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MN1-5575 Rev.11

vi

8. Periodic Inspection

8-1. Safety tests .....................................................................................................................49
8-2. 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.

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Summary of Contents for UST-5550

Page 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 Linear Probe UST 5550 Compatible with waterproof cover Instruction Manual MN1 5575 Rev 11 ...

Page 2: ...MN1 5575 Rev 11 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: ...al conditions 15 2 5 1 Operating 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 Deflection portion operation check 17 3 1 3 Trocar connection check 17 3 1 4 Probe insertion check 18 3 1 5 Verification of operation 18 3 1 6 Verification of cleaning disinfection and s...

Page 5: ...ing 34 5 6 2 Manual disinfection 35 5 6 3 Cable and connector 36 5 7 Automated cleaning and disinfecting 36 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 sterilization USA only 43 5 12 4 STERIS st...

Page 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 ...

Page 7: ...g 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 or patient Caution Indicates a potentially hazardous situation which if not avoided may result in minor or moderat...

Page 8: ...ng 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 sterilize the equipment which blood adhered Otherwise there is a risk of infection Also be sure to remove the cap from the protect tube before washing Always use a protective tube ...

Page 9: ...ely move the equipment away from the patient and stop use of the equipment The equipment is vulnerable to damage by impact Therefore handle it with care There is a risk of damage to the equipment when the equipment is fallen or hit somewhere Do not use this probe with other equipment except for those specifically approved in the manual Use with unapproved equipment can result in an electric shock ...

Page 10: ...f 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 equipment or reduced perfo...

Page 11: ...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...

Page 12: ... 6 MN1 5575 Rev 11 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 3 Labels 1 Probe unit Electronic linear probe mark Frequency ...

Page 13: ...pplied 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 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 This instrument complies with Direct...

Page 14: ... 8 MN1 5575 Rev 11 2 Storage case Label A Label C Label B Label D ...

Page 15: ...6 09 DATE OF MANUFACTURE in case 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 ...

Page 16: ... 10 MN1 5575 Rev 11 ...

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: ...t φ10mm Effective insertion distance 380mm Cable length 2 9 m Weight 1200 g Service life Three years Range of applied part As shown in the figure below Parts treated as applied parts As shown in the figure below IPX7 range As shown in the figure below waterproof cover MP 2790 unattached Whole parts of the probe waterproof cover attached External dimensions As shown in the figure below Unit mm Rema...

Page 19: ...protect tube Material Polyetherimide Protect tube Silicon rubber Cap Compatible trocar size 12mm Service life Three years External dimensions As shown in the figure below Unit mm Remarks The dimensions and weight are within 10 of the indicated values ...

Page 20: ...the angle knob Bending it while it is locked could make the probe unusable Angle markers The angle marker is a white line that indicats the angle of deflection portion Connector This is the part that connects the ultrasound diagnostic instrument and probe Follow the instructions in section 4 2 Lock lever This part make the angle knob fixed any direction Protect tube Protects the probe from the ext...

Page 21: ...ulfur 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 U...

Page 22: ... 16 MN1 5575 Rev 11 ...

Page 23: ...t and make sure there are no catching or loose parts Make sure the protect tube has no abnomalities such as scars cracks or separation Make sure the surface of the connector and the cable has no abnomalities such as scars cracks or separation 3 1 2 Deflection portion operation check Gently turn the angle knob in each direction until it stops and check the following Make sure there are no irregular...

Page 24: ...rrors 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 Caution Do not use the probe if the selected probe and image do not match the frequency An incorrect acoustic output can result in...

Page 25: ...ach part Angle knob Turning this wheel in the UP direction the deflection portion will bend to the opposite side of the ultrasonic irradiation area Turning the wheel in the DOWN direction the deflection portion will bend to the side of the ultrasonic irradiation area Lock lever Moving it to fully FREE direction sets free the angle knob and making it to fully LOCK direction sets fix the angle knob ...

Page 26: ...t tube Attach the cap to protect tube 4 1 3 Insertion of the probe Insert the protect tube into the trocar outer sheath and fix the lever to the trocar outer sheath Remarks After fixing the lever cover the insertion opening for the probe by finger to prevent gas leakage Manipulate the angle knob in FREE condition of the lock lever align the angle marker for straighten the deflection portion of the...

Page 27: ...ocar outer sheath The patient can be injured if the protective tube moves unexpectedly or comes off during the operation Also if the cap is not attached correctly the filled gas inside the patient s body will be released making it difficult to perform the procedure Do not try to forcibly perform operations Excessive force cause injury to the patient If an abnormal resistance force is felt stop use...

