MAJ-1720 PROBE DRIVING UNIT Instructions June 2014

6 Nomenclature and Functions Probe driving unit’s adapter

Supporting arm (sold separately)

This adapter is used to connect the MAJ-1720 to the supporting arm. Bolt Probe driving unit’s body This unit drives the ultrasound probe.

Endoscopic ultrasound center (sold separately)

Ultrasound probe connector

Ultrasound probe (sold separately)

Ultrasound probe for Dual Plane Reconstruction (DPR) (sold separately)

Ultrasound connector Ultrasound cable

This connector is used to connect to the endoscopic ultrasound center.

This cable contains the electrical wires needed for ultrasound functions.

Square socket cap

Round socket cap

Instruction manual

7 Symbols The meaning(s) of the symbol(s) shown on the package and/or this instrument are as follows:

Type BF applied part

Caution, refer to instructions.

Serial number

Release ultrasound connector

Lock ultrasound connector

CE marking

Crossed-out wheeled bin’ symbol

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

Manufacturer

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8 Preparation and Inspection 1. Remove the bolt from the probe driving unit’s adapter. 2. Insert the end of the supporting arm into the probe drive section adapter on the probe driving unit with the ultrasound cable pointing downward.

3. Align the holes on the supporting arm and the probe driving unit’s adapter, and insert the bolt from above. Tighten the bolt to secure the probe driving unit to the supporting arm (see Figure 1). •

Tighten the bolt firmly. Otherwise, the probe driving unit may fall off and rotate. Doing so may cause personal injury and/or equipment damage. • When rotating the supporting arm, take care not to strike people or equipment. Doing so may cause personal injury and/or equipment damage. • Do not use the supporting arm MD-808 with the probe driving unit. Otherwise, equipment damage may result. • When securing the supporting arm to prove driving unit, take care not to strike people or equipment. Doing so may cause personal injury and/or equipment damage. 4. Connect the probe driving unit’s ultrasound connector to the endoscopic ultrasound center (see Figure 2). Before connecting or disconnecting the ultrasound connector, confirm that the power switch lamp or active lamp on the endoscopic ultrasound center is not lit. Otherwise, equipment damage may result.

5. Hold the probe driving unit’s body and insert the ultrasound probe into the prove driving unit’s body (see Figures 3 and 4). •

Do not apply excessive force to the probe driving unit when attaching the probe. Otherwise, it may be damaged. • When connecting the probe to the probe driving unit, hold the probe driving unit’s body firmly so that it does not move. The prove driving unit’s body knocks against other equipment, and there is a possibility of breaking. • Do not put your fingers or anything inside the probe connector. Doing so may cause personal injury or damage to the probe driving unit. • Do not disconnect the ultrasound probe from the probe driving unit while the power switch lamp or active lamp on the endoscopic ultrasound center is lit. Otherwise, equipment damage may result. 6. Inspect the equipment as instructed in the instruction manuals of the ultrasound probe and endoscopic ultrasound center. Connect to the endoscopic ultrasound center

Attach to the supporting arm

Ultrasound connector

Bolt

Left socket

Supporting arm Lever Insert the ultrasound connector and turn the lever clockwise until it stops.

Figure 1 Connect the ultrasound probe

Figure 2 Connect the ultrasound probe for Dual Plane Reconstruction (DPR)

White marker

Gray marker

Contact pin

Align the slit on the connector with the gray marker () on the probe driving unit’s body, insert the ultrasound probe and turn it clockwise until it stops.

Align the contact pin on the ultrasound probe with the white marker ( ) on the probe driving unit and insert the ultrasound probe until it stops.

Figure 3

Figure 4

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9 Operation Operate the equipment as described in the instruction manuals of the ultrasound probe and endoscopic ultrasound center. •

•

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, turn the endoscopic ultrasound center OFF, and contact Olympus. The equipment will be hot if left switched on and it can result in patient injury and equipment damage. Do not apply excessive force to the ultrasound cable. Otherwise, damage to the ultrasound center or probe driving unit may result. It is also recommended to keep the endoscopic ultrasound center in the FREEZE mode, except during ultrasound observation.

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

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

2. If the equipment 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 probe driving unit. The probe driving unit is not waterproof. Never immerse it in disinfectant solution or any other fluids.

