EUB-7500 Series Instruction Manual

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MainConcept Motion-JPEG Codec © 1999/2000-2003 MainConcept AG. All rights reserved.

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Other product and company names mentioned in this document may be the trademarks of their respective owners.

Abbreviations •

In this document, the Windows® XP operating system is called Windows XP.

EC - CONFORMITY DECLARATION Manufacturer Hitachi Medical Corporation

4-14-1, Soto-Kanda, Chiyoda-Ku, Tokyo, 101-0021, Japan

European Representative Hitachi Medical Systems GmbH Kreuzberger Ring 66 D-65205 Wiesbaden, Germany

Medical Device Modality: Diagnostic Ultrasound System UMDNS Code: 14-278 MDD Classification: IIa Model Name: Ultrasound Diagnostic Scanner Model Type: EUB-7500 The undersigned hereby declares that the medical device as specified above and related options comply with the essential requirements of Annex I of the EC-Directive 93/42 EEC. The declaration of conformity is based on an assessment procedure in compliance with the EC Directive 93/42 EEC, Annex II for a

Full Quality Assurance System Notified Body :

TÜV Rheinland LGA Products GmbH Tillystraße 2, 90431 Nürnberg Germany

CE Ident No. :

0197

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EC - CONFORMITY DECLARATION Manufacturer Hitachi Medical Corporation

4-14-1, Soto-Kanda, Chiyoda-Ku, Tokyo, 101-0021, Japan

European Representative Hitachi Medical Systems GmbH Kreuzberger Ring 66 D-65205 Wiesbaden, Germany

Medical Device Modality: Diagnostic Ultrasound System UMDNS Code: 14-278 MDD Classification: IIa Model Name: Ultrasound Diagnostic Scanner Model Type: EUB-7500A The undersigned hereby declares that the medical device as specified above and related options comply with the essential requirements of Annex I of the EC-Directive 93/42 EEC. The declaration of conformity is based on an assessment procedure in compliance with the EC Directive 93/42 EEC, Annex II for a

Full Quality Assurance System Notified Body :

TÜV Rheinland LGA Products GmbH Tillystraße 2, 90431 Nürnberg Germany

CE Ident No. :

0197

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Manufacturer

: HITACHI MEDICAL CORPORATION 4-14-1, Soto-Kanda, Chiyoda-Ku, Tokyo, Japan

European Representative : Hitachi Medical Systems GmbH Kreuzberger Ring 66 D-65205 Wiesbaden, Germany Tel. : +49-(0)611-973220 Fax. : +49-(0)611-9732210 Local Distributor :

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CAUTION The EUB-7500/EUB-7500A Ultrasound Scanner and Probes have been designed to comply with the -Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Equipment- . This equipment provides the operator a much greater degree of real-time information than previously available regarding ultrasound exposure to the patient during an exam. To properly monitor and control the Real-Time Acoustic Indices displayed on the EUB-7500/EUB-7500A, before use of this system the operator should read the following sections of the Instruction Manual. Safety Consideration on Operation 7.5 Precautions against ultrasound output power 4.8.2 5.3.12 5.4.11 5.5.15 5.6.8 5.7.7

Acoustic output indices Using ALARA in B-mode Using ALARA in B/M-mode Using ALARA in B/PW-mode Using ALARA in CW-mode Using ALARA in CW-mode

5.8.14 5.8.15

Using ALARA in CFM mode Using ALARA in CFM mode with/M and/PW modes

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To safely and correctly use this equipment and to maintain its performance for a long time, the operator must fully understand safe operation procedure of the equipment, its performance, function and maintenance service. Before using the equipment, carefully read "Precautions in safe operation" and this "Instruction Manual" to fully understand the described contents. NOTICE: The contents of this instruction manual are subject to change without prior notice for improvement of the equipment performance. NOTICE: Some function can not be used, because the probe that can be connected is limited in EUB-7500A.

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Safety Consideration on Operation Observe the following for safe operation of the equipment 1.

