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MN1-5531 Rev. 10

Caution

Attach the waterproof cover if the connector will be soaked in liquid.

If the connector is soaked in liquid without the waterproof cover, liquid can get inside and result

in malfunction.

Attach the waterproof cover to the probe and use it by following the instructions in the waterproof

cover manual. Using the wrong combination of the probe and the waterproof cover, incorrectly

mounting the waterproof cover, or using the probe without properly mounting the cover can

cause the probe to malfunction.

Do not use a waterproof cover where a problem has been found.

Using a waterproof cover in an abnormal state can cause injury to the user. Contact one of our

offices and/or distributor's offices listed on the back cover.

Do not use the waterproof cover in sterilization that applies changes in pressure.

Using ethylene oxide gas sterilization, low-temperature plasma sterilization, or other steriliza-

tion methods that apply changes in pressure can damage the probe and the waterproof cover.

In these cases, do not use the waterproof cover.
After soaking in chemical solution, check that no liquid has entered into the connector.

If liquid appears to have entered the connector, immediately stop use and contact one of our

offices listed on the back cover.

Do not use the waterproof cover if the packing has been removed before.

The waterproof cover will not function correctly even if packing that was removed is returned

to its original location. Replace it by a new waterproof cover.
Do not rub the packing of the waterproof cover with a brush.

This could damage the packing. Use of the waterproof cover while the packing is damaged can

cause liquid to enter the probe resulting in malfunction.
Be sure to store the waterproof cover by removing it from the connector.

If the waterproof cover is stored while connected to the probe, the packing can become

deformed.
Replace the waterproof cover around two years after it is commercing for use.

The packing for preventing liquid deteriorates with time.

For safe use, replace the waterproof cover by a new one typically two years.

Additional information:
The Instructions provided above have been validated by the medical device manufacturer as being CAPABLE

of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the

processing as actually performed using equipment, material and personnel in the processing facility achieve

the desired result. This requires validation and routine monitoring of the process. Likewise any deviation

by the processor from the instructions provided should be properly evaluated for effectiveness and potential

adverse consequences.

Содержание UST-9120

Страница 1: ...on Manual carefully prior to use Keep this Instruction Manual together with the ultrasound diagnostic instru ment for any future reference Hitachi Ltd 2013 2017 All rights reserved Intraoperative Electronic Convex Probe UST 9120 Compatible with waterproof cover Instruction Manual MN1 5531 Rev 10 ...

Страница 2: ...MN1 5531 Rev 10 ii ...

Страница 3: ...that can occur when failing to observe the displayed safety information are indicated in four levels Danger Warning Caution and Note Danger Indicates an imminently hazardous situation which if not avoided will result in death or serious injury to the operator or patient Warning Indicates a potentially hazardous situation which if not avoided could result in death or serious injury to the operator ...

Страница 4: ...perating environmental conditions 15 2 5 2 Storage environmental conditions 15 2 6 Classification of ME equipment 15 3 Preparations for Use 3 1 Start up check 17 3 1 1 Visual check 17 3 1 2 Verification of cleaning disinfection and sterilization 17 3 1 3 Verification of operation 17 4 Usage 4 1 Operation 19 4 2 Connecting to the ultrasound diagnostic instrument 20 4 3 Removing from the ultrasound ...

Страница 5: ... and disinfection 35 5 6 1 Manual cleaning 35 5 6 2 Manual disinfection 36 5 6 3 Cable and connector 36 5 7 Automated cleaning and disinfecting 37 5 8 Applicable cleaners and disinfectants Suppliers List 38 5 9 Drying 40 5 10 Maintenance inspection and testing 40 5 11 Packaging 40 5 12 Sterilization 41 5 12 1 Ethylene oxide EtO gas sterilization 41 5 12 2 STERRAD sterilization 42 5 12 3 Liquid ste...

Страница 6: ...Testing of measurement tolerances 50 8 2 1 Conducting tests 50 8 2 2 Result judgement 50 9 Configuration 9 1 Standard configuration 51 9 2 Options 51 10 Disposal of the Device 53 This Instruction Manual contains the main body of 54pages and 6pages until the CONTENTS ...

Страница 7: ... of the hazard and injury that can occur when failing to observe the displayed safety information are indicated in four levels Danger Warning Caution and Note Danger Indicates an imminently hazardous situation which if not avoided will result in death or serious injury to the operator or patient Warning Indicates a potentially hazardous situation which if not avoided could result in death or serio...

