MAJ-2056 ULTRASOUND CABLE Instructions April 2014

7 Labels and Symbols The meanings of the symbols shown on the package and/or this instrument are as follows: Mark (red) Lock ultrasound connector

Release ultrasound connector

Serial number

CE marking

Caution

 Package Serial number

 Last page of this instruction manual Authorized representative in the European Community

Manufacturer

8 Preparation and Inspection Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment used with this instrument as instructed in their respective instruction manuals.

8.1

Inspection of the instrument

Confirm that the ultrasound cable is free from cracks, scratches, flaws and other damages. Should any irregularity be observed, do not use it and contact Olympus. It may cause user injury by an electric shock.

8.2

Preparation and inspection of related equipment

Prepare and inspect the ultrasound endoscope, and the diagnostic ultrasound system according to their respective instruction manuals.

8.3

Connection of related equipment

Connection of the ultrasound cable and Olympus universal endoscopic ultrasound center (EU-ME1) Insert the ultrasound connector properly into the right socket of the Olympus universal endoscopic ultrasound center. Rotate the connector’s lock handle 1/4 turn clockwise (see Figure 1). Lock handle

Figure 1

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Ultrasound connector

Connection of the ultrasound cable and the Hitachi Aloka Medical diagnostic ultrasound system (Hitachi Aloka Medical, LTD.) Insert the ultrasound connector properly into the transducer port of the diagnostic ultrasound system. Rotate the connector’s lock handle 1/4 turn clockwise (see Figure 2). Connect the ultrasound connector to one of the probe connectors on the lower side (PROBE 3 or 4) of the ProSound F75 (see Figure 2). If the ultrasound connector is connected to one of the probe connectors on the upper side (PROBE 1 or 2), the operation panel of the ProSound F75 may hit the ultrasound connector, which may result in equipment damage. When adjusting the height, a horizontal and/or vertical position of the operation panel of the ProSound F75 with the ultrasound connector connected to the PROBE 1 or 2, move slowly the operation panel with visually confirming the position of the bottom of the operation panel. ProSound 5/ProSound 71

ProSound 10 Transducer port

Ultrasound connector

Ultrasound connector Lock handle

Lock handle

ProSound F751

Transducer port

PROBE 2

PROBE 1

PROBE 3

PROBE 4

Lock handle Ultrasound connector 1

Figure 2

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These products may not be available in some areas.

Connection of the endoscope and ultrasound cable • •

The electrical contacts inside the ultrasound connector have sharp tips and may be damaged by handling. Do not touch the electrical contacts. For more information on combining the endoscope with the ultrasound cable, refer to Chapter 12, “System Chart”. When connecting the endoscope-side connector of the ultrasound cable to the ultrasound cable connector of the endoscope, do not tangle the universal cord with the ultrasound cable. Equipment damage can result.

1. Make sure that the inside of the ultrasound cable connector of the endoscope is dry and free of debris. 2. Align the red mark on the ultrasound cable with mark A on the ultrasound connector and push it in until it stops (see Figure 3).

3. Turn the endoscope-side connector of the ultrasound cable clockwise until it stops (see Figure 3). 4. Confirm that the red mark on the ultrasound cable is aligned with mark B on the endoscope connector (see Figure 3).

Mark B (red)

Mark B (red)

Mark A (red) Mark A (red)

Mark (red)

Mark (red)

Endoscope-side connector of the ultrasound cable

Figure 3

8.4

Inspection of the ultrasound image

Inspect the ultrasound image according to the respective instruction manuals for the ultrasound endoscopes. If any irregularity is observed in the ultrasound image, do not use this instrument and the ancillary equipment and contact Olympus. It may cause patient burns, injury, bleeding, perforation, and/or diagnostic error because of insulation breakdown of the ultrasound transducer and/or image noise.

