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| 1 2 | Antenna Specification | Operational Description | January 20 2021 | confidential | ||||
| 1 2 | Block Diagrams | Block Diagram | January 20 2021 | confidential | ||||
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RF Exposure RF Report r01 | RF Exposure Info | 217.98 KiB | January 20 2021 |
| 1 2 | User Manual 20210114 v1 - User manual | Users Manual | 1.70 MiB | January 20 2021 / July 20 2021 | delayed release |
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.
■ EN □ ES □ CS □ DA □ DE □ ET □ EL □ CZ □ RO □ MT □ RO □ PT
RIMS-IFU-001, Rev.0
This page is intentionally left blank.
Table of Contents
Chapter I. ABOUT MANUAL ……………………………………………………………………………………………………….. 2
1. General Information ............................................................................................................................ 2
2. Revision History ................................................................................................................................... 2
3. Applicable Standards ........................................................................................................................... 3
Chapter II. PRODUCT DESCRIPTION………………………………………………………………………………………………4
1. Product Description ............................................................................................................................. 4
2. Intended Use ........................................................................................................................................ 4
3. Principle of Operation ......................................................................................................................... 5
4. Features ................................................................................................................................................ 5
5. Specification ......................................................................................................................................... 6
6. Operating and Storage & Transport Conditions ................................................................................. 7
7. Product Description ............................................................................................................................. 8
8. Symbols (Including Safety Signs) ....................................................................................................... 11
9. Label and Packaging........................................................................................................................... 13
10. Product Component (List of Critical Components) ......................................................................... 17
Chapter III. HOW TO USE……………………………………………………………………………………………………………18
1. Preparation Before Use ..................................................................................................................... 18
2. Device Connection ............................................................................................................................. 19
3. Instruction to Use .............................................................................................................................. 23
4. Post-use Treatment ........................................................................................................................... 25
5. Storage and Transport Conditions .................................................................................................... 25
Chapter IV. WARNING AND SAFETY NOTICES……………………………………………………………………………..26
1. General Precaution ............................................................................................................................ 26
2. General Warning ................................................................................................................................ 26
3. Interaction .......................................................................................................................................... 26
4. Precaution to Use .............................................................................................................................. 27
5. Contraindications ............................................................................................................................... 27
6. Adverse Reaction ............................................................................................................................... 27
7. Warnings related to Wireless Communication .......................................................................... 28
8. Guidance and Manufacturer’s Declaration....................................................................................... 29
Chapter V. MAINTENANCE…………………………………………………………………………………………………………33
1. Maintenance and Trouble Shootings ................................................................................................ 33
2. Disposal of the Electronic Device ...................................................................................................... 33
Chapter VI. TECHNICAL CONTENTS…………………………………………………………………………………………….34
1. Safety Information and Customer Service ........................................................................................ 34
RIMS-IFU-001 / Rev. 0
Page 1 / 34
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.
2020.08.11
New establishment
Description
Chapter I. About Manual
1. General Information
2. Revision History
Rev. No.
Rev. Date
(YYYY.MM.DD)
0
RIMSCIENCE CO. Ltd.
601 (#602-1), 53, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea 03736
Tel. (+82) 2-3789-1010 Fax. (+82) 2-3789-1014
www.rimscience.com
slimbalance® GmbH
Hagenbrücke 1. D-38100 Braunschweig, Germany
Tel.: (+49) 531-61499559
Email: info@slimbalance.de
RIMS-IFU-001 / Rev. 0
Page 2 / 34
3. Applicable Standards
The device complies with the following international standards.
No.
Standard No.
(Reference document No.)
93/42/EEC as amended by
2007/47/EC
Title of Standard
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
EN ISO 13485:2016
(ISO 13485:2016)
Medical device – Quality management systems - Requirements for
regulatory purposes
EN 60601-1:2006/A1:2013
(IEC 60601-1:2005)
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
EN 60601-1-2:2015
(IEC 60601-1-2:2014)
Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
EN 60601-1-6:2010
(IEC 60601-1-6:2010)
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
Medical devices - Application of usability engineering to medical devices
Medical device software - Software life-cycle processes
Medical devices — Application of risk management to medical devices
1
2
3
4
5
6
7
8
EN 62366:2008
(IEC 62366:2007)
EN 62304:2006
(IEC 62304:2006)
EN ISO 14971:2012
(ISO 14971:2007, Corrected
version 2007-10-01)
9
EN 1041:2008
Information supplied by the manufacturer of medical devices
10
EN ISO 15223-1:2016
(ISO 15223-1:2016, Corrected
version 2017-03)
11
EN 301 489-1 V2.2.3 (2019-11)
12
EN 301 489-17 V3.2.4 (2020-09)
Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied — Part 1: General requirements
ElectroMagnetic Compatibility (EMC) standard for radio equipment and
services - Part 1: Common technical requirements - Harmonised Standard
for ElectroMagnetic Compatibility
ElectroMagnetic Compatibility (EMC) standard for radio equipment and
services – Part 17: Specific conditions for Broadband Data Transmission
Systems – Harmonised Standard for ElectroMagnetic Compatibility
13 MEDDEV 2.4/1 rev.9
Classification of medical devices
14 MEDDEV 2.7.1_rev 4
Clinical Evaluation: Guide for manufacturers and notified bodies
15 MEDDEV 2.12/1 rev.8
Guidelines on a Medical Devices Vigilance System
16 MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies
RIMS-IFU-001 / Rev. 0
Page 3 / 34
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.
While the epidural needle is being inserted, a pressure sensor located in EPIA detects the change of
pressure (Reaction force) applied to the tip of the needle, converts the pressure data of each tissue to digital
data and indicates them as a graph on a display device.
The operator can determine the target injection site by monitoring the pressure change in the graph and
can control or stop the movement of the epidural needle at the target site, which is the epidural space.
When needed, the device can be detached from the syringe, and the operator can inject an anesthetic
directly or can insert an epidural catheter.
2. 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.
2.1. Patient Population
Adult (men or women)
2.2. Age
18 years of age and older
2.3. Application Part
Vertebra part
2.4. Intended Medical Indication
- Epidural anesthesia
- Pain control (labor analgesia)
2.5. Patient Contacting Part
None
2.6. Potential/Possible Adverse Reaction
- Cerebrospinal fluid leakage due to dural puncture
- Spinal nerve damage
- Pain in the treatment area
RIMS-IFU-001 / Rev. 0
Page 4 / 34
- 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.
2.7. Contraindications
3. 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.
While the epidural needle is being inserted into the body, the pressure sensor in the syringe holder detects
the pressure change between each tissue. The detected pressure change is converted and stored as digital
data and displayed as a graph on the display device.
When the epidural needle is inserted into the body, the pressure will gradually increase in the
subcutaneous and ligament tissue, and the pressure will rapidly drop when it reaches the epidural space. In
this way, the operators can verify whether the needle tip has successfully entered into the epidural space.
4. Features
- Bluetooth communication or USB data transmitting
- Real-time graph via tablet PC
- Visualization of pressure and needle insertion length
-
-
-
-
-
5 mL syringe compatible
Internally powered
Steady and stable needle insertion
Fine control of needle movement – Safety control button (0.2mm fine advance, stop, backward)
Safety function – Automatic stop when the pressure detected is 50 gf lower than the maximal pressure
detected.
- Applicable for various treatments accompanying epidural anesthesia and pain control
RIMS-IFU-001 / Rev. 0
Page 5 / 34
Description
Epidural Instrument
EPIA-HU-B
EPIA
Lithium Battery, 3Vdc
217 g
Description
45 mm ± 10 %
0.2 mm ± 10 %
1.8 mm/s ± 10 %
Main body: 204.5 mm (L) X 41 mm (W) X 80 mm (H)
Electric Shock Protection Type and
Degree
Internally powered, No Applied part
Software Version
Rims_EPI-A version 1.0.0
Normal operation of Forward movement, Backward movement, Stop,
and Fine advance
Automatic stop when the pressure detected is 50 gf lower than the
maximal pressure detected.
Category
Description
Frequency Range
2,402 MHz ~ 2,480 MHz (Bluetooth Low Energy)
Modulation Technique
Number of Channels
GFSK (Bluetooth Low Energy)
40 Ch (Bluetooth Low Energy)
5. Specification
5.1. General Specifications
Category
Product Name
Model Name
Brand Name
Power Input
Dimension
Weight
5.2. Technical Specification
No
Category
Max. Travel Distance
Min. Travel Distance
Moving Speed
Operation
Safety Function
5.3. RF Specification
No
1
2
3
4
5
6
7
8
1
2
3
4
5
No
1
2
3
RIMS-IFU-001 / Rev. 0
Page 6 / 34
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. 0
Page 7 / 34
7. Product Description
7.1. Appearance
7.1.1. Main Body
No
Component
Description
Backward Button
Button to move syringe and needle backward
Stop Button
Button to stop the movement of syringe and needle
Fine advance (0.2mm) Button
Button to advance syringe and needle for an additional 0.2 mm
Forward Button
Button to advance syringe and needle forward constantly
Cover Open
Cover
Lock
Syringe Holder
Cable Connector
Button to open the syringe cover
Cover to fix the syringe and needle from falling out
Lock for syringe cover
Holder for syringe barrel flange
Transmitting device data to a tablet PC via cable
Battery Cover
Cover to fix the 3V battery inserted according to the electrode
1
2
3
4
5
6
7
8
9
10
7.1.2. Accessories
No
1
Accessory
Data Cable
Description
Data transmitting USB cable to connect EPIA main body and tablet PC
RIMS-IFU-001 / Rev. 0
Page 8 / 34
7.1.3. Software
No
Name
Description
EPIA Logo
Data transmission and move to Settings Page
Packet Information
Packet data transmitted from EPIA
NEW Button
Save Button
Clear Button
Open Button
7
Needle Progress Direction
Move to initial display (Reset graph and patient information)
Save current graph and data
Save current graph and reset the graph
Opens a pop-up window of saved graph file list
Show the status and the direction of the needle movement
- Green arrow rotating clockwise: needle moves forward
-
- No rotation: needle stops
Red arrow rotating counterclockwise: needle moves backward
Y-Axis
X-Axis
Pressure (Reaction force) (gf) measured from the needle
Current position (mm) of needle (needle insertion length)
1
2
3
4
5
6
8
9
Files are saved with names as below:
- Data file: YYMMDDhhmmss_S_[NAME]_[AGE].txt
- Graph: YYMMDDhhmmss_S_[NAME]_[AGE].png
RIMS-IFU-001 / Rev. 0
Page 9 / 34
7.2. Dimensions
7.2.1. Main Body
Part No.
EPIA-PL-B
Part No.
EPIA-CABLE
No
Name
Description
1
Main Body
1) Dimension: 204.5 mm (L) X 41 mm (W) X 80 mm (H)
2) Weight: 217 g
7.2.2. Accessories
7.2.2.1 Data Cable
1
No
Name
Description
Data Cable
1) Dimension: 2,500 mm (L)
2) Weight: 100 g
RIMS-IFU-001 / Rev. 0
Page 10 / 34
8. Symbols (Including Safety Signs)
Symbol
Title
Do Not Reuse
Description
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.
