Table of Contents
Advertisement
Quick Links
C41 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-EP1393-6
© Hitachi, Ltd. 2013,2017. All rights reserved
0123
Advertisement
Table of Contents
Related Manuals for Hitachi C41
Summary of Contents for Hitachi C41
- Page 1 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-EP1393-6 © Hitachi, Ltd. 2013,2017. All rights reserved 0123...
- 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-EP1393...
- 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 Medical Device Probe connector and Directive 2011/65/EU relating to RoHS IPX7 mark IPX7 Probe connector See section 1.5.
-
Page 6: Table Of Contents
CONTENTS Page General ............6 General............. 6 Principles of operation........6 Intended Use..........7 Components..........7 External View..........8 Inspection before Use .......... 9 Inspection for Appropriate Connection....... 9 ... -
Page 7: General
General General C41 Probe is a convex array probe. The acoustic output of this probe when connected to ultrasound scanner was measured according to IEC 60601-2-37 standard. The table of measured acoustic output data is contained in the operation manual of each ultrasound scanner. -
Page 8: Intended Use
Direct contact to the eye WARNING Never use the probe with (HF) surgical equipment. Intended Use C41 Probe is designed for observation and diagnosis mainly of the following regions by connecting with the HITACHI ultrasound scanner. Superficial organs... -
Page 9: External View
External View The external view of C41 Probe is shown in Fig. 1. Immersible part (IPX7) Head / Applied part Cable Connector Un-immersible part Immersible part: This part can be immersed in disinfectant solution and also can be cleaned by water. -
Page 10: Inspection Before Use
Inspection before Use Prior to use, the probe must be carefully inspected that it is appropriate for use. Inspection of appropriate connection 2.1.1 Confirm that the system is correctly operating. Refer to the instruction manual for the ultrasound diagnostic scanner. 2.1.2 Do not attach or connect unauthorized devices or instruments on the probe, such as unauthorized biopsy attachments. -
Page 11: Operation Procedure
Operation Procedure Confirm that the probe is cleaned and disinfected and/or sterilized. It is recommended to use a disposable probe cover for preventing a patient from infection. Connect 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 Use under sterile condition, protect the probe by using covers. Some Latex material may create allergic reaction. Please use allergy free material covers. After using the probe, perform the reprocessing procedure in accordance with the procedure stated in “4. Reprocessing Procedure” every time immediately after completing the ultrasound examination.
-
Page 13: Reprocessing Procedure
Reprocessing Procedure The probe must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. ‐ The probe is delivered unsterile. Prior to the first use, reprocess the probe. ‐ WARNINGS Temperature should not exceed 60°C during reprocessing. - Page 14 Disinfection semicritical mucosa (intracavitary (Disinfectant with application) virucidal effect) Cleaning Disinfection Application part contacts (Disinfectant with critical intracorporeal tissue directly virucidal effect - (operative application) minimum) Sterilization According to the intended use, C41 probe is classified as uncritical. -13- Q1E-EP1393...
- Page 15 The flowchart of the reprocessing process of this probe is as follows. Point of use (Pre-cleaning) Containment and transportation Manual cleaning and disinfection Manual Cleaning Rinsing after manual cleaning Manual Disinfection Rinsing after manual disinfection Drying Packing Sterilization -14- Q1E-EP1393...
-
Page 16: Point Of Use (Pre-Cleaning)
4.1 Point of use (Pre-cleaning) Point of use Pre-cleaning should be done immediately after each use. (Pre-cleaning) The procedure is as follows: 1) Remove the probe cover. 2) Clean the probe of all patient’s blood or fluid with running tap water until the surface of the probe looks visually clean. - Page 17 Manual Cleaning: Prepare the detergent solution in a tank with cold water (please follow the instructions of the detergent manufacturer regarding application, dilution and contact time). 1) The temperature of the detergent solution should be between 15-30 °C, concentration is 1.6%. Please note the minimum contact time of the detergent in the manufacturer’s instruction.
- Page 18 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 19: Drying
Drying Drying 1) Wipe the probe with a single-use, fluff-free wipe or towel to remove moisture from the surface of the equipment. 2) Dry the probe naturally in an ambient temperature between 15-30°C for a minimum of 4 hours. Alternatively the probe can be dried using a drying heater at a temperature of less than 60°C. - Page 20 The sterilization method and operating conditions are as follows. Sterilization Method Condition Plasma Sterilization: Short Cycle STERRAD® 50, 100S or 200 (*) Plasma Sterilization: Standard cycle Sterrad® NX or 100NX (*) Gas Type: 10% EO/ 90% HCFC Temperature: 50-55°C ...
-
Page 21: Storage
2) Seal the TYVEK Pouch using a heat TYVEK sealer. Ensure that the seal is Sealed Pouch complete. Fig. 5 Sealing 3) Put the sealed pouch into a tray or plastic mesh wire for sterilization. Tray for sterilization Probe in the Pouch Fig. -
Page 22: Maintenance And Safety Inspection
Maintenance and Safety Inspection After using the probe, the probe should be cleaned and disinfected and/or sterilized according to “4. Reprocessing Procedure”, store the probe in a cool and dark space to avoid high temperature, humidity and direct sunlight. Visually inspect the surface of the probe head, the housing, the cable and the connector for any crack, scratch or denaturalization. -
Page 23: Safety Precautions
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 24: Specifications
Specifications Probe Type : C41 Probe Acoustic working : 7.5MHz frequency Technology : Convex Array Probe Dimensions : See Fig. 7. Weight : Approx. 0.44kg (incl. cable and connector) Scanning angle : 100° Probe materials : Bio-compatible allergy free components... -
Page 25: Suppliers List
Suppliers List The products listed below are seriously tested and approved for use with C41 Probe. Product name Manufacturer Purpose Enzymatic detergent CIDEZYME® Johnson & Johnson /cleaner Cidex® OPA Johnson & Johnson Disinfectant HYAMINE SOLUTION RICCA CHEMICAL COMPANY Disinfectant STERIHYDE®... - Page 26 Unit:mm Fig. 7 Dimensions -25- Q1E-EP1393...
Need help?
Do you have a question about the C41 and is the answer not in the manual?
Questions and answers