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MN1-5029 Rev.22

Label 3

Label 2

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

STERRAD sterilization compatibility 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.

Model

Serial No.

Manufacturer

Address

Rx Only:

By prescription only. U.S. Federal Law restricts

this device to sale on order of a physician only.

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 Directive 93/42/EEC

relating to Medical Device and Directive 2011/65/EU

relating to RoHS.

Содержание UST-676P

Страница 1: ...his Instruction 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 Transrectum Puncture Electronic Convex Probe UST 676P Instruction Manual MN1 5029 Rev 22 ...

Страница 2: ...ii MN1 5029 Rev 22 ...

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: ...of ME equipment 17 3 Preparations for Use 19 3 1 Start up check of the probe 19 3 1 1 Visual check 19 3 1 2 Verification of cleaning disinfection and sterilization 19 3 1 3 Verification of operation 19 3 2 Start up check of the puncture guide tube 20 3 2 1 Visual check 20 3 2 2 Mechanical inspection 20 3 2 3 Mounting of rubber boot 20 3 2 4 Verification of operation 20 3 3 Checking the needle echo...

Страница 5: ...tenance inspection and testing 44 5 10 Packaging 44 5 11 Sterilization 45 5 11 1 Ethylene oxide EtO gas sterilization 45 5 11 2 STERRAD sterilization 46 5 11 3 Liquid sterilization USA only 47 5 11 4 Autoclave sterilization 47 5 12 Storage 47 6 Storage 49 6 1 Actions before storage 49 6 1 1 Actions before storing the probe 49 6 2 Environmental conditions for storage 49 7 Moving and Transporting 51...

Страница 6: ...vi MN1 5029 Rev 22 9 Configuration 57 9 1 Standard configuration 57 9 2 Options 57 10 Disposal of the Device 59 This Instruction Manual contains the main body of 60pages and 6pages until the CONTENTS ...

Страница 7: ...played 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 or patient Caution Indicates a potentially haz...

Страница 8: ... Note that the probe is not sterilized at the factory Before using the probe first be sure to clean disinfect and sterilize it Wear medical gloves during examination Conducting examinations with the bare hands can expose the operator to a risk of infection Dispose the probe used for patients with Creutzfeldt Jakob disease Otherwise there is a risk of infection to the operator or patient Our ultras...

Страница 9: ...se refer to the documentation supplied with the ultrasound diagnostic instrument Regularly perform maintenance inspection and safety tests of the ultrasound diagnostic instrument and probe and the puncture guide tube If you use equipment for a long period of time it can reduce the performance or cause smoke or fire If anything unusual occurs immediately stop using it and contact one of our offices...

Страница 10: ...ium 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 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 expo...

Страница 11: ...n unsterilized acoustic medium can cause an infection on the patient Check that the gauge size of the puncture needle that is used matches the gauge size of the puncture guide tube Using when the gauge sizes of the puncture needle and puncture guide tube do not match can result in puncturing of an unintended body part Also even if the gauge size is the same the diameters may vary between different...

Страница 12: ...intended body part and causing an injury to the patient For details about the reuse and disposal of puncture needles follow the instructions in the documentation supplied with the puncture needles Reuse of puncturing needles that are not reusable or improper disposal could result in an infection Do not use the puncture guide tube fallen on to floor Otherwise there is a risk of infection Stop the o...

Страница 13: ...ean 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 and the puncture guide tube or reduced performance The probe washing brush and storage tray cannot withstand autoclave sterilization or boiling and other types of sterilization at temperature...

Страница 14: ... 8 MN1 5029 Rev 22 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 1 2 5 Labels 1 Probe unit Label 3 Label 2 Label 1 Label 1 Electronic convex probe mark Frequency MH z ...

Страница 15: ... with a local regulation See section 10 Model Serial No Manufacturer Address Rx Only By prescription only U S Federal Law restricts this device to sale on order of a physician only 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...

Страница 16: ... 10 MN1 5029 Rev 22 Label A 2 Storage case Label C Label B Label D ...

Страница 17: ...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 ...

Страница 18: ...r latex RUBBER BOOT RB 665P NS MADE IN JAPAN Rx Only Non sterile 10 pieces RUBBER BOOT RB 665P NS LOT MADE IN JAPAN Rx Only Hitachi Medical Systems GmbH Otto von Guericke Ring 3 D 65205 Wiesbaden Germany Lot number Label for 10 pieces Rx Only By prescription only U S Federal Law restricts this device to sale on order of a physician only ...

