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Hitachi EUP-L75 Instruction Manual Download Page 33

 

 

- 27 - 

Q1E-EP1199 

 

6.  Maintenance and Safety Inspection   

1)

 

Visually inspect the surface of the probe head, housing, cable 
and connector for any crack, scratch or denaturalization. If you 
find any damage, do not use the probe and contact a service support 
immediately. 

2)

 

Visually inspect the surface of the magnetic sensor attachment 
and the spacer for RV2S for any crack, deformation or 
denaturalization. If you find any damage, do not use them and 
contact a service support immediately. 

3)

 

Visually inspect the surface of the elasto coupler for any crack, 
deformation or denaturalization. If you find any damage, do not 
use it and contact a service support immediately. 

 

4)

 

After using the probe, the magnetic sensor attachment, the spacer 
for RV2S and the elasto coupler, it should be cleaned and disinfected 
and sterilized according to “

 5.Reprocessing Procedure

”, then store it 

in a cool and dark place and avoid high temperature, humidity and 
direct sunlight. 

 

Summary of Contents for EUP-L75

Page 1: ...9 9 Hitachi Ltd 2013 2017 All rights reserved Notes for operators and responsible maintenance personnel Please read through this Instruction Manual carefully prior to use Keep this Instruction Manual together with the system with care to make it available anytime 0123 ...

Page 2: ...1 3 6284 3668 http www hitachi com businesses healthcare index html European Representative 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 Local Distributor ...

Page 3: ...uestions concerning the manual please contact a service support The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning is used to indicate the presence of a hazard which can cause severe personal injury death or substantial property damage if the warning is ignored CAUTION Caution is used to indicate the presence of a hazard which will or...

Page 4: ...ymbol Symbol Descriptive Content Manufacturer Company Name and Address Hitachi Ltd 2 16 1 Higashi Ueno Taito ku Tokyo 110 0015 Japan 81 3 6284 3668 http www hitachi com businesses healthcare index html Authorized Representative in The European Community Hitachi Medical Systems GmbH Otto von Guericke Ring 3 D 65205 Wiesbaden Germany Keep away from Sunlight Store the probe in a cool dry and dark pla...

Page 5: ...ltage Probe connector Caution Biohazard Probe connector Follow the instruction manual to operate this instrument If not avoided may result in injury property damage or the equipment trouble Probe connector STERRAD sterilization compatibility mark Probe connector Upper Limit of Temperature The probes that are applicable to Ethylene Oxide Gas Sterilization use symbol of Upper Limit of Temperature 55...

Page 6: ...dure 6 4 Option of EUP L75 10 4 1 Magnetic sensor EZU RV2S 10 4 2 Magnetic sensor EZU RV3S 13 4 3 elasto coupler 16 5 Reprocessing Procedure 17 5 1 Point of use Pre cleaning 20 5 2 Containment and transportation 20 5 3 Manual Cleaning and disinfection 20 5 4 Drying 24 5 5 Inspection 24 5 6 Packaging 24 5 7 Sterilization 24 5 8 Storage 26 6 Maintenance and Safety Inspection 27 7 Safety Precautions ...

Page 7: ...r enable image diagnosis using ultrasonic waves This system operates under the principles described below 1 When an electric pulse signal is applied from the transmitter to the transducer of the probe the transducer converts electric signals into mechanical vibration energy for emitting pulse shaped ultrasonic waves into the body part liquid or other medium contacting the transducer 2 The emitted ...

Page 8: ... scanner Mammary gland Thyroid Superficial organs 1 4 Composition The probe components of the EUP L75 are as follows 1 Probe EUP L75 1 piece 2 Instruction Manual 1 copy Sterilization has not been made to the probe the magnetic sensor attachment the spacer for RV2S and the elasto coupler shipped from the factory Prior to use be sure to clean disinfect and sterilize them CAUTION ...

Page 9: ...7L3 1 5 5 Acoustic coupler attachment EZU TEATC2 Option 1 Cover 1 piece 2 Base 1 piece 3 Instruction manual 1 copy Acoustic coupler attachment EZU TEATC2 fixes the acoustic coupler EZU TECPL1 or SF 001 to the probe The SF 001 and EZU TECPL1 are intended to be used for having a clear superficial image by keeping a certain distance between the probe and the skin EZU TECPL1 is used when the operator ...

Page 10: ...ed by water Un immersible part This part should not be immersed in disinfectant solution and also can not be cleaned by water Head Connector Cable elasto coupler for EUP L75 Option Spacer for EZU RV2S Option Magnetic sensor attachment for EUP L75 Option Applied part Acoustic coupler attachment EZU TEATC2 Option Acoustic coupler EZU TECPL1 Option or Acoustic coupler SF 001 Option ...

