■Item name/Item license number: Electric medical aspirator/Zane No. 20-4170
■Packing unit: 1EA
■Model name: XXXXX
■Manufacturing date: XXXXXX
■Manufacturing number: XXXXXX
■Expiration date: Within 3 years from the date of manufacture
■Manufacturer: Inseong Medical Co., Ltd., 168 Geoepdosi-ro, Jijeong-myeon, Wonju-si, Gangwon-do
■Manufacturing license number: No. 838
■Attached documents are provided in electronic form on the Internet homepage below.
http://www.insungmedical.co.kr/customer/userguide/
■Year, month, and date of user manual creation: March 2, 2020 (rev. ~)
■This product is a disposable sterilized medical device and reuse is prohibited.
[Attachment information]
■Purpose of use
A medical electric device that suctions blood, body fluids, etc. and uses external vacuum pressure.
■ How to use and operating sequence
1. General suction
① Press the vacuum pressure UP and DOWN buttons on the control panel to set the vacuum pressure you want to use. Vacuum pressure can be set from 1 to 5 levels, and each level is displayed as a bar graph in the Vacuum step of the display window.
※ Vacuum pressure cannot be set while suction is in progress. Vacuum pressure can be set when the suction function is OFF.
② Press the general suction button on the control panel to activate the general suction function. When the function is activated, the LED at the top of the button lights up in green and the status indicator in the display window changes from READY to suctioning.
③ While suction is in progress, the suction material is placed in a general suction container, and the maximum amount of suction material is displayed on the canister in the display window as 5.0L.
④ When the general suction container reaches 4.5L, suction stops, the message LEVEL appears on the display window, a warning sound sounds, and discharge proceeds automatically. At this time, the status indicator on the display window changes from suction to discharge.
※When the capacity of the general suction container is 4.5L or less and you want to discharge, stop suction and press the general discharge button to proceed with discharge.
⑤ After discharging is completed, the general suction container is automatically cleaned using detergent and washing water. At this time, the status indicator on the display window shows 'cleaning', and when cleaning is completed, it goes into standby mode and the status indicator shows 'READY'.
※Automatic cleaning is possible only when the hose for supplying washing water is connected to the washing water connection.
⑥ The suction function can be activated again by pressing the general suction button in standby mode.
⑦ If you press the general suction button during suction, suction will stop and the green LED will turn off.
2. Disposable suction
① Press the vacuum pressure UP and DOWN buttons on the control panel to set the desired vacuum pressure. Vacuum pressure can be set from 1 to 5 levels, and each level is displayed as a bar graph in the Vacuum Step of the display window.
※ Vacuum pressure cannot be set while suction is in progress. Vacuum pressure can be set when the suction function is OFF.
② Press the disposable suction button on the control panel to activate the disposable suction function. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to disposable suction.
③ If you press the disposable suction button during suction, suction will stop and the green LED will turn off.
④ When suction is complete, remove the disposable container from the device and dispose of it according to the hospital's biohazard disposal procedures.
3. Additional cleaning
① Additional cleaning should be performed after all suction processes are completed.
② Before additional cleaning, be sure to check whether there is enough detergent in the cleaning solution container.
③ Press the additional cleaning button on the control panel to activate the cleaning function using detergent. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to cleaning.
④ Substances generated during cleaning are automatically collected in the final collection container.
⑤ When cleaning is completed, the status indicator on the display window displays READY during cleaning and the green LED turns off.
※ Additional washing is possible only when the hose for supplying washing water is connected to the washing water connection.
4. General emissions
① Press the general discharge button on the control panel to activate the general discharge function. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to discharging.
② While general discharge is in progress, substances in the general suction container are collected into the final collection container at the bottom of the device, and the operation is performed until all substances are discharged.
③ After general discharge is completed, the general suction container is automatically cleaned using detergent and washing water. At this time, the status indicator on the display window shows cleaning, and when cleaning is completed, it goes into standby mode and the status indicator shows READY.
※ Automatic cleaning is possible only when the hose for supplying washing water is connected to the washing water connection.
④ To stop the general discharge function arbitrarily, press the power button on the control panel.
5. External emissions
① Before external discharge, be sure to check whether the discharge hose is correctly connected to the external discharge connection on the back of the device.