Do Not Re-sterilize
Indicates a medical device that is not to be re-sterilized.
General Prohibition Sign
To signify a prohibited action.
General Warning Sign
General warning sign.
Caution
To indicate that caution is necessary when operating the device or
control close to where the symbol is placed, or to indicate that the
current situation needs.
Manufacturer
Indicates the medical device manufacturer.
Date of Manufacture
Indicates the date when the medical device was manufactured.
Use-by-date
Indicates the date after which the medical device is not to be used.
Batch Code (LOT)
Indicates the manufacturer's batch code so that the batch or lot can
be identified.
Follow Instructions for Use
Indicates the need for the user to consult and follow the instructions
for use.
Catalog Number
Indicates the manufacturer's catalog number so that the medical
device can be identified.
Fragile, Handle with Care
Indicates a medical device that can be broken or damaged if not
handled carefully.
Keep Dry
Indicates a medical device that needs protection from moisture.
Temperature Limit
Indicates the temperature limits to which the medical device can be
safely exposed.
Humidity Limitation
Indicates the range of humidity t which the medical device can be
safely exposed.
Atmospheric Pressure Limitation
Indicates the range of atmospheric pressure to which the medical
device can be safely exposed.
RIMS-IFU-001 / Rev. 0
Page 11 / 34
Symbol
Title
Description
Battery, General
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.
Authorized Representative in
the European Community
Indicates the authorized representative in the European Community.
CE Marking
The requirements of accreditation and market surveillance relating
to the marketing of products.
RIMS-IFU-001 / Rev. 0
Page 12 / 34
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. 0
Page 13 / 34
9.1.3. Accessory Label
RIMS-IFU-001 / Rev. 0
Page 14 / 34
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 41.5 (W) X 109 (H) (mm)
- Inner packaging (Pouch): 390 (L) X 180 (W) (mm)
- Inner box: 300 (L) X 135 (W) X 55 (H) (mm)
- Outer box: 325 (L) X 305 (W) X 325 (H) (mm)
9.2.4 Inner Packaging (Blister)
9.2.5 Inner Packaging (Pouch)
RIMS-IFU-001 / Rev. 0
Page 15 / 34
9.2.6 Inner Box
9.2.7 Outer Box
RIMS-IFU-001 / Rev. 0
Page 16 / 34
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
UL 94
UL(E67171)
3
PCB
FR4-74
UL 94
UL(E136069)
Min Thk : 1.7 mm
V-1
60 °C
Min Thk : 0.38
mm
V-0
130 °C
ZHEJIANG WAZAM
NEW MATERIALS
CO., LTD.
DONGGUAN
MAJOR PRECITION
MANUFAXTURING
CO., LTD.
4
DC Motor
MJ-180PA-42
3 V
IEC 60601-1
Tested in equipment
10.2. Lifetime of Critical Component List
- Shelf life: 3 years
RIMS-IFU-001 / Rev. 0
Page 17 / 34
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
anesthetic (or saline) to be injected.
damaged.
- Prepare EPIA, 3V battery, USB cable (if needed), a display device, a 5 ml syringe, an epidural needle, and
- Check whether the sterile packaging of EPIA is damaged and whether the product is deformed or
- Check if the environment is suitable for product use. Avoid a humid or wet place.
- Read manual and be sure to be fully aware of the device features and cautions before use.
Syringes and needles must use separate certified medical products.
Standard requirements (not included):
- Syringe 5 mL (KOVAX-SYRINGE (Korea Vaccine)),
- Epidural needle (Tuohy type puncture needle for epidural anesthesia (TaeChang Industrial))
1.3. Power Check
① Open the battery cover ⓐ on the left side of the EPIA.
② Insert the 3V battery ⓑ, according to the electrode mark (Left: (+) pole, Right: (-) pole).
When the battery is inserted properly, the device will be turned on, and the syringe holder will
automatically move to the start (setting) position.
RIMS-IFU-001 / Rev. 0
Page 18 / 34
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
on the upper right to connect the EPIA with the display
device.
⑤ Click the “READ” button to complete the graph preparation.
RIMS-IFU-001 / Rev. 0
Page 19 / 34
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. Screen Layout
2.3.1. Patient Information
※ You can only start the program by entering patient information (Patient Name, Age, and Gender).
RIMS-IFU-001 / Rev. 0
Page 20 / 34
2.3.2. Main Screen
No
Name
Description
EPIA Logo
Data transmission and move to Settings Page
Packet Information
Packet data transmitted from EPIA
NEW Button
Save Button
Clear Button
Open Button
Move to initial display
(Reset graph and patient information)
Save current graph and data
Save current graph and reset the graph
7
Needle Progress Direction
Opens a pop-up window of saved graph file list
Show the status and the direction of the needle movement
- Green arrow rotating clockwise: needle moves forward
-
- No rotation: needle stops
Red arrow rotating counterclockwise: needle moves backward
Y-Axis
X-Axis
Reaction force (gf) measured from the needle
Current position (mm) of needle (needle insertion length)
※ Files are saved with names as below:
- Data file: YYMMDDhhmmss_S_[NAME]_[AGE].txt
- Graph: YYMMDDhhmmss_S_[NAME]_[AGE].png
1
2
3
4
5
6
8
9
RIMS-IFU-001 / Rev. 0
Page 21 / 34
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. 0
Page 22 / 34
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.
④
⑤
⑥
⑥ Close the EPIA cover until it clicks and secure the syringe to avoid shaking.
※ When using a Tuohy type needle, insert the needle and syringe in the correct direction considering
the bevel (slope) of the needle tip and the curved direction.
⑦ After connecting EPIA to the display device, start the program.
⑧ Before the start, check that the graph is located at the start (setting) position.
(The X and Y axes of the graph in the program are located at 0.)
⑨ 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.
During the operation, make sure that the device is pressed firmly against the injection
area to avoid being pushed back.
During the operation, the plunger is not affected, thereby the anesthetic is not injected
while the needle is being inserted.
RIMS-IFU-001 / Rev. 0
Page 23 / 34
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
.
By detecting a rapid drop in pressure, the device will automatically stop at the epidural space.
The operator can confirm that the pressure is constantly kept low by pressing the 0.2 mm
button, thereby confirming that the automatic stop point coincides with the epidural space.
⑬ After the stop, if additional progress is required, press the 0.2mm button
to advance the
needle finely.
If a withdrawal is required, press the Back button
to move the needle backward.
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.
⑮ Push the plunger of the syringe to inject the required amount of anesthetic or remove the syringe
from the needle. After the removal, an epidural catheter can be inserted into the epidural space
through the epidural needle that is inserted into the treatment area.
RIMS-IFU-001 / Rev. 0
Page 24 / 34
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. Storage and Transport Conditions
- Storage and transport temperature: -20 - 60 ℃
- Avoid wet or humid places and store in a well-ventilated place.
- Avoid exposure to extreme temperature changes, humidity, dust, or corrosive vapors.
- Do not store in chemical storage areas or gas generation areas.
- Keep out of direct sunlight. Long exposure to sunlight can damage some parts.
RIMS-IFU-001 / Rev. 0
Page 25 / 34
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.
Do not use the product beyond the Use-by-date specified on the label.
High temperature or liquid contact with the product is prohibited.
In the event of malfunction, stop using immediately and contact a specialist.
In the rare event of mechanical malfunctions, be aware of and press the Stop button
immediately.
2. General Warning
Use only by trained professional medical personnel.
Do not use for other than its intended use.
Only use for pharmaceutical treatment.
Discard after use and avoid reuse.
Do not disassemble, repair, or modify the product in any way.
3. Interaction
Check suitability and compatibility with other medical supplies before use.
Use sterile syringes and needles with this product.
RIMS-IFU-001 / Rev. 0
Page 26 / 34
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.
If an abnormality is detected during product operation, press the Stop button, or pull the
product backward to remove it from the patient’s body.
In the event of anesthesia side effects, it is recommended to be carried out by a specialist, a
facility or a transport system that can handle the situation.
If static electricity or sudden high voltage occurs, the device may stop or return to the initial
state. In this case, press the Back button to return the needle position to the initial state and
start operation again.
Do not touch the device with wet hands.
Do not place the device in a humid or wet environment.
Do not place the cable in humid or wet environment.
5. 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), or congenital heart disease.
6. Adverse Reaction
- Cerebrospinal fluid leakage due to dural puncture
- Spinal nerve damage
- Pain in the treatment area
RIMS-IFU-001 / Rev. 0
Page 27 / 34
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. FCC Interference Statement
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment. This equipment generates, uses,
and can radiate radio frequency energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be required to correct the
interference at his own expense.
7.3. FCC Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This
equipment should be installed and operated with minimum distance 20 cm between the radiator and
your body. This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter.
7.4. FCC Caution FCC Interference Statement
Any changes or modifications not expressly approved by the party responsible for compliance could void
the user's authority to operate this equipment. This transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.
RIMS-IFU-001 / Rev. 0
Page 28 / 34
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. 0
Page 29 / 34
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. 0
Page 30 / 34
RIMS-IFU-001 / Rev. 0
Page 31 / 34
8.3 Recommended separation distance between portable and mobile RF communications
equipment and the compatible device.
RIMS-IFU-001 / Rev. 0
Page 32 / 34
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.
The Epidural Instrument (EPIA) is supplied sterile and intended for SINGLE USE ONLY.
Do not clean, re-sterilize, or reuse the epidural instrument.
After use, discard with the standard medical waste disposal practices.
1.1. Disposal of the Device
1.2. Maintenance of Cable
1.2.1 Cleaning
After use, wipe the data cable with lint-free cloth soaked with 70 % Isopropyl Alcohol or Ethyl
Alcohol.
Or disinfect the cable appropriately according to hospital guidelines.
1.2.2 Sterilization
Sterilize the data transmitting cable appropriately according to hospital practices.
The cable can be sterilized using Ethylene Oxide gas or plasma.
Do not sterilize with steam or dry heat as autoclave.
2. Disposal of the Electronic Device
This symbol indicates that the waste of electrical and electronic equipment must not be
disposed as unsorted municipal waste and must be collected separately.
Please contact an authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.
RIMS-IFU-001 / Rev. 0
Page 33 / 34
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. 0
Page 34 / 34
Copyright © 2020 RIMSCIENCE
All Rights Reserved
| 1 2 | User Manual | Users Manual | 4.03 MiB | February 24 2021 / August 24 2021 | delayed release |
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.