Page 11: ...spection of material surface 2 2 1 Visually check the surface of the probe head housing and cable for any crack scratch or denaturalization If you find any damage do not use the probe and contact a service support immediately 2 2 2 Visually inspect the magnetic sensor attachment and the spacer for RV2S for any crack deformation or denaturalization If you find any damage do not use them and contact...

Page 12: ... ultrasound diagnostic scanner operate the scanner and adjust the image all according to the instructions given in the operation manual for the ultrasound diagnostic scanner with which the probe is used as connected 4 Relationship between direction of the probe and the image is shown in Fig 2 The right left orientation mark on the image indicates the index mark on the probe Fig 2 Relationship betw...

Page 13: ...action Please use allergy free material covers 7 After the use of the probe the magnetic sensor attachment the spacer for RV2S and the elasto coupler it should be cleaned and disinfected or sterilized then store it in an adequate place 8 Store the probe the magnetic sensor attachment the spacer for RV2S and the elasto coupler in the environment indicated in 6 Maintenance and Safety inspection Mark...

Page 14: ...ssist does not correspond to the display scale and the width of the probe does not correspond to the image width displayed in the image see the Figure below Display scale The scale of the Marking Assist Not correspond The width of the probe does not correspond to the image width CAUTION ...

Page 15: ...ctured very thin and delicate to get the high resolution Therefore in case of wiping off the ultrasound jelly or cleaning the surface of the acoustic lens please use a soft cloth or tissue paper and handle with care See Fig 4 Soft cloth or tissue Acoustic lens Fig 4 Wiping off the ultrasound jelly or cleaning the surface of the acoustic lens CAUTION ...

Page 16: ...etic sensor EZU RV2S for EUP L75 is shown in Fig 5 4 1 1 How to attach the magnetic sensor EZU RV2S The procedure of attaching the magnetic sensor EZU RV2S is as follows 1 Confirm that the probe and the magnetic sensor attachment are cleaned disinfected and or sterilized 2 Connect the probe operate the ultrasound diagnostic scanner and adjust the image according to the instructions given in the op...

Page 17: ...tachment to the probe at the incorrect direction otherwise it may result false diagnosis Never forget to attach the spacer for RV2S to the magnetic sensor otherwise it may result in false diagnosis Projected part of the magnetic sensor attachment Spacer for EZU RV2S Projected part of the magnetic sensor Magnetic sensor EZU RV2S Fig 6 How to attach the Magnetic sensor Fit the insertion direction Ma...

Page 18: ... it from the probe as shown in Fig 8 2 Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 9 and release the spacer for RV2S from the magnetic sensor The spacer for RV2S is small please do not lose it Fig 8 How to release the Magnetic sensor attachment from the probe Fig 9 How to release the EZU RV2S from the Magnetic sensor attachment CAUTION ...

Page 19: ...and the magnetic sensor attachment are cleaned disinfected and or sterilized 2 Connect the probe operate the ultrasound diagnostic scanner and adjust the image according to the instructions given in the operation manual for the ultrasound diagnostic scanner 3 To use RVS Real time Virtual Sonography attach the magnetic sensor as shown below Direction mark Fig 10 Magnetic sensor EZU RV3S Magnetic Se...

Page 20: ...ark of the probe Never attach the magnetic sensor attachment to the probe at the incorrect direction otherwise it may result in false diagnosis Index mark Projected part of the Magnetic sensor attachment Fig 12 How to attach the Magnetic sensor attachment Fit the insertion direction Fig 11 How to attach the Magnetic sensor Projected part of the Magnetic sensor attachment Direction mark of the Magn...

Page 21: ...Turn around the magnetic sensor attachment and remove it from the probe as shown in Fig 13 2 Release the magnetic sensor from the magnetic sensor attachment as shown in Fig 14 Fig 13 How to release the Magnetic sensor attachment from the probe Fig 14 How to release the Magnetic sensor from the Magnetic sensor attachment ...

Page 22: ...lasto coupler as shown below Attach the elasto coupler on the probe as straight as possible as shown in Fig 15 4 3 2 How to release the elasto coupler Release the elasto coupler from the probe as shown in Fig 16 elasto coupler Fig 15 How to attach the elasto coupler Fig 16 How to release the elasto coupler ...

Page 23: ...ocessing it WARNINGS The probe is delivered unsterile Prior to the first use reprocess the probe Temperature should not exceed 60 C during reprocessing Probe connector is not water resistant Limitations on reprocessing The probe is not completely submersible The immersible part is shown in Fig 1 The un immersible part should be disinfected by wipe disinfection Transportation before using The probe...