② Press the external discharge button on the control panel to activate the external discharge function. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to discharging.
③ While external discharge is in progress, the material in the final collection container located at the bottom of the device is discharged to the outside, and the device operates until all the material is discharged.
④ After external discharge is completed, the final collection container is automatically cleaned using washing water. At this time, the status indicator on the display window shows cleaning, and when cleaning is completed, it goes into standby mode and the status indicator shows READY.
※ Automatic cleaning is possible only when the hose for supplying washing water is connected to the washing water connection.
⑤ To stop the external discharge function arbitrarily, press the power button on the control panel.
6. Save
① The storage function must be performed in a standby state where all functions of the device are not operating.
② Connect the external storage medium to the USB port on the back of the device.
③ Press the Save (USB) button on the control panel to activate the save function. When the function is activated, the LED on the top of the button blinks green and the status indicator in the display window changes from READY to Saving.
④ While saving is in progress, information generated during operation that is stored inside the device is moved and stored from inside the device to an external storage medium.
⑤ When saving is complete, the status indicator in the display window will display READY while saving, and it will be in a standby state where other functions can be operated.
■Preparation before use
① Be sure to check the power supply before use. (220V, 60Hz)
② Supply power to the product using the power cord specified by the manufacturer.
③ Use after fully understanding the product’s user manual.
④ Check whether there is enough cleaning solution in the cleaning agent container before use.
⑤ If the cleaning solution is insufficient, refill the cleaning solution container according to the concentration below.
(1) Didecyldimethylammonium Chloride(Solution at 50%): 12.6%
(2) Polyhexamethylene Biguanide (Solution at 20 %): 4.8 %
(3) Dilute this solution 200 times (0.5%) in cold or lukewarm water. (25 mL / 5000 mL)
⑥ Before use, be sure to prepare for use with an expert or doctor.
⑦ Connect a separate external vacuum pump to the vacuum pump connection on the back of the product. At this time, the vacuum pressure supplied must be less than 760mmHg.
⑧ Connect a hose that can supply tap water to the washing water connection on the back of the product. At this time, the water pressure supplied must be less than 3 kgf/cm2.
⑨ Connect the hose to the external discharge connection on the back of the product, and connect the other side of the hose to the hospital's waste disposal site for high-risk substances.
⑩ Connect the barcode reader to the barcode reader connection on the back of the product and the barcode reader power connector, respectively.
⑪ Connect the previously reported suction tube to the suction tube connector on the general suction container and the disposable container (small), and connect the suction catheter to the other end.
⑫ Press the power switch on the left side of the product to turn it on and press the power button on the control panel to supply power to the display window.
⑬ When the device is turned on, the Operation Time in the display window increases, and this time continues to increase while the device is turned on, regardless of whether the device is operating or not.
■Precautions for use
1. Precautions
① Anyone using the device must read the user manual.
② The device must be used only by a qualified doctor.
③ Qualified doctors must have experience and knowledge in the use of medical aspirators.
④ Suction tubes, catheters, and disposable containers must be replaced and used only with accessories specified by the manufacturer.
⑤ Other devices may malfunction due to the influence of electromagnetic waves generated from the device, and the device may malfunction due to the influence of electromagnetic waves generated from other devices, so do not use it adjacent to other devices or load other devices.
⑥ The switch to cut off the power to the device is on the left side. When the switch is turned off, the positive pole of the power source can be cut off.
⑦ Insert the power plug into the outlet securely all the way so that it does not fall out easily.
⑧ When moving the device, turn off the power switch and remove the power plug from the outlet before moving.
⑨ To ensure proper operation of the device, avoid high places and store it in a flat, stable place.
⑩ Do not place objects or place your hands on this product to apply strong force, as it may cause malfunction.
⑪ As the product may move during use, secure the wheel lock before use.
⑫ When moving the device, unlock the wheels.
⑬ Large vibrations or shocks can cause malfunctions, so move the device slowly and avoid jumping over steps or hitting walls.
2. Warnings
① Do not aspirate excessive amounts of body fluid.
② Loss of blood and body fluids can have a detrimental effect on hemodynamic safety and patient safety during or after use, so an environment that can supply blood and body fluids in a timely manner must be created.
