File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 1 of 81 AMSure® Enteral Feeding Pump IFU Name Printed Job Title/Function Written By Jason Jiao Product Manager Reviewed By Othon Pan Senior RA Specialist Reviewed By Leo Qiu Director of Product Management Approved By Jane Gao VP of R&D and RA Signature Date 2022/7/15 2022/7/15 2022/7/15 2022/7/15 Document Revision History Rev Date B 2022/7/15 A 2021/9/20 Description Based on FDA AI Requi
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 2 of 81 Index 1. Symbols, Marking Instructions and Warnings .............................................................5 1.1 Description of Graphics and Symbols .................................................................................... 5 1.2 Contraindication .............................................................................................................................. 6 1.3 Warning ..
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 3 of 81 7.2.1 Feeding Mode Selection .................................................................................................. 27 7.2.2 Prime and Connect Feeding Set to Patient .............................................................. 29 7.2.3 Set Feeding Parameters .................................................................................................. 30 7.2.4 Start Feeding ............
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 4 of 81 13. Characteristics of ALARM SIGNALS ........................................................................ 74 14. Waste Disposal .................................................................................................................. 77 14.1 Battery ...........................................................................................................................................
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 5 of 81 1. Symbols, Marking Instructions and Warnings 1.1 Description of Graphics and Symbols Refer to instruction Caution manual/booklet BF type equipment Class II equipment WEEE Signifies waste from Date of manufacture electrical and electronic equipment IPX4 Serial No.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 6 of 81 1.2 Contraindication 1. Do not use the AMSure® enteral feeding pump and feeding set for parenteral feeding. This device is not intended for intravenous use. 2. Do not use the AMSure® enteral feeding pump and feeding set if enteral feeding is contraindicated. We recommend you contact your healthcare provider for further instructions. 3.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 7 of 81 11. Do not repair and calibrate the pump by untrained technicians or persons who is not authorized by Amsino. It may cause the failure of the pump or serious injury. Before repairing, be sure to unplug the power cable that supplies power to the device. 12. Do not using accessories, detachable parts and materials with the pump that are not recommended by Amsino.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 8 of 81 3 The pump should be in a place where it is easy to connect or disconnect the power plug. 4 Always disconnect the power adapter and turn off the pump before cleaning or repairing. After cleaning, make sure the power adapter is completely dry before plugging into an electrical outlet. 5 Patients with diabetic disorders are subject to enhanced surveillance.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 9 of 81 and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 10 of 81 rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food. 3.
File Name REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 11 of 81 5. Technical Specifications 5.1 Basic Parameters Dimensions 133mm×110mm×170mm Weight 1.08 Kg Power adapter No. Parameter Specification US market LXCP26-150160A EU market LXCP26-150160B 1 Power adapter specification 2 Frequency 3 Input voltage AC 100～240V 4 Input current 0.8A 5 Output voltage 15V 6 Output current Built-in battery No. Parameter 2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set Working and storage condition - Period of use REF# Version B L10196_US Page 12 of 81 Working ambient temperature: +16℃~+40℃ Transportation and storage environment temperature: 20℃~+60℃ Transportation, storage and use of environmental humidity: 20% ~ 90% Transportation, storage and use of atmospheric pressure: 700Hpa ~ 1060Hpa 5 years 5.
REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set File Name L10196_US Page 13 of 81 B RFID Scan Area Ultrasonic Sensor Infrared Sensor Pump Cover Pressure Sensor Set Socket Rotor Fig 6.1-2 Side View Handle Fg Battery Cover Power Interface Pole Clamp Fg Fig 6.1-3 Back View 6.2 System Description 6.2.1 Front Panel Icon Description No.
File Name REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 14 of 81 Red High priority alarm Not lit Pump is not powered on AC Power Indicator Green AC power supply is connected Light Not lit AC power supply is disconnected Battery Charging Green Battery is in charging Indicator Light Not lit Battery is not in charging 2 3 4 Power Button Switch the pump on or off 5 Start/Stop Button Pump run or stop 6 Home Button Fast back to home page 6.2.
File Name REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 15 of 81 4 Feeding mode display and switch 5 Status bar 6 Remaining Battery Capacity 7 Feeding parameters setting and display area User can touch the mode, switching to another feeding mode. Display system status such as: Setting, Running, Stop, alarms, tubing status User can check the remaining battery capacity when pump is not connected to AC supply.
REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set File Name No. Icon L10196_US Page 16 of 81 Description Name Continuous 1 B User can touch it to switch to intermittent feeding mode. Continuous Mode Mode 2 Rate Indicate number of feeding rate 3 Dose Setting Indicate number of feeding dose 4 Fed 5 Time left Indicate time left to feeding end 6 Prime Enter prime page. Refer to 7.2.2 for Prime section. 7 New Feeding 8 Lock 9 Unlock Execute screen unlock function.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set Setting Status REF# Version B L10196_US Page 17 of 81 Stop Status Running Status Interval Waiting Fig 6.2.5-2 Intermittent Mode No. Icon Name 1 Intermittent Mode Intermittent Mode 2 Rate Description User can touch it to switch to continuous mode.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set 3 Single Dose Feed Count – In Setting 4 REF# Version B L10196_US Page 18 of 81 Indicate number of single feeding dose Indicate number of feedings Status 5 Single Fed Interval time – In Setting Status 6 Single Time Left – In Running/Stop Status Indicate volume delivered in current single feeding task Interval time to be set between feedings Note: the maximum interval time is 23 h 59 mins.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 19 of 81 gastric tube → start feeding → complete feeding → remove the feeding set → switch off. 7.1 Preparation before Use 7.1.1 Pump Installation Before fix the pump to the I.V. pole, hang the formula bag and feeding set to I.V. pole and adjust the pump head height to the fluid level in the formula bag. For better accuracy, the initial fluid level shall be at 45±5cm (17.7±1.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 20 of 81 Lock Fig 7.1.1-2 Pump Installation 7.1.2 Connect to AC Power Supply Connect the pump to AC power supply as below shown. Connect to power interface Connect to AC power supply Fig 7.1.2-1 Connect to AC Power Supply AC Power Indicator turns green, and a message “AC Power Connected” prompt on the status bar for 2 seconds once AC power supply is connected when pump is switched on.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 21 of 81 Fig 7.1.2-2 AC Power Connected AC Power Indicator turns off and a message “AC Power Disconnected” prompt on the status bar for 2 seconds once AC power supply is disconnected when pump is switched on. Fig 7.1.2-2 AC Power Disconnected To protect battery life, the battery will be charged only when the battery capacity is below 92% and the charging indicator light turns green.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 22 of 81 7.1.3 Switch on and Self-Testing 7.1.3.1 Switch On Press the power button on the front panel to switch on the pump and the pump will perform self-testing automatically. Fig 7.1.3.1-1 Switch on and Self-Testing A prompt will pop up to ask if last parameter settings are kept. Detail information refer to 7.2.5 Stop Feeding and Start a New Feeding and 7.2.11 Feeding Entire Bag Fig 7.1.3.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 23 of 81 7.1.3.2 Self-Testing After the pump is switched on, the pump will automatically perform a safety self-check. After the self-check is passed, user will hear two short beeps of “DiDi”. The system automatically enters to the next step. If the self-test fails, the system will display the following prompt message “System error detected. Please contact your customer service. Fig 7.1.3.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 24 of 81 Fig 7.1.4-1 Swipe RFID Tag There is a RFID tag on the feeding set located above the drip chamber. Swipe the RFID tag on the pump reader area for identification (Tag needs to touch the reader area until the beeps heard) The status bar displays the remaining use time, which lasts for seconds, then the pump can be used for feeding.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 25 of 81 Note: 1) RFID tag should contact the scanning area directly. 2) User can swipe the RFID tag on the feeding set to check the remaining time of usage. If a feeding set is not identified by the pump, the pump cannot be started for feeding. A prompt will pop up showing “Please swipe the RFID tag” Fig 7.1.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 26 of 81 If the wrong feeding set (with RFID tag) or damaged RFID tag is used, the system will alert “Incorrect Tubing” on status bar. Fig 7.1.4-5 Incorrect Tubing Caution Feeding set identification system is an optional function on the pump. User can switch on/off it in system maintenance page, referring to 7.3.5.2 RFID Switch. The default setting is switch on. RFID tag can record the feeding set usage time.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 27 of 81 Step-3 Step-1 Step-2 Fig 7.1.5-1 Tubing Installation Diagram Caution Make sure that the drip chamber is inserted vertically and in position and the drip chamber is clean. 7.2 Feeding Operation Guidance 7.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 28 of 81 Fig 7.2.1-1 Switch Feeding Mode on Setting Page Method-2: Press Home button to enter home page. Touch the “Continuous Mode” or “Intermittent Mode” button to select feeding mode. Fig 7.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 29 of 81 Note: If a feeding task is stop and not finished, a prompt will pop up to remind user Switch feeding mode? Need user to double confirm. Fig 7.2.1-3 Switch Feeding Mode 7.2.2 Prime and Connect Feeding Set to Patient Open the roller clamp of the enteral feeding set. Touch the “Prime” button on the setting page (Figure 7.2.1-1) and the following prompt will appear on the screen: B A Fig 7.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 30 of 81 Touch the “Confirm” button to start prime. After prime, the page returns to the setting page (Figure 7.2.1-1). Repeat the prime process until the distal connector leaking the liquid and then user can terminate prime by touching “Stop” button. Connect distal connector of the feeding set to the patient’s gastric tube as shown below: Fig 7.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 31 of 81 Fig 7.2.3-1 Set Feeding Parameter In the same way, other parameters can be set. Note: In the operation interface, all the contents in orange can be edited by touching. The contents in blank, such as “Fed”, “Time Left” are information automatically displayed. 7.2.4 Start Feeding Press the “Start/Stop” button . The pump will run and display the set parameter and progress as shown in the figure below.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 32 of 81 Fig 7.2.4-1 Running Status Regarding KTO function please refer to 7.2.8 KTO. Regarding Lock function please refer to 7.2.9 Screen Lock. Caution 1) When pump is running, to avoid the user’s mis-operation and affect the patient, “Power” button and “Home” button cannot be used during running status. User needs to press “Start/Stop” button to stop feeding firstly before using them.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 33 of 81 Fig 7.2.5-1 Stop Feeding and Start a New Feeding Note: a prompt will pop up to ask whether to keep the last feeding parameters. 1) If selecting yes, the last feeding parameters will be loaded in setting page. Fig 7.2.5-2 Load Last Feeding Parameters 2) If selecting no, the setting page will come out with feeding parameters in blank as “---”.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 34 of 81 Fig 7.2.5-3 Not Select Last Feeding Parameters Caution If user decides to start a new feeding, the “Fed” volume will be cleared. User can check the fed volume in feed history (Refer to 7.3.1 Feed History). 7.2.6 Interval Waiting Under intermittent feeding mode, when each single feeding task finished, the system will start interval waiting. (Refer to 6.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 35 of 81 For example, as the page above, when the last 1mL is fed, the 3rd feeding is finished, the pump start interval waiting. The page indicate the Feed 3 is completed from the programed 8 feeds; the next task Feed 4 will start when time count down to zero. Caution KTO function will be performed during interval waiting if KT O between meals is switched on in system setting (Refer to 7.2.8 KTO) 7.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set “Power” button REF# Version B L10196_US Page 36 of 81 and touch the “Switch Off” button on the screen to turn off the pump. User also can hold the “Power” button for 4 seconds to turn off the pump directly. Press the power button to Hold the power button to turn turn off the pump off the pump Fig 7.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 37 of 81 Automatic KTO: When “KTO Between Meals” switched on in system setting, the pump will automatically run KTO during waiting intervals under intermittent mode. 7.2.8-1 KTO Between Meals Switched on for Interval Waiting 7.2.8-2 KTO Between Meals Switched off for Interval Waiting Manual KTO: Feeding task can be paused and auto resumed after set period.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 38 of 81 page. Touch the orange number to edit KTO time and then touch "Start KTO". The feeding task stops and KTO runs. Fig 7-2-8-3 Manual KTO for Continuous Mode Fig 7-2-8-4 Manual KTO for Intermittent Mode When KTO time reached, the pump will continue the unfinished feeding task. Note: • For manual KTO, KTO time can be set from 5 ~ 240 mins.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 39 of 81 Caution The amount of delivered fluid during KTO is monitored, tracked, and calculated into the final feed volume totalizer amounts displayed to the user. Displayed volume is actual and programmed volume. 7.2.9 Screen Lock To avoid the user accidentally touching the wrong key, accidental input, or erroneously changing pump settings, the pump enters the screen lock status when running.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 40 of 81 Fig 7.2.9-2 Screen Unlock Note: If users press the Start/Stop button, Home or Power button when screen is locked, a prompt will pop up the remind for 2-3 seconds. Unlock the screen to operate the pump if needed. Fig 7.2.9-3 Screen Locked Prompt 7.2.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 41 of 81 Or Fig 7.2.10 Invalid Entry Prompt Note: Invalid entry prompt includes the rate, dose, feed count, interval time, KTO time setting etc. 7.2.11 Feeding Entire Bag When solution bag is empty, Upstream Tube Alarm (display contents include Bag Empty) will occur.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 42 of 81 For entire bag feeding, it can be run under continuous mode. There are two ways to set entire bag feeding. ⚫ Route 1: Switch on the pump, a prompt will pop up to ask user if to keep the last feeding parameters. ⚫ Route 2: Touch “New Feeding” button to start a new feeding task, a prompt will pop up to ask user whether to keep the last feeding parameters.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 43 of 81 Fig 7.3.1 Feed History A maximum of 72 hours of feeding history can be retrieved, excluding data from the current hour. Input hour number (1-72) in the upper "History" window by touching the orange number to check the fed volume during the time range. The Total Fed volume from the time when the data was cleared. The data is real-time record.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 44 of 81 Fig 7.3.2 Log Record 7.3.3 Quick Guidance Touch the icon on the status bar on the home page（Refer to 6.2.2 System Icon Description） to enter the quick guidance page. It can help user learn to quickly set up the pump. Fig 7.3.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 45 of 81 7.3.4 System Setting Touching the "System Settings" button on the "Home" page leads into the interface for settings of screen brightness, alarm volume, lock screen time, date, and time etc. Note: English is the default language in the pump. There is no entry in the pump language setting. Fig 7.3.4 System Setting 7.3.4.1 Brightness The pump provides 8-level brightness settings.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 46 of 81 Fig 7.3.4.1 Brightness 7.3.4.2 Alarm Volume The pump provides 5-level alarm volume settings. The setting method can be referred to the brightness setting. From level 1 to level 5, the volume increases in sequence and level 5 is the maximum volume. Fig 7.3.4.2 Alarm Volume 7.3.4.3 Auto-Lock Time The pump provides 5-level settings for screen automatic lock time.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 47 of 81 Fig 7.3.4.3 Auto-Lock Time 7.3.4.4 Date & Time Setting Enter "Date & Time settings" page from the "System Settings", touch "Date Settings" or "Time Setting" to set the date or time and touch the "Confirm" button to save it. Note: when pump is in setting status, the date and time can be modified. 7.3.4.4 Date / Time Setting 7.3.4.5 Night Mode Enter the "Night Mode" page from the "System Settings”.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 48 of 81 Users can set the start time and end time of the night mode, as well as the alarm sound level and screen brightness for the night mode. 7.3.4.4 Night Mode 7.3.4.6 KTO Setting Enter the "KTO Settings" page from the "System Settings”. User can switch on /off the KTO function during the interval waiting under the intermittent mode. Switch Off Switch On 7.3.4.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 49 of 81 7.3.4.7 Version Enter the “Version” page from the "System Settings". User can check the current software and hardware version. 7.3.4.7 Version 7.3.5 System Maintenance System Maintenance section is only for product maintenance engineers. The authorization is managed via password from Amsino.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 50 of 81 1) “Yes” means the people who has the permission. 2) “No” means the people who doesn’t have the permission. Enter "System Maintenance" page from the home page, which can provide the functions such as calibration, RFID switch on/off, sensor parameter viewing, system self-test, and factory setting restoration. Maintenance engineers should provide the password before entering "System Maintenance". Fig 7.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 51 of 81 1) Close the roller clamp, connect the feeding set to feeding container and hang the container on IV pole. 2) Load the tubing and swipe RFID tag to identify the tubing. 3) Fill approximately 200ml distilled water into the feeding container, open the roller clamp and prime the feeding set. Make sure there is no air in the tubing and distal connector. 4) Adjust the feeding container height as fig 7.3.5.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 52 of 81 Fig 7.3.5.1-2 Calibration Page 3) Press the "Start/Stop" button . The pump will run automatically until progress bar to 100%. Then it returns to the calibration page. Fig 7.3.5.1-3 Calibration Running 4) Read the electronic balance weight and calculate the real volume via the following formula. M V= ρ M: electronic balance reading (g) ρ: distill water density (0.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 53 of 81 5) For example, V=2.55ml after calculation. Input 2.55 into the space of Real Volume. The pump may calculate and update the accuracy factor from 4840 to 4745 automatically as figure below. Fig 7.3.5.1-4 Accuracy Factor Updated Caution Only trained personnel can perform pump calibration. 7.3.5.
IFU of AMSure® Enteral Feeding Pump and Feeding Set File Name REF# Version B L10196_US Page 54 of 81 7.3.5.5 Restore to Factory Setting Touch "Restore Factory Settings" and enter the password to restore the screen brightness, alarm volume, system date and time, accuracy factor and other parameters to the system factory default values. System log records will not be deleted after factory setting restore.
File Name • • • • IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 55 of 81 Downstream Ultrasonic Sensor Voltage Pressure Sensor Voltage Microprocessor Timer Microprocessor handshake Voltage The breakdown for each alarm is as follows: • No Operation Alarm Sensor Input: Microprocessor Timer The pump uses the microprocessor timer to know when certain time of inactivity has elapsed. • Upstream Tube Alarm Sensor Input: Infrared Sensor Voltage.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 56 of 81 The pump will alarm when the battery voltage reaches a set minimum level, which is not able to support 3 minutes running. • Battery Degradation Alarm Sensor Input: Battery Voltage The pump will determine Battery Degradation Alarm when the battery voltage reaches a set minimum level after charging to the full capacity.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 57 of 81 Priority Handling of Alarms In all cases, higher priority alarms are more important and override any lower priority alarm conditions. A lower priority alarm will never disable a higher priority alarm. The High Priority alarms have same ranking. The latest alarm will not override the current alarm. When the earlier alarm is eliminated, the later alarm can be triggered if the alarm condition is still met.
File Name 4 IFU of AMSure® Enteral Feeding Pump and Feeding Set No Operation REF# Version Low B L10196_US Page 58 of 81 Non-latching Caution Latching alarm signal: Alarm signal that continues to be generated after its triggering event no longer exists until stopped by deliberate operation action (press "Alarm Reset"). Non-latching alarm signal: Alarm signal that automatically stops being generated when its associated triggering event no longer exists.
File Name 8.3 IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version Free Flow Stops the feeding Potential Cause: • Tubing is not in position B L10196_US Page 59 of 81 • Close the roller clamp on the feeding set. • Check if the silicone tube of the feeding set is in position. If not, please re-install the set to pump. 8.4 Air in Line Stops the feeding Potential Cause: • Air bubble in the tubing.
File Name 8.6 IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version No Operation All functions remain effective B L10196_US Page 60 of 81 • Any operations can eliminate this alarm. Potential Cause: • When the pump is turned on and not running, there is not any other operations within 1min50s2min, the alarm will be generated 8.7 Low Battery Doesn’t stop the feeding Pump keeps running < 30 mins • Touch” Mute”, a prompt page will pop up with detail information.
File Name 8.8 IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version Out of Battery Stops the feeding Pump turns off within 3 mins B L10196_US Page 61 of 81 • Connect the pump to AC power supply immediately. Potential Cause: • When the remaining capacity of battery is almost exhausted (<5%), the alarm is triggered. 8.9 Battery Error Stops the feeding • Please contact customer service. Potential Cause: • System error for battery. 8.
File Name 8.11 IFU of AMSure® Enteral Feeding Pump and Feeding Set Continuous beeping sound lasting approximately 3 mins. REF# Version Total Power Failure Stops the feeding Pump turns off. B L10196_US Page 62 of 81 • Connect the pump to AC power supply immediately and restart the pump. 8.12 Potential Cause: • Battery and power adapter failure. Motor Error Stops the feeding • Please contact customer service. Potential Cause: • The motor is malfunction. 8.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B Single Dose Complete 8.14 Doesn’t stop the intermittent feeding task L10196_US Page 63 of 81 • Touch” Mute”, a prompt page will pop up with detail information. Potential Cause: • One of the single intermittent feeds completed. • Remind user to flush the tubing per protocol. 9. Dedicated Enteral Feeding Sets (Disposable) The pump needs to be used with Amsino enteral delivery pump set (510(k) No.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 64 of 81 10. Accuracy Graphs Flow Rate 10.1 Accuracy Curve at 1 mL/hr. Rate Time Percentage Error Hours 0-2: Accuracy Curve at 1 mL/hr. Rate Observation Window Hour 0-2: Accuracy Trumpet Curve at 1 mL/hr.
REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 65 of 81 Percentage Error File Name Observation Window Hours 23-24: Accuracy Trumpet Curve at 1 mL/hr. Rate Flow Rate 10.2 Accuracy Curve at 25 mL/hr. Rate Time Hours 0-2: Accuracy Curve at 25 mL/hr.
IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 66 of 81 Percentage Error File Name Observation Window Percentage Error Hours 0-2: Accuracy Trumpet Curve at 25 mL/hr. Rate Observation Window Hours 23-24: Accuracy Trumpet Curve at 25 mL/hr.
File Name REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 67 of 81 Flow Rate 10.3 Accuracy Curve at 25 mL/hr. Rate under +13.3kpa Time Percentage Error Hours 0-2: Accuracy Curve at 25 mL/hr. Rate under +13.3kpa Observation Window Hours 0-2: Accuracy Trumpet Curve at 25 mL/hr. Rate under +13.
REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 68 of 81 Percentage Error File Name Observation Window Hours 23-24: Accuracy Trumpet Curve at 25 mL/hr. Rate under +13.3kpa Flow Rate 10.4 Accuracy Curve at 25 mL/hr. Rate under -13.3kpa Time Hours 0-2: Accuracy Curve at 25 mL/hr. Rate under -13.
IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 69 of 81 Percentage Error File Name Observation Window Percentage Error Hours 0-2: Accuracy Trumpet Curve at 25 mL/hr. Rate under -13.3kpa Observation Window Hours 23-24: Accuracy Trumpet Curve at 25 mL/hr. Rate under -13.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 70 of 81 Flow Rate 10.5 Accuracy Curve at 25 mL/hr. Rate under -0.5m Time Percentage Error Hours 0-2: Accuracy Curve at 25 mL/hr. Rate under -0.5m Observation Window Hours 0-2: Accuracy Trumpet Curve at 25 mL/hr. Rate under -0.
IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 71 of 81 Percentage Error File Name Observation Window Hours 23-24: Accuracy Trumpet Curve at 25 mL/hr. Rate under -0.5m 11. Internal Battery Maintenance The pump has a built-in rechargeable lithium battery with specifications: 18650/11.1V-2200mAH. After the grid power supply is interrupted, the system will automatically switch to the built-in battery working state. Daily maintenance of the battery: 1.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 72 of 81 • 3. 4. 5. 6. 7. To remove all visible soil, wipe down the pump with non-abrasive paper towel, sponge, or lint free soft cloth moistened with cleaning solution. • To remove soil from crevices, use a soft brush. • After the first cleaning, replace it with a new wet wipe and clean it again.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 73 of 81 • For better patient and personnel protection against the risks of contamination, disinfect per facility guidelines for the housing surfaces of the device. • It is necessary to clean and disinfect the pump after each use when these devices are used for multiple patients. This is to prevent spreading bacteria, viruses, and other germs between patients that interact with the same pump. 1. 2. 3. 4. 5.
File Name REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 74 of 81 Amsino shall not be liable for loss of or damage to the device during transport to our customer service center.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set 8 10 12 REF# Version L10196_US Page 75 of 81 B 64.9 70.2 70.8 Supplementary information 1.Including HIGH, MEDIUM, and LOW PRIORITY ALARM CONDITIONS 2.Including maximum and minimum settings 3.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set tb (s) Any two pulses amplitude difference REF# Version L10196_US Page 76 of 81 123 - - 337 - - 126 - - 18.12 - - 3.6dB - 0.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 77 of 81 14. Waste Disposal 14.1 Battery Please follow local regulations to dispose of used batteries. 14.2 Enteral feeding set After use, it shall be disposed of in accordance with relevant medical waste disposal regulations. 14.3 Pump The designed service life of the pump is 5 years. After the service life is exceeded, it should be disposed of in accordance with relevant medical waste disposal regulations. 15.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set Harmonic distortion IEC61000-3-2b) Voltage fluctuation/flicker IEC61000-3-3b) NA REF# Version B L10196_US Page 78 of 81 directly connected to the public low-voltage power supply network of households.
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 79 of 81 Guidelines and manufacturer’s declaration-electromagnetic immunity-for non-life support equipment and systems Guidelines and manufacturer's declaration-electromagnetic immunity The equipment is expected to be used in the following electromagnetic environment, and the purchaser or user should ensure that it is used in this electromagnetic environment: IEC60601 Immunity Coincidence Experimental Electromag
File Name IFU of AMSure® Enteral Feeding Pump and Feeding Set REF# Version B L10196_US Page 80 of 81 The equipment is expected to be used in an electromagnetic environment where radio frequency radiation disturbances are controlled.
File Name REF# Version IFU of AMSure® Enteral Feeding Pump and Feeding Set B L10196_US Page 81 of 81 17. Packing List The list of packaging with this product (single unit) is as follows: Accessory Quantity Unit IFU 1 Set Power Adapter 1 Set Pump 1 Set 18. Manufacturer Information Amsino International, Inc. 708 Corporate Center Drive, Pomona, CA 91768 • Amsino.com Phone: 800.632.6746 • Fax: 909.626.3888 • Email: info@amsino.
