RIMS‐IFU‐001, Rev.2 Instructions for Use EPIA Please read this manual carefully and thoroughly before using this device. Do not use this device for other than intended purpose.
RIMS‐IFU‐001, Rev.2 This page is intentionally left blank.
Table of Contents Chapter I. ABOUT MANUAL ……………………………………………………………………………………………………….. 2 1. General Information ............................................................................................................................ 2 2. Revision History ................................................................................................................................... 2 3. Manufacturer Information ..............................................................................................
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 New establishment 2021.01.29 EC Representative Information revised. The difference of two models [EPIA‐HU‐B and EPIA‐HU] described.
4. 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 approach the epidural space. An operator can control the movement of the syringe and the insertion of the epidural needle.
3. Intended Use EPIA is an epidural instrument intended for use with an epidural needle for the real‐time confirmation of the needle tip placement into the epidural space. The device assists in the insertion of the needle into the epidural space by showing the needle insertion progress and the pressure data of each tissue as a graph of reaction force on a display device. 3.1. Patient Population Adults (men or women) 3.2. Age 18 years of age and older 3.3. Application Part Vertebra 3.4.
4. Principle of Operation The product is used to assist with an epidural procedure that detects the epidural space by automatically pushing the syringe barrel to insert the epidural needle into the epidural space. The motor rotates by using the electric power of a 3V battery, and the rotational motion is converted to a linear motion of the syringe barrel and the needle fixed to the syringe holder.
5. Specifications 5.1. General Specifications 5.1.1. EPIA‐HU‐B 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_EPIA version 1.0.0 9 Communication Standard BLE (Bluetooth 4.
5.2. Technical Specifications 5.2.1. EPIA‐HU‐B No Category Description 1 Max. Travel Distance 45 mm ± 10 % 2 Min. Travel Distance 0.2 mm ± 20 % 3 Moving Speed 1.8 mm/s ± 10 % 4 Operation Normal Operation of Forward Movement, Backward Movement, Stop, and Fine Advance 5 Safety Function Automatic stop when the pressure detected is 50 gf lower than the maximal pressure detected.
6. Operating and Storage & Transport Conditions 6.1. Operation Conditions 1) Temperature: 10 ‐ 40 °C 2) Relative Humidity: 30 ‐ 75 % 3) Atmospheric Pressure: 800 ‐ 1060 hPa 6.2. Storage & Transportation Conditions 1) Temperature: ‐20 ‐ 60 °C 2) Relative Humidity: 10 ‐ 90 % 3) Atmospheric Pressure: 700 ‐ 1060 hPa 6.3. Sterilization Method 1) Sterilization Method : Sterilized with E.O.
7. Product Description 7.1. Appearance [EPIA‐HU‐B] 7.1.1. Main Body No Component 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.
7.1.2. Compatibility No Compatible Products Standard Requirements 1 Syringe 5 mL KOVAX‐SYRINGE (Korea Vaccine, Co. Ltd.) 2 Epidural Needle Puncture needle for epidural anesthesia Tuohy type Epidural needle (TaeChang Industrial Co. Ltd.) 3 Battery 3V Lithium battery CR123A (Panasonic) 4 Display Device ‐ Tablet PC (recommended) 5 Software ‐ Rims_EPIA ‐ ‐ ‐ OS Android 10.0 (or higher) Storage 64 GB Bluetooth 4.0 (or higher) Provided by manufacturer (Rimscience Co. Ltd.
7.2. Appearance [EPIA‐HU] 7.2.1. Main Body ‐ Same as EPIA‐HU‐B (Please refer to “section 7.1.1 of Chapter II”.) 7.2.2. Accessory No Accessory Description 1 Data Cable Data transmitting USB cable to connect EPIA main body and tablet PC 7.2.3. Compatibility No Compatible Products Standard Requirements 1 Syringe 5 mL KOVAX‐SYRINGE (Korea Vaccine, Co. Ltd.) 2 Epidural Needle Puncture needle for epidural anesthesia Tuohy type Epidural needle (TaeChang Industrial Co. Ltd.
7.3. Software [Rims_EPIA (Version 1.0.
7.4. Dimensions 7.4.1. 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 7.4.2. Accessory ‐ Data Cable [EPIA‐HU only] No Name 1 Data Cable RIMS-IFU-001 / Rev. 1 Description 1) Dimension: 2,500 mm (L) 2) Weight: 100 g Part No.
8.
Symbol Title Battery, General Description On battery powered equipment Do not throw this unit into a municipal trash bin when this unit Waste Electrical and Electronic has reached the end of its lifetime.
9. Label and Packaging 9.1. Label ‐ Please refer to “section 8 of Chapter II” to find more about symbols. 9.1.1. Label [EPIA‐HU‐B] Product Label [EPIA‐HU‐B] The label is fixed to the left exterior side of the product where it cannot be removed. Product Label [EPIA‐HU‐B] This product label is attached to the Tyvek paper of the inner packaging (pouch) (refer to 9.2.4 of Chapter II). RIMS-IFU-001 / Rev.
Packaging Label [EPIA‐HU‐B] This packaging label is attached to the side of the inner box (refer to 9.2.5 of Chapter II). RIMS-IFU-001 / Rev.
