Related Manuals for MDK Med MI27 Plus
Summary of Contents for MDK Med MI27 Plus
- Page 1 MI27 Plus Infusion Pump User Manual Version: 1.0 M D K M e d M e d ic a l Tec h n o lo g y C o ., L td . 2 0 2 4 .7 .5...
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Page 2: Table Of Contents
C o n te n t 1 Symbols, Graphics and Warnings ................5 1.1 Descriptions of Graphics and Symbols .............5 1.2 Warning ....................... 6 2 Terms and definitions ....................11 3 Brief Introduction and Scope of Application ............12 3.1 Brief Introduction ....................12 3.2 Intended Purpose ..................... - Page 3 7.3.2 Select infusion set ..................25 7.3.3 Set infusion parameters ................25 7.3.4 Remove Air Bubble from Infusion Line ............26 7.3.5 Start infusion ..................... 27 7.3.6 Infusion completed ..................28 7.4 Pause or Stop Infusion ..................28 7.5 Bolus Mode ....................... 29 7.5.1 Automatic bolus ..................... 29 7.6 Lock and Unlock Screen Function ..............
- Page 4 8.7 Battery Empty Alarm ..................48 8.8 Battery/External power Disconnect Alarm ............48 8.9 Motor Error Alarm ..................... 49 8.10 Communication Error Alarm ................49 8.11 Battery Error Alarm ..................49 8.12 KVO alarm .......................50 8.13 KVO end alarm ....................50 8.14 Standby end Alarm ..................
- Page 5 9.15 Night mode Setting ..................57 9.16 Date/Time setting ................... 58 9.17 Drop Speed Sensor Setting ................58 9.18 System Maintenance ..................59 10 Accuracy Calibration for Infusion Set ..............59 10.1 The IV Infusion Set Calibration Page ............59 10.2 Calibration Steps for IV Infusion Set Accuracy ..........59 11 Precautions for Using Disposable Consumables ..........
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Page 6: Symbols, Graphics And Warnings
1 S y m b o ls , G ra p h ic s a n d W a rn in g s 1 .1 D e s c rip tio n s o f G ra p h ic s a n d S y m b o ls Attention! Read the User’s Manual... -
Page 7: Warning
Manufacturer 1 .2 W a rn in g Please read the following information carefully, operation that does not strictly follow the guidance will possibly damage the device or do harm to patients’ health. The infusion pumps are intended for the intermittent or continuous delivery of parenteral fluids, enteral fluids, medications, blood and blood products through clinically accepted routes of administration. - Page 8 Do not use sharp objects to press on the buttons or the touch screen. 10) It is recommended to regularly maintain the device. The MI27 Plus Infusion Pump must be serviced and calibrated by trained professional technicians. Before maintenance, make sure to unplug the power cable that supplies power to the equipment.
- Page 9 service of MDKMed. 14) After loading the IV infusion set, the operator is required to periodically check the fluid pathway and all connections for leaks which could cause under delivery or contamination. If there is leakage, stop using the IV infusion set and notify the customer service of MDKMed.
- Page 10 upgrade to new products. 22) The device has a internal rechargeable lithium batter and its lifetime is 2 years. 23) Please check the voltage of the internal battery before using it for pump operation. The battery must be replaced and maintained by trained technical personnel in accordance with Section 13 Use, Maintenance and Uninstallation of the Internal Batteries in this manual.
