RIMS-IFU-001, Rev.0 Instruction for Use EPIA Please read this manual carefully and thoroughly before using this device. Do not use this device for other than intended purpose.
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Table of Contents Chapter I. ABOUT MANUAL ……………………………………………………………………………………………………….. 2 1. General Information ............................................................................................................................ 2 2. Revision History ................................................................................................................................... 2 3. Applicable Standards ..................................................................................................
Chapter I. About Manual 1. General Information This manual is provided to help users to understand this device’s characteristics as a medical device, method, and information for the safe use. For the proper and safe use of device, users must be fully aware of all the details given in this manual. 2. Revision History Rev. No. Rev. Date (YYYY.MM.DD) 0 2020.08.11 Description New establishment RIMSCIENCE CO. Ltd. 601 (#602-1), 53, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea 03736 Tel.
3. Applicable Standards The device complies with the following international standards. No. Standard No. (Reference document No.
Chapter II. Product Description 1. Product Description EPIA is a handheld device using internal power, which can hold a 5 mL syringe and an epidural needle. EPIA assists the epidural needle to be inserted and to approach to the epidural space. An operator can control the movement of the syringe and the insertion of epidural needle.
2.7. Contraindications - Do not use on a patient with sepsis, bacteremia, injection site infection, severe hypovolemia, severe coagulation abnormalities, therapeutic anticoagulant therapy, increased intracranial pressure, and patient refusal. - Do not use on a patient with neurological disorders, mental illness or dementia, aortic stenosis, left ventricular outflow tract obstruction (LVOTO), and congenital heart disease. 3.
5. Specification 5.1. General Specifications No Category Description 1 Product Name Epidural Instrument 2 Model Name EPIA-HU-B 3 Brand Name EPIA 4 Power Input Lithium Battery, 3Vdc 5 Dimension Main body: 204.5 mm (L) X 41 mm (W) X 80 mm (H) 6 Weight 217 g 7 Electric Shock Protection Type and Degree Internally powered, No Applied part 8 Software Version Rims_EPI-A version 1.0.0 5.2. Technical Specification No Category Description 1 Max. Travel Distance 45 mm ± 10 % 2 Min.
6. Operating and Storage & Transport Conditions 6.1. Operation Conditions 1) Temperature: 10 - 40 ℃ 2) Relative humidity: 30 - 75 % 3) Atmospheric pressure: 800 - 1060 hPa 6.2. Storage & Transportation Conditions 1) Temperature: -20 - 60 ℃ 2) Relative humidity: 10 - 90 % 3) Atmospheric pressure: 700 - 1060 hPa RIMS-IFU-001 / Rev.
7. Product Description 7.1. Appearance 7.1.1. Main Body No Component Description 1 Backward Button Button to move syringe and needle backward 2 Stop Button Button to stop the movement of syringe and needle 3 Fine advance (0.2mm) Button Button to advance syringe and needle for an additional 0.
7.1.3.
7.2. Dimensions 7.2.1. Main Body No Name 1 Main Body Description 1) Dimension: 204.5 mm (L) X 41 mm (W) X 80 mm (H) 2) Weight: 217 g Part No. EPIA-PL-B 7.2.2. Accessories 7.2.2.1 Data Cable No Name 1 Data Cable RIMS-IFU-001 / Rev. 0 Description 1) Dimension: 2,500 mm (L) 2) Weight: 100 g Part No.
8. Symbols (Including Safety Signs) Symbol Title Description Do Not Reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Do Not Use if Package is Damaged Indicates a medical device that should not be used if the package has been damaged or opened. Sterilized Using Ethylene Oxide Indicates a medical device that has been sterilized using ethylene oxide gas.
Symbol Title Battery, General Description On battery powered equipment. Waste Electrical and Electronic Equipment (WEEE) Do not throw this unit into a municipal trash bin when this unit has reached the end of its lifetime. To ensure utmost protection of the global environment and minimize pollution, please recycle this unit. Non-ionizing Electromagnetic Radiation Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
9. Label and Packaging 9.1. Label Please refer to “section 8 of Chapter II” to find more about symbols. 9.1.1. Product Label 9.1.2. Packaging Label RIMS-IFU-001 / Rev.
9.1.3. Accessory Label RIMS-IFU-001 / Rev.
9.2. Packaging 9.2.1 Packaging Unit: 1 Set / box - EPIA Main Body 1 ea + Accessory 1 Set + User Manual 1ea - Accessory: 3V Battery 1 ea + Data Cable 1 ea 9.2.2 Packaging Material - Inner Packaging (Blister): PET Blister + Tyvek paper - Inner Packaging (Pouch): PE Film + Tyvek paper - Inner Box : Paper (Manilla Paper) - Outer Box: Carton box (Paper) 9.2.3 Dimension - Inner packaging (Blister) (EPIA main body and 3V battery): 271 (L) X 41.
