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C22K Probe
INSTRUCTION MANUAL
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.
Tokyo, Japan
Q1E‐EP1389‐5
©Hitachi, Ltd. 2013,2017. All rights reserved.
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Table of Contents
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Summary of Contents for Hitachi C22K
- Page 1 C22K Probe INSTRUCTION MANUAL 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. Tokyo, Japan Q1E‐EP1389‐5 ©Hitachi, Ltd. 2013,2017. All rights reserved.
- Page 2 Manufacturer: 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 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: Q1E-EP1389...
- Page 3 About this manual This instruction manual shall provide instructions for using, cleaning, and disinfecting and/or sterilizing the HITACHI ultrasound probes. It also describes safety considerations, maintenance. For instructions for operating the main unit, refer to the operation manual for it.
- Page 4 Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are compliant with EN980:2008 standard. Refer to the following table about the meanings of them. Explanation of Symbol...
- Page 5 Definition of symbol The following symbol is also used for HITACHI Ultrasound Probes. Location Symbol Definition This instrument complies with Directive 93/42/EEC relating to Probe connector Medical Device and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.6.
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Page 6: Table Of Contents
CONTENTS Page 1. General ······················································ 1 General ···················································· 1 Principles of operation ···································· 1 Intended Use ··············································· 1 Components ················································· 2 Option ····················································· 2 1.5.1 Puncture adapter (MP-2781) ······························ 2 1.5.2 Puncture adapter (MP-2781-5) ···························· 2 1.5.3 Puncture adapter (MP-2781-25) ··························· 2 1.5.4 CIVCO Bracket (CIV-614-108) ·····························... -
Page 7: General
Electric signals are converted to shades of brightness by brightness modulation to obtain an image. 1.3 Intended Use C22K Probe is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner. Intraoperative... -
Page 8: Components
1.4 Components The components of C22K Probe are given below: 1) Probe ····················· 1 piece 2) Instruction manual ········ 1 copy CAUTION Sterilization has not been made to the probe, shipped from the factory. Prior to use of the probe, be sure to clean, disinfect and sterilize the probe. -
Page 9: External View
1.6 External View The external view of C22K Probe is shown in Fig. 1. Immersible part (IPX7) Head / Applied part Cable Connector Un-immersible part Immersible This part can be immersed in disinfectant part: solution and also can be cleaned by water. -
Page 10: Inspection Before Use
2. Inspection before Use Prior to use, the probe must be carefully inspected that they are appropriate for use. 2.1 Inspection for Appropriate Connection 1) Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner. 2) Do not attach or connect unauthorized devices or instruments on the probe, such as unauthorized biopsy attachments. -
Page 11: Operation Procedure
3. Operation Procedure 1) Confirm that the probe is disinfected and sterilized. 2) It is recommended to use a disposable probe cover for preventing a patient from infection. 3) When connecting the probe to the 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. -
Page 12: Cleaning, Disinfection And Sterilization
Application part contacts Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with intracorporeal tissue critical virucidal effect - directly minimum) (operative application) Sterilization According to the intended use, C22K probe is classified as critical. Q1E-EP1389... -
Page 13: Point Of Use (Pre-Cleaning)
The flowchart of the reprocessing process of this probe is as follows. Manual cleaning and disinfection Drying Point of use Manual Cleaning (Pre-cleaning) Packing Rinsing after manual Containment and cleaning transportation Sterilization Manual Disinfection Rinsing after manual disinfection 4.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each (Pre-cleaning) -
Page 14: Manual Cleaning And Disinfection
4.3 Manual Cleaning and disinfection Manual cleaning and disinfection Prepare following items before manual cleaning and disinfection: Manual Cleaning a) Detergent: Cidezyme (Johnson & Johnson, #2258) or another cleaning agent with Rinsing after manual approved material compatibility for this cleaning medical device b) Disinfectant: Cidex OPA (Johnson &... -
Page 15: Drying
Manual disinfection: 1) Prepare the disinfectant solution in a tank with cold water (please follow the instructions of the disinfectant manufacturer regarding application, concentration, microbiological efficiency, service life and contact time). 2) Confirm the concentration of the disinfectant before immersing the probe. -
Page 16: Packaging
Packaging 4.6 Packaging Pack the equipment in a sterile barrier such as Polypropylene fleece or transparent package made from Polyethylene film and Tyvek®, and then place it into a tray. The tray should be also covered with a sterile barrier. Additionally the equipment can be placed on plastic mesh wires supplied for plasma sterilization and then packed as mentioned above. -
Page 17: Sterilization
Sterilization 4.7 Sterilization The probe and accessory can be sterilized using either ethylen oxide gas (EtO) sterilization or plasma sterilization (see table below). Follow the manufacturer's instructions of the sterilizer regarding usage, temperature and sterilization-time. The sterilization method and operating conditions are as follows. ETO Gas Sterilizer, closed system ... - Page 18 The packaging before sterilization is as follows. 1) Put the probe into TYVEK pouch. Probe TYVEK Pouch Fig. 4 Packaging in the pouch 2) Seal the TYVEK Pouch using a heat sealer. Ensure that Sealed the seal is complete. Probe TYVEK Pouch Fig.
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Page 19: Storage
4.8 Storage Store the equipment in a cool, dustproof, dry, and dark space to avoid high temperature, humidity and direct sunlight. Limitations for the time for sterilized equipment belong to package. 5. Maintenance and Safety Inspection 1) After using the probe, the probe should be cleaned and disinfected and sterilized according to “4. -
Page 20: Safety Precautions
6. Safety Precautions WARNING Never use the probe if the probe head, housing or cable are cracked or damaged. Warning is case of using probe covers which latex is contained to. The latex may cause such allergic reactions as itching, rubor, urticaria, swelling, fever, anhelation, wheezing, and depression of blood pressure, shock and so on. -
Page 21: Specifications
Temperature; –10 – +55°C Relative humidity; 10 – 95% (subject to no condensation) 8. Suppliers List The products listed below are seriously tested and approved for use with C22K Probe. Product name Manufacturer Purpose Enzymatic detergent CIDEZYME® Johnson & Johnson /cleaner Cidex®... -
Page 22: Disposal Of The Probe
9. Disposal of the probe Recycle or dispose of equipment properly in compliance with your organizational rules and your local laws. CAUTION Before disposing of the equipment, disinfect or take other infection-prevention measures. Disposal of the equipment without taking the proper preventative measures can lead to infection. - Page 23 Unit: mm Fig. 7 Dimensions -17- Q1E-EP1389...