Страница 8: ...sult Contact one of our offices and or distribu tor s offices listed on the back cover to request repair Clean disinfect and sterilize before using the probe Perform proper cleaning disinfection and sterilization after use Otherwise there is a risk of infection Note that the probe is not sterilized at the factory Before using the probe first be sure to clean disinfect and sterilize it Be sure to s...

Страница 9: ...mum length of time necessary for the diagnosis and at the lowest suitable output Overuse can adversely affect the internal tissues of the patient For details about the acoustic output please refer to the documentation supplied with the ultrasound diagnostic instrument Do not use it in continuous contact with the human body more than 60 minutes Overuse can adversely affect the internal tissues of t...

Страница 10: ...there is nothing wrong with the transducer cover and that the puncture adapter is properly attached on the transducer when puncturing If you attach the puncture adapter incorrectly it may come off during the procedure or it may be punctured into a non intended area Refer to the details on Section 4 5 3 How to puncture using MP 2458 and Section 4 5 5 How to puncture using CIVCO bracket Properly use...

Страница 11: ...s of the operator or patient Perform aeration completely after gas sterilization Residual gas can cause an adverse reaction on the bodies of the operator or patient Do not clean disinfect or sterilize using procedures other than those specified in this manual Infection could result due to incomplete cleaning disinfection and sterilization It can also result in damage to the probe or reduced perfor...

Страница 12: ...roof cover After soaking in chemical solution check that no liquid has entered into the connector If liquid appears to have entered the connector immediately stop use and contact one of our offices listed on the back cover Do not use the waterproof cover if the packing has been removed before The waterproof cover will not function correctly even if packing that was removed is returned to its origi...

Страница 13: ... 7 MN1 5531 Rev 10 㻞㻙㻝㻢㻙㻝㻘㻌㻴㼕㼓㼍㼟㼔㼕㻙㼁㼑㼚㼛㻘㻌㼀㼍㼕㼠㼛㻙㼗㼡㻘㻌㼀㼛㼗㼥㼛㻘㻌㻝㻝㻜㻙㻜㻜㻝㻡㻘㻌㻶㼍㼜㼍㼚㻌㻌㻌㼀㻱㻸㻌㻗㻤㻝㻙㻟㻙㻢㻞㻤㻠㻙㻟㻢㻢㻤 Label 3 Label 2 Label 1 Label 1 1 2 4 Labels 1 Probe unit Electronic convex probe mark Frequency ...

Страница 14: ...ion 5 Follow the instruction manual to operate this instrument If not avoided may result in injury property damage or the equipment trouble IPX7 This instrument complies with Directive 93 42 EEC relating to Medical Device and Directive 2011 65 EU relating to RoHS 㻞㻙㻝㻢㻙㻝㻘㻌㻴㼕㼓㼍㼟㼔㼕㻙㼁㼑㼚㼛㻘㻌㼀㼍㼕㼠㼛㻙㼗㼡㻘㻌㼀㼛㼗㼥㼛㻘㻌㻝㻝㻜㻙㻜㻜㻝㻡㻘㻌㻶㼍㼜㼍㼚㻌㻌㻌㼀㻱㻸㻌㻗㻤㻝㻙㻟㻙㻢㻞㻤㻠㻙㻟㻢㻢㻤 Model Serial No Manufacturer Address Rx Only By prescripti...

Страница 15: ... 9 MN1 5531 Rev 10 Label A 2 Storage case Label B ...

Страница 16: ...e of 2016 09 MANUFACTURER AUTHORISED REPRESENTATIVE IN EUROPEAN COMMUNITY This instrument complies with Directive 93 42 EEC relating to Medical Device and Directive 2011 65 EU relating to RoHS 2016 09 Hitachi Medical Systems GmbH Otto von Guericke Ring 3 D 65205 Wiesbaden Germany P 3258F ...

Страница 17: ...nic waves into the body part contacting the transducer or into liquid or other medium 2 The emitted ultrasonic waves are reflected by boundaries with different acoustic characteristics acoustic impedance within the body 3 The transducer is also used to receive reflected ultrasonic waves The transducer vibrates mechanically due to the received ultrasonic vibrations and uses an electro mechanical co...

Страница 18: ...ur probe Connectable instruments SSD α5 SSD α10 Prosound α7 Prosound F75 Field of view 65 Frequency 4 10MHz Cable length 3 0 m Weight 800 g Service life Three years Range of applied part As shown in the figure below Parts treated as applied parts Probe tip itself and 20 cm of the cable near the probe tip IPX7 range As shown in the figure below waterproof cover MP 2790 unattached Whole parts of the...