9.2.6 Inner Box 9.2.7 Outer Box RIMS-IFU-001 / Rev.
10. Product Components (List of Critical Components) 10.1. List of Critical Components No Component Part reference Manufacturer Technical Data Standard Conformity Reference 1 Lithium Metal Battery CR123A Panasonic 3, 0 V, 1550 mAh IEC 60086-4 CB(NL-64193) AF365(&) LG CHEM LTD Min Thk : 1.7 mm V-1 60 °C UL 94 UL(E67171) FR4-74 ZHEJIANG WAZAM NEW MATERIALS CO., LTD. Min Thk : 0.38 mm V-0 130 °C UL 94 UL(E136069) MJ-180PA-42 DONGGUAN MAJOR PRECITION MANUFAXTURING CO., LTD.
Chapter III. How to USE 1. Preparation Before Use 1.1. Training - Before use, refer to the video or training materials provided by the manufacturer. - The device must be used by well-trained, professional medical personnel for medical use only. - The device requires sufficient training before use. 1.2. Preparation of the Device - Prepare EPIA, 3V battery, USB cable (if needed), a display device, a 5 ml syringe, an epidural needle, and anesthetic (or saline) to be injected.
2. Device Connection 2.1. Bluetooth Connection ① Turn on the display device. ② Run the EPIA program. ③ Enter the patient information (Patient Name, Age, Gender). ④ Click the “CONNECT” button device. on the upper right to connect the EPIA with the display ⑤ Click the “READ” button to complete the graph preparation. RIMS-IFU-001 / Rev.
2.2. USB Cable Connection (Option) ① Insert the USB Cable into the cable connector located at the back of the EPIA device. ② Connect the USB cable and a display device. ③ After connection, the following message appears. ④ Click the OK button to start the program. ※ If you click the CANCEL button, EPIA will not be connected. Reconnect EPIA with USB cable, and press the OK button to start the program. ⑤ Enter the patient information (Patient Name, Age, Gender) and click the OK button to complete. 2.3.
2.3.2.
2.3.3. File Import ① Click the OPEN button on the top right of the main screen to open the file list. ② Select a file from the file list and click the SELECT button to import the data. ③ When the selected file is imported, the data will appear on the screen. ④ To return to the patient information page, click the BACK button ⑤ To return to the file list, click the OPEN button. RIMS-IFU-001 / Rev.
3. Instruction to Use ① Prepare the sterilized EPIA device, an epidural needle, and a 5 ml syringe. If needed, fill the syringe with saline or an anesthetic to be injected into the epidural space. ② Remove a stylet from the epidural needle. ③ Combine the syringe and the epidural needle. ④ Open the syringe cover of EPIA by pressing the OPEN button. ⑤ Insert the flange of the syringe barrel into the syringe holder of EPIA and place the needle in the groove in the front of the device.
⑪ The pressure data are transmitted in real-time to the display device. Through the pressure graph, the operator can monitor the intra-injection movement and the pressure change applied to the needle. ⑫ When the tip of the needle enters the epidural space, the pressure decreases rapidly. While monitoring the changes in the pressure graph, the operator can stop the progress of the needle by pressing the STOP button .
4. Post-use Treatment - EPIA device is single-use only; do not reuse the used device. - Do not attempt to re-sterilize the device. - Dispose used device according to hospital or government regulations regarding medical devices. - After the use, wipe the cable clean with a disinfectant or disinfect it appropriately according to hospital regulations. - Syringe and needle are disposable; do not reuse them. 5.
Chapter IV. Warning and Safety Notices 1. General Precaution Check whether the package is damaged before use. Check for any apparent deformation, discoloration, cracking, or foreign substances before use. Check the cleanliness and disinfection of the product before use. Check whether the device and other medical supplies are operating normally before use. Be sure to read and be aware of the instructions and cautions before use. After use, dispose of the device as medical waste.
Use the supplied battery or CR123-A 3V battery. For wired communication with a tablet PC, use the supplied USB cable. For Bluetooth communication, use the devices within 10m2 area and check whether there is any interference from other communication equipment. 4. Precaution to Use This product is a medical device, and the user cannot use it by modifying the product at will. It is an assistant device to assist doctor’s operation.
7. Warnings related to Wireless Communication 7.1. FCC Compliance Statement This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 7.2.
8. Guidance and Manufacturer’s Declaration 8.1 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The device is intended for use in the electromagnetic environment specified below. The customer or the end user of the device should assure that it is used in such an environment. RIMS-IFU-001 / Rev.
8.2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the end user of the device should assure that it is used in such an environment. RIMS-IFU-001 / Rev.
RIMS-IFU-001 / Rev.
8.3 Recommended separation distance between portable and mobile RF communications equipment and the compatible device. RIMS-IFU-001 / Rev.
Chapter V. Maintenance 1. Maintenance and Trouble Shooting The Epidural Instrument (EPIA) is supplied sterile and intended for SINGLE USE ONLY. Do not clean, re-sterilize or reuse the epidural instrument. This may result in product malfunction, failure, or patient injury and may expose the patient to the risk of transmitted infectious diseases. After use, discard with standard medical waste disposal practices. 1.1.
Chapter VI. Technical Contents 1. Safety Information and Customer Service Please call RIMSCIENCE Co. Ltd. Customer Service at (+82) 2-3789-1010 or send an e-mail to sales@rimscience.com. If you have any device returns or questions about the device, visit our website www.rimscience.com for details. Some limitations apply. Any refurbishments made outside of our facility will automatically void the warranty. RIMS-IFU-001 / Rev.
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