Hitachi Aloka Medical ASU-1003, Instruction Manual

Page 1: ...i MN1 5008 Rev 7 MN1 5008 Rev 8 Transvaginal Electronic Convex Sector Scanner ASU 1003 Instruction Manual MN1 5008 Rev 8 ...

Page 2: ...MN1 5008 Rev 7 ii ...

Page 3: ...erities 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 o...

Page 4: ...onmental conditions 14 2 5 2 Storage environmental conditions 14 2 6 Classification of ME equipment 14 3 Preparations for Use 3 1 Start up check 15 3 1 1 Visual check 15 3 1 2 Verification of washing disinfection and sterilization 15 3 1 3 Verification of operation 15 4 Usage 4 1 Operation 17 4 2 Mounting of rubber boot 18 4 3 Removal of rubber boot 19 4 4 Connecting to the ultrasound diagnostic i...

Page 5: ...onmental conditions for storage 29 7 Moving and Transporting 7 1 Moving and transporting 31 7 2 Preparing the scanner for moving 31 7 3 Packing for transportation 31 7 4 Environmental conditions during transportation 31 8 Periodic Inspection 8 1 Safety tests 33 8 2 Testing of measurement tolerances 34 8 2 1 Conducting tests 34 8 2 2 Result judgment 34 9 Configuration 9 1 Standard configuration 35 ...

Page 6: ...MN1 5008 Rev 7 vi ...

Page 7: ...s 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 or patient Caution Indicates a potentially hazardous situation which if not avoided may result in m...

Page 8: ... examination Conducting examinations with the bare hands can expose the operator to a risk of infection Dispose of scanners used for patients with Creutzfeldt Jakob disease Otherwise there is a risk of infection to the operator or patient Currently there are no methods for washing disinfecting and sterilizing scanners which have been used on patients afflicted by Creutzfeldt Jacob disease When usi...

Page 9: ...perform maintenance of the equipment specified in this manual Long term use of the equipment could reduce the performance or cause smoke or fire If finds any abnormal condition immediately stop use the equipment and contact one of our offices and or distributor s offices listed on the back cover Use move and transport the scanner under the environmental conditions specified in this manual Otherwis...

Page 10: ...n can cause an infection on the patient Do not use on patients who may have an allergic reaction to latex products Use of the rubber boot for these types of patients could result in anaphylactic shock Ask the patient about allergy history beforehand Caution Check the rubber boot for abnormalities before use Store the rubber boots in a cool dry location not exposed to direct sunlight and do not use...

Page 11: ...the scanner with sterilized water Residual chemicals can cause an adverse reaction on the bodies of the operator or patient Perform aeration completely after gas disinfection Residual gas can cause an adverse reaction on the bodies of the operator or patient Do not wash disinfect or sterilize using procedures other than those specified in this manual Infection could result due to incomplete washin...

Page 12: ... 6 MN1 5008 Rev 7 Label 3 Label 2 Label 1 Label 1 Electronic convex scanner mark Frequency 1 2 4 Labels 1 Scanner unit ASU 1003 ASU 1003 ...

Page 13: ... Specifications Type BF applied part Do not waste the equipment as general waste Comply with a local regulation See section 10 Manufacturer Model Serial No Safety warning sign Biohazard See section 5 Follow the instruction manual to operate this equipment If not avoided may result in injury property damage or the equipment trouble IPX7 ...

Page 14: ... 8 MN1 5008 Rev 7 Label A 2 Storage case Label B ...

Page 15: ... 9 MN1 5008 Rev 7 MN1 5008 Rev 8 Label A Model Serial No Label B 2012 This equipment complies with Directive 93 42 EEC relating to Medical Device DATE OF MANUFACTURE in case of 2012 MANUFACTURER 2012 ...

Page 16: ... 5008 Rev 8 Use by Do not reuse Keep away from sunlight 3 rubber boot Label for 1 piece Contains or presence natural rubber latex Non sterile Lot number Label for 10 pieces 10 pieces RUBBER BOOT RB 945BP NS LOT MADE IN JAPAN ...

Page 17: ...ducer 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 conversion operation to convert the received mechan...

Page 18: ...requency 6 0MHz Cable length 2 0 m Weight 1 350 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 External dimensions As shown in the figure below Unit mm Remarks The dimensions and weight are within 10 of the indicated values Cable length Range of applied part Parts trea...

Page 19: ... covers the insertion portion for preventing infection Follow the instructions in section 4 2 Insertion portion The component that is inserted into the patient Handle This section is held when performing insertion Connector This is the part that connects the ultrasound diagnostic instrument and scanner Follow the instructions in section 4 4 Cable This cable propagates the ultrasonic signals that a...

Page 20: ...ur 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 scanner from a cool location to a warm one Us...

Page 21: ...scanner match the convex display and the displayed frequency and check the image for errors Verify that there are no abnormal vibrations or noise Remarks For details on the displayed screens see the documentation supplied with the ultrasound diagnostic instrument Warning Be sure to preparations for use Using the scanner without noticing an abnormal condition can result in injury to the operator or...

