MDK Med MI 20 Series User Manual
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MDK Med MI 20 Series User Manual

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MI 20-CETF-005
MI 20 Series Infusion Pump User's Manual
Version：1.0
Zhejiang MDKingdom Technology co., Ltd.
2017.11
1 / 83

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  • Page 1 MI 20-CETF-005 MI 20 Series Infusion Pump User’s Manual Version：1.0 Zhejiang MDKingdom Technology co., Ltd. 2017.11 1 / 83...

  • Page 2: Table Of Contents

    MI 20-CETF-005 Contents 1 SYMBOLS, GRAPHICS AND WARNINGS .......... 6 1.1 DESCRIPTIONS OF GRAPHICS AND SYMBOLS ......6 1.2 WARNINGS ..................7 1.3 CAUTIONS ..................8 1.4 NOTES ................... 9 2 TERMS AND DEFINITIONS .............. 10 3 INTRODUCTIONS AND SCOPES ............11 3.1 INTRODUCTIONS .................
  • Page 3 MI 20-CETF-005 7.2.1 POWER ON ................24 7.2.2 SYSTEM SELF-TEST ............24 7.3 SETTING PARAMETERS ............. 25 7.3.1 INFUSION SET SELECTION ..........25 7.3.2 INFUSION MODE SELECTION ..........26 7.3.3 SETTINGVolume to Be Infused (VTBI) ........ 27 7.3.4 SETTING INFUSION FLOW RATE ........27 7.3.5 SETTING INFUSION TIME ............
  • Page 4 MI 20-CETF-005 7.14 BODY WEIGHT MODE SETTING ..........41 7.15 DRUG LIBRARY MODE ............. 42 7.16 DRUG LIBRARY ................ 43 7.17 VIEWING LOG ................44 8 ALARMS ................... 44 8.1 DOOR OPEN ALARM ..............46 8.2 DOWNSTREAM OCCLUSION ALARM ......... 46 8.3 UPSTREAM OCCLUSION ALARM ..........
  • Page 5 MI 20-CETF-005 9.11 SYSTEM MAINTENANCE ............61 9.12 RESTORE TO FACTORY SETTINGS ......... 62 10 PARAMETERS SETTING FOR INFUSION SET ........ 63 10.1 ENTER INFUSION SET CALIBRATION SETTING SCREEN..63 10.2 CALIBRATION FOR INFUSION SET ACCURACY ..... 63 11 CAUTIONS FOR USING DISPOSIBLE INFUSION SET ....64 12 TECHNICAL SPECIFICATIONS ............

  • Page 6: Symbols, Graphics And Warnings

    MI 20-CETF-005 Symbols, graphics and warnings 1.1 DESCRIPTIONS OF GRAPHICS AND SYMBOLS Caution! Read included files Type CF device Compliant to ROHS standards Date of manufacturing Serial Number Manufacturer Power On/Power Off Start/Stop BOLUS Mute alarm sound. 6 / 83...

  • Page 7: Warnings

    MI 20-CETF-005 AC (Alternating Current) Classified collection, uncontrolled discard not allowed. Ingress Protection Grade 2. Class II device 1.2 WARNINGS Please read the following warnings carefully. Any operation that does not strictly follow the guidance will possibly damage the device or do harm to patients’...

  • Page 8: Cautions

    MI 20-CETF-005 accuracy and eventually lead to operation failures. While being used, the height of the infusion set can neither be ➢ placed lower or higher than 1 meter from the patient’s heart. ➢ Do not use the same infusion set on more than one machine. Do not press the buttons with finger nails or other sharp objects.

  • Page 9: Notes

    MI 20-CETF-005 ➢ Fix the pump in a level and secured position before and during operation ➢ Pump operator must strictly follow doctor’s prescriptions to set the infusion parameters, otherwise patient’s health may be harmed. ➢ After setting infusion parameters, operator must make sure that the infusion set is correctly installed on the pump before the pump is started.

  • Page 10: Terms And Definitions

    MI 20-CETF-005 ➢ Please check the voltage of the internal battery before using it for pump operation. ➢ Please do not connect any other device to the USB port other than the included DC adapter shipped with the pump. ➢ When using the power plug or other separable plug as the isolation means from the main power, please do not position the device so that it is difficult to operate the disconnection device.