Page 28: ...gle marker Gently pull out the probe from the protect tube Take care that the trocar outer sheath does not move and pull out the protect tube by release the lever from the trocar outer sheath Immediately clean disinfect and sterilize the probe protect tube and cap Angle knob Deflection portion of probe Protect tube Probe Trocar outer sheath Lever of protect tube Trocar outer sheath ...

Page 29: ...ection portion Removing it while it is locked may injure the patient Whenever you feel a resistance in the probe stop its operation Be sure to sterilize the probe and accessories which blood adhered Otherwise there is a risk of infection Be sure to remove the cap from protect tube before cleaning ...

Page 30: ...nto 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 inserted into the probe connector This completes connection...

Page 31: ...itch 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 sterilization of the probe by followingtheprocedureinsection5 C...

Page 32: ... treatment 4 4 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 equipment where a problem has been found Using a equipment in an abnormal state can cause injury to the patient Contact one of our offic...

Page 33: ... 2 Table 1 Applicable cleaning disinfection and sterilization methods Model Refer the corresponded items in Chapter 5 3 5 5 5 6 and 5 7 Cleaning Disinfection Sterilization Waterproof cover MP 2790 Manual Automated 1 Manual Automated 1 EtO STERRAD Liquid 2 Autoclave STERIS UST 5550 A X X X X X X X X X MP 2485B B X X X X X X X Note X means Applicable 1 Automated Need waterproof cover 2 Liquid steril...

Page 34: ...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...

Page 35: ... 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...

Page 36: ... 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...

Page 37: ... 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 ...

Page 38: ...waterproof cover is attached Also automated cleaning and disinfecting is only available for probes which are compatible with the waterproof cover Therefor refer to the specifications of the 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 water...

Page 39: ...of the manufacturer for the detergent and the disinfectant B Protect tube MP 2485B 1 Detergent ENZOL Cidezyme Johnson Johnson 2258 or another cleaning agent with approved material compatibility for this medical device 2 Disinfectant Cidex OPA Johnson Johnson 20391 or another disinfectant with approved material compatibility for this medical device 3 Cleaning brushes if applicable i e REF 09098 Int...

Page 40: ... all above steps B Protect tube MP 2485B 1 The temperature of the detergent solution should be between 15 30 C 59 86 F concentration is 1 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 medical device 2 Immerge the 3 parts of the disassembled protective tube ...

Page 41: ...e part B Protect tube MP 2485B 1 Confirm the concentration of the disinfectant before immersing the protective tube Although Cidex OPA does not need to be diluted it is recommended to use test strips to verify the concentration The test strips can indicate whether or not the concentration is above the Minimum Effective Concentration MEC Please also note the expiration date of the test stripes Temp...

Page 42: ...e max 60 C 140 F b Waterproof cover for probe connector MP 2790 c Detergent Korsolex Endo Cleaner Bode Chemie 972 020 d Disinfectant Korsolex Endo Disinfectant Bode Chemie 972 030 1 The parameters of the cleaning and disinfection of the device 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 ...

Page 43: ...ction of the protective tube to WD reprocessing tray for the holder and the cap of the protective tube 1 The parameters of the cleaning and disinfection of the device 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 Deio...

Page 44: ...VANCED STERILIZATION 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 ANIOXY...

Page 45: ...taraldehyde WAVICIDE 01 Solution 2 65 Medical Chemical Corporation 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 reaction to the operator or ...

Page 46: ...drying heater at a temperature of less than 60 C 140 F 5 10 Maintenance inspection and testing Confirm following items 1 the function of mechanical moving parts 2 the image performance when the probe is connected to the scanner 3 there are no abnormal exterior damages such as cracks on the surface of the equipment 4 Safety tests See section 8 1 5 11 Packaging Store the disinfected probe and protec...

Page 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 ...

Page 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...

Page 49: ...tes 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 the operation of the sterilize...

Page 50: ... 44 MN1 5575 Rev 11 ...

Page 51: ...disinfection 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 ...

Page 52: ... 46 MN1 5575 Rev 11 ...

Page 53: ...king 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 preci...

Page 54: ... 48 MN1 5575 Rev 11 ...

Page 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...

Page 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...

Page 57: ...tion Probe UST 5550 1 set Protect tube MP 2485B 1 set Cap spare 2 Storage case STB 45 PA3 1 set Instruction manual MN1 5575 1 copy 9 2 Options Waterproof cover MP 2790 Attaching the waterproof cover MP 2790 option enables sorking in liquid up to the connector ...

Page 58: ... 52 MN1 5575 Rev 11 ...

Page 59: ...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 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 5575 Rev 11 17 01 11 ...

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