③ When suction is not in progress, remove the suction tube from the patient.
④ When cleaning the device, do not use liquid or detergent.
⑤ Avoid exposure to environments with direct sunlight, heat sources, water, high humidity, and mechanical shock.
⑥ Avoid places with high temperatures, dust, and salt, and use in a well-ventilated place.
⑦ Do not connect to a power source outside the specified rated power range.
⑧ If the device does not operate normally, you must not arbitrarily repair or disassemble it. You must contact the manufacturer to receive necessary measures.
⑨ To avoid the risk of electric shock, this device should only be connected to a power supply with protective grounding.
⑩ After using the general suction function, always clean it to keep the general container free of suction substances.
⑪ When using on patients suspected of secondary infection by pathogens, use the disposable suction function to place the suction material in a disposable container, and remove and discard it after use.
3. Prohibitions
① Do not operate the device without connecting the external vacuum pump supplied to the device.
② Do not operate the device when the detergent is not filled.
③ Do not operate the device without external tap water being supplied to the device.
④ Do not turn off the power while the device is operating.
⑤ Do not open the top cover of the device while suction is in progress.
⑥ Do not proceed with suction when the final collection container is full. In this case, the external discharge function is activated and suction is started after completion.
⑦ Do not reuse disposable containers after use.
■Storage method 1. Storage and environmental conditions
Temperature: -18℃ ~ 50℃ Humidity: 10% to 90% Atmospheric pressure: 70 kPa to 106 kPa 2. Operation/environmental conditions
Temperature: 15℃ ~ 40℃ Humidity: 15% to 85% Atmospheric pressure: 76 kPa to 106 kPa ■Packaging unit: 1EA
■Manufacturer (importer): Inseong Medical Co., Ltd., 168 Geoepdosi-ro, Jijeong-myeon, Wonju-si, Gangwon-do
■Manufacturing License Number: No. 838
■This product is a disposable sterilized medical device and reuse is prohibited.
■Year, month, and date of user manual creation: March 2, 2020
■Item name/Item license number: Electric medical aspirator/Zane No. 20-4170
■Packing unit: 1EA
■Model name: XXXXX
■Manufacturing date: XXXXXX
■Manufacturing number: XXXXXX
■Expiration date: Within 3 years from the date of manufacture
■Manufacturer: Inseong Medical Co., Ltd., 168 Geoepdosi-ro, Jijeong-myeon, Wonju-si, Gangwon-do
■Manufacturing license number: No. 838
■Attached documents are provided in electronic form on the Internet homepage below.
http://www.insungmedical.co.kr/customer/userguide/
■Year, month, and date of user manual creation: March 2, 2020 (rev. ~)
■This product is a disposable sterilized medical device and reuse is prohibited.
[Attachment information]
■Purpose of use
A medical electric device that suctions blood, body fluids, etc. and uses external vacuum pressure.
■ How to use and operating sequence
1. General suction
① Press the vacuum pressure UP and DOWN buttons on the control panel to set the vacuum pressure you want to use. Vacuum pressure can be set from 1 to 5 levels, and each level is displayed as a bar graph in the Vacuum step of the display window.
※ Vacuum pressure cannot be set while suction is in progress. Vacuum pressure can be set when the suction function is OFF.
② Press the general suction button on the control panel to activate the general suction function. When the function is activated, the LED at the top of the button lights up in green and the status indicator in the display window changes from READY to suctioning.
③ While suction is in progress, the suction material is placed in a general suction container, and the maximum amount of suction material is displayed on the canister in the display window as 5.0L.
④ When the general suction container reaches 4.5L, suction stops, the message LEVEL appears on the display window, a warning sound sounds, and discharge proceeds automatically. At this time, the status indicator on the display window changes from suction to discharge.
※When the capacity of the general suction container is 4.5L or less and you want to discharge, stop suction and press the general discharge button to proceed with discharge.
⑤ After discharging is completed, the general suction container is automatically cleaned using detergent and washing water. At this time, the status indicator on the display window shows 'cleaning', and when cleaning is completed, it goes into standby mode and the status indicator shows 'READY'.