  • Page 11: Introductions And Scopes

    MI 20-CETF-005 an already existing danger is confirmed. Calibration: To ensure the infusion pump to meet its designed high accuracy, calibration and proper parametric compensation have to be done on the infusion sets. Calibration has to be performed only by trained professionals. VTBI: Volume to be infused.

  • Page 12: Intended Use

    MI 20-CETF-005 will be ensured when using MI 20 pump. 2. Meeting flow rate requirements: A certain flow rate has to be met for a given medication treatment, which can range from 1ml/h to 1800ml/h. Unless infusion pump is to be used, otherwise the flow rate requirements cannot be met by using the gravity or manual infusion methods.

  • Page 13: Important Features

    MI 20-CETF-005 MI 2 0 Secondary identification code for product series Product series identification code Product platform code for infusion pump IMPORTANT FEATURES ➢ High accuracy: The accuracy for both infusion flow rate and volume are kept within 3% when the MDK recommended infusion set is used.

  • Page 14: Basic Parameters, Main Performances And Functionalities

    MI 20-CETF-005 addition to downstream occlusion alarm. When infusion bag is running out or the free-flow clamp is not turned on by mistake, the embedded internal pressure sensor will detect these problems automatically and an alarm will be initiated accordingly. ➢...

  • Page 15: Main Performance

    MI 20-CETF-005 Dimensions 215mm×129mm×80mm(width x depth x height) Weight 1.5 Kg Power Adaptor A.C100V～240V 47-63Hz 0.7-0.35A， rate voltage and D.C15V 1.66A frequency A.C. input 100V～240V 47-63Hz 0.7-0.35A, D.C. output 15V 1.66A Input voltage to D.C：15V infusion pump Power <55VA Requirements Section CAUTIONS USING...
  • Page 16 MI 20-CETF-005 (Essential Performance) 0.01~9999.99ml， VTBI range with resolution 0.01ml Infusion volume accuracy ±3% (Essential Performance) Purge speed 1ml/h～1800ml/h；±20%； Occlusion High: 100kPa ± 30kPa middle 60 kPa ± 20kPa alarm(pressure) (Essential Low: 40kPa±20kPa Performance) Maximum infusion >160kPa pressure Minimum flow rate: occlusion alarm is activated when pressure is within 40kPa±20kPa for 13 Time to activate minutes, or when pressure is within 100kPa±30kPa...

  • Page 17: Main And Frequently Used Functionalities

    MI 20-CETF-005 KVO=1ml/h when flow rate ≥ 1ml/h <10ml/h; KVO=the set infusion flow rate when flow rate <1ml/h. Recover time after the 1min50s～ 2min recoverable alarm sound is cleared. Time for pause 1min50s～ 2min over time alarm. Door open alarm, occlusion alarm, VTBI complete High priority alarm, air in line alarm, out of battery alarm, alarm...

  • Page 18: Product Structure And Operation Interface

    MI 20-CETF-005 ➢ Display the already infused volume; ➢ Purge/bolus; ➢ Alarms; ➢ Automatically change the flow rate to KVO rate after the VTBI complete alarm is activated; ➢ Temporary mute for alarm sound and timer for recovering alarm sound; ➢...
  • Page 19 MI 20-CETF-005 Battery Pump door Foot compartment cover 10 DC power port Fixation pole 12 Positioning pin On/off button Clamping port Powered free- for infusion set for stacking flow clamp test Downstream Pumping Air in line occlusion operation sensor sensor device Upstream occlusion...

  • Page 20: Display And Operation Interface

    MI 20-CETF-005 Back view. Side view. Pump door open view. 6.2 DISPLAY AND OPERATION INTERFACE The display interface is shown in Figure 6-3. The keypad 20 / 83...
  • Page 21 MI 20-CETF-005 operation interface is shown in Figure 6-4. Figure 6-2-1 Display screen. Descriptions for Figure 6-2-1： Alarm indication Time indicator Mute indicator zone Low temperature Screen locked Wi-Fi indicator indicator indicator Internal power Parameter setting Return to the source status zone previous menu indicator...