- Page 11 34) Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the MI27 Plus, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Page 12: Terms And Definitions
hospital): make sure the device is securely fixed and placed. If the device is changed in position, or the pump is severely shaken, the accuracy of the infusion may be affected. 37) Do not use unapproved cleaners, materials or chemicals as they may damage device surfaces, labels, or cause equipment failures. -
Page 13: Brief Introduction And Scope Of Application
3 .2 In te n d e d P u rp o s e In te n d e d u s e : MI27 Plus infusion pump is intended for the intermittent or continuous delivery of parenteral fluids, enteral fluids, medications, blood and blood products through clinically accepted routes of administration. -
Page 14: Configurations And Variants Of The Device
3 .3 C o n fig u ra tio n s a n d v a ria n ts o f th e d e v ic e V a ria n ts : No variants. M o d e l N o .: MI27 Plus M o d e l N a m in g... -
Page 15: Important Features
4.8% when the IV infusion sets recommended by MDKMed are used. F lo w ra te : Infusion flow rate can be adjusted from 1 mL/h to 2000mL/h in a continuous manner, which makes MI27 Plus capable of meeting various flow rate requirements in different infusion situations. -
Page 16: Main Performance
height) Weight 1.26 kg Network power supply: ~ 100 V-240 V, 50/60 Hz Power supply Internal battery: 7.4 V rechargeable Lithium battery Power 55 VA IV infusion set Refer to Section 11 Cautions for Using Disposable requirements IV Infusion Sets Maximum flow 2000 mL/h rate... - Page 17 rate. Variable speed KVO: Flow rate 0.10mL/h ~ 5.00mL/h, step by 0.01mL/h When infusion rate is > 10 mL/h, run at the user-defined KVO flow rate > 10 mL/h. When 1 mL/h < infusion rate ≤10 mL/h, run at the user-defined KVO rate within the range: 1 mL/h <...
- Page 18 (25.00mL/h): < 1min30s when occlusion alarm pressure threshold is set to the lowest pressure, and the Bolus produced by occlusion is < 0.20 mL; < 2min30s, when occlusion alarm pressure threshold is set to the highest pressure, the Bolus produced by occlusion is not more than 0.40 mL. (Tested with the Hanaco IV infusion set when an occlusion occurred 1 meter away from the pump outlet for testing purpose at 20 ℃)
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Page 19: Main Functions And Common Functions
Ambient pressure for transportation, storage and operation: 700 hPa ~ 1060 hPa Software version MI27 Plus-V1 Product lifetime 8 years 5 .3 M a in F u n c tio n s a n d C o m m o n F u n c tio n s 1) Set infusion rate, infusion volume preset and real-time data display function;... -
Page 20: Structure And Operation Interface
12) External power adapter; 13) Dose-error Reduction Software. 6 S tru c tu re a n d O p e ra tio n In te rfa c e 6 .1 S tru c tu ra l C o m p o s itio n The device is consisted of a pump outer housing, a motor actuation system, an input interface system, a storage system, control system, a display system, a sensing and monitoring system,... - Page 21 Figure 6-1-1 Front view Figure 6-1-2 Rear view...
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Page 22: Display And Operation Interface
Figure 6-1-3 Side view Figure 6-1-4 Front view with pump door opened 6 .2 D is p la y a n d O p e ra tio n In te rfa c e The interface during operation is shown in Figure 6-2-1. -
Page 23: Operation Instructions
Figure 6-2-1 Operation interface on the screen Lock screen WiFi Battery Occlusion Start/Stop brand pressure button Remaining more Infused volume volume information Unlock Purge/Bolus Rate Infusion state Infusion mode Bed number Time remaining 7 O p e ra tio n In s tru c tio n s Install infusion pump →... -
Page 24: Installation Of Infusion Pump
Before infusion starts, please confirm that the IV infusion set in use matches the current IV infusion set setting selected in the menu. Any IV infusion set which brand is not included in the list of recommended brands must be calibrated before being used. 7 .1 In s ta lla tio n o f In fu s io n P u m p 7 .1 .1 In s ta lla tio n o f th e m o u n tin g cla m p The mounting clamp is a separate accessory. -
Page 25: Device Safety Self-Test
key for at least 3 seconds to turn the device off. Do not power off when the device is in operation mode, otherwise the infusion therapy will be stopped. 7 .2 .2 D e v ic e s a fe ty s e lf-te s t Device safety self-test: The pump will perform an automatic safety self-test after powered on, if the test is passed then there will be two short beeps. -
Page 26: Select Infusion Set
7 .3 .2 S e le c t in fu s io n s e t After the infusion pump is powered on and the safety self-test is passed, the parameter setting page will show up. Press on the Brand button in the upper right corner to enter the IV infusion set brand selection page. -
Page 27: Remove Air Bubble From Infusion Line
enter the RVT mode parameter setting interface. Click "Inf. rate" on the touch screen, a numeric button board appears on the screen, click to enter the value of the flow rate to be set, and press "√" on the screen to complete the input. Setting the infusion volume and infusion time is the same as setting the infusion rate above. -
Page 28: Start Infusion
