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File

 

Name

 

IFU of

 

AMSure

®

 

Enteral

 

Feeding

 

Pump and Feeding Set

 

REF

# 

L10196_US

 

Version

 

B 

Page

 

9

 

of

 

81

 

 

 

AMSINO Confidential

 

 

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.  If  this  equipment  does  cause  harmful 
interference to radio or television reception, which can be determined by 
turning the equipment off and on, the user is encouraged to try to correct 
the interference by one or more of the following measures: 
- 

Reorient or relocate the receiving antenna. 

- 

Increase the separation between the equipment and receiver. 

- 

Connect the equipment into an outlet on a circuit different from that 
to which the receiver is connected. 

- 

Consult the dealer or an experienced radio/TV technician for help. 

1.5 Complications 

Enteral feeding may lead to digestive complications such as diarrhea, 
bloating, etc. Feeding rate must be adapted to suit the patient and the 
patient’s condition should be assessed regularly. 

2. Glossary of Terms 

1. 

Enteral Feeding Set: 

A device that transfers nutrient solution or water to 

the patient from the liquid supply through the equipment, feeding set or 
tubing for short. 

2. 

Interval:

 When pump in intermittent feeding mode, the system will  display 

interval waiting status between two single feedings. 

3. 

Free Flow: 

The liquid in delivery set is not controlled by the equipment and 

flows freely under gravity. 

4. 

KTO: 

Keep Tube Open. A feature that effectively pauses the pump but 

keeps the rotor turning very slowly to prevent fluid from clogging in the 
feeding set tube. 

5. 

RFID: 

Radio Frequency Identification.   

6. 

Head Height:

 The distance from the top of the fluid in the feeding set bag 

(or container) to the top of the pump. 

7. 

Dose:

 A feature that allows a fixed amount of fluid to be delivered during a 

feeding. The pump will stop operation when the programmed amount of 
fluid is delivered. 

8. 

Rotor

：

The wheel on the pump that rotates to push fluid through the 

feeding set. 

3. Introduction and Application Scope 

3.1 Device Description 

The 

AMSure

®

  enteral feeding pump and feeding set consists of an enteral 

feeding pump and disposable enteral feeding sets that deliver formula via 

Содержание AMSure

Страница 1: ...unction Signature Date Written By Jason Jiao Product Manager 2022 7 15 Reviewed By Othon Pan Senior RA Specialist 2022 7 15 Reviewed By Leo Qiu Director of Product Management 2022 7 15 Approved By Jane Gao VP of R D and RA 2022 7 15 Document Revision History Rev Date Description Originator B 2022 7 15 Based on FDA AI Requirement Jason Jiao A 2021 9 20 First issue Jason Jiao ...

Страница 2: ...09 4 Critical Features 10 5 Technical Specifications 1110 5 1 Basic Parameters 1110 5 2 Main Performance 11 5 3 Others 1211 6 Pump Overview 1211 6 1 General Description 1211 6 2 System Description 13 6 2 1 Front Panel Icon Description 13 6 2 2 Operation Interface Layout 14 6 2 3 Continuous Mode Icon Description 1514 6 2 4 Intermittent Mode Icon Description 16 7 Operation Guidance 18 7 1 Preparatio...

Страница 3: ...1 Feeding Entire Bag 41 7 3 Other Functions 42 7 3 1 Feed History 42 7 3 2 Log Record 43 7 3 3 Quick Guidance 44 7 3 4 System Setting 45 7 3 5 System Maintenance 49 8 Alarm 54 9 Dedicated Enteral Feeding Sets Disposable 63 10 Accuracy Graphs 64 10 1 Accuracy Curve at 1 mL hr Rate 64 10 2 Accuracy Curve at 25 mL hr Rate 65 10 3 Accuracy Curve at 25 mL hr Rate under 13 3kpa 67 10 4 Accuracy Curve at...

Страница 4: ... Version B Page 4 of 81 AMSINO Confidential 13 Characteristics of ALARM SIGNALS 74 14 Waste Disposal 77 14 1 Battery 77 14 2 Enteral feeding set 77 14 3 Pump 77 15 Electromagnetic Compatibility 77 16 Anti Static Precautions 80 17 Packing List 81 18 Manufacturer Information 81 ...