※Automatic cleaning is possible only when the hose for supplying washing water is connected to the washing water connection.
⑥ The suction function can be activated again by pressing the general suction button in standby mode.
⑦ If you press the general suction button during suction, suction will stop and the green LED will turn off.
2. Disposable suction
① Press the vacuum pressure UP and DOWN buttons on the control panel to set the desired vacuum pressure. Vacuum pressure can be set from 1 to 5 levels, and each level is displayed as a bar graph in the Vacuum Step of the display window.
※ Vacuum pressure cannot be set while suction is in progress. Vacuum pressure can be set when the suction function is OFF.
② Press the disposable suction button on the control panel to activate the disposable suction function. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to disposable suction.
③ If you press the disposable suction button during suction, suction will stop and the green LED will turn off.
④ When suction is complete, remove the disposable container from the device and dispose of it according to the hospital's biohazard disposal procedures.
3. Additional cleaning
① Additional cleaning should be performed after all suction processes are completed.
② Before additional cleaning, be sure to check whether there is enough detergent in the cleaning solution container.
③ Press the additional cleaning button on the control panel to activate the cleaning function using detergent. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to cleaning.
④ Substances generated during cleaning are automatically collected in the final collection container.
⑤ When cleaning is completed, the status indicator on the display window displays READY during cleaning and the green LED turns off.
※ Additional washing is possible only when the hose for supplying washing water is connected to the washing water connection.
4. General emissions
① Press the general discharge button on the control panel to activate the general discharge function. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to discharging.
② While general discharge is in progress, substances in the general suction container are collected into the final collection container at the bottom of the device, and the operation is performed until all substances are discharged.
③ After general discharge is completed, the general suction container is automatically cleaned using detergent and washing water. At this time, the status indicator on the display window shows cleaning, and when cleaning is completed, it goes into standby mode and the status indicator shows READY.
※ Automatic cleaning is possible only when the hose for supplying washing water is connected to the washing water connection.
④ To stop the general discharge function arbitrarily, press the power button on the control panel.
5. External emissions
① Before external discharge, be sure to check whether the discharge hose is correctly connected to the external discharge connection on the back of the device.
② Press the external discharge button on the control panel to activate the external discharge function. When the function is activated, the LED on the top of the button lights up green and the status indicator in the display window changes from READY to discharging.
③ While external discharge is in progress, the material in the final collection container located at the bottom of the device is discharged to the outside, and the device operates until all the material is discharged.
④ After external discharge is completed, the final collection container is automatically cleaned using washing water. At this time, the status indicator on the display window shows cleaning, and when cleaning is completed, it goes into standby mode and the status indicator shows READY.
※ Automatic cleaning is possible only when the hose for supplying washing water is connected to the washing water connection.
⑤ To stop the external discharge function arbitrarily, press the power button on the control panel.
6. Save
① The storage function must be performed in a standby state where all functions of the device are not operating.
② Connect the external storage medium to the USB port on the back of the device.
③ Press the Save (USB) button on the control panel to activate the save function. When the function is activated, the LED on the top of the button blinks green and the status indicator in the display window changes from READY to Saving.
④ While saving is in progress, information generated during operation that is stored inside the device is moved and stored from inside the device to an external storage medium.
⑤ When saving is complete, the status indicator in the display window will display READY while saving, and it will be in a standby state where other functions can be operated.
■Preparation before use
① Be sure to check the power supply before use. (220V, 60Hz)
② Supply power to the product using the power cord specified by the manufacturer.
③ Use after fully understanding the product’s user manual.
④ Check whether there is enough cleaning solution in the cleaning agent container before use.
⑤ If the cleaning solution is insufficient, refill the cleaning solution container according to the concentration below.
(1) Didecyldimethylammonium Chloride(Solution at 50%): 12.6%
(2) Polyhexamethylene Biguanide (Solution at 20 %): 4.8 %
(3) Dilute this solution 200 times (0.5%) in cold or lukewarm water. (25 mL / 5000 mL)
⑥ Before use, be sure to prepare for use with an expert or doctor.
⑦ Connect a separate external vacuum pump to the vacuum pump connection on the back of the product. At this time, the vacuum pressure supplied must be less than 760mmHg.