When the pump is standby, confirm that the IV infusion set is disconnected from the patient and press the Bolus button. The pump pops up “Please disconnect IV Set!”, after clicking "√" on the touch screen, the pump will run at the flow rate and total volume set by the system to quickly remove the air bubbles in the infusion pipeline. -
Page 29: Infusion Completed
Figure 7-3-5 Infusion operation interface 7 .3 .6 In fu s io n c o m p le te d When the total infusion volume (the incremental of infused volume) has reached the set value, the device completes the infusion. If KVO is turned on, the device will convert to the KVO flow rate to continue running automatically and trigger high priority alarm at the same time, make an alarm sound. -
Page 30: Bolus Mode
Figure 7-4 Infusion pause On the Infusion pause page, press the Start-Stop key or click the start button again can start the device operation, and the device will continue to infuse the remaining volume based on the set flow rate. During the infusion pause, any parameter of the infusion flow rate, total volume, and time is modified will be considered a new infusion task, and when press the Start-Stop key or click the start... -
Page 31: Lock And Unlock Screen Function
infusion, the bolus volume is included in the infusion accumulative volume. Figure 7-5-1-1 Bolus Settings interface Figure 7-5-1-2 Bolus running interface 7 .6 L o c k a n d U n lo c k S c re e n F u n c tio n The device will be locked automatically after running for a certain period of time. -
Page 32: Infusion Mode Selection And Setting
Figure 7-6-1 Lock screen 7 .7 In fu s io n M o d e S e lec tio n an d S ettin g MI27 Plus has 10 major infusion modes, including RVT mode(intravenous therapy, blood transfusion and enteral nutrition),... -
Page 33: Dose Mode
Home-Infusion Mode - RVT Mode to enter the page of mode parameter setting. 7 .7 .1 D o s e m o d e Select to enter the body weight mode setting screen, as shown in Figure 7-7-1-1; 7-7-1-2. Based on the prescriptions given by doctor, input information such as Dose, Concentration, Weight and Volume. -
Page 34: Drug Library Mode
Figure 7-7-1-2 Dose mode setting page (b) In the Dose Mode Settings interface, click "Unit" to the right of any parameter in "Dose", "Concentration" and "Dose Rate" to select different unit expression modes, and the other two corresponding units will be automatically adjusted. Dose（mg）... -
Page 35: Drop Speed Mode
parameter settings page. Once the parameters are set, click the "√" button to confirm the infusion parameters, press the Start-Stop button or click the Start button to start the infusion. Figure 7-7-2-1 Drug library mode setting page 7 .7 .3 D ro p s p e e d m o d e Connect the interface of the drop sensor to the drop sensor port of the device, and install the drop sensor on the drip pot. -
Page 36: Rtm Mode
Figure 7-7-3-1 Drop speed mode setting page The infusion pump can be used in conjunction with the matching drop sensor to monitor the flow rate in the infusion pipeline. When the drop speed deviates from the set infusion speed by 50%, an alarm will be triggered. In order to ensure the reliability and accuracy of the drop detection, the drop sensor should be installed as close to the liquid level as possible, and the liquid level height should be 1/3 of the... -
Page 37: Sequence Mode
Figure 7-7-4-1 RTM mode setting page In the RTM mode parameters, VTBI, Up Time, and Down Time must be set. After setting one of the two parameters of Plateau rate or Total Time, the other parameter will be calculated automatically. After setting the parameters, click "√"... -
Page 38: Loading Dose Mode
Figure 7-7-5-2 Sequence Mode Setting 2 Figure 7-7-5-3 Sequence Mode Setting 3 As shown in the figure, Set any two of the Infusion VTBI, Infusion Rate, Infusion Time, the device will automatically calculate another parameter. After setting infusion parameters for all sequences according to clinical needs, click "√"... -
Page 39: Intermittent Mode
Figure 7-7-6-1 Loading dose mode setting page As shown in the figure, After setting the VTBI, Loading VTBI, Loading Rate, and Maintain Rate, the device automatically calculated the Loading Time and Maintain Time, and click the "√" button to confirm the infusion parameters. 7 .7 .7 In te rm itte n t m o d e Select to enter the intermittent mode setting page, as shown in... -
Page 40: Relay Mode
VTBI completed. 7 .7 .8 R e la y m o d e The MI27 Plus Infusion pump can be used on our infusion workstation for advanced application functions such as relay infusion and drug library management through the Infusion Information Collection System. -
Page 41: Alarms
infusion status and alarm can be displayed. Click the event can view the detailed event information such as Infusion Rate, VTBI, time, Alarm priority and time. Through the infusion information collection system, all infusion and alarm log information can be stored and queried in unlimited, and the log information can be printed out on the Internet to facilitate the needs of medical management. - Page 42 The pump door is not Door open High Latching closed during operation or purge. Pump starts to operate IV-Set Setup High Latching without an IV infusion Fail set being installed. OCCL When the downstream High Latching (occlusion) infusion line is occluded. Upstream When the upstream High...