Страница 5: ...te from electrical and electronic equipment Serial No Alternating current IPX4 IPX4 protection level Number of Units Direct current Manufacturer Stand by Temperature limit Medical Device Atmospheric pressure limitation Humidity limitation Keep dry Label located on box Keep away from sunlight Label located on box MR unsafe Magnetic resonance Federal USA law restricts the use of this device to sale ...

Страница 6: ...tting it up and operating 3 Do not install the pump in dusty places or in an environment where flammable or explosive materials are placed to prevent fire or explosion Such as flammable anesthetic gas or a mixture of oxygen and nitrous oxide gas 4 Do not use the pump in an environment of strong shocking vibrations and strong external electromagnetic interference and radiation such as MRI environme...

Страница 7: ...ient noise Auditory alarm signal sound pressure levels which are less than ambient levels can impede OPERATOR recognition of ALARM CONDITIONS and the ALARM SYSTEM provides 19 Patients with implanted devices such as an implantable cardioverter defibrillator pacemaker or neurostimulator need to refer to the implanted device s instructions for use to know if there is any restriction to use electrical...

Страница 8: ...uld be wiped regularly to ensure that it is clean Blocking the sensors will cause detection failure or false alarms Refer to Section 12 1 Maintenance 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 A...

Страница 9: ...t and the patient s condition should be assessed regularly 2 Glossary of Terms 1 Enteral Feeding Set A device that transfers nutrient solution or water to the patient from the liquid supply through the equipment feeding set or tubing for short 2 Interval When pump in intermittent feeding mode the system will display interval waiting status between two single feedings 3 Free Flow The liquid in deli...

Страница 10: ... feeding pump is for use with only the Amsino AMSure feeding sets 3 3 Model Naming AMSure Enteral Feeding Pump Model ASEP00 4 Critical Features 1 Two options for feeding history review 1 View previous 72 hours of feeding history 2 View cumulative feeding history record since it was cleared last time 2 Audible and visual alarm to indicate errors 3 4 3 inch touch screen is used for direct parameter ...

Страница 11: ...ge DC 11 1V 3 Battery capacity 2200mAh 4 Working time Continuously working for 7 hours with a feeding rate of 120ml h after fully charged 5 Battery power 24 42Wh Requirement of enteral feeding set Refer to 9 Dedicated Enteral Feeding Sets Disposable 5 2 Main Performance Range of feeding rate 1 400mL h step value 1mL h Range of feeding volume 1 9999mL step value 1mL Feeding accuracy 10 Interval wai...

Страница 12: ...pping motor is used to release the pressure in the tubing after the occlusion to control the bolus The storage time of the electronic memory function after shutdown the equipment life cycle The unit of measurement used for equipment calibration milliliters namely mL 6 Pump Overview 6 1 General Description This pump is composed of pump shell motor drive system input system storage system control sy...

Страница 13: ...6 1 3 Back View 6 2 System Description 6 2 1 Front Panel Icon Description No Indicator and Button Status Description 1 Status Indicator Light Green Normal status Yellow Medium or Low priority alarm Infrared Sensor Set Socket Ultrasonic Sensor Pressure Sensor RFID Scan Area Rotor Pump Cover Pole Clamp Fg Handle Fg Battery Cover Power Interface ...

Страница 14: ...Green Battery is in charging Not lit Battery is not in charging 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 2 Operation Interface Layout Fig 6 2 2 1 Operation Interface No Name Description 1 Function selection area User can select the function by touch the screen directly 2 System time display area Display system time with ...

Страница 15: ...meters setting and display area User can set feeding parameters by touching the numbers in orange 8 Function button Display the related function button Note All the orange color words in the parameter setting page are editable 6 2 3 Continuous Mode Icon Description This feeding mode allows the device to feed the patient by setting flow rate and dose When the actual feeding amount reaches the dose ...

Страница 16: ... goes to setting page 8 Lock Execute screen lock function Refer to 7 2 9 Screen lock 9 Unlock Execute screen unlock function Refer to 7 2 9 Screen lock 10 KTO Execute KTO function Refer to 7 2 8 KTO 11 Back Back to previous page Note All the orange color words in the parameter setting page are editable 6 2 4 Intermittent Mode Icon Description This feeding mode allows the pump to be programed and a...

Страница 17: ...rsion B Page 17 of 81 AMSINO Confidential Fig 6 2 5 2 Intermittent Mode No Icon Name Description 1 Intermittent Mode Intermittent Mode User can touch it to switch to continuous mode 2 Rate Indicate number of feeding rate Setting Status Running Status Stop Status Interval Waiting ...

Страница 18: ...that have been run from total programed feeds 9 KTO Running The icon is rotating to show KTO running status Refer to 7 2 8 KTO 10 Prime Enter prime page Refer to 7 2 2 for Prime section 11 New Feeding End current feeding task and goes to setting status 12 Lock Execute screen lock function Refer to 7 2 9 Screen lock 13 Unlock Execute screen unlock function Refer to 7 2 9 Screen lock 14 KTO Execute ...

Страница 19: ...in the formula bag For better accuracy the initial fluid level shall be at 45 5cm 17 7 1 96 inches higher than the pump and the pump shall be placed higher than the feeding site to the patient Note To reach the required head height fold the upstream tube in half the pump position can be adjusted on the I V pole with the door s upper edge flushing to the tube middle point Fig 7 1 1 1 Initial Fluid ...

Страница 20: ...ion 7 1 2 Connect to AC Power Supply Connect the pump to AC power supply as below shown 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 Connect to power interface Connect to AC power supply Lock ...

Страница 21: ...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 When the battery is charged to 100 it stops charging and battery indicator light turns off Refer to 6 2 1 Front Panel Icon and 6 2 3...

Страница 22: ...ess 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 1 2 Prompt for load parameters confirmation ...

Страница 23: ...or detected Please contact your customer service Fig 7 1 3 2 1 Self Testing Failed Caution When self testing failed pump is not allowed to run for feeding but user still can check other interfaces through Home button 7 1 4 Feeding Set Identification System To guarantee the feeding accuracy of the pump only the feeding sets listed in chapter 9 Dedicated Enteral Feeding Sets Disposable are recommend...

Страница 24: ...s 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 After the RFID tag identified keep the RFID tag away from the scanning area to avoid the pump to keep reading and beeps Fig 7 1 4 2 Correct Tubing Inserted Correct Tubing Remaining time 23h59min Correct Tubing Remaining time 21h00min Swipe th...

Страница 25: ... 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 4 3 Swipe RFID Tag After 24 hours from the first time of RFID tag swipe the system will show prompt info on status bar that tubing used 24hrs Fig 7 1 4 4 Tubing Used 24hrs Note The prompt Tubing Used 24 hrs can only be cle...

Страница 26: ... display on the status bar to remind user to replace a new feeding set 2 It will not interrupt the feeding task until feeding complete alarm occurred 3 If new feeding button is touched it will end current feeding task The pump cannot be used for feeding until a new feeding set is replaced to clear this prompt If user press start stop button a prompt will pop up to remind Please swipe RFID tag 4 Wh...

Страница 27: ...aution 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 1 Feeding Mode Selection On setting page the user can switch the feeding mode in the following 2 methods Method 1 Touch the Continuous Mode or Intermittent Mode on the screen to switch feeding mode Step 2 Step 3 Step 1 ...

Страница 28: ...10196_US Version B Page 28 of 81 AMSINO Confidential 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 1 2 Select Feeding Mode on Home Page ...

Страница 29: ...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 Fig 7 2 2 1 Prime A B ...

Страница 30: ...patient it must be ensured that there is no air in the feeding set When the set has been primed and connected to the patient s gastric tube user can start feeding Note 1 Prime rate is 1200mL h and cannot be adjusted 2 When prime is in processing the function of infrared sensor ultrasonic sensor will be bypassed however the pressure sensor will keep monitor the tube pressure 3 The prime warning pag...

Страница 31: ... 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 The green arrow will be rolling to the right direction to indicate that feeding is running ...

Страница 32: ... button and Home button cannot be used during running status User needs to press Start Stop button to stop feeding firstly before using them 2 Long press the power button for 4 seconds still can switch off the pump for emergency Fig 7 2 4 2 Home and Start Stop Button Lock Prompt 7 2 5 Stop Feeding and Start a New Feeding Press Start Stop button to stop feeding User can perform prime Refer to the p...

Страница 33: ... 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 In this page the blank can be touched and input with new parameters It also supports feeding entire bag Refer to 7 2 11 Feeding Entire Bag ...

Страница 34: ...ution 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 5 Intermittent Feeding Mode Icon Description Fig 7 2 6 1 Interval Waiting ...