■ EN □ ES □ CS □ DA □ DE □ ET □ EL □ CZ □ RO □ MT □ RO □ PT
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 .................................................................................................................. 2
4. Applicable Standards ........................................................................................................................... 3
Chapter II. PRODUCT DESCRIPTION………………………………………………………………………………………………4
1. Product Description ............................................................................................................................. 4
2. Features ................................................................................................................................................ 4
3. Intended Use ........................................................................................................................................ 5
4. Principle of Operation ......................................................................................................................... 6
5. Specifications ....................................................................................................................................... 7
6. Operating and Storage & Transport Conditions ................................................................................. 9
7. Product Description ........................................................................................................................... 10
8. Symbols (Including Safety Signs) ....................................................................................................... 15
9. Label and Packaging ........................................................................................................................... 17
10. Product Component (List of Critical Components) ......................................................................... 23
Chapter III. HOW TO USE……………………………………………………………………………………………………………24
1. Preparation Before Use ..................................................................................................................... 24
2. Device Connection ............................................................................................................................. 25
3. Instruction to Use .............................................................................................................................. 29
4. Post‐use Treatment ........................................................................................................................... 32
5. Storage and Transport Conditions .................................................................................................... 32
Chapter IV. WARNING AND SAFETY NOTICES……………………………………………………………………………..33
1. General Precautions .......................................................................................................................... 33
2. General Warnings .............................................................................................................................. 33
3. Interaction .......................................................................................................................................... 34
4. Precaution to Use .............................................................................................................................. 34
5. Contraindications ............................................................................................................................... 34
6. Adverse Reaction ............................................................................................................................... 35
7. Warnings Related to Wireless Communication ................................................................................ 35
8. Guidance and Manufacturer’s Declaration ....................................................................................... 36
Chapter V. MAINTENANCE AND DISPOSAL………………………………………………………………………………...41
1. Maintenance and Disposal ................................................................................................................ 41
Chapter VI. TECHNICAL CONTENTS…………………………………………………………………………………………….42
1. Safety Information and Customer Service ........................................................................................ 42
RIMS-IFU-001 / Rev. 1
Page 1 / 43
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.
Description
2020.08.11
New establishment
2021.01.29
EC Representative Information revised.
The difference of two models [EPIA‐HU‐B and EPIA‐HU] described.
Declaration of Conformity (CE RED) included.
Chapter I. About Manual
1. General Information
2. Revision History
Rev. No.
Rev. Date
(YYYY.MM.DD)
0
1
3. Manufacturer Information
RIMSCIENCE CO. Ltd.
601(#602‐1), 53, Chungjeong‐ro, Seodaemun‐gu, Seoul, Republic of Korea 03736
Tel: (+82) 2‐3789‐1010
Fax: (+82) 2‐3789‐1014
Website: www.rimscience.com
Email: sales@rimscience.com
Sachsenhausener Straβe 16, 65824 Schwalbach am Taunus, Germany
JaviTech e.K.
Tel.: (+49) 6196‐4021549
Email: info@javitech.de
RIMS-IFU-001 / Rev. 1
Page 2 / 43
4. Applicable Standards
The device complies with the following international standards.
No.
Standard No.
(Reference document No.)
93/42/EEC as amended by
2007/47/EC
Title of Standard
Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices
EN ISO 13485:2016
(ISO 13485:2016)
Medical Device – Quality Management Systems ‐ Requirements for
Regulatory Purposes
EN 60601‐1:2006/A1:2013
(IEC 60601‐1:2005)
Medical Electrical Equipment ‐ Part 1: General Requirements for Basic Safety
and Essential Performance
EN 60601‐1‐2:2015
(IEC 60601‐1‐2:2014)
Medical Electrical Equipment ‐ Part 1‐2: General Requirements for Basic
Safety and Essential Performance ‐ Collateral Standard: Electromagnetic
Disturbances ‐ Requirements and Tests
EN 60601‐1‐6:2010
(IEC 60601‐1‐6:2010)
Medical Electrical Equipment ‐ Part 1‐6: General Requirements for Basic
Safety and Essential Performance ‐ Collateral Standard: Usability
Medical Devices ‐ Application of Usability Engineering to Medical Devices
EN 62366:2008
(IEC 62366:2007)
EN 62304:2006
(IEC 62304:2006)
EN ISO 14971:2012
(ISO 14971:2007, Corrected
version 2007‐10‐01)
Medical Device Software ‐ Software Life‐cycle Processes
Medical devices — Application of Risk Management to Medical Devices
1
2
3
4
5
6
7
8
9
EN 1041:2008
Information Supplied by the Manufacturer of Medical Devices
10
EN ISO 15223‐1:2016
(ISO 15223‐1:2016, Corrected
version 2017‐03)
11
EN 301 489‐1 V2.2.3 (2019‐11)
Medical Devices — Symbols to be Used with Medical Device Labels, Labelling
and Information to be Supplied — Part 1: General Requirements
ElectroMagnetic Compatibility (EMC)
Standard for Radio Equipment and Services ‐ Part 1: Common Technical
Requirements ‐ Harmonised Standard for ElectroMagnetic Compatibility
12
EN 301 489‐17 V3.2.4 (2020‐09) ElectroMagnetic Compatibility (EMC) Standard for Radio Equipment and
Services – Part 17: Specific Conditions for Broadband Data Transmission
Systems – Harmonised Standard for ElectroMagnetic Compatibility
13
EN 300 328 V2.1.1 (2016‐11)
14
EN 62311:2008
Wideband Transmission Systems; Data Transmission Equipment Operating in
the 2.4 GHz ISM Band and Using Wide Band Modulation techniques;
Harmonised Standard Covering the Essential Requirements of Article 3.2 of
Directive 2014/53/EU
Assessment of Electronic and Electrical Equipment Related to Human
Exposure Restrictions for Electromagnetic Fields (0 Hz – 300 GHz)
15 MEDDEV 2.4/1 rev.9
Classification of Medical Devices
16 MEDDEV 2.7.1_rev 4
Clinical Evaluation: Guide for Manufacturers and Notified Bodies
17 MEDDEV 2.12/1 rev.8
Guidelines on a Medical Devices Vigilance System
18 MEDDEV 2.12/2 rev.2
Post Market Clinical Follow‐up Studies
RIMS-IFU-001 / Rev. 1
Page 3 / 43
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.
While the epidural needle is being inserted, a pressure sensor located in EPIA detects the change of
pressure (Reaction Force) applied to the tip of the needle, converts the pressure data of each tissue to digital
data and indicates them as a graph on a display device.
The operator can determine the target injection site by monitoring the pressure change in the graph and
can control or stop the movement of the epidural needle at the target site, which is the epidural space.
When needed, the device can be detached from the syringe, and the operator can inject an anesthetic
directly or can insert an epidural catheter.
2. Features
Data transmitting via Bluetooth communication or USB data cable
Real‐time graph shown by display device
Visualization of pressure and needle insertion length
Internally powered
5 mL syringe compatible
Steady and stable needle insertion
Fine control of needle movement – Safety control button (0.2mm fine advance, stop, backward)
Safety function – Automatic stop when the pressure detected is 50 gf lower than the maximal pressure
Applicable for various treatments accompanying epidural anesthesia and pain control
EPIA‐HU‐B
The device can be connected to a display device via Bluetooth function.
The device can be connected to a display device using data cable connection.
Data cable is included in the package as an accessory.
Description
2.1. Model Difference
detected.
Model
EPIA‐HU
RIMS-IFU-001 / Rev. 1
Page 4 / 43
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. Intended Medical Indication
‐ Epidural anesthesia
‐ Pain control (labor analgesia)
3.5. Patient Contacting Part
None
3.6. Potential/Possible Adverse Reaction
‐ Cerebrospinal fluid leakage due to dural puncture
‐ Spinal nerve damage
‐ Pain in the treatment area
3.7. 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.
RIMS-IFU-001 / Rev. 1
Page 5 / 43
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.
While the epidural needle is being inserted into the body, the pressure sensor in the syringe holder detects
the pressure change between each tissue. The detected pressure change is converted and stored as digital
data and displayed as a graph on the display device.
When the epidural needle is inserted into the body, the pressure will gradually increase in the
subcutaneous (①) and ligament tissue (②), and the pressure will rapidly drop when it reaches the epidural
space (③). In this way, the operators can verify whether the needle tip has successfully entered into the
epidural space.
EPIA also makes use of this phenomenon and detects reaction force, which is made against the force that
the needle penetrates the tissue. While the tip of needle inserts through the subcutaneous and ligament
tissue, the reaction force as well as pressure at the tip of the needle increases (① and ② in the graph
below). When the tip of needle reaches the epidural space, the pressure and the reaction force rapidly
decrease (③). The pressure sensor of EPIA detects this change in reaction force and convert it as visual data.
Decrease of ∆𝒇
∆𝒕
at ③
indicates epidural space
⇒ auto-stop
RIMS-IFU-001 / Rev. 1
Page 6 / 43
Description
Epidural Instrument
EPIA‐HU‐B
EPIA
Lithium Battery, 3Vdc
217 g
N/A
EPIA‐HU
EPIA
217 g
Description
Epidural Instrument
5. Specifications
5.1. General Specifications
5.1.1. EPIA‐HU‐B
No
Category
Product Name
Model Name
Brand Name
Power Input
Dimension
Weight
Accessories
Category
Product Name
Model Name
Brand Name
Power Input
Dimension
Weight
5.1.2. EPIA‐HU
10
No
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
7
8
9
Main body: 204.5 mm (L) X 41 mm (W) X 80 mm (H)
Electric Shock Protection Type and Degree
Internally powered, No Applied part
Software Version
Rims_EPIA version 1.0.0
Communication Standard
BLE (Bluetooth 4.0 or higher), RS‐232
Lithium Battery, 3Vdc
Main body: 204.5 mm (L) X 41 mm (W) X 80 mm (H)
Electric Shock Protection Type and Degree
Internally powered, No Applied part
Software Version
Rims_EPIA version 1.0.0
Communication Standard
10
Accessories
RS‐232
Data cable (USB‐C)
RIMS-IFU-001 / Rev. 1
Page 7 / 43
Normal Operation of Forward Movement, Backward Movement,
Stop, and Fine Advance
Automatic stop when the pressure detected is 50 gf lower than
the maximal pressure detected.
Frequency Range
2,402 MHz ~ 2,480 MHz
(Bluetooth Low Energy)
Modulation Technique
GFSK (Bluetooth Low Energy)
Number of Channels
40 Ch (Bluetooth Low Energy)
Description
45 mm ± 10 %
0.2 mm ± 20 %
1.8 mm/s ± 10 %
Description
45 mm ± 10 %
0.2 mm ± 20 %
1.8 mm/s ± 10 %
Normal Operation of Forward Movement, Backward Movement,
Stop, and Fine Advance
Automatic stop when the pressure detected is 50 gf lower than
the maximal pressure detected.