Страница 19: ...osurgery application CIVCO Transducer cover 610 1107 610 1107 EU This transducer cover can be used in neurosurgery applications and it is Pyrogen free If you are unable to obtain the transducer cover locally please contact your local Hitachi Medical Systems representative ...

Страница 20: ...ip This area is held during operation Cable This cable propagates the ultrasonic signals that are sent and received Front Mark The round protrusion corresponds to the front mark direction mark on the image display Caution Do not pull bend twist or apply excessive force to the cable The conductors may break and the cable may become unusable Do not subject the ultrasonic radiation part to hard impac...

Страница 21: ...r or other corrosive substances Locations where chemical substances are stored or where gases are generated Storage in these locations can result in a breakdown or reduced performance Avoid rapid temperature change which may cause condensation Avoid using in locations where condensation or water droplets can form Condensation can occur when moving the probe from a cool location to a warm one Use w...

Страница 22: ... 16 MN1 5531 Rev 10 ...

Страница 23: ...d the displayed frequency and check the image for errors Remarks For details on the displayed screens see the documentation supplied with the ultrasound diagnostic instrument If the probe is operated in still air brightness on the top of the image may be non uniform but this does not affect the performance of the probe Warning Be sure to preparations for use Using the probe without noticing an abn...

Страница 24: ... 18 MN1 5531 Rev 10 ...

Страница 25: ...n necessary can cause injury to the patient Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output There is the possibility that the patient s internal tissues could be affected For details about the acoustic output please refer to the documentation supplied with the ultrasound diagnostic instrument Do not touch the connector terminal pin of the probe The...

Страница 26: ... that the connector pins are not bent 1 Turn the connector lock lever to align the mark on the lever with the RELEASE position 2 Firmly insert the connector into the probe connector on the ultrasound diagnostic instrument 3 Turn the lock lever clockwise by 1 4 turn until the mark is aligned with the LOCK position 4 Check that the connector is firmly inserted into the probe connector on the instrum...

Страница 27: ...tes The power switch is set to OFF The image displayed on the ultrasound diagnostic instrument is frozen 1 Turn the connector lock lever to align the mark on the lever with the RELEASE position 2 Firmly grasp the connector unit and pull it out from the probe connector of the ultrasound diagnostic instrument This completes the removal of the probe After use perform cleaning disinfection and sterili...

Страница 28: ...puncture needle size Use of a puncture needle that is not a compatible size can result in the puncture adapter coming off during puncturing or puncturing of an unintended body part causing injury to the patient For the compatible puncture needle sizes see the documentation supplied with the puncture adapter Always use a straight needle Puncturing of an unintended body part can cause injury to the ...

Страница 29: ...ly or is forced to bend when inserted in or pulled out of the puncture adapter it may damage the insulation membrane covering the cannula and may cause burns to the tissue exposed to the damaged area of the cannula Do not puncture the heart region Puncturing the heart region may cause a micro electric shock Caution Handle the needle carefully to ensure that the probe is not damaged Using a probe t...

Страница 30: ...of the probe When using the probe in neurosurgery applications please attach our recommended transducer cover to our sterilized probe 4 5 When using the probe for neurosurgery applications Apply some sterilized acoustic medium Transducer cover 4 5 2 How to remove the transducer cover 1 To prevent infection use surgical gloves to remove the used transducer cover from the probe 2 Dispose the used su...

Страница 31: ...ter use 4 5 3 How to puncture using MP 2458 1 Attach the transducer cover to the probe according to Section 4 5 1 and then withdraw it to the side of probe front mark 2 Attach the puncture adapter according to instruction manual of the puncture adapter 3 Verify the puncture needle does not touch the transducer cover Withdraw the transducer cover Front mark Puncture needle Puncturing root of punctu...

Страница 32: ... cover 3 Tuck in any part of the transducer cover that may be protruding and attach the CIVCO biopsy needle guide Attach the CIVCO biopsy needle guide according to the instruction manual Tuck in any part of the transducer cover that may be protruding Attach the CIVCO biopsy needle guide to the probe and nip the transducer cover protruding by CIVCO bracket to prevent the contact of the puncture nee...

Страница 33: ...there is nothing wrong with the transducer cover and that the puncture adapter is properly attached on the transducer when puncturing If you attach the puncture adapter incorrectly it may come off during the procedure or it may be punctured into a non intended area Refer to the details on Section 4 5 3 How to puncture using MP 2458 and Section 4 5 5 How to puncture using CIVCO bracket Properly use...