9.1.2. Label [EPIA‐HU] Product Label [EPIA‐HU] This product label is attached to the Tyvek paper of the inner packaging (pouch) (refer to 9.2.4 of Chapter II). Packaging Label [EPIA‐HU] This packaging label is attached to the side of the inner box (refer to 9.2.5 of Chapter II). RIMS-IFU-001 / Rev.
9.1.3. Accessory Label [EPIA‐HU] Data Cable Label [EPIA‐HU] RIMS-IFU-001 / Rev.
9.2. Packaging 9.2.1. Packaging Unit ‐ 1 Set / Box Model Contents EPIA‐HU‐B EPIA Main Body (1 ea) + 3V Battery (1 ea) + User Manual (1 ea) EPIA‐HU EPIA Main Body (1 ea) + 3V Battery (1 ea) + User Manual (1 ea) + Data Cable (1 ea) 9.2.2. Packaging Material and Dimension Packaging Material Dimensions (mm) Inner Packaging (Blister) PET Blister, Tyvek Paper 271 (L) X 41.
9.2.5. Inner Box (Gift Box) ※ The packaging label is attached to the side of the inner box (where indicated as a red box and arrow shown in the drawing above). 9.2.6. Outer Box (Carton Box) ※ The product information (Model name, Lot No., Expiry date, Manufacturer information etc.) is printed or stamped to the side of the outer box (where indicated as a red box and arrow shown in the drawing above) . 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) 2 Enclosure AF365(&) LG CHEM LTD Min Thk : 1.7 mm V‐1, 60 °C UL 94 UL(E67171) 3 PCB FR4‐74 ZHEJIANG WAZAM NEW Min Thk : 0.38 mm MATERIALS 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 [EPIA‐HU‐B] ① Turn on the display device. ② Run the EPIA program. ③ Enter the patient information (Patient Name, Age, Gender) on the patient information input screen. After you fill out, click the OK button to continue. on the upper right of screen to connect the EPIA with the ④ Click the “CONNECT” button display device. If EPIA is not connected properly with the display device, reconnect the device by click the “CONNECT” button again.
2.2. USB Cable Connection [EPIA‐HU] 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 through USB‐C port. 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.
2.3.
2.4. File Import ① Click the OPEN button on the top right of the main screen to open the file list. The example file list is shown below. 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 ⑤ To return to the file list again, click the OPEN RIMS-IFU-001 / Rev. 1 button. button.
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.
⑨ Insert the protruding part of the needle into the patient’s injection site, and hold the EPIA firmly against the operation site. Hold the EPIA firmly and fix it onto the patient’s injection area with one hand (left hand recommended). Operate the buttons of EPIA with the other hand (right hand recommended). ⑩ By pressing the Forward button, the syringe and the needle will automatically advance, and the needle will be inserted into the patient’s body.
⑭ When the needle is located at the epidural space, open the syringe cover, and remove the EPIA device from the syringe. Remove the EPIA carefully so that the tip of the needle located in the epidural space does not deviate from its proper position. The operator can confirm whether the needle has reached the epidural space successfully by using the Loss of Resistance (LOR) Method, manually pressing the plunger to check the pressure within the syringe.
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 of the used device as medical waste according to hospital or government regulations regarding medical devices. Syringes and needles are disposable; do not reuse them and dispose them as medical waste after the use. In the event of malfunction, stop the use immediately and contact a specialist.
Chapter IV. Warning and Safety Notices 1. General Precautions Be sure to read and be aware of the instructions and cautions before use. 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.
3. Interactions Check suitability and compatibility with other medical supplies before use. Use sterile syringes and needles with this product. Use the battery provided or CR123‐A 3V Lithium battery (Panasonic). [EPIA‐HU‐B] Use the device within 10m2 area and check whether there is any interference from other communication equipment. [EPIA‐HU] Use the supplied Data cable ONLY. The use of other cables may not be compatible with EPIA. 4.
6. Adverse Reactions ‐ Cerebrospinal fluid (CSF) leakage due to dural puncture ‐ Spinal nerve damage ‐ Pain in the treatment area 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 [EPIA‐HU‐B] 8.1. GUIDANCE AND MANUFACTURER’S DECLARATION – Mobile RF COMMUNICATIONS 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. ETSI EN 300 328 V2.1.1 (2016‐11) Wideband transmission systems; Data transmission equipment operating in the 2.
8.2. GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC COMPATIBILITY 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. ETSI EN 301 489‐1 V2.2.3 (2019‐11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility ETSI EN 301 489‐17 V3.2.
8.3. GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC SAFETY 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.
8.9 Electrical Fast transients / Bursts IEC 61000‐4‐4:2012 N/A 8.9 Surges IEC 61000‐4‐5:2005 N/A 8.9 Conducted Disturbances Induced by RF Fields IEC 61000‐4‐6:2013 N/A 8.9 RATED Power Frequency Magnetic Fields IEC 61000‐4‐8:2009 P 8.9 Voltage Dips IEC 61000‐4‐11:2004 N/A 8.9 Voltage Interruptions IEC 61000‐4‐11:2004 N/A 8.9 Electrical Transient Conduction along Supply Lines ISO 7637‐2: 2011 8.
RIMS-IFU-001 / Rev.
Chapter V. Maintenance and Disposal 1. Maintenance and Disposal 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. Maintenance of Cable [EPIA‐HU] 1.1.1.
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.
Copyright © 2021 RIMSCIENCE All Rights Reserved RIMS-IFU-001 / Rev.
