of days in Interval 5 To reset the interval after cleaning the filter under Filter Cleaned click Done 6 To exit SupportConnect touch Close Transducer Maintenance Transducers require proper care cleaning and handling Reasonable care includes inspection cleaning and disinfection or sterilization as necessary Cleaning and Maintaining the System System Maintenance...

Page 294: ...or the Transducer Care section You can also contact your local Philips representative For contact information see Customer Service on page 22 If you encounter poor image quality or transducer problems see Troubleshooting on page 295 Printer and DVD Recorder Maintenance Before performing any maintenance on a device observe the following warnings and cautions WARNING If the device is internal to the...

Page 295: ...tions to take to correct the problems Troubleshooting Symptoms Corrective Action The system does not power up The monitor indicator light is off 1 Verify the power connections 2 Check the circuit breaker on the back of the system No image displays on the monitor 1 After power up the system takes about 20 seconds to initialize During this time the monitor is blank 2 After 20 seconds adjust the moni...

Page 296: ...t patterns on the system were adapted for the 1024 x 768 pixel image area of the 54 6 cm 21 5 in system monitor For information on using these test patterns read IEC publication 61223 3 6 62B 588 CD Transferring the Test Patterns The test patterns are stored on a separate part of the system hard drive You must transfer the test patterns to a different part of the hard drive before you can view the...

Page 297: ...you suspect problems with the system If an error message is displayed during the test restart the system with the On Off control NOTE The system test can take several minutes to run 1 Turn on the system 2 Disconnect all transducers from the system 3 Press Support 4 In Philips SupportConnect click the Test Utilities tab 5 Under Navigator click System Test 6 In the System Test area click Run The sys...

Page 298: ...System Maintenance For Assistance 298 EPIQ 7 User Manual 4535 617 25341 ...

Page 299: ...t with monitor folded down 125 7 cm 49 5 in Depth Maximum extension 111 8 cm 44 in Depth Minimum extension 79 4 cm 31 25 in Weight 102 kg 225 lb Gray Shades 255 in 2D M mode and Doppler Scan Lines Up to 1 024 scan lines depending on transducer and mode Monitor 54 6 cm 21 5 in flat panel monitor on a tilt swivel arm 128 hues of color available 24 bit color Input Signals Four transducer receptacles ...

Page 300: ...Philips products are available at this website www healthcare philips com us about connectivity dicom_conformance_main wpd Physio ECG amplitude range between 0 15 mV and 5 0 mV Duration of the QRS wave between 40 ms and 120 ms Lower Frequency Cut off 0 70 Hz 10 Upper Frequency Cut off 17 Hz 10 Nominal Input Amplitude 5 mV peak Minimum QRS Wave Amplitude 0 05 mV Peripherals Black and white image pr...

Page 301: ...sh French Norwegian Localized documentation other than Help Bulgarian Greek Norwegian Chinese Traditional and Simplified Hungarian Polish Czech Indonesian Portuguese Brazilian Danish Italian Romanian Dutch Japanese Russian Estonian Kazakh Slovak Finnish Korean Spanish French Latvian Swedish German Lithuanian Turkish Pressure Limits Operating 525 mmHg to 795 mmHg 700 hPa to 1 060 hPa Storage 427 mm...

Page 302: ...inary Equipment Continuous Operation Non AP APG Electromechanical Safety Standards Met The system complies with the requirements of IEC 60601 1 Medical Electrical Equipment General Requirements for Safety including all applicable collateral and particular standards as well as all applicable national deviations Compliance Philips products comply with relevant international and national standards an...

Page 303: ... education program 50 example 50 related guidance documents 60 Alcohol restricted use on transducers 264 Allergic reactions to latex 49 Analysis 167 Analysis applications 86 Applications analysis 86 clinical 86 Applications clinical 86 152 Artifacts 179 181 Assistance 22 297 Audience intended 15 Audio troubleshooting 295 Auto Freeze function 140 Auto Cool 228 229 231 B Battery indicators 132 Batte...

Page 304: ...system 83 Capillary rupture 46 Capturing images 165 loops 165 Cautions described 27 CD loading and ejecting 144 CD User Information 17 Changing setups 151 CIVCO Medical Solutions 21 Cleaning air filter 291 cables 258 control panel 291 ECG equipment 287 printers 294 system surfaces 287 system cables and connectors 287 trackball 291 transducers 258 Cleaning solutions 277 278 Clinical applications 86...

Page 305: ...ball 126 X7 2t transducer 211 213 Controls affecting MI and TI direct controls 50 indirect controls 50 receiver controls 50 Conventions product 18 system 18 user information 19 Covers TEE transducer 233 transducer 46 101 183 255 Creutzfeldt Jakob disease 257 Custom procedure creating 152 selecting 153 Customer comments 21 Customer service 22 Customizing the system 147 D Data connections specificat...

Page 306: ...immersion 266 with wipes and sprays 264 Display dimming 119 Display avoiding damage 36 Disposable drape 192 234 Disposal of system 22 Distance measurements M mode 169 performing 168 Doppler measuring velocity 169 velocity on live image 169 Doppler velocity minus sign 151 DVD erase 144 image acquisition and review 84 loading and ejecting 144 media compatibility 143 using 144 DVD drive 93 143 DVD dr...