Страница 19: ...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 20: ...80 Frequency 3 0 to 8 5MHz Cable length 2 5 m Weight 1 000 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 1000 IPX7 range Range...

Страница 21: ...ture guide tube Material Stainless steel Usable puncture needle sizes and diameter 18G 1 26 0 02mm Service life Three years External dimensions As shown in the figure below 119 20 15 5 Remarks The dimensions are within 10 of the indicated values Unit mm ...

Страница 22: ...s tube is attached to the probe to help insert the probe needle Attach it as described in the instructions in section 4 4 Rubber boots Cover the insertion part with this rubber boots to prevent infection Follow the instructions in section 4 2 Guide tube Rear guide Holding clip Cover Please do slide on the cable side and detach it when you do puncturing Ultrasonic irradiation area This incorporates...

Страница 23: ...lt sulfur 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 o...

Страница 24: ... 18 MN1 5029 Rev 22 ...

Страница 25: ...play 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 and the puncture...

Страница 26: ...spection Check the puncture guide tube mechanism while attached to the probe The screws have no looseness backlash immobility or other abnormalities The puncture guide tube is firmly attached to the probe There are no tears in the rubber boot 3 2 3 Mounting of rubber boot Cover the probe insertion portion with the rubber boot to prevent infection and then attach the puncture guide tube over this 3...

Страница 27: ...the probe and insert the puncture needle into the puncture guide tube Check the puncture needle has no bending or other defects 3 Connect the probe to the ultrasound diagnostic instrument Turn on the ultrasound diagnostic instrument to display the puncture guide line on the monitor screen Remarks For details of the puncture guide line refer to the instruction manual of the ultrasound diagnostic in...

Страница 28: ...e the puncture guide tube See manual of puncture guide tube MP 2452 2 Clean disinfect and sterilize the probe to be used in accordance with its usage purpose Warning Clean disinfect and sterilize before using the equipment Perform proper cleaning disinfection and sterilization after use Otherwise there is a risk of infection Note that the equipment is not sterilized at the factory Before using the...

Страница 29: ...than 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 ...

Страница 30: ... 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 the patient about all...

Страница 31: ...nfection prevention measures Disposal of the equipment without taking the proper preventative measures can lead to infection 1 Wrap the rubber boots in tissue paper and remove it from the probe 2 Dispose used tissue paper and rubber boots using infection prevention procedures based on the rules of your facility ...

Страница 32: ...e top of the puncture guide tube holding clip are squeezed from both sides the hold ing clip opens 2 Open the holding clip and insert the hooks of the front guide into the grooves on both sides of the probe tip as shown in figure below 3 Put the holding clip on the fixing position 4 When part marked G is pushed holding clip closes and fixes on the probe Needle size is indicated G Squeeze handles f...

Страница 33: ...ndles on the top of the puncture guide tube holding clip are squeezed from both sides the holding clip opens 2 Open holding clip and pull up the puncture guide tube as shown in figure below 3 Immediately clean disinfect and sterilize the puncture guide tube after it is removed from the probe Move and check the fixing condition Confirm that there are no air bubbles on the acoustic irradiation area ...

Страница 34: ...e 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 instrument This...

Страница 35: ...er 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 sterilization of t...

Страница 36: ...sing an unsterilized ultrasound medium can cause an infection on the patient Check that the gauge size of the puncture needle that is used matches the gauge size of the puncture guide tube Using when the gauge sizes of the puncture needle and puncture guide tube do not match can result in puncturing of an unintended body part Also even if the gauge size is the same the diameters may vary between d...

Страница 37: ...ng of an unintended body part and causing an injury to the patient For details about the reuse and disposal of puncture needles follow the instructions in the documentation supplied with the puncture needles Reuse of puncturing needles that are not reusable or improper disposal could result in an infection Do not use the puncture guide tube fallen on to floor Otherwise there is a risk of infection...