- Page 43 detected or the internal battery fails. Start infusion until the total volume complete. 8.12 High Latching When the KVO is turned on, the alarm will be triggered then. Run in KVO status for 30 minutes and the alarm 8.13 KVO end High Latching will be triggered once...
- Page 44 High priority and low priority alarms are distinguished by different sound and light indications based on the requirements from the related standards. When an alarm occurs, the operator should be able to notice it 1 m away from the device. The time for triggering an alarm shall not be more than 2 sec.
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Page 45: Door Open Alarm
low-priority alarm, the low-priority one will be interrupted to give way to the high-priority one. Both alarm sound and displayed message will be replaced by those of the high-priority alarm. If a low-priority alarm is triggered when the device is giving out a high-priority alarm, the high-priority one will continue without being interrupted, including both its alarm sound and displayed message. -
Page 46: Set Setup Fail Alarm
Figure 8-1 Door open alarm 8 .2 IV S et S e tu p F ail A la rm C a u s e : When operation is started without an IV infusion set being installed on the pump, a high-priority alarm sound will be given out by the device, operation will be stopped, and a IV-Set Setup Fail alarm message will be displayed on the screen. -
Page 47: Upstream Occlusion Alarm
1) Click the "√" button on the screen to clear the alarm and the message "OCCL" disappear. 2) Check whether the infusion line is kinked or the patient is pressing on the infusion line by accident. 3) If there is still an occlusion alarm, shut off the roller clamp on the IV infusion set, open the pump door, pull out the IV infusion set, check whether the filter or the needle on IV infusion set is occluded, change to a new IV infusion set if necessary and... -
Page 48: Air-In-Line Alarm
current display window reaches the preset value, the pump will give out a high-priority alarm sound and a flashing red light alarm signal. The infusion based on the preset flow rate will be stopped and a “End of Infusion” alarm message will be displayed on the screen. safety protection measure,... -
Page 49: Battery Empty Alarm
alcohol, reinstall the IV infusion set, and restart infusion. If the alarm remains, change to a new IV infusion set, install the IV infusion set and restart. The air-in-line alarm will be activated too if the infusion line between the infusion bag and the pump is occluded. Remove the occlusion in infusion line and restart infusion. -
Page 50: Motor Error Alarm
8 .9 M o to r E rro r A la rm C a u s e : When an error is detected in the motor feedback signal (too fast or too slow, or spinning in the wrong direction or etc.), a high-priority alarm sound will be triggered and a flashing red light alarm signal will be started, while a Motor Error alarm message will be displayed on the screen. -
Page 51: Kvo Alarm
restart the device. If the fault alarm is still reported, please contact our service personnel. 8 .1 2 K V O a la rm C a u s e : When KVO is enabled and the infusion is complete, the device will automatically convert to the KVO Rate to continue operation. -
Page 52: No Ac Power Alarm
appear with the message "Standby End" and the operation status indicator flash red at the same time. S o lu tio n : Click the "√" button on the screen to clear the alarm. 8 .1 5 N o A C P o w e r A la rm C a u s e : When the device is powered on without the network power and use battery power supply, the device will trigger an alarm, make a low priority alarm sound, the screen appear with the... -
Page 53: Near End Of Infusion Alarm
the set time, the device will trigger an alarm, make a low priority alarm sound, the screen appear with the message "Call Back" and the operation status indicator steady on yellow at the same time. S o lu tio n : Click the "√" button on the screen to clear the alarm 8 .1 8 N ea r e n d o f in fu sio n a larm C a u s e : When the remaining time is less than the preset alarm time, the device will initiate a low-priority alarm sound, and display... -