Страница 34: ...al treatment 4 7 2 Handling the instrument Turn off the ultrasound diagnostic instrument remove its plug from the AC socket and sterilize if it is contaminated For details refer to the instruction manual for the ultrasound diagnostic instrument Caution Do not use a probe where a problem has been found Using a probe in an abnormal state can cause injury to the patient Contact one of our offices and...

Страница 35: ...ail of each method is described in Chapter 5 2 Table 1 Applicable cleaning disinfection and sterilization methods Model Cleaning Disinfection Sterilization Waterproof cover MP 2790 Manual Automated 1 Manual Automated 1 EtO STERRAD Liquid 2 Autoclave STERIS UST 9120 X X X X X X X X X Note X means Applicable 1 Automated Need waterproof cover 2 Liquid sterilization USA only ...

Страница 36: ...re to clean and sterilize the equipment can result in an infection It can also result in damage to the probe or reduced performance The probe is not compatible with autoclave sterilization or boiling and other types of sterilization at temperatures exceeding 60 C 140 F For details on the usage conditions of chemicals and sterilization procedures refer to the documentation supplied with the respect...

Страница 37: ... of our offices listed on the back cover Do not use the waterproof cover if the packing has been removed before The waterproof cover will not function correctly even if packing that was removed is returned to its original location Replace it by a new waterproof cover Do not rub the packing of the waterproof cover with a brush This could damage the packing Use of the waterproof cover while the pack...

Страница 38: ... level of processing required depends on the type of equipment and its use The CDC Centers for Disease Control and Prevention in the USA and the RKI Robert Koch Institute in Germany classify medical devices according to their use For each classification they specify the level of disinfection sterilization processing that is required before use Table 3 summarizes this information Table 2 Classifica...

Страница 39: ... Rinsing after manual cleaning Automated disinfection Automated cleaning Manual disinfection Rinsing after manual disinfection Drying Maintenance inspection and testing Packaging Sterilization Drying Flowchart of reprocessing process of this probe and accessories is as follows NOTE Only the accessories are compatible with automated reprocessing according to the flowchart above ...

Страница 40: ...probe in this manual for the compatibility of the waterproof cover Connector and part of the cable which are out of the IPX7 range belong to the part which cannot be soaked into a liquid without using the waterproof cover See section 2 2 1 for information about the range of IPX7 5 5 Containment and transportation Putting the contaminated equipment into exclusive shock and damage proof container fo...

Страница 41: ...nshouldbebetween15 30 C 59 86 F concentrationis1 6 Please note the minimum contact time of the detergent in the manufacturer s instruction If a differing detergent is used please also consider the approved material compatibility for this probe 2 Immerge the submergible part of the probe see figure without connector into the detergent 3 Wipe the submergible part of the probe under the surface of th...

Страница 42: ... submergible part of the probe with running deionized water for 1 minute 5 Alternatively to step 4 suspend the submergible part of the probe in a tray filled with deionized water for 5 min 6 Visually check the outer surface of the probe for that there are no leavings of the disinfectant If necessary repeat the rinsing Caution Do not wipe the ultrasonic radiation part with alcohol Alcohol could dam...

Страница 43: ... are as follows Program step Water 40l Dosage ml l Temp C F time min Pre Rinse Cold water 5 Cleaning Deionized water 5 0 5 50 122 10 Rinse Deionized water 1 Disinfection Deionized water 10 1 55 131 5 Rinse Deionized water 1 Rinse Deionized water 55 131 1 Drying 55 131 15 2 Connect the waterproof cover MP 2790 to the probe connector and confirm there is no air leak by the tester About detail inform...

Страница 44: ...PRODUCTS A Johnson Johnson company Division of Ethicon Inc Ortho phthalaldehyde CIDEX OPA Solution 0 55 Glutaral Cidex plus Glutaral STERIHYDE Practical liquid 2W V Maruishi Pharmaceutical Co Ltd Benzethonium chloride Hyamine Practical liquid 0 1W V DAIICHI SANKYO Co Ltd Didecyl dimethylammonium chloride Cleanisept Wipes Solution 7 5 Dr Schumacher GmbH Hydrogen peroxide ANIOXYDE 1000 Solution 0 15...

Страница 45: ...tion 2 65 Medical Chemical Corporation Glutaraldehyde STERANIOS Solution 2 0 Laboratoires ANIOS Glutaral Cidex plus Solution 3 4 ADVANCED STERILIZATION PRODUCTS A Johnson Johnson company Division of Ethicon Inc Note indicates that the marked disinfectant is not applicable in Canada Warning After disinfection thoroughly rinse the probe with deionized water Residual disinfectant can cause an adverse...