  • Page 22: Instruction For Operation

    MI 20-CETF-005 Start/Stop Up/Down Left/Right button selection selection Purge/Bolus Mute/Cancel Confirm button button button Power On/Off Back up Mode selection button INSTRUCTION FOR OPERATION ====================================================== Attention -------------------------------------------------------------------------------------------- All infusion sets must follow Section 10 PARAMETERS SETTING FOR INFUSION SET before they can be used on this device for the first time.

  • Page 23: Installation Of Infusion Pump

    MI 20-CETF-005 The fixation clamp is a separate accessory. First loosen the locking screw, fix the clamp to the pole, adjust the height of clamp, and then tighten the locking screw. INSTALLATION OF INFUSION PUMP 7.1.2 As shown in Figure 7-1, fix the fixation clamp onto the fixation pole, make sure the positioning pin is inside the correct hole accordingly, and make sure the infusion pump is installed in an upright position.

  • Page 24: Power On And System Self-Test

    MI 20-CETF-005 Figure 7-1-2 Stacking installation. 7.2 POWER ON AND SYSTEM SELF-TEST 7.2.1 POWER ON Connect to mains power, check the power indicator on the pump front panel. If the indicator is not lit up, check the connection of power cable and the pump, or check if there is a power outage. Then press the “...

  • Page 25: Setting Parameters

    MI 20-CETF-005 MDK customer service immediately. 7.3 SETTING PARAMETERS INFUSION SET SELECTION 7.3.1 After power on, select the brand for infusion set in the Home – Settings – Brand, then go back to the HOME page. No selection or modification is needed if the infusion set used in current use is the same as the last time.

  • Page 26: Infusion Mode Selection

    MI 20-CETF-005 INFUSION MODE SELECTION 7.3.2 MI 20 has seven different infusion modes, including Rate – Volume (R+V) Mode, Rate – Time (R+T) Mode, Volume – Time (V+T) Mode, Rate ® Mode, Drug Library Mode, Body Weight Mode, Micro Mode. Click on HOME-Select Infusion Mode page.

  • Page 27: Settingvolume To Be Infused (Vtbi)

    MI 20-CETF-005 7.3.3 SETTING Volume to Be Infused (VTBI) When pump is in standby, a keypad will show up when the volume parameter on touch screen is pressed. Input VTBI and confirm to complete the setting. Figure 7-3-3-1 Set VTBI. Figure 7-3-3-2 Data input with keypad.

  • Page 28: Purge Setting

    MI 20-CETF-005 Same as the operation described in Section 7.3.3. Figure 7-3-5-1 Set infusion time. Figure 7-3-5-2 Data input with keypad. 7.3.6 PURGE SETTING Click on HOME-Settings-Purge Setting to set speed and volume for purge. The factory default purge speed is 800ml/h with resolution of 1ml/h.

  • Page 29: Setting Occlusion Pressure Levels

    MI 20-CETF-005 Figure 7-3-6 Purge Setting. SETTING OCCLUSION PRESSURE LEVELS 7.3.7 Enter the occlusion pressure setting screen by pressing the upside-down triangle shape icon on touch screen. The occlusion pressure has 3 levels, with the maximum pressure being 100kPa and minimum pressure being 40 kPa.

  • Page 30: Installation And Uninstallation Of Infusion Set

    MI 20-CETF-005 7.4 INSTALLATION AND UNINSTALLATION OF INFUSION SET INSTALLATION OF INFUSION SET 7.4.1 First, open the pump door by unlocking the door lock on the right hand side of the infusion pump. Straighten the infusion line below the drip chamber, clamp the line into the two notches on both sides of the pump.

  • Page 31: Infusion Set Replacement

    MI 20-CETF-005 Figure 7-4-1 Powered free-flow clamp. ====================================================== Attention -------------------------------------------------------------------------------------------- After the infusion set is installed and the pump door is closed, make sure the roller clamp on infusion set is opened before infusion is started. ====================================================== INFUSION SET REPLACEMENT 7.4.2 Before changing infusion set or changing drug solution, the roller clamp on infusion set has to be turned to the close position to...
  • Page 32 MI 20-CETF-005 the “ ” button, MI 20 pump will show the following message “Purge or Not?” on screen. If YES is selected, the pump will run based on the fast infusion rate and volume values that are set in the HOME-System Settings-Purge Setting, pushing the air inside the infusion set out.