Storage 1. Make sure the probe driving unit is completely dry before storage. 2. Confirm that the power switch lamp or active lamp on the endoscopic ultrasound center is not lit. Then disconnect the ultrasound connector from the endoscopic ultrasound center.

3. Fold the supporting arm before storing it. 4. Attach the square socket cap and round socket cap before storage. 5. When storing the probe driving unit separately from the supporting arm, refer to the following steps;    • • • •

Unscrew the bolt of the probe driving unit’s adapter and remove the supporting arm from the probe driving unit. Re-attach the bolt to the probe driving unit’s adapter. Store the equipment in a stable location.

Store the probe driving unit in a clean room at normal temperature and humidity. Avoid exposure to direct sunlight and X-rays. The ultrasound cable should be stored without being tightly coiled or twisted. Store the ultrasound connector in a stable location. Otherwise, personal injury or equipment damage may result. Do not apply excessive force in the up-and-down direction when removing the probe driving unit from the supporting arm. Doing so may cause probe driving unit’s adapter deformation and/or incorrect attachment.

Disposal When disposing of this probe driving unit, or any of its components, follow all applicable national laws and guidelines.

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

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12 System chart The recommended equipment combinations that can be used with the probe driving unit are listed below. New products released after the introduction of the probe driving unit 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 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 below.

Supporting arm3 (MAJ-683) Ultrasound probe1 (UM-DP12-25R, UM-DP20-25R, UM-DG20-31R)

Probe driving unit (MAJ-1720)

Ultrasound probe (UM-2R, UM-3R, UM-G20-29R, UM-S20-20R, UM-S20-17S, UM-BS20-26R, UM-S30-20R, UM-S30-25R, RU-75M-R1, RU-12M-R1) Endoscopic ultrasound center (EU-ME12, EU-M30S2, EU-M20002, EU-M602) 1

This equipment is not compatible with the EU-M30S.

2

This equipment may not be available in some countries.

3

The supporting arm MD-808 is not compatible with the probe driving unit MAJ-1720.

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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

Dimensions

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia) Probe driving unit’s body without probe driving unit's adapter

71 (W) × 94 (H) × 190 (D) mm

Total length

1850 mm

Weight Classification (medical electrical equipment)

1.4 kg

Equipment type

Class I: when combined with the endoscopic ultrasound center (Type BF), defined in IEC standard 60601-1, safety of medical electrical equipment.

Degree of protection against explosion

Never use the probe driving unit where flammable gases are present.

Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a

WEEE Directive

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately. Refer to your local Olympus distributor for return and/or collection systems available in your country.

EMC

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.

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14 EMC information  Guidance and manufacturer’s declaration - Electromagnetic emissions This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - 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

 Guidance and manufacturer’s declaration - Electromagnetic immunity This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Immunity test 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

IEC 60601 test level

Electromagnetic environment - 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

Definition:

UT is the a.c. mains voltage prior to application of the test level.

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 Guidance and manufacturer’s declaration - Electromagnetic immunity This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment.

Portable and mobile RF communications equipment should be used no closer to any part of this model, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - Guidance

Recommended separation distance Conducted RF IEC 61000-4-6

3 Vrms (150 kHz – 80 MHz)

3 V (V1)

3,5 d = ------V1

P

Recommended separation distance Radiated RF IEC 61000-4-3

Definition:

•

• • •

•

3 V/m (80 MHz – 2.5 GHz)

3 V/m (E1)

3,5 d = ------E1

P

7 d = -----E1

P

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. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Electromagnetic interference may occur on this instrument near a high-frequency electrosurgical equipment and/or other equipment marked with the following symbol:

Field strength from fixed RF transmitters as determined by an electromagnetic site surveya) should be less than the compliance level in each frequency rangeb).

a)

Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) 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 this model is used exceeds the applicable RF compliance level above, this model should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this model.

b)

Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

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 Recommended separation distances between portable and mobile RF communications equipment and this model This model is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this model can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this model as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter P (W)

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

Others:

• •

Separation distance according to frequency of transmitter (m) (calculated as V1=3 and E1=3)

For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’ in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where ‘p’ is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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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

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GT5961 07

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