5.2. Technical Specifications
5.2.1. EPIA‐HU‐B
No
Category
5.2.2. EPIA‐HU
No
Category
Max. Travel Distance
Min. Travel Distance
Moving Speed
Operation
Safety Function
RF Specifications
Max. Travel Distance
Min. Travel Distance
Moving Speed
Operation
Safety Function
1
2
3
4
5
6
1
2
3
4
5
RIMS-IFU-001 / Rev. 1
Page 8 / 43
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. (Ethylene oxide) Gas
2) Sterilization Process Condition
Process
Condition
Gas Mixture
30% Ethylene Oxide + 70% CO2
Gas Concentration
700 – 800 mg/L
Exposure Pressure
0.7 ± 0.05 kgf/cm2
Temperature
Humidity
Exposure Time
Flushing
Temperature
Time
SAL
40 ± 5 °C
50 ± 25% RH
240 min
7 times or more
10 – 40 °C
48 hours
10‐6
6.4. Lifecycle of Device
Shelf life: 3 years
‐
RIMS-IFU-001 / Rev. 1
Page 9 / 43
7. Product Description
7.1. Appearance [EPIA‐HU‐B]
7.1.1. Main Body
1
2
3
4
5
6
7
8
9
No
Component
Symbol
Description
Backward Button
Button to move syringe and needle backward
Stop Button
Button to stop the movement of syringe and needle
Fine Advance (0.2mm)
Button
Button to advance syringe and needle for an additional 0.2 mm
Forward Button
Button to advance syringe and needle forward constantly
Cover Open
Button to open the syringe cover
Cover
Lock
Cover to fix the syringe and needle from falling out
Lock for syringe cover
Syringe Holder
Holder for syringe barrel flange
Cable Connector
Transmitting device data to a tablet PC via cable
10
Battery Cover
Cover to fix the 3V battery inserted according to the electrode
RIMS-IFU-001 / Rev. 1
Page 10 / 43
7.1.2. Compatibility
No
Compatible Products
Standard Requirements
5 mL
KOVAX‐SYRINGE
(Korea Vaccine, Co. Ltd.)
Puncture needle
for epidural
anesthesia
Tuohy type Epidural needle
(TaeChang Industrial Co. Ltd.)
3V Lithium
battery
CR123A (Panasonic)
Tablet PC
(recommended)
‐ OS Android 10.0 (or higher)
‐
‐
Storage 64 GB
Bluetooth 4.0 (or higher)
Rims_EPIA
Provided by manufacturer
(Rimscience Co. Ltd.)
‐
‐
※ Must use sterile syringes and sterile needles with separate and certified medical products compatible with
※ Use of Tuohy type Epidural Needle is highly recommended.
※ A battery is enclosed in the product packaging.
※ Use of a display device as tablet PC is highly recommended to confirm the needle progress (insertion length)
and the pressure change detected by EPIA.
1
Syringe
2
Epidural
Needle
3
Battery
4
Display
Device
5
Software
EPIA.
RIMS-IFU-001 / Rev. 1
Page 11 / 43
7.2. Appearance [EPIA‐HU]
7.2.1. Main Body
7.2.2. Accessory
‐
Same as EPIA‐HU‐B (Please refer to “section 7.1.1 of Chapter II”.)
No
1
Accessory
Data Cable
7.2.3. Compatibility
Description
Data transmitting USB cable to connect EPIA main body and tablet PC
No
Compatible Products
Standard Requirements
1
Syringe
2
Epidural
Needle
3
Battery
4
Display
Device
5
Software
5 mL
KOVAX‐SYRINGE
(Korea Vaccine, Co. Ltd.)
Puncture needle
for epidural
anesthesia
Tuohy type Epidural needle
(TaeChang Industrial Co. Ltd.)
3V Lithium
battery
CR123A (Panasonic)
Tablet PC
(recommended)
‐ OS Android 10.0 (or higher)
‐
Storage 64 GB
‐ USB port C‐type
Rims_EPIA
Provided by manufacturer
(Rimscience Co. Ltd.)
‐
‐
※ Must use syringes and needles with separate and certified medical products compatible with EPIA.
※ Use of Tuohy type Epidural Needle is highly recommended.
※ A battery is enclosed in the product packaging.
※ Use of a display device as tablet PC is highly recommended to confirm the needle progress (insertion length)
and the pressure change detected by EPIA.
RIMS-IFU-001 / Rev. 1
Page 12 / 43
7.3. Software [Rims_EPIA (Version 1.0.0)]
No
Name
Symbol
Description
Data transmission and move to Settings Page
‐
Packet data transmitted from EPIA
1
2
3
4
5
6
7
8
9
EPIA Logo
Packet
Information
NEW Button
Save Button
Clear Button
Open Button
Needle Progress
Direction
Y‐Axis
X‐Axis
Move to initial display (Reset graph and patient information)
Save current graph and data
Save current graph and reset the graph
Opens a pop‐up window of saved graph file list
Show the status and the direction of the needle movement
‐ Green arrow rotating clockwise: needle moves forward
‐ Red arrow rotating counterclockwise: needle moves backward
‐ No rotation: needle stops
Reaction Force
Reaction force (gf) measured from the needle
Current Position
Current position (mm) of needle (needle insertion length)
※ Files are saved with names as below:
‐ Data file: YYMMDDhhmmss_S_[NAME]_[AGE].txt
‐ Graph: YYMMDDhhmmss_S_[NAME]_[AGE].png
RIMS-IFU-001 / Rev. 1
Page 13 / 43
7.4. Dimensions
7.4.1. Main Body
Part No.
EPIA‐PL‐B
Part No.
EPIA‐CABLE
No
Name
Description
1
Main Body
1) Dimension: 204.5 mm (L) X 41 mm (W) X 80 mm (H)
2) Weight: 217 g
7.4.2. Accessory
‐ Data Cable [EPIA‐HU only]
No
Name
Description
1
Data Cable
1) Dimension: 2,500 mm (L)
2) Weight: 100 g
RIMS-IFU-001 / Rev. 1
Page 14 / 43
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
Do Not Re‐sterilize
Indicates a medical device that is not to be re‐sterilized
General Prohibition Sign
To signify a prohibited action
General Warning Sign
General warning sign
Caution
To indicate that caution is necessary when operating the device
or control close to where the symbol is placed, or to indicate
that the current situation needs
Manufacturer
Indicates the medical device manufacturer
Date of Manufacture
Indicates the date when the medical device was manufactured
Use‐by‐date
Indicates the date after which the medical device is not to be
used
Batch Code (LOT)
Indicates the manufacturer's batch code so that the batch or lot
can be identified
Follow Instructions for Use
Indicates the need for the user to consult and follow the
instructions for use
Catalog Number
Indicates the manufacturer's catalog number so that the medical
device can be identified
Fragile, Handle with Care
Indicates a medical device that can be broken or damaged if not
handled carefully
Keep Dry
Indicates a medical device that needs protection from moisture
Temperature Limit
Indicates the temperature limits to which the medical device can
be safely exposed
Humidity Limitation
Indicates the range of humidity t which the medical device can
be safely exposed
Atmospheric Pressure
Limitation
Indicates the range of atmospheric pressure to which the
medical device can be safely exposed
RIMS-IFU-001 / Rev. 1
Page 15 / 43
Symbol
Title
Description
Battery, General
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
FCC Mark
The electromagnetic interference from the device is under limits
approved by the Federal Communications Commission (United
States)
Authorized Representative in
the European Community
Indicates the authorized representative in the European
Community
CE Marking
The requirements of accreditation and market surveillance
relating to the marketing of products
RIMS-IFU-001 / Rev. 1
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9. Label and Packaging
9.1. Label
‐
9.1.1. Label [EPIA‐HU‐B]
Please refer to “section 8 of Chapter II” to find more about symbols.
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. 1
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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. 1
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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. 1
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9.1.3. Accessory Label [EPIA‐HU]
Data Cable Label [EPIA‐HU]
RIMS-IFU-001 / Rev. 1
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9.2. Packaging
9.2.1. Packaging Unit
‐ 1 Set / Box
Model
EPIA‐HU‐B
EPIA‐HU
9.2.2. Packaging Material and Dimension
Contents
EPIA Main Body (1 ea) + 3V Battery (1 ea) + User Manual (1 ea)
EPIA Main Body (1 ea) + 3V Battery (1 ea) + User Manual (1 ea) + Data Cable (1 ea)
Packaging
Material
Dimensions (mm)
Inner Packaging (Blister)
PET Blister, Tyvek Paper
271 (L) X 41.5 (W) X 109 (H)
Inner Packaging (Pouch)
PE Film, Tyvek Paper
390 (L) X 180 (W)
Inner Box (Gift Box)
Paper (Manilla Paper)
300 (L) X 135 (W) X 55 (H)
Outer Box (Carton Box)
Carton box (Paper)
325 (L) X 305 (W) X 325 (H)
9.2.3. Inner Packaging (Blister)
9.2.4. Inner Packaging (Pouch)
※ The product label is attached to the Tyvek paper of the packaging.
RIMS-IFU-001 / Rev. 1
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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. 1
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Conformity
Reference
10. Product Components (List of Critical Components)
10.1. List of Critical Components
No
Component
Manufacturer
Technical Data
Standard
Part
reference
Lithium Metal
Battery
1
2
3
CR123A
Panasonic
3, 0 V, 1550 mAh
IEC 60086‐4 CB(NL‐64193)
Enclosure
AF365(&)
LG CHEM LTD
UL 94
UL(E67171)
Min Thk : 1.7 mm
V‐1, 60 °C
PCB
FR4‐74
ZHEJIANG WAZAM NEW
MATERIALS CO., LTD.
Min Thk : 0.38 mm
V‐0, 130 °C
UL 94
UL(E136069)
4
DC Motor MJ‐180PA‐42
3 V
IEC 60601‐1
Tested in
equipment
DONGGUAN MAJOR
PRECITION
MANUFACTURING CO.,
LTD.
10.2. List of Critical Components of Control Board (PCB) [EPIA‐HU‐B]
10.3. List of Critical Components of Control Board (PCB) [EPIA‐HU]
16Mhz Oscillator
ABLS7M2‐16.000MHZ‐D2Y‐T
No
1
2
3
4
5
6
7
8
1
2
3
4
5
6
7
No
Name
P‐MOSFET
Voltage Sensor IC
MCU
Boost IC
Bluetooth Module
Motor Driver
RS232 Converter IC
Name
P‐MOSFET
Voltage Sensor IC
MCU
Boost IC
Motor Driver
RS232 Converter IC
Part No.
DMG2301L
APX803L‐28SA‐7
ATmega328PB‐MUR
MT3608
BOT‐nle521
LB1930MC
SP3222eey
Part No.
DMG2301L
APX803L‐28SA‐7
ATmega328PB‐MUR
MT3608
LB1930MC
SP3222eey
16Mhz Oscillator
ABLS7M2‐16.000MHZ‐D2Y‐T
10.4. Lifetime of Critical Components
‐ Shelf life: 3 years
RIMS-IFU-001 / Rev. 1
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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
anesthetic (or saline) to be injected.
‐ Prepare EPIA, 3V battery, USB cable (if needed), a display device, a 5 ml syringe, an epidural needle, and
‐ Check whether the sterile packaging of EPIA is damaged and whether the product is deformed or
damaged.
‐ Check if the environment is suitable for product use. Avoid a humid or wet place.
‐ Read manual and be sure to be fully aware of the device features and cautions before use.