  • Page 33: Manual Purge And Start Infusion

    MI 20-CETF-005 and fix the needle. Press the “ ” button to start infusion. From right to left, the operation indicator arrow on the bottom of the screen will start to flash continuously in a cyclic manner. MANUAL PURGE AND START INFUSION 7.5.2 When the purge indication page is turned off, press the “...

  • Page 34: Stop And Clear Alarms

    MI 20-CETF-005 preset alarm pressure value, a red triangle will be displayed on the screen, and an occlusion alarm message will be shown at the same time. Figure 7-5-3 Infusion in progress. 7.6 STOP AND CLEAR ALARMS The “ ” button can be pressed to stop an alarm, or to stop infusion, while the operation indicator will stop flashing as well.

  • Page 35: Mute Alarm Sound

    MI 20-CETF-005 Infusion will be stopped if the “ ” button is pressed when infusion operation is in progress. If no infusion parameters are changed during the stop, the infusion will pick up from where it left last time and continue to run when the “ ”...
  • Page 36 MI 20-CETF-005 return to the parameter setting page. The total volume for purge is not included in the accumulated volume. The AIR IN LINE alarm will be disabled in automatic purge mode. Figure 7-8 Purging operation. ➢ Automatic bolus mode: when infusion operation is in progress, bolus speed and bolus volume setting page will be entered by a single click on “...

  • Page 37: Infusion Complete

    MI 20-CETF-005 continuously press down the “ ” button, the pump will enter manual bolus mode. Bolus operation will run based on the set bolus speed (total bolus volume is not effective during manual bolus mode) until the “ ” button is released. Pump will return to where it left before manual bolus was entered and continue to run infusion.
  • Page 38 MI 20-CETF-005 When the infused volume (the incremental of accumulated infusion volume) has reached the set value, the infusion preset volume complete alarm will be triggered. The pump will annunciate an alarm sound and display a “VTBI Infused” alarm message in the alarm indication area.

  • Page 39: Automatic Infusion Accumulation And Accumulatioin Zeroing

    MI 20-CETF-005 ====================================================== Attention -------------------------------------------------------------------------------------------- When KVO is entered, a KVO indication message will be shown on top of the infusion speed numbers, indicating the device has entered the KVO state. However, the KVO speed will not be shown on the screen. ====================================================== 7.10 AUTOMATIC INFUSION ACCUMULATION AND ACCUMULATIOIN ZEROING...

  • Page 40: Power Off

    MI 20-CETF-005 certain period of time. When under operation mode, press and hold the “ ” button for 3 seconds to unlock. See the automatic locking time setting in HOME - Settings - Auto-Lock Time. Figure 7-11 Screen auto-lock time setting. When not in operation mode, click the “...

  • Page 41: Uninstallation Of Infusion Pump

    MI 20-CETF-005 Figure 7-12 Power off count down. ====================================================== Attention -------------------------------------------------------------------------------------------- Do not turn the pump off when infusion operation is in progress, otherwise the device will stop infusion. ====================================================== 7.13 UNINSTALLATION OF INFUSION PUMP To uninstall the pump, pull the ring on the fixation base up and pull the pump outward while holding it.

  • Page 42: Drug Library Mode

    MI 20-CETF-005 Figure 7-14 Body weight mode setting On the body weight mode setting page, click the “Units” button on the upper right corner to change between different units, which will in turn change the units of parameters such as dosage and concentration accordingly.

  • Page 43: Drug Library

    MI 20-CETF-005 into R+V mode parameter setting page, where speed shows the flow rate value of this drug during last infusion, and total volume shows the solution volume during last infusion. Click on the “ ” button, the pump will run infusion under the drug library mode, while the drug name is shown on top of the infusion speed number during operation.