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Page 23: ...ecessary 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 scanner The ...

Page 24: ...an infected item could spread infection to the patient Do not apply unsterilized acoustic medium to the outer surface of the rubber boot Use of an acoustic medium that is contaminated by a pathogen can cause an infection on the patient Do not use on patients who may have an allergic reaction to latex products Use of the rubber boot for these types of patients could result in anaphylactic shock Ask...

Page 25: ...ing of the equipment disinfect or take other infection prevention measures Disposal of the equipment without taking the proper preventative measures can lead to infection After remove the equipment from the patient check for anything abnormal about the rubber boot If the rubber boot stay inside of the patient s body the rubber boot can cause injury to the patient When the rubber boot stay inside o...

Page 26: ...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 instrument 5 Connect the cable for driving to...

Page 27: ...rument is frozen 1 Remove the cable for driving to the upper part of the connector box 2 Turn the connector lock lever to align the mark on the lever with the RELEASE position 3 Firmly grasp the connector unit and pull it out from the probe connector of the ultrasound diagnostic instrument This completes the removal of the scanner After use perform washing disinfection and sterilization of the sca...

Page 28: ...4 6 2 Handling the ultrasound 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 the equipment where a problem has been found If used the equipment in an abnormal conditon there is injury to the patient Contact one of o...

Page 29: ...nner with sterilized water Residual chemicals can cause an adverse reaction on the bodies of the operator or patient Perform aeration completely after gas disinfection Residual gas can cause an adverse reaction on the bodies of the operator or patient Do not wash disinfect or sterilize using procedures other than those specified in this manual Infection could result due to incomplete washing disin...

Page 30: ...ng a sponge or gauze or Soaking in cleaning agent Minimize the soaking time Water rinsing Sufficiently rinse the insertion portion and handle using running water to remove all traces of chemicals Warning After soaking in cleaning agents thoroughly wash the scanner with running water Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient 5 1 2 Cable and conn...

Page 31: ...tical liquid 0 1W V DAIICHI SANKYO Co Ltd Disinfection procedure Washing Be sure to wash and fully dry the scanner before disinfection See section 5 1 Soaking in chemical solution Soak the insertion portion and handle in a chemical solution at the shortest time where effective disinfection can be achieved Water rinsing Sufficiently rinse the scanner using sterilized water to remove chemicals Remar...

Page 32: ...ion Disinfection the following conditions Temperature Room temperature Humidity Normal humidity Atmospheric pressure Normal pressure Aeration Aerate the following conditions to ensure that no gases remain Temperature 10 C to 60 C 50 F to 140 F Humidity 30 to 85 Compression to 4 675kPa Decompression to 31 325kPa Period 5 days natural aeration Warning Perform full aeration after gas disinfection Res...

Page 33: ... the scanner tip in a chemical solution at the shortest time where effective sterilization can be achieved Be sure to wash and fully dry the scanner before sterilization See section 5 1 General name Trade name Manufacturer Hydrogen peroxide PERASAFETM Practical liquid 1 62W V ANTEC INTERNATIONAL Warning After chemical sterilization thoroughly wash the scanner with sterilized water Residual chemica...

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Page 35: ... used for an extended period perform the procedures described in section 5 Washing 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 ...

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Page 37: ...ransportation Store in the storage case after performing the procedure in section 5 Washing Disinfection and Sterilization and then put the storage case in a cardboard box for additional protection 7 4 Environmental conditions during transportation Ambient temperature 0 C to 50 C 32 F to 122 F Relative humidity 10 to 90 Atmospheric pressure 700 hPa to 1060 hPa Note The scanner is precision equipme...

Page 38: ... 32 MN1 5008 Rev 7 ...

Page 39: ...in saline solution 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 insertion portion and handle in saline solution and measure the leakag...

Page 40: ...row gaps between them for confirming the resolution This enables 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 scanner gain focus...

Page 41: ... 35 MN1 5008 Rev 7 9 Configuration 9 1 Standard configuration Scanner ASU 1003 1 set Storage case CB UST1 P7 1 set Instruction manual MN1 5008 1 copy 9 2 Options Rubber boot RB 945BP NS unsterilized ...

Page 42: ... 36 MN1 5008 Rev 7 ...

Page 43: ...asures Disposal of the equipment without taking the proper preventative measures can lead to infection Waste Electrical and Electronic Equipment WEEE Directive This products is a duty of the display of WEEE marking is imposed into the European Union EU If dispose this product in the EU member nation should follow the law of each country or local legislation Please contact one of our offices and or...

Page 44: ... shi Tokyo 181 8622 Japan TEL 81 422 45 6049 URL http www hitachi aloka com Hitachi Medical Ultrasound Logistics Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl Zeiss Strasse 5 D 72555 Metzingen Germany Distributor MN1 5008 Rev 8 12 04 01 ...