Syringes and needles must use separate certified medical products. (Please refer to “section 7.2.3
of Chapter II”)
Standard requirements (not included)
‐ Syringe 5 mL (KOVAX‐SYRINGE (Korea Vaccine)),
‐ Epidural needle (Tuohy type puncture needle for epidural anesthesia (TaeChang Industrial))
1.3. Power Check
① Open the battery cover ⓐ on the left side of the EPIA.
② Insert the 3V battery (included) into ⓑ, according to the electrode mark.
Left (anterior side of EPIA): (+) pole, Right (posterior side of EPIA): (‐) pole)
③ Close the battery cover again as ⓐ.
When the battery is inserted properly, the device will be turned on, and the syringe holder will
automatically move to the start (setting) position.
RIMS-IFU-001 / Rev. 1
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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.
④ Click the “CONNECT” button
on the upper right of screen to connect the EPIA with the
display device.
If EPIA is not connected properly with the display device, reconnect the device by click the
“CONNECT” button again.
⑤ Click the “READ” button to complete the graph screen preparation.
If Bluetooth Communication is not working well, the device can be connected to a display device
using data cable (USB cable) provided by manufacturer (optional). For the cable connection
method, please refer to “section 2.2 USB Cable Connection [EPIA‐HU] of Chapter III”.
RIMS-IFU-001 / Rev. 1
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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.
⑤ Enter the patient information (Patient Name, Age, Gender) and click the OK button to start the
program.
RIMS-IFU-001 / Rev. 1
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2.3. Main Screen
No
Name
Symbol
Description
Data transmission and move to Settings Page
‐
Packet data transmitted from EPIA
Move to initial display (Reset graph and patient information)
Save current graph and data
Save current graph and reset the graph
6 Open Button
Opens a pop‐up window of saved graph file list
Show the status and the direction of the needle movement
‐ Green arrow rotating clockwise: needle moves forward
‐ Red arrow rotating counterclockwise: needle moves backward
‐ No rotation: needle stops
Reaction Force
Reaction force (gf) measured from the needle
Current Position
Current position (mm) of needle (needle insertion length)
EPIA Logo
Packet
Information
NEW Button
Save Button
Clear Button
Needle
Progress
Direction
Y‐Axis
X‐Axis
1
2
3
4
5
7
8
9
※ Files are saved with names as below:
‐ Data file: YYMMDDhhmmss_S_[NAME]_[AGE].txt
‐ Graph: YYMMDDhhmmss_S_[NAME]_[AGE].png
RIMS-IFU-001 / Rev. 1
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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
button.
⑤ To return to the file list again, click the OPEN
button.
RIMS-IFU-001 / Rev. 1
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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.
When using a Tuohy type needle, insert the needle and syringe in the correct direction considering
the bevel (slope) of the needle tip and the curved direction.
Typically, the bevel faces to anterior (cranial, toward head) so that the injected anesthetic can easily
spread into anterior epidural space.
④
⑤
⑥
⑥ Close the EPIA cover until it clicks and secure the syringe to avoid shaking.
⑦ After connecting EPIA to a display device (Please refer to “section 2. Device Connection of Chapter
III”), run the program on the display device.
⑧ Before the start, check that the graph is located at the start (setting) position.
(The X and Y axes of the graph in the program should be located at 0.)
Also check that the syringe holder of EPIA is located at the start (setting) position.
For the proper insertion, it is recommended to protrude a part of needle (about 20 mm) by
pressing the Forward button and then Stop button.
Use the protruding part of the needle, to insert it into the injection site in advance.
RIMS-IFU-001 / Rev. 1
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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.
During the operation, make sure that the device is pressed firmly against the injection
area to avoid being pushed back.
During the operation, the plunger is not affected, thereby the anesthetic is not injected
while the needle is being inserted.
⑪ The pressure data are transmitted in real‐time to the display device.
Through the pressure graph, the operator can monitor the intra‐insertion movement of the needle,
needle insertion length, 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
.
By detecting a rapid drop in pressure, the device will automatically stop at the epidural space.
The operator can confirm that the pressure is constantly kept low by pressing the 0.2 mm
button, thereby confirming that the automatic stop point coincides with the epidural space.
⑬ After the stop, if additional progress is required, press the 0.2mm button
to advance the
If a withdrawal is required, press the Back button
to move the needle backward.
needle finely.
RIMS-IFU-001 / Rev. 1
Page 30 / 43
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.
※ LOR (Loss of Resistance) method: The method to check the pressure within the syringe
by manually pressing the plunger of the syringe. At the epidural space, where the
relative pressure is lower, the pressure within the syringe decreases thereby the plunger
goes into the syringe.
⑮ Push the plunger of the syringe to inject the required amount of anesthetic.
Alternatively, after removing the syringe from the needle, an epidural catheter can be inserted into
the epidural space through the epidural needle that is inserted into the treatment area, then
subsequent procedures can be taken.
RIMS-IFU-001 / Rev. 1
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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
Syringes and needles are disposable; do not reuse them and dispose them as medical waste after the
regarding medical devices.
use.
In the event of malfunction, stop the use immediately and contact a specialist.
Do not disassemble, repair, or modify the product by anyone other than the manufacturer.
After use, for EPIA‐HU‐B model, wipe the data cable clean with a disinfectant of disinfect it
appropriately according to hospital regulations.
5. Storage and Transport Conditions
Storage and transport temperature: ‐20 – 60 °C
Avoid wet or humid places and store in a well‐ventilated place.
Avoid exposure to extreme temperature changes, humidity, dust, or corrosive vapors.
Do not store near or in chemical storage areas or gas generation areas.
Keep out of direct sunlight. Long exposure to sunlight can damage some parts.
RIMS-IFU-001 / Rev. 1
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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.
In the rare event of mechanical malfunctions, be aware of and press the Stop button
immediately. Stop using immediately and contact a specialist.
If the static electricity or sudden high voltage occurs, the device may stop or return to the
initial state. In this case, press the Back button to return the needle position to the initial
state and start operation again.
If an abnormality is detected during the device operation, press the Stop button, or pull the
product backward to remove it from the patient’s body.
After use, dispose of the device as medical waste. Improper disposal methods may damage
third parties or cause environmental pollution.
Do not use the product beyond the Use‐by‐date specified on the label.
High temperature or liquid contact with the product is prohibited.
2. General Warnings
Use only by trained professional medical personnel.
Do not use for other than its intended use.
Only use for pharmaceutical treatment.
Discard after use and avoid reuse.
Do not disassemble, repair, or modify the product in any way.
RIMS-IFU-001 / Rev. 1
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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. Precautions 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.
If an abnormality is detected during product operation, press the Stop button, or pull the
product backward to remove it from the patient’s body.
In the event of anesthesia side effects, it is recommended to be carried out by a specialist, a
facility or a transport system that can handle the situation.
If static electricity or sudden high voltage occurs, the device may stop or return to the initial
state. In this case, press the Back button to return the needle position to the initial state and
start operation again.
Do not touch the device with wet hands.
Do not place the device in a humid or wet environment.
Do not place the cable in humid or wet environments.
5. 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), or congenital heart disease.
RIMS-IFU-001 / Rev. 1
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‐ Cerebrospinal fluid (CSF) leakage due to dural puncture
6. Adverse Reactions
‐ 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. FCC Interference Statement
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment. This equipment generates, uses,
and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. Operation of this equipment in a residential area is
likely to cause harmful interference in which case the user will be required to correct the interference at his
own expense.
7.3. FCC Radiation Exposure Statement
This equipment complies with RF exposure requirements set forth for an uncontrolled environment.
7.4. FCC Caution FCC Interference Statement
Any changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate this equipment. This transmitter must not be co‐located or operating in conjunction
with any other antenna or transmitter.
RIMS-IFU-001 / Rev. 1
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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 2.4 GHz ISM band and using wide band modulation
techniques;
Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
Parameter
RF output Power
Power Spectral Density
Duty Cycle, Tx‐sequence, Tx‐gap
Medium Utilization (MU) Factor
Adaptivity
Occupied Channel Bandwidth
Transmitter Unwanted Emissions
Domain
Transmitter Unwanted Emissions in the Spurious Domain
Receiver Spurious Emissions
Receiver Blocking
Geo‐location Capability
in the Out‐of‐band
Test Result
Pass
Pass
N/ANote1
N/A Note1
N/A Note1
Pass
Pass
Pass
Pass
Pass
N/A Note2
1. These requirements do not apply for equipment with a maximum declared RF output power
of less than 10 dBm e.i.r.p. or for equipment when operating in a mode where the RF output
power is less than 10 dBm e.i.r.p.
2. This device does not support Geo‐location capability.
Assessment of Electronic and Electrical Equipment related to Human Exposure Restrictions for
Electromagnetic Fields (0 Hz – 300 GHz)
Reference Clause No.
4.3.2.2
4.3.2.3
4.3.2.4
4.3.2.5
4.3.2.6
4.3.2.7
4.3.2.8
4.3.2.9
4.3.2.10
4.3.2.11
4.3.2.12
N/A= Not Applicable
Notes:
EN 62311:2008
RIMS-IFU-001 / Rev. 1
Page 36 / 43
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)
ETSI EN 301 489‐17 V3.2.4 (2020‐09)
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;
Part 1: Common technical requirements; Harmonised Standard for ElectroMagnetic Compatibility
ElectroMagnetic Compatibility (EMC) Standard for Radio Equipment and Services;
Part 17: Specific Conditions for Broadband Data Transmission Systems;
Harmonised Standard for ElectroMagnetic Compatibility
Basic Standard
ETSI EN 301 489‐1 clause 8.2
ETSI EN 301 489‐1 clause 8.3
ETSI EN 301 489‐1 clause 8.4
ETSI EN 301 489‐1 clause 8.5
ETSI EN 301 489‐1 clause 8.6
ETSI EN 301 489‐1 clause 8.7
ETSI EN 301 489‐1 clause 9.2
ETSI EN 301 489‐1 clause 9.3
ETSI EN 301 489‐1 clause 9.4
ETSI EN 301 489‐1 clause 9.5
ETSI EN 301 489‐1 clause 9.6
ETSI EN 301 489‐1 clause 9.7
ETSI EN 301 489‐1 clause 9.8
NA=Not Applicable
Test Result
Description
Emission‐enclosure
of
Ancillary
Radiated
Equipment
Conducted Emission‐DC Power Input/output Port
Conducted Emission‐AC Mains Input/output Port
Harmonic Current Emissions‐AC Mains Input Port
Voltage Fluctuations and Flicker‐AC Mains Input
Port
Conducted Emission‐Wired Network Port
Radio Frequency Electromagnetic Field (80 MHz to
6,000 MHz) – Enclosure Port
Electrostatic Discharge – Enclosure
Fast Transients Common Mode‐signal, Wired
Network and Control Ports, DC and AC Power Ports
Radio Frequency Common Mode
0.15 MHz to 80 MHz‐signal, Wired Network and
Control Ports, DC and AC Power Ports
Transients and Surges‐DC Power Input Ports
Voltage Dips and Interruptions‐AC Mains Power
Input Ports
Surges, Line to Line and Line to Ground‐AC Mains
Power Input Ports, Wired Network Ports
Pass
NA
NA
NA
NA
NA
Pass
Pass
NA
NA
NA
NA
NA
RIMS-IFU-001 / Rev. 1
Page 37 / 43
7.1
7.1
7.1
7.1
7.1
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.