  • Page 44: Viewing Log

    MI 20-CETF-005 7.17 VIEWING LOG In HOME-Log page, 200 log messages are shown, including information such as time, speed, and volume for each infusion event. Using the MX infusion work station, infusion and alarm log information can be saved and inquired without capacity limitations. All logs can also be transferred via network and be printed out, helping care providers in managing their work.
  • Page 45 MI 20-CETF-005 Priority Type of Alarm Conditions Level Door open alarm, occlusion alarm, VTBI High complete alarm, air in line alarm, out of battery Priority alarm, battery/mains power double disconnect alarm, malfunction alarm. Pause over time alarm, internal battery low Low Priority voltage alarm, infusion near to end alarm.

  • Page 46: Door Open Alarm

    MI 20-CETF-005 the alarm (press the “ ” button); unlatching alarm: alarm stops automatically when the alarm causing event is not there anymore. ====================================================== 8.1 DOOR OPEN ALARM Reason: while in operation, if the pump door is not closed, or the pump door is opened by accident, the pump will initiate an alarm sound, stop infusion, and display “Door Open”...

  • Page 47: Upstream Occlusion Alarm

    MI 20-CETF-005 “Occlusion” will be displayed in the alarm indication area and the pump will stop infusion. As a safety measure at the same time, the motor will rotate in the opposite direction to retrieve a small amount of drug solution to reduce the bolus volume before occlusion is removed.

  • Page 48: Vtbi Complete Alarm

    MI 20-CETF-005 or the roller clamp between the bag and pump has been forgotten to be opened, the infusion line will become flat when infusion gets started. The pump will then initiate an upstream occlusion alarm and display an “Upstrm Occl” alarm message in the alarm indication area on screen, while giving out high-priority alarm sound and red light alarm signal, and the pump will stop infusion.

  • Page 49: Air In Line Alarm

    MI 20-CETF-005 speed, and display a “VTBI Infused” alarm message in the alarm indication area on screen. As a safety and protection measure, the pump will automatically switch to KVO mode to continue infusion. Solution: during VTBI infused alarm, press the button to clear alarm sound, and the “VTBI Infused”...

  • Page 50: Out Of Battery Alarm

    MI 20-CETF-005 2) To remove air bubbles from the infusion line, close the roller clamp, open pump door, pull out infusion set, check whether there is air bubbles in line, shake and move the air bubbles to the drip chamber by hands if there is, reinstall the infusion set, close the pump door, open the roller clamp, and press the to restart infusion.

  • Page 51: Battery/Mains Power Double Disconnection Alarm

    MI 20-CETF-005 an “Out of Battery” alarm message in the alarm indication area on screen. The infusion will stop, and the pump operation will remain in stop and it will completely shut down in 3 minutes. Solution: Connect to mains power for power supply. When connected to mains power, the battery charging indicator will be lit up while the battery is being charged.

  • Page 52: Pause Overtime Alarm

    MI 20-CETF-005 as system errors: motor error, communication error, and the internal battery communication error. Solution: Press the button to clear alarm sound. Check if infusion set is installed correctly. Restart infusion after corrections are made. Contact the MDK customer service if alarm remains. Figure 8-8 Motor error alarm.

  • Page 53: Internal Battery Low Voltage Alarm

    MI 20-CETF-005 Figure 8-9 Pause overtime alarm. 8.10 INTERNAL BATTERY LOW VOLTAGE ALARM Reason: When internal battery is low, the device will annunciate a low-priority alarm sound, and display a “Low Battery” alarm message in the alarm indication area. If infusion is in progress, the pump will not stop operation.

  • Page 54: Infusion Near End Alarm

    MI 20-CETF-005 Figure 8-10: Low battery alarm. 8.11 INFUSION NEAR END ALARM Reason: When the remaining time is less than the preset alarm time, the device will initiate a low-priority alarm sound, and display a “Near End” alarm message in the alarm indication area on screen. Infusion will not stop.

  • Page 55: Alarm Sound Volume

    MI 20-CETF-005 Figure 9-1 Brightness setting. 9.2 Alarm Sound Volume Alarm sound level can be set in the HOME-Settings-Alarm Volume page. Drag the slider along the horizontal axis to adjust the volume of alarm sound, which can also be done by clicking on the + or –...

  • Page 56: Purge Setting

    MI 20-CETF-005 Air in line detection sensitivity level can be set in the HOME- Settings-Air Bubble Sensitivity setting page. Drag the slider along the horizontal axis to adjust the sensitivity level for air in line detection, which can also be done by clicking on the + or – signs. After setting is completed, click on the “Back”...