Страница 38: ...al treatment 4 9 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 39: ...le cleaning disinfection and sterilization methods Model Refer the corresponded items in Chapter 5 3 5 5 5 6 and 5 8 Cleaning Disinfection Sterilization Waterproof cover MP 2790 Manual Automated 1 Manual Automated 1 EtO STERRAD Liquid 2 Autoclave STERIS UST 676P A X X X X X Accessories Washing brush Size M L Ki 266 Size L L Ki 265 B X X X X X X Note X means Applicable 1 Automated Need waterproof c...

Страница 40: ...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...

Страница 41: ... 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...

Страница 42: ...use Pre cleaning Containment and transportation Manual cleaning Automated cleaning Rinsing after manual cleaning Automated disinfection Manual disinfection Rinsing after manual disinfection Drying Maintenance inspection and testing Packaging Sterilization Drying NOTE Only the accessories are compatible with automated reprocessing according to the flowchart above ...

Страница 43: ...rface of the accessory looks visually clean 2 Wipe the whole surface of the accessory by gauze pad 5 4 Containment and 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 immerse the probe in any...

Страница 44: ...ment gloves water repellent protective skirt face protection mask or protective glasses see also instructions of the manufacturer for the detergent and the disinfectant B Accessories 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 approv...

Страница 45: ...t of the probe in a tray filled with deionized water tap water for 5 min 7 Visually check the outer surface of the probe for cleanness If necessary use magnifying glass for visually check If there is still soil visible repeat all above steps B Accessories 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 d...

Страница 46: ...t If necessary repeat the rinsing Caution Do not wipe the ultrasonic radiation part with alcohol Alcohol could damage the part B Accessories 1 Before immersing the equipment it is recommended to test the concentration of disinfectant solution before each usage The solution Cidex OPA is ready for use and does not need to be diluted Test strips to verify that the appropriate concentration of Cidex O...

Страница 47: ...B Accessories The following items must be provided prior to automated cleaning and disinfection a Washer disinfector according to ISO 15883 with chemo thermal program temperature max 60 C 140 F b Detergent Korsolex Endo Cleaner Bode Chemie 972 020 c Disinfectant Korsolex Endo Disinfectant Bode Chemie 972 030 1 The parameters of the cleaning and disinfection of the device are as follows Program ste...

Страница 48: ...ution 2 4 ADVANCED 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 Dimethyl dio...

Страница 49: ...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 50: ...owing 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 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 s...

Страница 51: ...ration 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 Relative humidity 40 90 Aeration is minimum 12 hours RB 665P NS Perform sterilization in the following conditions Gas Type 30 EO ...

Страница 52: ...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...

Страница 53: ...aral 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 reaction to the operator or patient 5 11 4 Autoclave sterilization A Probe Warning The probe cann...

Страница 54: ... 48 MN1 5029 Rev 22 ...

Страница 55: ...e tube and store it in the sterilized storage tray Warning Store it in a sterilized storage tray If the puncture guide tube is stored in an unsterilized storage tray the puncture guide tube can become contaminated and cause an infection Caution Be sure to close the clip while it is not being used When holding clip is left open for a long time the spring may loose force or even break 6 2 Environmen...

Страница 56: ... 50 MN1 5029 Rev 22 ...

Страница 57: ... for transportation Store in the storage case and the storage tray 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...

Страница 58: ... 52 MN1 5029 Rev 22 ...

Страница 59: ...ine 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 leakage curr...

Страница 60: ...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 61: ...hecking the needle echo Also conduct the safety tests for the probe that is used Warning Be sure to perform a safety test at least once a year Failure to notice an abnormal condition while using the equipment can result in an injury to the operator or patient If a problem is found in the inspection immediately stop use and contact one of our offices and or distributor s offices listed on the back ...

Страница 62: ... 56 MN1 5029 Rev 22 ...

Страница 63: ...ay MP 2724 1 set Instruction manual MN1 5029 1 copy Storage case STB 45 PA1 1 set 9 2 Options Puncture guide tube The following puncture guide tubes are provided for various puncture needle sizes MP 2452 G14 for 14G needles MP 2452 G16 for 16G needles MP 2452 G21 for 21G needles Washing brush L L Ki 265 for MP 2452 G14 Rubber boot RB 665P NS unsterilized ...

Страница 64: ... 58 MN1 5029 Rev 22 ...

Страница 65: ...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...

Страница 66: ...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 5029 Rev 22 17 01 11 ...

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