IEC 60601‐1‐2:2014
Medical electrical equipment ‐
Part 1‐2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Clause
Requirement – Test case
Basic standard
Terminal Disturbance Voltages
Radiation Disturbance
CISPR 11:2009 +A1:2010
CISPR 11:2009 +A1:2010
CISPR 11
CISPR 14‐1
ISO 7137
IEC 61000‐3‐2
IEC 61000‐3‐3
IEC 60601‐1‐2
Clause
Requirement – Test case
Terminal Disturbance Voltages
Disturbance Power
Radiated Disturbances
Basic standard
CISPR 14‐1:2005
CISPR 14‐1:2005
CISPR 14‐1:2005
Clause
Requirement – Test case
Basic standard
7.1
RF EMISSIONS
7.1
Conducted RF EMISSIONS
□ RTCA DO‐160C:1989 /
EUROCAE ED‐14C:1989
□ RTCA DO‐160G:2010 /
EUROCAE ED‐14G:2011
□ RTCA DO‐160C:1989 /
EUROCAE ED‐14C:1989
□ RTCA DO‐160G:2010 /
EUROCAE ED‐14G:2011
Clause
Requirement – Test Case
Basic Standard
7.2.1
AC‐Mains Harmonics
IEC 61000‐3‐2:2005 +A1:2008
+A2:2009
Clause
Requirement – Test Case
Basic Standard
7.2.2
AC‐Mains Voltage fluctuations and flicker
IEC 61000‐3‐3:2013
Clause
Requirement – Test Case
8.9
8.9
ELECTROSTATIC DISCHARGE
Radiated RF EM Fields
Basic Standard
IEC 61000‐4‐2:2008
IEC 61000‐4‐3:2006 +A1:2007
+A2:2010
Verdict
N/A
P
Verdict
N/A
N/A
N/A
Verdict
N/A
N/A
Verdict
N/A
Verdict
N/A
Verdict
P
P
RIMS-IFU-001 / Rev. 1
Page 38 / 43
8.9
8.9
8.9
8.9
8.9
8.9
8.9
8.10
Electrical Fast transients / Bursts
Surges
IEC 61000‐4‐4:2012
IEC 61000‐4‐5:2005
Conducted Disturbances Induced by RF Fields
IEC 61000‐4‐6:2013
RATED Power Frequency Magnetic Fields
IEC 61000‐4‐8:2009
Voltage Dips
Voltage Interruptions
IEC 61000‐4‐11:2004
IEC 61000‐4‐11:2004
Electrical Transient Conduction along Supply Lines ISO 7637‐2: 2011
IMMUNITY to Proximity Fields from RF Wireless
Communications Equipment
IEC 60601‐1‐2:2014 Table 10
N/A
N/A
N/A
P
N/A
N/A
N/A
P
Supplementary Information:
N/A=Not Applicable
P=Pass
RIMS-IFU-001 / Rev. 1
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RIMS-IFU-001 / Rev. 1
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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. Cleaning
After use, wipe the data cable with lint‐free cloth soaked with 70 % Isopropyl Alcohol or Ethyl Alcohol.
Or disinfect the cable appropriately according to hospital guidelines.
Sterilize the data transmitting cable appropriately according to hospital practices.
The cable can be sterilized using Ethylene Oxide gas or plasma.
Do not sterilize with steam or dry heat as autoclave.
1.1.2. Sterilization
1.2. Disposal of the Device
The Epidural Instrument (EPIA) is supplied sterile and intended for SINGLE USE ONLY.
Do not clean, re‐sterilize, or reuse the epidural instrument.
After use, discard with the standard medical waste disposal practices.
1.3. Disposal of the Electronic Device
This symbol indicates that the waste of electrical and electronic equipment must not be
disposed of as unsorted municipal waste and must be collected separately.
Please contact an authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.
RIMS-IFU-001 / Rev. 1
Page 41 / 43
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. 1
Page 42 / 43
Copyright © 2021 RIMSCIENCE
All Rights Reserved
RIMS-IFU-001 / Rev. 1
Page 43 / 43
| 1 2 | User manual r01 | Users Manual | 2.17 MiB | January 20 2021 / July 20 2021 | delayed release |
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.
■ EN □ ES □ CS □ DA □ DE □ ET □ EL □ CZ □ RO □ MT □ RO □ PT
RIMS-IFU-001, Rev.0
This page is intentionally left blank.
Table of Contents
Chapter I. ABOUT MANUAL ……………………………………………………………………………………………………….. 2
1. General Information ............................................................................................................................ 2
2. Revision History ................................................................................................................................... 2
3. Applicable Standards ........................................................................................................................... 3
Chapter II. PRODUCT DESCRIPTION………………………………………………………………………………………………4
1. Product Description ............................................................................................................................. 4
2. Intended Use ........................................................................................................................................ 4
3. Principle of Operation ......................................................................................................................... 5
4. Features ................................................................................................................................................ 5
5. Specification ......................................................................................................................................... 6
6. Operating and Storage & Transport Conditions ................................................................................. 7
7. Product Description ............................................................................................................................. 8
8. Symbols (Including Safety Signs) ....................................................................................................... 11
9. Label and Packaging........................................................................................................................... 13
10. Product Component (List of Critical Components) ......................................................................... 17
Chapter III. HOW TO USE……………………………………………………………………………………………………………18
1. Preparation Before Use ..................................................................................................................... 18
2. Device Connection ............................................................................................................................. 19
3. Instruction to Use .............................................................................................................................. 23
4. Post-use Treatment ........................................................................................................................... 25
5. Storage and Transport Conditions .................................................................................................... 25
Chapter IV. WARNING AND SAFETY NOTICES……………………………………………………………………………..26
1. General Precaution ............................................................................................................................ 26
2. General Warning ................................................................................................................................ 26
3. Interaction .......................................................................................................................................... 26
4. Precaution to Use .............................................................................................................................. 27
5. Contraindications ............................................................................................................................... 27
6. Adverse Reaction ............................................................................................................................... 27
7. Warnings related to Wireless Communication .......................................................................... 28
8. Guidance and Manufacturer’s Declaration....................................................................................... 29
Chapter V. MAINTENANCE…………………………………………………………………………………………………………33
1. Maintenance and Trouble Shootings ................................................................................................ 33
2. Disposal of the Electronic Device ...................................................................................................... 33
Chapter VI. TECHNICAL CONTENTS…………………………………………………………………………………………….34
1. Safety Information and Customer Service ........................................................................................ 34
RIMS-IFU-001 / Rev. 0
Page 1 / 34
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.
2020.08.11
New establishment
Description
Chapter I. About Manual
1. General Information
2. Revision History
Rev. No.
Rev. Date
(YYYY.MM.DD)
0
RIMSCIENCE CO. Ltd.
601 (#602-1), 53, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea 03736
Tel. (+82) 2-3789-1010 Fax. (+82) 2-3789-1014
www.rimscience.com
slimbalance® GmbH
Hagenbrücke 1. D-38100 Braunschweig, Germany
Tel.: (+49) 531-61499559
Email: info@slimbalance.de
RIMS-IFU-001 / Rev. 0
Page 2 / 34
3. Applicable Standards
The device complies with the following international standards.
No.
Standard No.
(Reference document No.)
93/42/EEC as amended by
2007/47/EC
Title of Standard
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
EN ISO 13485:2016
(ISO 13485:2016)
Medical device – Quality management systems - Requirements for
regulatory purposes
EN 60601-1:2006/A1:2013
(IEC 60601-1:2005)
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
EN 60601-1-2:2015
(IEC 60601-1-2:2014)
Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
EN 60601-1-6:2010
(IEC 60601-1-6:2010)
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
Medical devices - Application of usability engineering to medical devices
Medical device software - Software life-cycle processes
Medical devices — Application of risk management to medical devices
1
2
3
4
5
6
7
8
EN 62366:2008
(IEC 62366:2007)
EN 62304:2006
(IEC 62304:2006)
EN ISO 14971:2012
(ISO 14971:2007, Corrected
version 2007-10-01)
9
EN 1041:2008
Information supplied by the manufacturer of medical devices
10
EN ISO 15223-1:2016
(ISO 15223-1:2016, Corrected
version 2017-03)
11
EN 301 489-1 V2.2.3 (2019-11)
12
EN 301 489-17 V3.2.4 (2020-09)
Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied — Part 1: General requirements
ElectroMagnetic Compatibility (EMC) standard for radio equipment and
services - Part 1: Common technical requirements - Harmonised Standard
for ElectroMagnetic Compatibility
ElectroMagnetic Compatibility (EMC) standard for radio equipment and
services – Part 17: Specific conditions for Broadband Data Transmission
Systems – Harmonised Standard for ElectroMagnetic Compatibility
13 MEDDEV 2.4/1 rev.9
Classification of medical devices
14 MEDDEV 2.7.1_rev 4
Clinical Evaluation: Guide for manufacturers and notified bodies
15 MEDDEV 2.12/1 rev.8
Guidelines on a Medical Devices Vigilance System
16 MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies
RIMS-IFU-001 / Rev. 0
Page 3 / 34
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.
While the epidural needle is being inserted, a pressure sensor located in EPIA detects the change of
pressure (Reaction force) applied to the tip of the needle, converts the pressure data of each tissue to digital
data and indicates them as a graph on a display device.
The operator can determine the target injection site by monitoring the pressure change in the graph and
can control or stop the movement of the epidural needle at the target site, which is the epidural space.
When needed, the device can be detached from the syringe, and the operator can inject an anesthetic
directly or can insert an epidural catheter.
2. 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.
2.1. Patient Population
Adult (men or women)
2.2. Age
18 years of age and older
2.3. Application Part
Vertebra part
2.4. Intended Medical Indication
- Epidural anesthesia
- Pain control (labor analgesia)
2.5. Patient Contacting Part
None
2.6. Potential/Possible Adverse Reaction
- Cerebrospinal fluid leakage due to dural puncture
- Spinal nerve damage
- Pain in the treatment area
RIMS-IFU-001 / Rev. 0
Page 4 / 34
- 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.
2.7. Contraindications
3. 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.
While the epidural needle is being inserted into the body, the pressure sensor in the syringe holder detects
the pressure change between each tissue. The detected pressure change is converted and stored as digital
data and displayed as a graph on the display device.
When the epidural needle is inserted into the body, the pressure will gradually increase in the
subcutaneous and ligament tissue, and the pressure will rapidly drop when it reaches the epidural space. In
this way, the operators can verify whether the needle tip has successfully entered into the epidural space.
4. Features
- Bluetooth communication or USB data transmitting
- Real-time graph via tablet PC
- Visualization of pressure and needle insertion length
-
-
-
-
-
5 mL syringe compatible
Internally powered
Steady and stable needle insertion
Fine control of needle movement – Safety control button (0.2mm fine advance, stop, backward)
Safety function – Automatic stop when the pressure detected is 50 gf lower than the maximal pressure
detected.