  • Page 57: Purge Indication

    MI 20-CETF-005 Figure 9-4 Purge setting. 9.5 PURGE INDICATION Whether or not to turn on the purge indication page can be set in the HOME-Settings-Purge Indication Page. The icon means the purge indication page is turned on. With purge indication page turned on, the pump will ask operator if the infusion set needs to be purged when is pressed after all infusion related parameters...

  • Page 58: Load Settings From Last Use

    MI 20-CETF-005 9.6 LOAD SETTINGS FROM LAST USE In the HOME-Settings-Load Settings from Last Use page, operator can decide whether to load the parameters from last use. The icon means that the feature to load parameters from last use is turned on. When power is turned on, the pump will show an indication page reminding the operator that parameters from last use are being loaded.

  • Page 59: Types Of Infusion Sets

    MI 20-CETF-005 turned off. When MI 20 is used together with an MX infusion work station, please read the MX’s user’s manual for directions on how to set up the connection between the two and how to perform relayed infusion operations. Figure 9-7 Wi-Fi on/off setting.

  • Page 60: Screen Auto-Lock Time

    MI 20-CETF-005 Figure 9-2 Selection for infusion set type. 9.9 SCREEN AUTO-LOCK TIME The time for locking the screen or the keypad can be set in the HOME-Settings-Auto-Lock Time page. Drag the slider along the horizontal axis to adjust the time that is allowed to elapse before the screen or keypad is locked, which can also be done by clicking on the + or –...

  • Page 61: System Maintenance

    MI 20-CETF-005 values for brightness and sound volume for daytime and nighttime. Drag the slider along the horizontal axis to adjust the numbers for alarm sound volume and screen brightness. When completed, click on the “Back” button on the lower left corner to return to the previous menu.

  • Page 62: Restore To Factory Settings

    MI 20-CETF-005 password is required to enter the system maintenance page. Contact the customer service at MDK for password assistance. Read Section 10 in this manual for the procedure of performing calibration for infusion sets. Figure 9-2 System Maintenance setting. 9.12 RESTORE TO FACTORY SETTINGS Factory settings can be restored in the HOME-Settings-Restore to Factory Settings page.

  • Page 63: Parameters Setting For Infusion Set

    MI 20-CETF-005 Figure 9-2 Restore to factory settings. 10 PARAMETERS SETTING FOR INFUSION SET 10.1 ENTER INFUSION SET CALIBRATION SETTING SCREEN Follow Section 9 SETTING SYSTEM PARAMETERS to enter the infusion set calibration setting screen. Select the brand name of the infusion set accordingly, as it is shown in the following figure.

  • Page 64: Cautions For Using Disposible Infusion Set

    MI 20-CETF-005 being used. 4) While in the Calibration page, press the “ ”key and the infusion pump will output 8ml drug solution based on the current accuracy setting. The pump will automatically stop infusion when the 8ml solution has been infused. 5) Check the remaining solution in the measuring tube (use the bottom point of the concave surface to measure liquid level), and enter the volume to the slot next to the Real Volume in the...

  • Page 65: Technical Specifications

    MI 20-CETF-005 different manufacturer. The recommended syringe brand list is as follows: Brand Name Accuracy Ambient Temperature HANACO 10℃~30℃ ±3% 12 TECHNICAL SPECIFICATIONS 1) The methods of controlling bolus volume before occlusion is removed: control bolus volume by making the stepper motor to rotate in the opposite direction to reduce the pressure in infusion line after it has been occluded.
  • Page 66 MI 20-CETF-005 In the above figure, the dashed line shows the set flow rate (1ml/h in this figure), and the solid line is the continuous connection line for the average flow rate during a sampling period. 7) The rising curve for HANACO infusion set with intermediate flow rate during the first two hours of operation.
  • Page 67 MI 20-CETF-005 The dashed line is the final value that the error of the device is eventually converging to. The solid line above the dashed line is the maximum positive deviation during the second hour of operation. The solid line below the dashed line is the maximum negative deviation during the second hour of operation.

  • Page 68: Use And Maintenance Of Internal Battery

    MI 20-CETF-005 deviation during the second hour of operation. 11) The sensitivity of the air in line sensor: the minimum air bubble size that can be detected is 50uL. 13 USE AND MAINTENANCE OF INTERNAL BATTERY MI 20 has an internal rechargeable Lithium battery with the following specification: DF18650/2200mAh /1P3S/10.8V.

  • Page 69: Product Service And Maintenance

    MI 20-CETF-005 Then a device can be disassembled and the battery can be changed by these agencies on their own. MI 20 is installed with one internal single use button battery. The battery life is larger than 5 years. When the battery is expired, the device should be disposed according to the instruction in section 16, “Wast Disposal”.

  • Page 70: Installation Of The Removable Battery

    MI 20-CETF-005 2）Use a clean and dampened cloth or an alcohol pad to wipe clean the device. Take caution to avoid any liquid from entering the device. 3) Keep the surface of the air bubble sensor probe clean. A dirty probe will reduce the sensor’s sensitivity in air bubble detection or cause false alarm.

  • Page 71: Mi 20 Infusion Pump

    MI 20-CETF-005 after use. 16.3 MI 20 INFUSION PUMP The product lifetime of this device is 5 years. Dispose the device after its lifetime has expired. The disposed infusion pump can be returned to MDK or its distributors to be recycled properly. 17 ELECTROMAGNETIC COMPATIBILITY Guidance and MANUFACTURER’S declaration –...
  • Page 72 MI 20-CETF-005 CISPRⅡ functions. Therefore, it has a low RF emission and it is likely not to produce any interference to nearby electronic equipment. emissions Class A CISPRⅡ The infusion pump is Harmonic suitable for use in all emissions establishments other than IEC 61000-3- applicable domestic and those...
  • Page 73 MI 20-CETF-005 Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The infusion pump is intended for use in the electromagnetic environment specified below. The customer or the user of the infusion pump should make sure that it is used in such an environment.
  • Page 74 MI 20-CETF-005 material, the relative humidity should be at least 30 %. ±2 KV ±2 KV Mains power power connected quality should be that Electric supply to power of a al fast lines lines typical transient/bur commercial or ±1 KV applicable.
  • Page 75 MI 20-CETF-005 earth earth hospital environment. <5%U <5%U Mains power quality should be that (>95% (>95% of a dip in UT ) dip in UT ) typical Voltage for 0,5 for 0,5 commercial or sags, short cycle cycle hospital environment. interruptions 40%U 40%U...
  • Page 76 MI 20-CETF-005 <5%U <5%U be powered from an uninterruptible (>95% (>95% power supply or UT dip in UT dip in a battery. UT )for 5s UT )for 5s Power Power frequency frequency magnetic fields magnetic should be at field（50/60 levels characteristic Hz）...
  • Page 77 MI 20-CETF-005 IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The infusion pump is intended for use in the electromagnetic environment specified below. The customer or the user of the infusion pump should make sure that it is used in such an environment.
  • Page 78 MI 20-CETF-005 d=1.2 80MHz to 800MHz d=2.3 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the Condu transmitter manufacturer and d ction RF Vrms is the recommended separation distance in metres (m).
  • Page 79 MI 20-CETF-005 NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a). Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 80 MI 20-CETF-005 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE- SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the type MI 20 infusion pump The infusion pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 81: Anti-Static Precautions

    MI 20-CETF-005 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 82: Packaging And Accessories

    MI 20-CETF-005 body to the framework of equipment , or to the ground, or to a large piece of metal; 3 Use a wrist band to connect human body to the equipment or to the ground. b)All staffs who may be in contact with connectors with electrostatic discharge warning signs should receive training, including all clinical/biomedical engineering and healthcare personnel.
  • Page 83 MI 20-CETF-005 Registrant：Zhejiang MDKingdom Technology co., Ltd. Address: 5F, No. 28 Cangling Road, Huzhen Town, Jinyun County, Lishui City, Zhejiang Province. After sale service: Zhejiang MDKingdom Technology co., Ltd. Manufacturer: Zhejiang MDKingdom Technology co., Ltd. Factory:508,5F, No. 28 Cangling Road, Huzhen Town, Jinyun County, Lishui City, Zhejiang Province.

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