Authorized personnel for operation of this equipment This equipment must be used by the authorized personnel such as doctor and sonographer.

2.

Definition of words and symbols 2.1

Types and definition of precautionary notices

Type of precautionary notice

Meaning (Definition)

DANGER

This note indicates any condition or action which, if not strictly observed, could result in direct danger such as serious personal injury or possible death, or serious property damage such as total loss of equipment or fire.

WARNING

This note indicates any condition or action which, if not strictly observed, could result in indirect danger such as possible death, serious personal injury or light or medium-degree personal injury, or serious property damage such as total loss of equipment or fire.

CAUTION

This note indicates any condition or action which, if not strictly observed, could result in possible danger such as partial equipment damage or data loss of computer.

NOTICE

This note indicates important precautions which are not related to danger but are to be taken against operation, installation and maintenance.

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2.2

Type and definition of symbol Protective earth (ground) Equipotentiality Caution Off (Power disconnection from the mains) On (Power connection to the mains) Dangerous voltage Operating instructions Refer to instruction manual/ booklet NOTE On ME EQUIPMENT “Follow instructions for use”

TYPE B APPLIED PART

Probe connector

TYPE BF APPLIED PART

ECG connector

Defibrillator-roof TYPE BF APPLIED PART

Some graphical symbols that are used in labeling of Hitachi Ultrasound Diagnostic Scanner are compliant with EN 980:2008 standard. Refer to the following about the meanings of them. Manufacturer Company Name and Address Authorized Representative in The European Community KEEP AWAY FROM SUNLIGHT KEEP DRY

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3.

User's responsibility on equipment management It is the responsibility of the user (hospital or clinic) to manage use and maintenance of the equipment.

4.

Prohibition of remodeling Do not remodel the equipment without the consent of Hitachi. If the equipment would be remodeled without the consent, the guarantee service will not be applied to the equipment. If any modification is required on the equipment, consult with Hitachi or our authorized dealer.

5.

Liability limitation 5.1

Hitachi shall not be liable for any failure or damage on the equipment cased due to the installation, transfer, modification, maintenance or repair that has been carried out by the party other than Hitachi or our authorized dealer.

5.2

Hitachi shall not be liable for any failure or damage on the equipment caused due to trouble of other maker's equipment.

5.3

Hitachi shall not be liable for any failure or damage on the equipment caused due to modification, maintenance or repair carried out by using repair parts other than the genuine part specified by Hitachi.

5.4

Hitachi shall not be liable for any failure or damage on the equipment caused as the result that precaution or operation procedure described in this instruction manual was not observed by the user.

5.5

Hitachi shall not be liable for any consequential damage or loss caused due to the diagnostic result or data obtained with this equipment by any person other than the personnel authorized to use this equipment.

5.6

Hitachi shall not be liable for any failure or damage on the equipment caused due to use of the equipment in the environmental conditions such as power requirements or siting requirements which are not in compliance with the conditions specified in this instruction manual.

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5.7

6.

Hitachi shall not be liable for any failure or damage on the equipment caused due to force majeure such as fire, earthquake, flood, lightning or acts of God.

Necessity of periodical maintenance service 6.1

From a viewpoint of the purpose and importance of medical equipment, it is essential to maintain safety and reliability of the equipment always in the best condition. Hitachi has been doing our best to assure the persistent product quality of the equipment during manufacturing and installation works so that the equipment can be used by users with the best conditions for safety and reliability of the equipment. However, safety and reliability of the equipment after delivered shall be maintained by the user on his own responsibility.

6.2

Carry on the daily checkup and periodical maintenance service for the equipment according to the procedures described in "Maintenance serve" of this Instruction Manual.

6.3

Maintenance service for the equipment of which warranty period has expired can be carried out by Hitachi or our authorized dealer under maintenance service contract. Contact Hitachi or our authorized dealer for this maintenance service contract.

6.4

When daily checkup and periodical maintenance service were carried out, keep and retain records of executed date, person and serviced contents.

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7.

Precautions in Operation of Ultrasound Scanner System Observe the following to protect safety of the patient and operator. 7.1

Precautions in operation

1. Should any abnormality occur on the equipment, immediately turn off the power switch, disconnect the power cable and contact Hitachi's Service Division or our authorized dealer. 2. Do not operate the power switch with hand contaminated with jelly. If the power switch is contaminated with jelly, immediately wipe it off. 3. Do not use and connect any recording device other than the ones specified by Hitachi. 4. Contents in the memory such as hospital name, set parameters and various measurement data may be erased by expiration of the built-in battery or temporary power failure. Keep and retain records of hospital name, set parameters and various measurement data in the printer or VCR. 5. Carry out the periodical checkup of the dust filter located on the air inlet window of the power supply unit once a week, and clean it if dust is found in it. 6. Clean dirt on the covers and panel of the equipment by using cloth soaked with neutral detergent and wipe it off with dry, soft cloth. Never use organic solvent such as thinner.

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7.2

Precaution on installation environmental conditions

1. This equipment is not CATEGORY AP/APG EQUIPMENT. This equipment is not explosion-proof type. Never use it in the atmosphere where explosive gas, toxic gas, inflammable gas or flammable gas.

1. This equipment is not drip-proof or water-proof type. Never use it at the following place: The equipment is exposed to water or other liquid. Humidity is excessively high. The equipment is exposed to steam. The equipment is exposed to saline air. NOTICE:Probe head ,probe cable and footswitch is dripproof and water-proof type by the IP protection. 2. Be sure to install the equipment on the horizontal floor. If the equipment is placed on the floor inclining more than 10°, it may fall down. Securely lock the stoppers of the casters at the place where the equipment is operated. 3. In addition to the above places, do not use the equipment at the following places There is much dust or sand dust. The equipment is applied with excessive vibration or shock. The power line voltage fluctuates abnormally. The power line voltage excessively drops while the equipment being operated under a load. The equipment is exposed to a direct sunlight. 4. Do not block the opening for air ventilation located on the rear, top and side covers of the equipment, or the equipment failure may be caused. 5. Neither incline the equipment more than 10° nor give an abnormal shock when moving it. When moving the equipment weighing more than 200kg, be sure to move it by two persons.

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7.3

Precautions for Electrical Safety

1. This ultrasound scanner has been designed as a class 1 equipment classified according to the type of protection against electric shock, and Type B/BF equipment classified according to the degree of protection against electric shock in accordance with the IEC60601-1 (General Requirements for safety of Medical Electrical Equipment by International Electro technical Commission). To prevent electric shock, be sure to directly connect the power cable of the equipment to the 3-wire power outlet which has a protective earth terminal (with less than 10Ω grounding resistance) of the grounding facility. 2. Do not detach the covers fixed with screws. Detaching the cover and contacting with electrical component inside may cause electric shock. For repair and checkup of the inside of the equipment, be sure to call service from Hitachi or our authorized dealer. 3. All ECG leads must be removed from patient to use with high-frequency (HF) surgical equipment. 4. Do not use the ECG function to patient which uses cardiac pacemaker or other electrical stimulators.

7.4

Precautions in use of probe

1. Do not use the probe of which the head surface is scratched or the cable cover is damaged. If the probe is used as damaged, it may cause electric shock. 2. The needle guide line to be displayed on the screen when biopsy is performed with the probe connected to this equipment is just a guide for direction of needle puncture. When operating the biopsy needle, do it as checking the actual position of the needle on the ultrasound image.

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1. Handle the probes with great care. Be careful neither to hit the probe to any hard object nor drop it, otherwise trouble may be caused. 2. As the probe connector is not water-proof type (IP40), do not apply any liquid or dip it in liquid. If this precaution is not observed, it may be damaged. 3. Be sure to connect or disconnect the probe under the following conditions. If it is done under the conditions other than the specified below, the equipment may malfunction or be failed. Therefore, strictly observe the procedures described below. Turn off the power switch. If the equipment is provided with more than two probe connectors, using the probe selection key select the other probe connector than the one to which the probe is connected or disconnected and set FREEZE ON. 4. The probes to which pressurized or depressurized gas sterilization can be applied are described in the Instruction Manual of each probe. Sterilize probe according to the method described in the Instruction Manual. 5. In case of the probes to which pressurized or depressurized gas sterilization cannot be applied, never put them in the following atmosphere. If this is not observed, the probe may be damaged. At temperature higher than 40°C In the pressurized gas In the depressurized gas Disinfection or sterilization other than the specified

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7.5

Precautions against ultrasound output power

When the equipment is used for the patient with high susceptibility such as fetus, pay attention to the following: Set the ultrasound output power to the level as low as possible and adjust sensitivity with the gain control. To prevent unnecessary ultrasound output power, try to set FREEZE to ON whenever depiction of ultrasound image is not necessary. Because effect by ultrasound power on the imaging area in the M, PW, CW and CFM-modes is greater than in the B-mode, try to use it at the level as minimum as possible. 8.

Electromagnetic Compatibility 8.1

Cautions in Handling (1) EMC: Electro Magnetic Compatibility Importance of the electromagnetic environment issue on medical sites has been pointed out especially in recent years, and the international standards (IEC60601-1-2:2001, EN 60601-1-2:2001+A1:2006) claims the following two items of electromagnetic compatibility: (a) Electromagnetic emission (EMI: Electro Magnetic Interference) Preventing the Ultrasound system from causing electromagnetic interference (b) Electromagnetic immunity (EMS: Electro Magnetic Susceptibility) Susceptibility to electromagnetic interference the Ultrasound system receives EUB-7500/EUB-7500A is compatible with the Euro Standards (EN) based on these international standards. When using the Ultrasound system, it is necessary to install and use it following EMC information described in this Appendix. (2) Mobile and portable RF communication devices Ultrasound frequency used in the Ultrasound system agrees accidentally with radio frequency; therefore, noise can be mixed in the image due to electromagnetic interference of radio frequency to the ultrasound transducer circuit. Mobile and portable RF communication devices should not be used in the place where the Ultrasound system is used. Also, other causes of electromagnetic interference are the

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radio and TV antennas and so on. It is uneasy to identify the cause of electromagnetic interference. When the cause of electromagnetic interference is to be identified, check the following points: Electromagnetic interference is intermittent or continuous? Only single or multiple probes receive electromagnetic interference? Electromagnetic interference is not resolved even if the system is moved to any isolated area in the facility? There is any antenna of communication, broadcasting and so on near the facility? Checking the above points may provide a means of judging whether the cause of electromagnetic interference is in the system or operating environment. When the cause of electromagnetic interference cannot be identified even if checking all of the above, please contact our liaison. (3) Electrostatic discharge (ESD) precautions Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring phenomenon. ESD is most prevalent during conditions of low humidity, which can be caused by heating or air conditioning. During low humidity conditions, electrical charges naturally build up on persons and can create static shocks. An ESD condition occurs when a person with an electrical energy build-up comes in contact with objects such as metal door-knobs, cabinets, electrical equipment, and other persons. The static shock or ESD is a discharge of the electrical energy build-up from a charged person to a lesser or non-charged person or object. The level of electrical energy discharged from a system user or patient to the ultrasound system can be significant enough to cause damage to the system or transducers. The following cautions can help to reduce ESD effect. Anti-static spray on carpets; anti-static spray on linoleum; anti-static mats; or a ground wire connection between the system and the patient table or bed. Do not touch transducer connector pins or the system’s transducer receptacle. Handle the transducer by the metal connector shell. Make contact with a metal surface of the system before connecting a transducer to the system. On connectors that display the ESD sensitivity symbol

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, do not touch the connector pins, and always follow the previously listed ESD precautions when using the connector. The education of above-mentioned cautions to a related entire staff is recommended. (4) Handling of peripheral devices Any digital recording device connected with our ultrasound system (not only a DICOM server but also a computer, printer and so on) may not carry out data transfer normally in an environment where there is electromagnetic interference and may cause data elimination and loss. After data transfer, therefore, refer to the destination to check that transfer operation has been carried out certainly. It is recommended to save images also in the hard disk drive mounted on the system for security purposes. (5) Statement for the Essential Performance The following depend on essential performance.

8.2

1.

Accuracy of display (Essential performance requirement): No distortion in display.

2.

Artefact of display (Essential performance requirement): No problematic artefact for qualified person.

3.

MI/TI and distance display (Essential performance requirement): No error in numerals.

4.

Ultrasound output power (Essential performance requirement): Equal to FDA regulation and Japanese MHLW requirements, or less.

5.

Probe surface temperature (Essential performance requirement): 50°C or less in still air, and 43°C or less in normal use. (Uncertainty: Air:3.1°C, TMM:0.7°C）

Technical Information in EMC Standards (1) Cable list Only the probes listed in Table 1 should be used for EUB-7500, additionally only the probes marked with ¡ should be used for EUB-7500A. Only cables listed in Table 2 should be used for EUB-7500/EUB-7500A. If using any cable of which combination is not found in these

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tables, increased electromagnetic emission or decreased electromagnetic immunity can result. Table 1 Probes Connectable with EUB-7500/EUB-7500A No.

Probe name

Features of probe

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34

EUP-S50 EUP-S50A¡ EUP-S70¡ EUP-S52¡ EUP-C511¡ EUP-C514¡ EUP-C715¡ EUP-C516¡ EUP-C524¡ EUP-CV524¡ EUP-C532¡ EUP-C312T EUP-C314G EUP-C318T EUP-C321T EUP-L52¡ EUP-L73S¡ EUP-L53S¡ EUP-L53¡ EUP-L53L¡ EUP-L54MA¡ EUP-L74M¡ EUP-L65¡ EUP-L34T EUP-B512¡ EUP-B514¡ EUP-B314 EUP-B31 EUP-V53W¡ EUP-V33W EUP-VV531¡ EUP-R54A-19¡ EUP-R54A-33¡ EUP-R54AW-19¡

35

EUP-R54AW-33¡

36 37

EUP-R53W EUP-CC531¡

38

EUP-CC331

39 40 41 42 43 44

EUP-U533¡ EUP-U531¡ EUP-O53T¡ EUP-O54J¡ EUP-O33J EUP-OL334¡

Phased array probe 4-2MHz Phased array probe 4-2MHz Phased array probe 5-1MHz Phased array probe 7-3MHz Convex type probe 4-2MHz 10R Convex type probe 5-2MHz 40R Convex type probe 5-1MHz 50R Convex type probe 5-2MHz 60R Convex type probe 6-3MHz 40R Convex type probe 6-3MHz 40R Convex type probe 8-4MHz 20R Convex type probe 3.5MHz 20R Convex type probe 3.5MHz 40R Convex type probe 3.5MHz 76R Convex type probe 5.0MHz 10R Linear type probe 7-3MHz Linear type probe 9-4MHz Linear type probe 9-4.5MHz Linear type probe 10-5MHz Linear type probe(Wide view type) 10-5MHz Linear type probe 13-6MHz Linear type probe 13-5MHz Linear type probe 14-6MHz Linear type probe 10MHz Biopsy probe (Convex type) 5-2MHz 20R Biopsy probe (Convex type) 5-2MHz 40R Puncture probe (Convex type) 3.5MHz 40R Puncture probe (Linear type) 3.5MHz Transvaginal probe (Wide view type) 8-4MHz 10R Transvaginal probe (Wide view type) 6.5MHz 10R Transvaginal probe 8-4MHz 10R Transrectal probe (Electrical radial type) 10-5MHz 10R Transrectal probe (Electrical radial type) 10-5MHz 10R Transrectal probe (Electrical radial type 360°) 10-5MHz 6R Transrectal probe (Electrical radial type 360°) 10-5MHz 6R Transrectal probe (Convex type) 8-4MHz 10R Intracavital probe (Convex/Convex type) 8-4MHz 10R/8-4MHz 10R Intracavital probe (Convex/Convex type) 6.5MHz 10R/6.5MHz 10R Transrectal probe (10-5MHz Linear/8-4MHz Convex) Transrectal probe (Convex) 8-4MHz 10R Intra-operative probe(10-5MHz Linear) Intra-operative probe(Linear type) 13-7MHz Intra-operative probe(Linear type) 7.5MHz Laparoscopic probe 7.5MHz 40R

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Cable length (m) 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.3 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.2 2.0 2.2 2.2 2.3 2.2 2.2 2.2 2.2 2.2 2.8 2.8 2.2 2.2 2.2 2.2 2.2 3.0

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No.

Probe name

45 46 47 48

EUP-OL531¡ EUP-F531¡ EUP-F334¡ EUP-ES52E¡

49

EUP-ES52M¡

50

EUP-ES322

51

EUP-ES533

52 53 54 55 56 57

EUP-TC3¡ FG-34UX¡ FG-36UX¡ FG-38UX¡ EG-3630U¡ EG-3630UR¡

58 59

EG-3830UT¡ EG-3670URK¡

60 61

EG-3870UTK¡ EB-1970UK¡

Features of probe Laparoscopic probe 10-5MHz 10R Finger tip probe 8-4MHz 10R Finger tip probe 7.5MHz 40R Trans esophageal probe (Electronic phased array multi plane type) 8-3MHz Trans esophageal probe (Phased array multi plane type) 6-3.5MHz Trans esophageal probe (Phased array biplane type) 5.0MHz/5.0MHz Trans esophageal probe (Phased array biplane type) 7.5MHz/7.5MHz Single Element CW Doppler probe 2.5MHz Ultrasound endoscopic probe(Convex) 7.5MHz 10R Ultrasound endoscopic probe(Convex) 7.5MHz 10R Ultrasound endoscopic probe(Convex) 7.5MHz 10R Ultrasound endoscopic probe(Convex) 7.5MHz 10R Ultrasound endoscopic probe(electrical Radial type) 10-5MHz 6R Ultrasound endoscopic probe(Convex) 10-5MHz 10R Ultrasound endoscopic probe(electrical Radial type 360°) 10-5MHz 6R Ultrasound endoscopic probe(Convex) 10-5MHz 10R Ultrasound videobronchoscope probe(Convex) 10-5MHz 6R

Cable length (m) 4.2 2.2 2.2 3.0 3.0 2.8 2.6 1.8 3.3 3.3 3.3 3.3 3.4 3.4 3.7 3.7 3.2

Table 2 Cables Connectable with EUB-7500/EUB-7500A No. 1 2 3 4 5 6 7 8 9 10 11 12 13

Name CP103US (ECG cable) FOOT SWITCH FOOT SWITCH (Twin) LINE OUT LAN RS-232C Parallel RCA BNC S-VHS VCR Remote Print Remote Mini-Probe interface

Shielding Yes Yes Yes No No Yes Yes Yes Yes No Yes Yes Yes

Maximum cable length (m) 3.3 2.0 2.0 1.0 3.0 1.7 1.5 1.5 1.5 1.9 1.7 1.5 1.0

(2) Table of electromagnetic emission compatibility standards EUB-7500/EUB-7500A is compatible with the standards of electromagnetic emission shown in Table 3. Table 3 Electro Magnetic Emission Compatibility Standards of EUB-7500/EUB-7500A Guidance and manufacturer’s declaration - electromagnetic emissions EUB-7500/EUB-7500A is intended for use in the electromagnetic environment specified below. The customer or the user of the EUB-7500/EUB-7500A should assure that it is used in such an environment.

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