- Applicable for various treatments accompanying epidural anesthesia and pain control
RIMS-IFU-001 / Rev. 0
Page 5 / 34
Description
Epidural Instrument
EPIA-HU-B
EPIA
Lithium Battery, 3Vdc
217 g
Description
45 mm ± 10 %
0.2 mm ± 10 %
1.8 mm/s ± 10 %
Main body: 204.5 mm (L) X 41 mm (W) X 80 mm (H)
Electric Shock Protection Type and
Degree
Internally powered, No Applied part
Software Version
Rims_EPI-A version 1.0.0
Normal operation of Forward movement, Backward movement, Stop,
and Fine advance
Automatic stop when the pressure detected is 50 gf lower than the
maximal pressure detected.
Category
Description
Frequency Range
2,402 MHz ~ 2,480 MHz (Bluetooth Low Energy)
Modulation Technique
Number of Channels
GFSK (Bluetooth Low Energy)
40 Ch (Bluetooth Low Energy)
5. Specification
5.1. General Specifications
Category
Product Name
Model Name
Brand Name
Power Input
Dimension
Weight
5.2. Technical Specification
No
Category
Max. Travel Distance
Min. Travel Distance
Moving Speed
Operation
Safety Function
5.3. RF Specification
No
1
2
3
4
5
6
7
8
1
2
3
4
5
No
1
2
3
RIMS-IFU-001 / Rev. 0
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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. 0
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7. Product Description
7.1. Appearance
7.1.1. Main Body
No
Component
Description
Fine advance (0.2mm) Button
Button to advance syringe and needle for an additional 0.2 mm
Button to move syringe and needle backward
Button to stop the movement of syringe and needle
Button to advance syringe and needle forward constantly
Button to open the syringe cover
Cover to fix the syringe and needle from falling out
Lock for syringe cover
Holder for syringe barrel flange
Transmitting device data to a tablet PC via cable
Cover to fix the 3V battery inserted according to the electrode
1
2
3
4
5
6
7
8
9
Backward Button
Stop Button
Forward Button
Cover Open
Cover
Lock
Syringe Holder
Cable Connector
Battery Cover
10
7.1.2. Accessories
No
1
Accessory
Data Cable
Description
Data transmitting USB cable to connect EPIA main body and tablet PC
RIMS-IFU-001 / Rev. 0
Page 8 / 34
7.1.3. Software
No
Name
Description
1
2
3
4
5
6
7
8
9
EPIA Logo
Packet Information
NEW Button
Save Button
Clear Button
Open Button
Needle Progress Direction
Data transmission and move to Settings Page
Packet data transmitted from EPIA
Move to initial display (Reset graph and patient information)
Save current graph and data
Save current graph and reset the graph
Opens a pop-up window of saved graph file list
Show the status and the direction of the needle movement
- Green arrow rotating clockwise: needle moves forward
-
- No rotation: needle stops
Red arrow rotating counterclockwise: needle moves backward
Y-Axis
X-Axis
Pressure (Reaction force) (gf) measured from the needle
Current position (mm) of needle (needle insertion length)
Files are saved with names as below:
- Data file: YYMMDDhhmmss_S_[NAME]_[AGE].txt
- Graph: YYMMDDhhmmss_S_[NAME]_[AGE].png
RIMS-IFU-001 / Rev. 0
Page 9 / 34
7.2. Dimensions
7.2.1. Main Body
Part No.
EPIA-PL-B
Part No.
EPIA-CABLE
No
Name
Description
1
Main Body
1) Dimension: 204.5 mm (L) X 41 mm (W) X 80 mm (H)
2) Weight: 217 g
7.2.2. Accessories
7.2.2.1 Data Cable
1
No
Name
Description
Data Cable
1) Dimension: 2,500 mm (L)
2) Weight: 100 g
RIMS-IFU-001 / Rev. 0
Page 10 / 34
8. Symbols (Including Safety Signs)
Symbol
Title
Do Not Reuse
Description
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.
Do Not Re-sterilize
Indicates a medical device that is not to be re-sterilized.
General Prohibition Sign
To signify a prohibited action.
General Warning Sign
General warning sign.
Caution
To indicate that caution is necessary when operating the device or
control close to where the symbol is placed, or to indicate that the
current situation needs.
Manufacturer
Indicates the medical device manufacturer.
Date of Manufacture
Indicates the date when the medical device was manufactured.
Use-by-date
Indicates the date after which the medical device is not to be used.
Batch Code (LOT)
Indicates the manufacturer's batch code so that the batch or lot can
be identified.
Follow Instructions for Use
Indicates the need for the user to consult and follow the instructions
for use.
Catalog Number
Indicates the manufacturer's catalog number so that the medical
device can be identified.
Fragile, Handle with Care
Indicates a medical device that can be broken or damaged if not
handled carefully.
Keep Dry
Indicates a medical device that needs protection from moisture.
Temperature Limit
Indicates the temperature limits to which the medical device can be
safely exposed.
Humidity Limitation
Indicates the range of humidity t which the medical device can be
safely exposed.
Atmospheric Pressure Limitation
Indicates the range of atmospheric pressure to which the medical
device can be safely exposed.
RIMS-IFU-001 / Rev. 0
Page 11 / 34
Symbol
Title
Description
Battery, General
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.
Authorized Representative in
the European Community
Indicates the authorized representative in the European Community.
CE Marking
The requirements of accreditation and market surveillance relating
to the marketing of products.
RIMS-IFU-001 / Rev. 0
Page 12 / 34
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. 0
Page 13 / 34
9.1.3. Accessory Label
RIMS-IFU-001 / Rev. 0
Page 14 / 34
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 41.5 (W) X 109 (H) (mm)
- Inner packaging (Pouch): 390 (L) X 180 (W) (mm)
- Inner box: 300 (L) X 135 (W) X 55 (H) (mm)
- Outer box: 325 (L) X 305 (W) X 325 (H) (mm)
9.2.4 Inner Packaging (Blister)
9.2.5 Inner Packaging (Pouch)
RIMS-IFU-001 / Rev. 0
Page 15 / 34
9.2.6 Inner Box
9.2.7 Outer Box
RIMS-IFU-001 / Rev. 0
Page 16 / 34
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
UL 94
UL(E67171)
3
PCB
FR4-74
UL 94
UL(E136069)
Min Thk : 1.7 mm
V-1
60 °C
Min Thk : 0.38
mm
V-0
130 °C
ZHEJIANG WAZAM
NEW MATERIALS
CO., LTD.
DONGGUAN
MAJOR PRECITION
MANUFAXTURING
CO., LTD.
4
DC Motor
MJ-180PA-42
3 V
IEC 60601-1
Tested in equipment
10.2. Lifetime of Critical Component List
- Shelf life: 3 years
RIMS-IFU-001 / Rev. 0
Page 17 / 34
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.
- Check whether the sterile packaging of EPIA is damaged and whether the product is deformed or
damaged.
- Check if the environment is suitable for product use. Avoid a humid or wet place.
- Read manual and be sure to be fully aware of the device features and cautions before use.
Syringes and needles must use separate certified medical products.
Standard requirements (not included):
- Syringe 5 mL (KOVAX-SYRINGE (Korea Vaccine)),
- Epidural needle (Tuohy type puncture needle for epidural anesthesia (TaeChang Industrial))
1.3. Power Check
① Open the battery cover ⓐ on the left side of the EPIA.
② Insert the 3V battery ⓑ, according to the electrode mark (Left: (+) pole, Right: (-) pole).
When the battery is inserted properly, the device will be turned on, and the syringe holder will
automatically move to the start (setting) position.
RIMS-IFU-001 / Rev. 0
Page 18 / 34
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
on the upper right to connect the EPIA with the display
device.
⑤ Click the “READ” button to complete the graph preparation.
RIMS-IFU-001 / Rev. 0
Page 19 / 34
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. Screen Layout
2.3.1. Patient Information
※ You can only start the program by entering patient information (Patient Name, Age, and Gender).
RIMS-IFU-001 / Rev. 0
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2.3.2. Main Screen
No
Name
Description
EPIA Logo
Data transmission and move to Settings Page
Packet Information
Packet data transmitted from EPIA
NEW Button
Save Button
Clear Button
Open Button
Move to initial display
(Reset graph and patient information)
Save current graph and data
Save current graph and reset the graph
7
Needle Progress Direction
Opens a pop-up window of saved graph file list
Show the status and the direction of the needle movement
- Green arrow rotating clockwise: needle moves forward
-
- No rotation: needle stops
Red arrow rotating counterclockwise: needle moves backward
Y-Axis
X-Axis
Reaction force (gf) measured from the needle
Current position (mm) of needle (needle insertion length)
※ Files are saved with names as below:
- Data file: YYMMDDhhmmss_S_[NAME]_[AGE].txt
- Graph: YYMMDDhhmmss_S_[NAME]_[AGE].png
1
2
3
4
5
6
8
9
RIMS-IFU-001 / Rev. 0
Page 21 / 34
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. 0
Page 22 / 34
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.
④
⑤
⑥
⑥ Close the EPIA cover until it clicks and secure the syringe to avoid shaking.
※ When using a Tuohy type needle, insert the needle and syringe in the correct direction considering
the bevel (slope) of the needle tip and the curved direction.
⑦ After connecting EPIA to the display device, start the program.
⑧ Before the start, check that the graph is located at the start (setting) position.
(The X and Y axes of the graph in the program are located at 0.)
⑨ 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.
During the operation, make sure that the device is pressed firmly against the injection
area to avoid being pushed back.
During the operation, the plunger is not affected, thereby the anesthetic is not injected
while the needle is being inserted.
RIMS-IFU-001 / Rev. 0
Page 23 / 34
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
.
By detecting a rapid drop in pressure, the device will automatically stop at the epidural space.
The operator can confirm that the pressure is constantly kept low by pressing the 0.2 mm
button, thereby confirming that the automatic stop point coincides with the epidural space.
⑬ After the stop, if additional progress is required, press the 0.2mm button
to advance the
needle finely.
If a withdrawal is required, press the Back button
to move the needle backward.
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.
⑮ Push the plunger of the syringe to inject the required amount of anesthetic or remove the syringe
from the needle. After the removal, an epidural catheter can be inserted into the epidural space
through the epidural needle that is inserted into the treatment area.
RIMS-IFU-001 / Rev. 0
Page 24 / 34
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. Storage and Transport Conditions
- Storage and transport temperature: -20 - 60 ℃
- Avoid wet or humid places and store in a well-ventilated place.
- Avoid exposure to extreme temperature changes, humidity, dust, or corrosive vapors.
- Do not store in chemical storage areas or gas generation areas.
- Keep out of direct sunlight. Long exposure to sunlight can damage some parts.
RIMS-IFU-001 / Rev. 0
Page 25 / 34
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.
Do not use the product beyond the Use-by-date specified on the label.
High temperature or liquid contact with the product is prohibited.