9 Operation Operate the instrument described in the instruction manuals for the ultrasound endoscope and the diagnostic ultrasound system. •

• •

If the ultrasound image on the video monitor should unexpectedly disappear or freeze during an examination, and cannot be restored, stop the examination immediately. Press the “FREEZE” switch to turn the diagnostic ultrasound system OFF. Using a defective ultrasound center may cause patient and/or operator injury. Then, take action according to “Troubleshooting” described in the instructions of the diagnostic ultrasound system after withdrawing the endoscope. If the problems cannot be resolved by the remedial action described in the instructions of the diagnostic ultrasound system, do not use the equipment and contact Olympus. Do not apply excessive force to the ultrasound cable. Otherwise, damage to the ultrasound endoscope, the diagnostic ultrasound system, and/or ultrasound cable may result. Before disconnecting the ultrasound cable from the related equipment, turn the diagnostic ultrasound system OFF. Otherwise, it may result in equipment damage. It is also recommended to keep the endoscopic ultrasound center in the FREEZE mode, except during ultrasound observation.

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10 Maintenance, Storage, and Disposal Maintenance After using the ultrasound cable, inspect for debris. Should any debris remain, perform the following cleaning procedure.

1. To remove dust, dirt, and non-patient debris, wipe the ultrasound cable using a soft lint-free cloth moistened with 70% ethyl or isopropyl alcohol.

2. If the ultrasound cable is soiled with blood or other potentially infectious materials, first wipe off all gross debris using a neutral detergent, then wipe with a lint-free cloth moistened with a surface disinfectant. • • •

Never apply water to the ultrasound cable. The ultrasound cable is not waterproof. Never immerse it in disinfectant solution or any other fluids. Alcohol is flammable. Handle with care. Alcohol is not a sterilant or a high-level disinfectant.

Storage The storage cabinet must be kept clean, dry, well ventilated, and maintained at ambient temperature. Storing the ultrasound cable in direct sunlight, at high temperature, in high humidity, or exposed to X-rays and/or ultraviolet-rays may damage the ultrasound cable.

1. Make sure the ultrasound cable is completely dry before storage. 2. The ultrasound cable should be stored without being tightly coiled or twisted.

Disposal When disposing of this ultrasound cable, or any of its components, follow all applicable national laws and guidelines.

11 Service In the event of equipment malfunction, contact Olympus. Do not disassemble, modify, or attempt to repair this instrument; patient or user injury and/or equipment damage can result.

12 System Chart The recommended equipment combinations that can be used with the ultrasound cable are listed below. New products released after the introduction of the ultrasound cable may also be compatible. For further details, contact Olympus. If equipment combinations other than those shown below are used, the full responsibility should be assumed by the medical facility. Such combinations do not optimize the equipment functionality but may also imperil the safety of the patient and medical personnel. In addition, the endurance of the ultrasound center and ancillary equipment can not be guaranteed in this case. Repairs that may result in this case are not covered by the Olympus warranty. Be sure to use the equipment as recommended.

Universal endoscopic ultrasound center (EU-ME11)

Hitachi Aloka Medical diagnostic ultrasound system1

Ultrasound cable (MAJ-2056)

1

Ultrasound endoscope (TGF-UC180J1, GF-UCT1801, GF-UCT2601, BF-UC180F1, BF-UC260FW1)

Refer to the instruction manual for the ultrasound endoscope to check the compatibility of the diagnostic ultrasound system.

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13 Specifications Operating environment

Transportation and storage environment

Ambient temperature

10 – 40C (50 – 104F)

Relative humidity

30 – 85%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Ambient temperature

–25 to +70C (–13 to +158F)

Relative humidity

10 – 90%

Atmospheric pressure

Size

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Cable length

1500 mm

Weight Medical Devices Directive EMC

1.0 kg This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I

Applied standards; IEC 60601-1-2: 2001, 2007 IEC 60601-2-37: 2001, 2007

This instrument complies with the standards listed in the left column. CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Year of manufacture

1112345

The last digit of the year of manufacture is given in the second digit of the serial number.

14 EMC information This model is intended for use in the electromagnetic environments specified below. The user and the medical staff should ensure that it is used only in these environments. Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

 Magnetic emission compliance information and recommended electromagnetic environments Emission standard

Compliance

Guidance

RF emissions CISPR 11

Group 1

This instrument uses RF (Radio Frequency) energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Radiated emissions CISPR 11

Class B

This instrument’s RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Harmonic emissions IEC 61000-3-2

Class A

This instrument’s harmonic emissions are low and are not likely to cause any problem in the typical commercial power supply connected to this instrument.

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

This instrument stabilizes its own radio variability and has no affect such as flicker in lighting apparatus.

Main terminal conducted emissions CISPR 11

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 Electromagnetic immunity compliance information and recommended electromagnetic environments Immunity test

IEC 60601-1-2 test level

Electrostatic discharge (ESD)

Contact: ±2, ±4, ±6 kV

IEC 61000-4-2

Air: ±2, ±4, ±8 kV

Electrical fast transient/burst

±2 kV for power supply lines

IEC 61000-4-4

±1 kV for input/output lines

Surge

Differential mode: ±0.5, ±1 kV

IEC 61000-4-5

Compliance level

Guidance

Same as left

Floors should by be made of wood, concrete, or ceramic tile that hardly produces static. If floors are covered with synthetic material that tends to produce static, the relative humidity should be at least 30%.

Same as left

Mains power quality should be that of a typical commercial (original condition feeding the facilities) or hospital environment.

Same as left

Mains power quality should be that of a typical commercial or hospital environment.

Same as left

Mains power quality should be that of a typical commercial or hospital environment. If the user of this instrument requires continued operation during power mains interruptions, it is recommended that this instrument be powered from an uninterruptible power supply or a battery.

Same as left

It is recommended to use this instrument by maintaining enough distance from any equipment that operates with high current.

Common mode: ±0.5, ±1, ±2 kV Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5% UT (> 95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycle < 5% UT (> 95% dip in UT) for 5 seconds

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

UT is the AC mains power supply prior to application of the test level.

 Cautions and recommended electromagnetic environment regarding portable and mobile RF communications equipment such as cellular phones Immunity test

IEC 60601-1-2 test level

Compliance level

Guidance Formula for recommended separation distance (V1=E1=3 according to the compliance level)

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms (150 kHz – 80 MHz)

3 V (V1)

3.5 d = --------V1

P

3 V/m (80 MHz – 2.5 GHz)

3 V/m (E1)

3.5 d = --------E1

P

7 d = -----

P

E1

• •

•

80 MHz – 800 MHz

800 MHz – 2.5 GHz

Where “P” is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and “d” is the recommended separation distance in meters (m). This instrument complies with the requirements of IEC 60601-1-2: 2001, IEC 60601-1-2: 2007. However, under electromagnetic environment that exceeds its noise level, electromagnetic interference may occur on this instrument. Electromagnetic interference may occur on this instrument near a high-frequency electrosurgical equipment and/or other equipment marked with the following symbol:

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 Recommended separation distance between portable and mobile RF communications equipment and this instrument Rated maximum output power of transmitter P (W)

Separation distance according to frequency of transmitter (m) (calculated as V1=3 and E1=3) 150 kHz – 80 MHz

80 MHz – 800 MHz

800 MHz – 2.5 GHz

Rated maximum output power of transmitter P (W)

d = 1.2 P

d = 1.2 P

d = 2.3 P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

The guidance may not apply in some situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Portable and mobile RF communications equipment such as cellular phones should be used no closer to any part of this instrument, including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (042)646-2429 Telephone: (042)642-2111

Distributed by (Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany (Letters) Postfach 10 49 08, 20034 Hamburg, Germany Fax: (040)23773-4656 Telephone: (040)23773-0

3 Acacia Place, Notting Hill, VIC 3168, Australia Fax: (03)9543-1350 Telephone: (03)9265-5400

3500 Corporate Parkway, P.O. Box 610, Center Valley, PA 18034-0610, U.S.A. Fax: (484)896-7128 Telephone: (484)896-5000

5301 Blue Lagoon Drive, Suite 290 Miami, FL 33126-2097, U.S.A. Fax: (305)261-4421 Telephone: (305)266-2332

KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom Fax: (01702)465677 Telephone: (01702)616333

Olympus Tower 9F, 446, Bongeunsa-ro, Gangnam-gu, Seoul, Korea 135-509 Fax: (02)6255-3494 Telephone: (02)6255-3210

A8F, Ping An International Financial Center, No. 1-3, Xinyuan South Road, Chaoyang District, Beijing, 100027 P.R.C. Fax: (86)10-5976-1299 Telephone: (86)10-5819-9000

117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia Fax: (095)958-2277 Telephone: (095)958-2245

491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 6834-2438 Telephone: 6834-0010

RC0461 06

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