Страница 46: ...on the surface of the equipment 4 Safety tests See section 8 1 5 11 Packaging Store the disinfected probe in a dustproof environment until next application Before sterilization it is necessary to pack all parts in a pouch suitable for sterilization or in a tray with wrap according to ISO 11607 1 and ISO 11607 2 Packaging for terminally sterilized devices and ISO TS 16775 Packaging for terminally s...

Страница 47: ...zation Sterile conditions of applicable sterilization methods are as follows Regarding the operation of the sterilizer refer to the documentation supplied with the sterilizer Perform sterilization in the following conditions Gas Type 10 EO 90 HCFC Temperature 50 60 C 122 140 F Exposure Time More than 120 minutes Pressurization 162 200 kPa Depressurization 13 8 kPa Relative humidity 40 90 Aeration ...

Страница 48: ...ce or safety Warning Do not use the waterproof cover during sterilization process Caution Do not sterilize the probe using the STERRAD system if the probe is not compatible with the STERRAD system STERRAD compatibility is shown by the STERRAD label on the con nector Perform STERRAD sterilization only for STERRAD compatible probes otherwise it can cause damage or deterioration to the probe Do not p...

Страница 49: ...on of Ethicon Inc Note indicates that the marked sterilant is not applicable in Canada Warning After chemical sterilization thoroughly rinse the probe with sterile water Residual sterilant can cause an adverse reaction to the operator or patient 5 12 4 STERIS sterilization The applicable product is listed below General name Trade name Manufacturer Peracetic acid STERIS SYSTEM 1E STERIS Regarding t...

Страница 50: ... 44 MN1 5531 Rev 10 ...

Страница 51: ...sinfection and sterilization and then store it in its storage case Caution Be sure to store the waterproof cover by removing it from the connector If the waterproof cover is stored while connected to the probe the packing can become deformed 6 2 Environmental conditions for storage For details about the storage environmental conditions see section 2 5 2 Storage environmental conditions ...

Страница 52: ... 46 MN1 5531 Rev 10 ...

Страница 53: ... for transportation Store in the storage case after performing the procedure in section 5 Cleaning disinfection and sterilization and then put the storage case in a cardboard box for additional protection 7 4 Environmental conditions during transportation Ambient temperature 10 C to 50 C 14 F to 122 F Relative humidity 10 to 90 Atmospheric pressure 700 hPa to 1060 hPa Note The probe is a precision...

Страница 54: ... 48 MN1 5531 Rev 10 ...

Страница 55: ...lution beyond the IPX7 range provided in section 2 2 2 Test of patient leakage current caused by an external voltage on the patient connection of an F type applied part Using the measuring instruments which usable to the requirement of IEC 60601 1 2005 conduct the test as shown in Fig 16 of IEC 60601 1 2005 Soak the probe tip in saline solution and measure the leakage current between the applied p...

Страница 56: ...ow gaps between them for confirming the resolution This enables you to check the level of detail that images can be viewed on the display For phantoms with no targets the resolution determines the fineness of the displayed textures The sensitivity can be determined by examining the luminance of ultrasonic images Other factors that affect the resolution include the type of connected probe gain focu...

Страница 57: ...use this probe in combination with either a puncture adapter or CIVCO bracket and CIVCO probe cover or biopsy needle guide set Puncture adapter MP 2458 MP 2783 Puncturing for the internal jugular vein CIVCO Bracket 614 068 CIVCO Probe cover Biopsy needle guide set 610 608 Waterproof cover MP 2790 Attaching the waterproof cover MP 2790 option enables sorking in liquid up to the connector ...

Страница 58: ... 52 MN1 5531 Rev 10 ...

Страница 59: ...easures Disposal of the equipment without taking the proper preventative measures can lead to infection Waste Electrical and Electronic Equipment WEEE Directive The illustration on the right is required by the EU WEEE Directive to appear on all electrical and electronic equipment For proper disposal of this product in an EU nation contact an EU office or agency and observe appropriate local and na...

Страница 60: ...81 3 6284 3668 http www hitachi com businesses healthcare index html Overseas Offices Hitachi Medical Systems GmbH Otto von Guericke Ring 3 D 65205 Wiesbaden Germany EU Importer Hitachi Medical Systems Europe Holding AG Address Sumpfstrasse 13 CH 6300 Zug Switzerland Distributor MN1 5531 Rev 10 17 01 11 ...

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