Page 54: Alarm Sound Volume
Figure 9-2 Brightness setting 9.3 A la rm so u n d vo lu m e In the Setting- Volume- page, alarm sound volume can be adjusted by clicking the "+" and "-" to set. After sound volume setting is completed, click the "√" button to return to the previous page. Figure 9-3 Alarm sound volume setting 9.4 B o lu s se ttin g The Bolus Rate and Bolus VTBI can be set on the Setting- Bolus... -
Page 55: Purge Setting
After setting is completed, click the "√" button to return to the previous page. The smaller the bubble level, the more sensitive it is.The minimum bubble size detectable for each level is shown in the following table: Air Bubble Level Bubble 1000 1200... -
Page 56: Auto Screen Lock Time
Figure 9-7 Occlusion pressure level setting 9.8 A u to sc re en lo c k tim e In the Setting- Auto Screen Lock page, set the Lock time for the screen and keys of the device during infusion operation. If the screen lock time is set to 0, the Auto Screen Lock function is disabled. -
Page 57: Kvo Setting
Accuracy for how to do calibration for an IV infusion set. 9.1 0 K V O S e ttin g In the Setting - KVO page, set the KVO Mode and KVO Rate after the End Of Infusion. Select the Constant KVO mode and the device will operate according to the currently set KVO Rate. -
Page 58: Near End Of Infusion Time Setting
9.11 N ea r en d o f in fu sio n tim e S ettin g The near end of infusion time can be set on the Setting- Near End of infusion page. 9.1 2 C all b a ck tim e se ttin g In the Setting- Call Back Time page, can set the Call Back Alarm time when the device is placed without operation and not running. -
Page 59: Date/Time Setting
Figure 9-13 Night mode setting 9 .1 6 D ate /Tim e se ttin g The device of Time and date can be set on the Maintenance- Date/Time page. Figure 9-14-1 Date Setting Figure 9-14-2 Time Setting 9 .1 7 D ro p S p e ed S e n s o r S ettin g In order to monitor the status of the infusion flow rate, the standard drop speed for an IV infusion set can be set on the... -
Page 60: System Maintenance
System Settings-Drop Speed setting page. The standard drop speed varies among different IV infusion sets by their brand or type. Please make sure to set the correct drop speed value for the IV infusion set that is currently being used, for example 20 drops/mL. 9 .1 8 S ys te m M ain te n a n c e System maintenance can be performed on the System Settings-Maintenance page, including the calibration of IV infusion... -
Page 61: Precautions For Using Disposable Consumables
infusion set first, place the scalp needle into a measuring tube with scales. Enter System Settings-System Maintenance-Calibration page. 2) Click on Brand to select the brand name. Return to the Calibration page. 3) Click on High flow rate or Low flow rate to select the range of flow rate in which the calibration will be done. - Page 62 when a recommended consumable is used. The infusion accuracy will be compromised if ambient temperature is lower than 10 ℃. The recommended consumables are listed in the table below: Brand Model Infusion Ambient accuracy temperature +10 ℃ ~ +40 ℃ H-06APD-8 ±...
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Page 63: Technical Specifications
the following points should be noted: infection or microbial hazards such as explants, needles or — surgical equipment contaminated with potentially infectious substances of human origin, and physical hazards such as from sharps. — 1 2 Te c h n ic a l S p e c ific a tio n s 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... - Page 64 In the above figure, the dashed line shows the set flow rate (1 mL/h in this figure), and the solid line is the continuous connection line for the average flow rate during a sampling period. The rising curve for HANACO IV infusion set with the intermediate flow rate during the first two hours of operation.
- Page 65 was plotted based on the test data gathered during the second hour of operation. The dashed line in green color is the final value that the infusion error of the device is eventually converging to. The solid blue line above the dashed line is the maximum positive deviation during the second hour of operation.
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Page 66: Restore To Factory Setting
solid blue line above the dashed line is the maximum positive deviation during the second hour of operation. The solid red line below the dashed line is the maximum negative deviation during the second hour of operation. 10) The sensitivity of the air-in-line sensor: the minimum air bubble size that can be detected is 25 uL. -
Page 67: Use, Maintenance And Uninstallation Of The Internal Batteries
U s e , M a in te n a n c e a n d U n in s ta lla tio n o f th e In te r n a l B a tte rie s The MI27 Plus infusion pump has an internal rechargeable... - Page 68 as drug solution residue). Confirm that the system has passed the self-test after the pump is powered on. 2) Select the correct type for IV infusion set. Check the battery level. Charge the battery if necessary. During operation: 1) To avoid giving an incorrect dosage of drug to a patient, disconnect the pump from the patient before changing a device.
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Page 69: Waste Disposal
used. After using the disinfectant, after wetting with a soft cloth in water, wring out the soft cloth for scrub treatment. When using disinfectants, follow their instructions. 1 6 W a s te D is p o s a l 1 6 .1 B a tte r y Follow the local laws and regulations to dispose the expired old battery. - Page 70 The cable information is as below: Cable Name Length DC Power adapter 2.9 m Using cables that are other than the ones provided with the device may lead to increased electromagnetic emission and to reduced immunity to external electromagnetic interference. To ensure safe operation of this pump, do not stack the pump with other equipment that has electromagnetic emission.
- Page 71 G u id a nc e a n d m a n u fa c tu re’s d e cla ra tion – e le ctro m a g n e tic im m u nity The infusion pump MI27 Plus is intended for use in the electromagnetic environment specified below. The customer or the user of infusion pump MI27 Plus should assure that it is used in such an environment.
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Page 72: Systems That Are Not Life-Supporting
G u id a n c e a n d m a n u fa c t u re ’s d e c la ra tio n – e le c tro m a g n e tic im m u n ity The Infusion pump MI27 Plus is intended for use in the electromagnetic environment specified below. The customer or the user of Infusion pump MI27 Plus should assure that it is used in such an environment. - Page 73 G u id a n c e a n d m a n u fa c t u re r ’s d e c la ra t io n - e le c t ro m a g n e tic Im m u n ity The Infusion pump MI27 Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the Infusion pump MI27 Plus should assure that it is used in such an environment...
- Page 74 1845 1990 1800; modulati CDMA on b) 1970 1900; 217 Hz 1900; DECT; Band 1, 4, 25; UMTS 2450 2 400 – Bluetooth Pulse 2 570 modulati WLAN, on b) 802.11 217 Hz b/g/n, RFID 2450, Band 7 5240 5 100 – WLAN Pulse 5 800...
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Page 75: Antistatic Precautions
G u id a n c e a n d m a n u fa c t u re r ’s d e c la ra tio n - e le c tro m a g n e tic Im m u n ity The Infusion pump MI27 Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the Infusion pump MI27 Plus should assure that it is used in such an environment... -
Page 76: Cyber Security Notes
2. Discharge electrostatic charge from human 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 staff who may be in contact with connectors with electrostatic discharge warning signs should receive training, including clinical/biomedical... -
Page 77: Packaging And Accessories
Wi-Fi connection is used for communication, where the data encryption is based on internal communication protocol created by MDKMed. The data transmission is based on TCP protocol. 4) Access Control: Access to the device configuration is password protected. Unauthorized access is not allowed. 5) Software Environment: No any other supporting software or application software. - Page 78 L e g a l m a n u fa c tu re : MDKMed Medical Technology Co., Ltd. A d d re s s : 502A, Building 7, No. 22, Xinyan Road, Donghu Street, Linping District,Hangzhou City, Zhejiang Province, P. R China 311323 A fte r s a le s e rv ic e : MDKMed Medical Technology Co., Ltd.
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