Page 307: ...o transmitters 79 types 77 Electromagnetism 32 Electrostatic discharge ESD 70 Electrosurgical units ESUs 32 Emergency studies about 138 starting 139 Endocavity studies 239 Endocavity transducers biopsy guides 243 C10 3v 241 C10 4ec 241 operator qualifications 239 overview 239 patient safety 239 patient contact parts 242 preparing for imaging 240 transducer covers 240 Equipment protection 36 Erase ...

Page 308: ... Help 18 Hiding Doppler minus sign 151 Hiding Doppler signs 151 Hiding patient name ID 157 High level disinfection 263 HIPAA 84 Humidity limits 299 I Icons battery indicators 132 imaging display 135 status icons 129 trackball 126 IEC symbols 38 Image review 164 Image title adding 161 Image updating inconsistent 46 Images acquiring 84 165 capturing 165 false needle 252 troubleshooting the display o...

Page 309: ...s 187 patient safety 188 patient contact parts 189 204 preparing for imaging 191 transducer covers 191 iSCAN status 129 Isolation transformers 31 101 Isopropyl alcohol restrictions 264 K Keyboard retractable 128 touch screen 128 L L15 7io transducer 190 Labeled measurements 169 Labels adding 159 161 image title 161 Languages 299 Latex allergic reactions 49 bite guards 46 in Philips products 256 pa...

Page 310: ...abeled obtaining 169 live Doppler velocity 169 M mode 169 QLAB software 86 tools 83 types 83 unlabeled 170 Measure then label method 170 Mechanical index MI 54 controls affecting 58 display 54 display precision and accuracy 54 on screen 54 Mechanical safety 34 Media compatibility 143 Medical Ultrasound Safety 18 Messages error 46 296 MI 54 MI and TI accuracy estimates 54 Microphone status 129 M mo...

Page 311: ...temperature 36 299 Operator safety 65 Options connectivity 85 imaging 85 system 84 152 Ordering supplies and accessories 21 Output display 54 Output signals 299 Output tables acoustic 18 54 63 Overview system 83 P Pacemakers 30 Passing system to others 22 Password protection 88 Passwords 133 Patient contact temperature 173 Patient data creating a custom procedure 152 entering 156 hiding name and I...

Page 312: ...ing 150 overview 147 Quick Save 148 selecting 143 setting default 148 174 Pressure limits 299 Preventricular contractions 46 Printers adding 104 configuring 104 maintaining 294 supported models 102 types 163 Printing about 163 live images 163 status 130 Problems correcting 295 Procedure setup 152 Product compatibility 37 Product conventions 18 Protection against system damage 36 Protocols Stress E...

Page 313: ...manipulating the tip 220 using 217 Safety 27 acoustic output and measurement 60 ALARA principle 50 basic 27 biological 46 biopsy 46 245 defibrillators 33 electrical 29 electromagnetic emissions and immunity 68 electrosurgical units 32 endocavity studies 239 endocavity transducers 239 equipment protection 36 fire 34 general warnings 16 guidance documents 60 intraoperative studies 188 mechanical 34 ...

Page 314: ...dimensions 299 electrical parameters 299 gray shades 299 humidity limits 299 input signals 299 languages 299 modality interface 299 monitor 299 output signals 299 peripherals 299 physio 300 pressure limits 299 safety requirements 302 scan lines 299 temperature limits 299 Spongiform encephalopathy 257 Starter kits ordering biopsy 245 Static shock 70 Status icons 129 Steering locks system wheels 99 ...

Page 315: ... about 199 accessories 233 Auto Cool 229 231 avoiding problems 204 bite guards 233 controls 207 213 215 220 221 222 controls inspection 223 correcting tip fold over 227 covers 233 disinfecting by immersion 270 disinfecting in automated disinfector 273 disposable drape 192 234 electrical safety 205 electrical safety test 234 237 ensuring safe temperatures 229 entering patient temperature 231 inspec...

Page 316: ...ols affecting 58 display precision and accuracy 54 displays 54 modes of operation 54 on screen 54 using appropriate for application 54 Thumbnail view 165 TI 54 TI and MI values 58 Time and date setting 114 Tip fold over 226 correcting 227 recognizing 226 Tip protector TEE transducer 234 Tools measurement 83 unlabeled 170 Touch screen 122 controls 124 layout 123 Trackball annotation 159 controls 18...

Page 317: ...lizing 255 273 storage daily and long term 186 storage for transport 185 storing 185 transesophageal 199 using 173 Transesophageal transducers 199 Transferring the system to other users 22 Transformers isolation 31 101 Transmissible spongiform encephalopathy 257 Transporting the system safety precautions 106 setting up after 112 Troubleshooting 295 Turning the system on and off 113 U U S Health In...

Page 318: ...s described 27 general 16 27 Waste Electrical and Electronic Equipment European Union Directive 22 Website Philips 22 WEEE recycling information 22 Wheel brakes 34 99 Wheels 34 106 Worklist searching for exams 157 selecting patient 156 X X7 2t transducer controls 211 213 description 209 manipulating tip 213 parts 210 rotating image plane 215 xMatrix array transducers 177 178 209 210 Index 318 EPIQ...

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