Hitachi UST-547 Instruction Manual Download Page 15 | Manualshive

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MN1-5053 Rev. 15

Label A

Label B

2016

DATE OF MANUFACTURE

(in case of 2016)

MANUFACTURER

This instrument complies with Directive 93/42/EEC

relating to Medical Device and Directive 2011/65/EU

relating to RoHS.

Model

Serial No.

2016

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Summary of Contents for UST-547

Page 1: ...gh this Instruction Manual carefully prior to use Keep this Instruction Manual together with the ultrasound diagnostic instru ment for any future reference Hitachi Ltd 2013 2016 All rights reserved Intraoperative Electronic Linear Probe UST 547 Instruction Manual MN1 5053 Rev 15 ...

Page 2: ...MN1 5053 Rev 15 ii ...

Page 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...

Page 4: ...ing 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 diagn...

Page 5: ...5 5 11 Sterilization 36 5 11 1 Ethylene oxide EtO gas sterilization 36 5 11 2 STERRAD sterilization 37 5 11 3 Liquid sterilization USA only 38 5 12 Storage 38 6 Storage 6 1 Actions before storing the probe 39 6 2 Environmental conditions for storage 39 7 Moving and Transporting 7 1 Moving and transporting 41 7 2 Preparing the probe and accessories for moving 41 7 3 Packing for transportation 41 7 ...

Page 6: ...MN1 5053 Rev 15 ...

Page 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...

Page 8: ... Contact one of our offices and or distributor 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 steril...

Page 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...

Page 10: ...ge such as a tear Take precaution in handling the transducer cover so as not to break it as this may then result in direct contact with the edge of bone during a craniotomy If the transducer cover breaks it may cause harm to the patient Verify that the probe is sterilized Use the sterilized echo jelly attached to our recommended transducer cover as the acoustic medium If you use contaminated ones ...

Page 11: ...erilize 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 performance The probe cannot withstand 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 st...

Page 12: ...53 Rev 15 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 MH z R E L E A S E L O C K Label 3 Label 2 Label 1 Label 1 1 2 4 Labels 1 Probe unit Electronic linear probe mark Frequency ...

Page 13: ...tibility mark See section 5 IPX7 mark See section 2 2 Specifications Type BF applied part Do not waste the instrument as general waste Comply with a local regulation See section 10 Safety warning sign Biohazard See section 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 Direct...

Page 14: ... 8 MN1 5053 Rev 15 Label A 2 Storage case Label B ...

Page 15: ...ev 15 Label A Label B 2016 DATE OF MANUFACTURE in case of 2016 MANUFACTURER This instrument complies with Directive 93 42 EEC relating to Medical Device and Directive 2011 65 EU relating to RoHS Model Serial No 2016 ...

Page 16: ... 10 MN1 5053 Rev 15 ...

Page 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...

Page 18: ...mended transducer cover is attached to our probe Connectable instruments SSD α5 SSD α10 Prosound α7 Field of view 28 8mm Frequency 7 0 to 13 0MHz Cable length 2 0 m Weight 990 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 External dimensi...

Page 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 ...

Page 20: ... tip This area is held during operation Cable This cable propagates the ultrasonic signals that are sent and received Front Mark The 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 irradiation area to hard impact ...

Page 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...

Page 22: ... 16 MN1 5053 Rev 15 ...

Page 23: ...lay and 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 ...

Page 24: ... 18 MN1 5053 Rev 15 ...

Page 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...

Page 26: ...iagnostic instrument is frozen Before inserting the probe into the probe connector check 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 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 ...

Page 27: ...removed when in one of the following states 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 This completes the removal of the probe After use perform cleaning disinfection and sterili...

Page 28: ...of the probe When using the probe in neurosurgery applications please attach our recommended transducer cover to our sterilized probe 4 4 When using the probe for neurosurgery applications 4 4 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 surgical gloves and transducer cover in a manner that pre...

Page 29: ... such as a tear Take precaution in handling the transducer cover so as not to break it as this may then result in direct contact with the edge of bone during a craniotomy If the transducer cover breaks it may cause harm to the patient Verify that the probe is sterilized Use the sterilized echo jelly attached to our recommended transducer cover as the acoustic medium If you use contaminated ones it...

Page 30: ...al treatment 4 6 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...

Page 31: ... detail 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 547 X X X X X Note X means Applicable 1 Automated Need waterproof cover 2 Liquid sterilization USA only ...

Page 32: ...zation 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 respective chemical or sterilization equipment Infection can be resulted due to incomplete sterilization Wrong sterilization procedure could cause deterioration of the probe Caution Do not immerse the probe into any liquid beyond the...

Page 33: ... 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 Classification Definition Processing Noncritical Applicatio...

Page 34: ...f this probe is as follows Point of use Pre cleaning Containment and transportation Manual cleaning Rinsing after manual cleaning Drying Manual disinfection Rinsing after manual disinfection Drying Maintenance inspection and testing Packaging Sterilization ...

Page 35: ...nd transportation Putting the contaminated equipment into exclusive shock and damage proof container for transportation is recommended It is recommended that instruments are reprocessed as soon as possible and not later than 4 hours after usage Caution Do not place the insertion portion and handle in any liquids beyond the range shown in the figure right Use when liquid has gotten inside the conne...

Page 36: ...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...

Page 37: ... 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...

Page 38: ... 32 MN1 5053 Rev 15 5 6 Automated cleaning and disinfecting Probe Warning The probe cannot withstand Automated cleaning and disinfecting ...

Page 39: ...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...

Page 40: ...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...

Page 41: ...racks on the surface of the equipment 4 Safety tests See section 8 1 5 10 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 termin...

Page 42: ...1 Ethylene oxide EtO gas sterilization 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 200kPa Depressurization 13 8kPa Rel...

Page 43: ...but this does not affect performance or safety 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 put the probe directly into the ster...

Page 44: ...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 sterilant is not applicable in Canada Warning After chemical sterilization thoroughly rinse the probe with sterile water Residual sterilant can cause an adverse reactio...

Page 45: ...for an extended period of time perform the procedures described in section 5 Cleaning disinfection and sterilization and then store it in its storage case 6 2 Environmental conditions for storage For details about the storage environmental conditions see section 2 5 2 Storage environmental conditions ...

Page 46: ... 40 MN1 5053 Rev 15 ...

Page 47: ... 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...

Page 48: ... 42 MN1 5053 Rev 15 ...

Page 49: ...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...

Page 50: ...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...

Page 51: ... 45 MN1 5053 Rev 15 9 Configuration 9 1 Standard configuration Probe UST 547 1 set Storage case CB UST1 P1 1 set Instruction manual MN1 5053 1 copy ...

Page 52: ... 46 MN1 5053 Rev 15 ...

Page 53: ...ntion measures 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...

Page 54: ...m businesses healthcare index html Overseas Offices Hitachi Medical Ultrasound Logistics Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl Zeiss Strasse 5 D 72555 Metzingen Germany EU Importer Hitachi Medical Systems Europe Holding AG Address Sumpfstrasse 13 CH 6300 Zug Switzerland Distributor MN1 5053 Rev 15 16 04 01 ...

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