⑧ Connect a hose that can supply tap water to the washing water connection on the back of the product. At this time, the water pressure supplied must be less than 3 kgf/cm2.
⑨ Connect the hose to the external discharge connection on the back of the product, and connect the other side of the hose to the hospital's waste disposal site for high-risk substances.
⑩ Connect the barcode reader to the barcode reader connection on the back of the product and the barcode reader power connector, respectively.
⑪ Connect the previously reported suction tube to the suction tube connector on the general suction container and the disposable container (small), and connect the suction catheter to the other end.
⑫ Press the power switch on the left side of the product to turn it on and press the power button on the control panel to supply power to the display window.
⑬ When the device is turned on, the Operation Time in the display window increases, and this time continues to increase while the device is turned on, regardless of whether the device is operating or not.
■Precautions for use
1. Precautions
① Anyone using the device must read the user manual.
② The device must be used only by a qualified doctor.
③ Qualified doctors must have experience and knowledge in the use of medical aspirators.
④ Suction tubes, catheters, and disposable containers must be replaced and used only with accessories specified by the manufacturer.
⑤ Other devices may malfunction due to the influence of electromagnetic waves generated from the device, and the device may malfunction due to the influence of electromagnetic waves generated from other devices, so do not use it adjacent to other devices or load other devices.
⑥ The switch to cut off the power to the device is on the left side. When the switch is turned off, the positive pole of the power source can be cut off.
⑦ Insert the power plug into the outlet securely all the way so that it does not fall out easily.
⑧ When moving the device, turn off the power switch and remove the power plug from the outlet before moving.
⑨ To ensure proper operation of the device, avoid high places and store it in a flat, stable place.
⑩ Do not place objects or place your hands on this product to apply strong force, as it may cause malfunction.
⑪ As the product may move during use, secure the wheel lock before use.
⑫ When moving the device, unlock the wheels.
⑬ Large vibrations or shocks can cause malfunctions, so move the device slowly and avoid jumping over steps or hitting walls.
2. Warnings
① Do not aspirate excessive amounts of body fluid.
② Loss of blood and body fluids can have a detrimental effect on hemodynamic safety and patient safety during or after use, so an environment that can supply blood and body fluids in a timely manner must be created.
③ When suction is not in progress, remove the suction tube from the patient.
④ When cleaning the device, do not use liquid or detergent.
⑤ Avoid exposure to environments with direct sunlight, heat sources, water, high humidity, and mechanical shock.
⑥ Avoid places with high temperatures, dust, and salt, and use in a well-ventilated place.
⑦ Do not connect to a power source outside the specified rated power range.
⑧ If the device does not operate normally, you must not arbitrarily repair or disassemble it. You must contact the manufacturer to receive necessary measures.
⑨ To avoid the risk of electric shock, this device should only be connected to a power supply with protective grounding.
⑩ After using the general suction function, always clean it to keep the general container free of suction substances.
⑪ When using on patients suspected of secondary infection by pathogens, use the disposable suction function to place the suction material in a disposable container, and remove and discard it after use.
3. Prohibitions
① Do not operate the device without connecting the external vacuum pump supplied to the device.
② Do not operate the device when the detergent is not filled.
③ Do not operate the device without external tap water being supplied to the device.
④ Do not turn off the power while the device is operating.
⑤ Do not open the top cover of the device while suction is in progress.
⑥ Do not proceed with suction when the final collection container is full. In this case, the external discharge function is activated and suction is started after completion.
⑦ Do not reuse disposable containers after use.
■Storage method 1. Storage and environmental conditions
Temperature: -18℃ ~ 50℃ Humidity: 10% to 90% Atmospheric pressure: 70 kPa to 106 kPa 2. Operation/environmental conditions
Temperature: 15℃ ~ 40℃ Humidity: 15% to 85% Atmospheric pressure: 76 kPa to 106 kPa ■Packaging unit: 1EA
■Manufacturer (importer): Inseong Medical Co., Ltd., 168 Geoepdosi-ro, Jijeong-myeon, Wonju-si, Gangwon-do
■Manufacturing License Number: No. 838
■This product is a disposable sterilized medical device and reuse is prohibited.
■Year, month, and date of user manual creation: March 2, 2020