Page 24: ...his topic is listed in the table below The user is responsible for correct classification of the medical device Classification Definition Processing uncritical Application part only contacts intact and uninjured skin Cleaning Disinfection semicritical Application part contacts mucosa intracavitary application Cleaning Disinfection Disinfectant with virucidal effect critical Application part contac...

Page 25: ...ocess of this probe is as follows Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Disinfection Drying Manual cleaning and disinfection Rinsing after manual disinfection Packing Sterilization Containment and transportation ...

Page 26: ...eaning and disinfection a Detergent Cidezyme Johnson Johnson 2258 or another cleaning agent with approved material compatibility for this medical device b Disinfectant Cidex OPA Johnson Johnson 20391 or another disinfectant with approved material compatibility for this medical device c Two tanks one for cleaning and one for disinfection optional 1 additional tank for rinsing with deionized tap wat...

Page 27: ...ergent solution according to the specified contact time of the detergent manufacturer 4 Wipe the un immergible parts of the probe with a soft cloth dipped with the detergent solution 5 Rinse the probe with running tap water for 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 17 for 5 min 6 Visually check the outer surface of t...

Page 28: ...ersing the probe 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 Temperature of disinfectant solution should be minimum 20 C The minimum contact time is 5 minutes If a ...

Page 29: ...e spacer for EZU RV2S with deionized water for 1 minute alternatively immerse them in a tray filled with deionized water see Fig 17 for 5 min 4 Visually check the outer surface of the magnetic sensor attachment and the spacer for EZU RV2S for leavings of the disinfectant If necessary repeat the rinsing Water Detergent Disinfectant Fig 17 Immersion of the probe the magnetic sensor attachment the sp...

Page 30: ...covered with a sterile barrier Additionally the probe can be placed on plastic mesh wires supplied for plasma sterilization and then packed as mentioned above The probe can be packed in a simple or double packing Please note that the size of a sterile barrier should be large enough to be able to pack the equipment leaving sufficient space to seal it completely A sterile barrier should be sealed by...

Page 31: ...Pa Depressurization 13 8kPa Relative humidity 40 90 Aeration is minimum 12 hours STERRAD systems are manufactured by Johnson Johnson 1 Before performing sterilization check that the operation data of sterilizer are in conjunction with min and max data applicable for the probe and the attachment 2 Do not sterilize the probe and the attachment by Steam Autoclaving If you autoclave them they suffer s...

Page 32: ... plastic mesh wire for sterilization 5 8 Storage Store the equipment in a cool dustproof and dark space to avoid high temperature humidity and direct sunlight Limitations for the time for sterilized equipment belong to package Sealed Fig 19 Sealing TYVEK Pouch Tray for sterilization Fig 20 Packaging in a tray Probe in the Pouch ...

Page 33: ...ation or denaturalization If you find any damage do not use them and contact a service support immediately 3 Visually inspect the surface of the elasto coupler for any crack deformation or denaturalization If you find any damage do not use it and contact a service support immediately 4 After using the probe the magnetic sensor attachment the spacer for RV2S and the elasto coupler it should be clea...

Page 34: ...ent to the patient By examination of an early pregnancy the exposure time shall be as short as possible Start examination with acoustic output power set to L Low The probe connector is not waterproof Do not allow liquid to contact the connector Do not drop hit or bent the probe Use only water detergents and disinfectants in the suppliers list Between uses store the probe holder off scanner Under s...

Page 35: ...production and upgrade status For detailed information contact a service support Classification MDD classification IIa Cleaning Applicable detergents are listed in the supplier s list Disinfection Applicable disinfectants are listed in the suppliers list Sterilization ETO gas sterilization Plasma sterilization Operating conditions Ambient temperature 25 35 C Contact surface temperature max 42 C Te...

Page 36: ...Disinfectant ANIOXYDE1000 ANIOS Disinfectant Virkon S ANIOS Disinfectant ASPHENE SPRAY RIVADIS Laboratories Disinfectant Bacillol 25 BODE CHEMIE Disinfectant CIDEX Johnson Johnson Disinfectant CIDEX plus Johnson Johnson Disinfectant CIDEX OPA Johnson Johnson Disinfectant Gigasept FF Schülke Mayr Disinfectant Tristel 1 Day Tristel Company Disinfectant Tristel Multi Shot Tristel Company Disinfectant...

Page 37: ...es 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 nationa...

Page 38: ... 32 Q1E EP1199 Unit mm Fig 21 Dimensions 2200 43 59 105 9 25 ...

Page 39: ... 33 Q1E EP1199 Fig 22 External view with the Elast coupler ...

Page 40: ... 34 Q1E EP1199 Fig 23 External view with the Magnetic sensor attachment ...

Page 41: ... 35 E Fig 24 External View with the Acoustic coupler attachment EZU TEATC2 and the Acoustic coupler EZU TECPL1 or SF 001 ...

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