In the event of malfunction, stop using immediately and contact a specialist.
In the rare event of mechanical malfunctions, be aware of and press the Stop button
immediately.
2. General Warning
Use only by trained professional medical personnel.
Do not use for other than its intended use.
Only use for pharmaceutical treatment.
Discard after use and avoid reuse.
Do not disassemble, repair, or modify the product in any way.
3. Interaction
Check suitability and compatibility with other medical supplies before use.
Use sterile syringes and needles with this product.
RIMS-IFU-001 / Rev. 0
Page 26 / 34
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.
If an abnormality is detected during product operation, press the Stop button, or pull the
product backward to remove it from the patient’s body.
In the event of anesthesia side effects, it is recommended to be carried out by a specialist, a
facility or a transport system that can handle the situation.
If static electricity or sudden high voltage occurs, the device may stop or return to the initial
state. In this case, press the Back button to return the needle position to the initial state and
start operation again.
Do not touch the device with wet hands.
Do not place the device in a humid or wet environment.
Do not place the cable in humid or wet environment.
5. 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), or congenital heart disease.
6. Adverse Reaction
- Cerebrospinal fluid leakage due to dural puncture
- Spinal nerve damage
- Pain in the treatment area
RIMS-IFU-001 / Rev. 0
Page 27 / 34
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. FCC Interference Statement
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment. This equipment generates, uses,
and can radiate radio frequency energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be required to correct the
interference at his own expense.
7.3. FCC Radiation Exposure Statement
This equipment complies with RF exposure requirements set forth for an uncontrolled environment.
7.4. FCC Caution FCC Interference Statement
Any changes or modifications not expressly approved by the party responsible for compliance could void
the user's authority to operate this equipment. This transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.
RIMS-IFU-001 / Rev. 0
Page 28 / 34
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. 0
Page 29 / 34
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. 0
Page 30 / 34
RIMS-IFU-001 / Rev. 0
Page 31 / 34
8.3 Recommended separation distance between portable and mobile RF communications
equipment and the compatible device.
RIMS-IFU-001 / Rev. 0
Page 32 / 34
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.
The Epidural Instrument (EPIA) is supplied sterile and intended for SINGLE USE ONLY.
Do not clean, re-sterilize, or reuse the epidural instrument.
After use, discard with the standard medical waste disposal practices.
1.1. Disposal of the Device
1.2. Maintenance of Cable
1.2.1 Cleaning
After use, wipe the data cable with lint-free cloth soaked with 70 % Isopropyl Alcohol or Ethyl
Alcohol.
Or disinfect the cable appropriately according to hospital guidelines.
1.2.2 Sterilization
Sterilize the data transmitting cable appropriately according to hospital practices.
The cable can be sterilized using Ethylene Oxide gas or plasma.
Do not sterilize with steam or dry heat as autoclave.
2. Disposal of the Electronic Device
This symbol indicates that the waste of electrical and electronic equipment must not be
disposed as unsorted municipal waste and must be collected separately.
Please contact an authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.
RIMS-IFU-001 / Rev. 0
Page 33 / 34
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. 0
Page 34 / 34
Copyright © 2020 RIMSCIENCE
All Rights Reserved
| 1 2 | Internal photos | Internal Photos | 592.16 KiB | February 24 2021 / August 24 2021 | delayed release |
| 1 2 | External photos | External Photos | 509.96 KiB | February 24 2021 / August 24 2021 | delayed release |
| 1 2 | Label Info. r01 | ID Label/Location Info | 48.57 KiB | January 20 2021 |
[LabelInformation&Location]
Left Theleftsideoftheproduct. Thelabelwasfixedwhereitcannotberemoved.
| 1 2 | C2PC Letter r01 | Cover Letter(s) | 217.60 KiB | February 24 2021 |
RIMSCIENCE CO.Ltd. 601(#602-1), 53, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea Tel +82-2-3789-1007 / Fax +82-2-3789-1014 Date: February 23, 2021 UL Verification Services Inc.(formerly UL CCS) 47173 Benicia Street, Fremont, CA 94538 Subject : RIMSCIENCE CO.Ltd. FCC ID : 2AXYN-EPIA-HU-B Class II Permissive Change Orig. Grant Date : January 20, 2021 This is to request a Main board change for FCC ID : 2AXYN-EPIA-HU-B Same as before, except for the main board. The components removed are as below:
No. 1 2 3 Components RC0603FR-07130KL RC0603FR-07066KL RC0603FR-0722RL Specification 1608 / 130K 1608 / 66K 1608 / 22R 4 SN74LV1T34DBVRG4 Logic Level Shifter Function Resistance Resistance Resistance Voltage maintenance Effects To lower the RF signal of the electrical circuit To stabilize the signal transmitted between the EUT and BLE The components removed are not related with RF. Sincerely Yours, ___ NAME : Saeram Park TITLE : Assistant Manager E-MAIL: psr@rimscience.com FAX: +82-2-3789-1014 TEL: +82-2-3789-1010 RIMSCIENCE CO.Ltd.
| 1 2 | External Authorization Letter for FCC application | Cover Letter(s) | 133.76 KiB | February 24 2021 |
RIMSCIENCE CO.Ltd. 601(#602-1), 53, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea Date: February 09, 2021 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 c.c. UL Verification Services Certification Division 47173 Benicia Street Fremont, CA 94538, USA To whom it may concern:
I, the undersigned, hereby authorize Ms. Chloe Lee / Manager of KCTL Inc. and hereafter referred to as KCTL to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Ms. Chloe Lee / Manager of KCTL Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing KCTL as our agent, we still recognize that we are responsible to:
comply with the relevant provisions of the certification program;
a) b) c) d) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;
make claims regarding certification only in respect of the scope for which certification has been granted;
do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;
e) f) g) h) i) j) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;
use certification only to indicate the products are certified as being in conformity with specified standards;
endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;
ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;
keep a record of all complaints made known to the us relating to the products compliance with requirements of the relevant standard and to make these records available to the Certification Division when requested;
take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;
k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Saeram Park / Assistant Manager
| 1 2 | FCC Confidentiality Request letter | Cover Letter(s) | 88.65 KiB | February 24 2021 |
RIMSCIENCE CO.Ltd. 601(#602-1), 53, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea CONFIDENTIALITY REQUEST Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 February 09, 2021 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b)(4) of the Freedom of Information Act, RIMSCIENCE CO.Ltd. requests confidentiality for the following products:
FCC ID Number Product Title/Model 2AXYN-EPIA-HU-B Epidural Instrument / EPIA-HU-B, EPIA-AN-B The following exhibits contain trade secrets and proprietary information that could be of benefit to our competitors regarding the design of our product. This material is not customarily available to the general public and we request that it be withheld from public inspection. We request that the following information submitted be held permanent confidential treatment. We also hereby request Short-Term Confidentiality for 180 days after the grant as outlined in Public Notice DA 04-1705. This provision will give temporary confidentiality of commercially sensitive information prior to product release. If you have any questions, please feel free to contact me at the address shown below. Permanent Confidential Request
-. Schematics Short-Term Confidential Request
-. External Photos
-. Internal Photos
-. Test set-up photo
-. User Manual Sincerely, Saeram Park / Assistant Manager
| 1 2 | KR21-SRF0031 00467 RIMSCIENCE BluetoothLE[P15.247] | Test Report | 1.17 MiB | February 24 2021 |
| 1 2 | Test setup photos | Test Setup Photos | 311.69 KiB | February 24 2021 / August 24 2021 | delayed release |
| 1 2 | Letter of Variant Model | Cover Letter(s) | 173.65 KiB | January 20 2021 |
RIMSCIENCE CO.Ltd. 601(#602-1), 53, Chungjeong-ro, Seodaemun-gu, Seoul, Republic of Korea Tel +82-2-3789-1007 / Fax +82-2-3789-1014 Date: January 12, 2021 Dear Sir/Madam, Re: Letter of Similarity We, RIMSCIENCE CO.Ltd. declare the differences for between original model and variant models.
-Product: Epidural Instrument
-Model name: EPIA-HU-B
-Variant Model name: EPIA-AN-B Classified as animal use (AN) and human use (HU) Sincerely Yours, ___ NAME : Saeram, Park TITLE : Assistant Manager E-MAIL: psr@rimscience.com FAX: +82-2-3789-1014 TEL: +82-10-3121-9781 RIMSCIENCE CO.Ltd.
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2021-02-24 | 2402 ~ 2480 | DTS - Digital Transmission System | Class II Permissive Change |
| 2 | 2021-01-20 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 2 | Effective |
2021-02-24
|
||||
| 1 2 |
2021-01-20
|
|||||
| 1 2 | Applicant's complete, legal business name |
RIMSCIENCE CO.Ltd.
|
||||
| 1 2 | FCC Registration Number (FRN) |
0030126346
|
||||
| 1 2 | Physical Address |
601(#602-1), 53, Chungjeong-ro
|
||||
| 1 2 |
Seodaemun-gu, Seoul, N/A
|
|||||
| 1 2 |
South Korea
|
|||||
| app s | TCB Information | |||||
| 1 2 | TCB Application Email Address |
L******@ul.com
|
||||
| 1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
| app s | FCC ID | |||||
| 1 2 | Grantee Code |
2AXYN
|
||||
| 1 2 | Equipment Product Code |
EPIA-HU-B
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 2 | Name |
S******** P****
|
||||
| 1 2 | Title |
Assistant Manager
|
||||
| 1 2 | Telephone Number |
+82-1********
|
||||
| 1 2 | Fax Number |
+82-2********
|
||||
| 1 2 |
p******@rimscience.com
|
|||||
| app s | Technical Contact | |||||
| 1 2 | Firm Name |
KCTL Inc.
|
||||
| 1 2 | Name |
C****** L******
|
||||
| 1 2 | Physical Address |
65, Sinwon-ro, Yeongtong-gu
|
||||
| 1 2 |
Suwon-si,Gyeonggi-do, 16677
|
|||||
| 1 2 |
South Korea
|
|||||
| 1 2 | Telephone Number |
82-70********
|
||||
| 1 2 | Fax Number |
82-50********
|
||||
| 1 2 |
k******@kctl.co.kr
|
|||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 08/24/2021 | ||||
| 1 2 | 07/20/2021 | |||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 2 | Equipment Class | DTS - Digital Transmission System | ||||
| 1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Epidural Instrument | ||||
| 1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 2 | Modular Equipment Type | Does not apply | ||||
| 1 2 | Purpose / Application is for | Class II Permissive Change | ||||
| 1 2 | Original Equipment | |||||
| 1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
| 1 2 | Grant Comments | Class II permissive change as documented. Output power listed is conducted. | ||||
| 1 2 | Output power listed is conducted. | |||||
| 1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 2 | Firm Name |
KCTL INC
|
||||
| 1 2 | Name |
S******** L******
|
||||
| 1 2 | Telephone Number |
+82-3********
|
||||
| 1 2 |
s******@kctl.co.kr
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0012000 | ||||||||||||||||||||||||||||||||||||
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 2 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0012000 | ||||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC