Amsino AMSure User Manual

Enteral feeding pump and feeding set

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IFU of AMSure

File Name

Pump and Feeding Set

Name

Printed

Written

Jason

Jiao

Reviewed

Othon

Pan

Reviewed

Leo

Qiu

Approved

Jane

Gao

Rev

Date

2022/7/15

2021/9/20

Enteral Feeding

AMSure

Enteral Feeding Pump IFU

Job

Title/Function

Product Manager

Senior RA

Specialist

Director of

Product

Management

VP of R&D and

Document Revision History

Based on FDA AI

Requirement

AMSINO Confidential

REF

Version

Signature

Description

First issue

L10196_US

Page 1 of 81

Date

2022/7/15

Originator

Jason Jiao

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Page 1 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 1 of 81 ® AMSure Enteral Feeding Pump IFU Name Signature Date Printed Title/Function Written Jason Product Manager 2022/7/15 Jiao 2022/7/15 Reviewed Othon Senior RA...
Page 2: Table Of Contents
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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 .............................. 6 1.4 Caution ...............................
Page 3 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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 ........................
Page 4 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 4 of 81 13. Characteristics of ALARM SIGNALS ................ 74 14. Waste Disposal ........................77 14.1 Battery ............................77 14.2 Enteral feeding set ........................77 14.3 Pump ..............................
Page 5: Symbols, Marking Instructions And Warnings
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 5 of 81 1. Symbols, Marking Instructions and Warnings 1.1 Description of Graphics and Symbols Refer to instruction Caution manual/booklet Class II equipment BF type equipment...
Page 6: Contraindication
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 7: Caution
16. Do not replace the battery by unauthorized person by Amsino. It could result in damage to the pump or serious injury. 17. Do not use a power adapter of a brand or model not specified by Amsino to charge the pump. It could result in damage to the pump or serious injury.
Page 8 12 The pump and accessories are designed to provide a minimum of 5 years shelf life. 13 Use Amsino specified power adapter. Do not use unknown power adapter. 14 The power adapter cord, feeding set tubing, and pump accessories may cause a tripping hazard.
Page 9: Glossary Of Terms
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 10: Indication For Use
The feeding pump and feeding sets are intended to be used in medical facilities by licensed healthcare professional users only. ® ® The AMSure Enteral feeding pump is for use with only the Amsino AMSure feeding sets. 3.3 Model Naming ® AMSure...
Page 11: Technical Specifications
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 11 of 81 5. Technical Specifications 5.1 Basic Parameters Dimensions 133mm×110mm×170mm Weight 1.08 Kg Power adapter Parameter Specification US market LXCP26-150160A Power adapter specification EU market...
Page 12: Others
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 12 of 81 Working and storage Working ambient temperature: +16℃~+40℃ condition Transportation and storage environment temperature: - 20℃~+60℃ Transportation, storage and use of environmental humidity: 20% ~ 90%...
Page 13: System Description
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 13 of 81 RFID Scan Area Ultrasonic Sensor Infrared Sensor Pump Cover Pressure Sensor Set Socket Rotor Fig 6.1-2 Side View Handle Battery Cover Power Interface Pole Clamp Fig 6.1-3 Back View...
Page 14: Operation Interface Layout
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 14 of 81 High priority alarm Not lit Pump is not powered on AC Power Indicator Green AC power supply is connected Light Not lit...
Page 15: Continuous Mode Icon Description
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 15 of 81 User can touch the mode, switching to Feeding mode display and switch another feeding mode. Display system status such as: Setting, Status bar...
Page 16: Intermittent Mode Icon Description
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 16 of 81 Description Icon Name Continuous User can touch it to switch to Continuous Mode intermittent feeding mode. Mode Indicate number of feeding rate...
Page 17 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 17 of 81 Stop Status Running Status Setting Status Interval Waiting Fig 6.2.5-2 Intermittent Mode Description Icon Name User can touch it to switch to...
Page 18: Operation Guidance
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 18 of 81 Indicate number of single feeding Single Dose dose Feed Count – In Setting Indicate number of feedings Status Indicate volume delivered in current...
Page 19: Preparation Before Use
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 20: Connect To Ac Power Supply
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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...
Page 21 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 22: Switch On And Self-Testing
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 23: Feeding Set Identification System
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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”.
Page 24 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 25 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 26: Load Feeding Set
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 27: Feeding Operation Guidance
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 28 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 28 of 81 Fig 7.2.1-1 Switch Feeding Mode on Setting Page Method-2: to enter home page. Touch the “Continuous Press Home button Mode” or “Intermittent Mode” button to select feeding mode.
Page 29: Prime And Connect Feeding Set To Patient
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 30: Set Feeding Parameters
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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”...
Page 31: Start Feeding
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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...
Page 32: Stop Feeding And Start A New Feeding
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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...
Page 33 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 34: Interval Waiting
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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).
Page 35: Feeding Complete And Switch Off
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 35 of 81 For example, as the page above, when the last 1mL is fed, the 3 feeding is finished, the pump start interval waiting. The page indicate the Feed 3 is completed from the programed 8 feeds;...
Page 36: Kto
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 36 of 81 “Power” button 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.
Page 37 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 38 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 39: Screen Lock
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 40: Parameter Out Of Range
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 41: Feeding Entire Bag
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 41 of 81 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.
Page 42: Other Functions
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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 ⚫...
Page 43: Log Record
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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"...
Page 44: Quick Guidance
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 45: System Setting
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 46 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 47 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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"...
Page 48 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 49: System Maintenance
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. User Definition Commands Normal User Maintenance Engineer...
Page 50 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 51 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 52 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 53 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 54: Alarm
Please be cautious to restore factory settings. 8. Alarm Overview The AMSure® Enteral Feeding Pump has alarms that are broken into three different priorities: High Priority, Medium Priority, and Low Priority. Light signals are listed as below. Alarm signal can be perceived correctly at distance of 4m from the alarm system.
Page 55 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 55 of 81 • Downstream Ultrasonic Sensor Voltage • Pressure Sensor Voltage • Microprocessor Timer • Microprocessor handshake Voltage The breakdown for each alarm is as follows: •...
Page 56 Voltage received between Control CPU and Monitor CPU. Fluid Occlusion/Air in Line Detection Overview The AMSure® Enteral Feeding Pump uses infrared sensor, pressure sensors for fluid detection. One sensor is positioned on the upstream side of the rotor and the other sensor is positioned on the downstream side of the rotor. The dual sensor system also provides the capability to distinguish between upstream occlusions, downstream occlusions.
Page 57 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 58 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 58 of 81 No Operation 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").
Page 59 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 59 of 81 Free Flow • Close the roller clamp on the feeding Stops the feeding set. • Check if the Potential Cause: • Tubing is not in position...
Page 60 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 60 of 81 No Operation • Any operations can eliminate this alarm. All functions remain effective Potential Cause: • When the pump is turned on...
Page 61 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 61 of 81 Out of Battery • Connect the pump to AC power supply Stops the feeding immediately. Pump turns off within 3 mins Potential Cause: •...
Page 62 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 62 of 81 Total Power Failure • Connect the pump 8.11 Continuous beeping sound lasting to AC power supply Stops the feeding approximately 3 mins.
Page 63: Dedicated Enteral Feeding Sets (Disposable)
9. Dedicated Enteral Feeding Sets (Disposable) The pump needs to be used with Amsino enteral delivery pump set (510(k) No. K992719) together to achieve the designed feeding flow rate accuracy. Below are detail lists. ®...
Page 64: Accuracy Graphs
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 64 of 81 10. Accuracy Graphs 10.1 Accuracy Curve at 1 mL/hr. Rate Time Hours 0-2: Accuracy Curve at 1 mL/hr. Rate Observation Window Hour 0-2: Accuracy Trumpet Curve at 1 mL/hr. Rate...
Page 65: Accuracy Curve At 25 Ml/Hr. Rate
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 65 of 81 Observation Window Hours 23-24: Accuracy Trumpet Curve at 1 mL/hr. Rate 10.2 Accuracy Curve at 25 mL/hr. Rate Time Hours 0-2: Accuracy Curve at 25 mL/hr. Rate...
Page 66 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 66 of 81 Observation Window Hours 0-2: Accuracy Trumpet Curve at 25 mL/hr. Rate Observation Window Hours 23-24: Accuracy Trumpet Curve at 25 mL/hr. Rate...
Page 67: Accuracy Curve At 25 Ml/Hr. Rate Under +13.3Kpa
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 67 of 81 10.3 Accuracy Curve at 25 mL/hr. Rate under +13.3kpa Time 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.
Page 68: Accuracy Curve At 25 Ml/Hr. Rate Under -13.3Kpa
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 68 of 81 Observation Window Hours 23-24: Accuracy Trumpet Curve at 25 mL/hr. Rate under +13.3kpa 10.4 Accuracy Curve at 25 mL/hr. Rate under -13.3kpa Time Hours 0-2: Accuracy Curve at 25 mL/hr.
Page 69 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 69 of 81 Observation Window 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 -13.3kpa...
Page 70: Accuracy Curve At 25 Ml/Hr. Rate Under -0.5M
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 70 of 81 10.5 Accuracy Curve at 25 mL/hr. Rate under -0.5m Time 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.
Page 71: Internal Battery Maintenance
Manual - 7.2.6 Disassembly and Reassembly of Battery”. 12. Product Maintenance and Warranty 12.1 Technical Maintenance Regular calibration and other technical maintenance are recommended. Only persons authorized by Amsino can carry out maintenance on the ® AMSure Enteral Feeding Pump.
Page 72: Disinfection
® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 72 of 81 • To remove all visible soil, wipe down the pump with non-abrasive paper towel, sponge, or lint free soft cloth moistened with cleaning solution.
Page 73: Warranty
3. The pump has been opened, repaired, altered, or adjusted by personnel other than those authorized by Amsino. 4. The pump has not been used with Amsino tubing, battery, or power adapter. Pumps under warranty should be returned in accordance with the instructions.
Page 74 Version Page 74 of 81 Amsino shall not be liable for loss of or damage to the device during transport to our customer service center. With the exception of the obligations set out in this limited warranty, Amsino shall not be liable for direct or indirect damage or...
Page 75 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 75 of 81 64.9 70.2 70.8 Supplementary information 1.Including HIGH, MEDIUM, and LOW PRIORITY ALARM CONDITIONS 2.Including maximum and minimum settings 3.Position selected based on STATIONARY ME EQUIPMENT...
Page 76 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 76 of 81 18.12 Any two pulses amplitude 3.6dB 0.7dB difference Pulse frequency Low priority Alarm: f0=512Hz Pulse frequency 6 harmonic f0=528Hz components in the...
Page 77 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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.
Page 78 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 78 of 81 Harmonic distortion directly connected to the public low-voltage IEC61000-3-2 power supply network of households. Voltage fluctuation/flicker IEC61000-3-3 Guidelines and manufacturer's declaration-electromagnetic immunity...
Page 79 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version 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...
Page 80 ® IFU of AMSure L10196_US Enteral Feeding File Name Pump and Feeding Set Version Page 80 of 81 The equipment is expected to be used in an electromagnetic environment where radio frequency radiation disturbances are controlled. According to the maximum rated output...
Page 81 Unit Power Adapter Pump 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.com Product(s) described may not be licensed or available for sale in all countries.

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