Страница 35: ... button to eliminate the feeding complete alarm The pump returns to the last setting page and then the next feeding task can be prepared 7 2 7 1 Feeding Complete Notes 1 Continuous mode the fed volume reaches dose setting volume the feeding complete alarm will occur Refer to 8 5 Feeding Complete 2 Intermittent mode when all the feeds are finished the feeding complete alarm will occur Refer to 8 5 ...

Страница 36: ...ty causing over feeding and harm to patient if there is still nutrition in the container 7 2 8 KTO The Keep Tube Open KTO function within the pump will help prevent a blockage of the feeding set by moving the feeding solution periodically within the tube On regular intervals calculated from the pump s presently programmed feed rate a small and clinically insignificant portion of feeding solution 0...

Страница 37: ...rvals 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 It can be used for both continuous mode and intermittent mode that user want to pause some time When pump is running the user touches the KTO button Fig 7 2 8 3 Running Page Fig 7...

Страница 38: ... 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 For automatic KTO under intermittent mode KTO time equals to the interval waiting time If KTO time Interval Waiting time 30mins 0 2ml bolus is run every 30 mins If KTO time Interval Waiting time 30mins 0 2mL bolus is run one time in the middle of time ...

Страница 39: ...ttings the pump enters the screen lock status when running The start time is according to the Auto Lock Time set in the system setting When the screen locked both the touch screen and physical buttons cannot be used To set Auto Lock Time in system setting refers to 7 3 4 3 Auto Lock Time Settings Another way is to touch the Lock button on the running page and the pump will enter the lock screen st...

Страница 40: ...n 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 10 Parameter Out of Range When the parameters input is out of the range specified in display a prompt will pop up in 2 3 seconds to remind user that Invalid Entry numbers entered are outside of allowable range ...

Страница 41: ...B Page 41 of 81 AMSINO Confidential 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 Or ...

Страница 42: ...oute 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 In both conditions selecting No set Rate setting only keep Dose Setting as the pump run for Entire Bag Feeding under this program Fig 7 2 11 Feeding Entire Bag Caution Upstream alarm may be caused by other reasons For details of Upstream Tube Alarm refers to 8 1 ...

Страница 43: ...uring the time range The Total Fed volume from the time when the data was cleared The data is real time record It s normally cleared for a new patient or before a new feeding Note The 72 hour history includes time when the pump is powered off 7 3 2 Log Record Touch Log Record button from the home page to query operation and alarm records The pump can save approximately 10 240 logs When the memory ...

Страница 44: ...sion B Page 44 of 81 AMSINO Confidential 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 3 Quick Guidance ...

Страница 45: ...ock 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 Touch the blocks of each level to set brightness then touch Confirm button to save the setting otherwise system will restore the original brightness From level 1 to level 8 the bri...

Страница 46: ...ettings 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 From level 1 to level 4 the waiting time to auto lock screen increases in turn and level 5 is to turn off the screen lock func...

Страница 47: ... 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 Touch the on off button to switch on off night mode ...

Страница 48: ...rt 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 7 3 4 6 KTO Setting Switch Off Switch On ...

Страница 49: ...uthorization is managed via password from Amsino User Definition Commands Normal User Maintenance Engineer Serial Number Check Yes Yes Product Name Check Yes Yes Log Event Yes Yes Feed History Yes Yes System Setting Yes Yes Brightness Yes Yes Alarm volume Yes Yes Auto Lock time Yes Yes Date Time setting Yes Yes Night Mode Yes Yes KTO setting Yes Yes Version Yes Yes System Maintenance No Yes Calibr...

Страница 50: ... The pump has been calibrated before leaving the factory and can be used directly To keep normal use re calibrate the pump every 12 months Carry out accuracy calibration according to the following steps 1 Items Required for Calibration The calibration shall be carried out at room temperature No Items Model Quantity pcs Remark 1 Enteral feeding pump ASEP00 1 2 Enteral feeding set ENF 1004K2 1 3 Fee...

Страница 51: ...ust the feeding container height as fig 7 3 5 1 1 5 Put the collecting container on the electronic balance Hang the distal connector above the container clear the balance to zero Refer to the fig 7 3 5 1 1 as below Fig 7 3 5 1 1 Calibration Preparation 3 Procedures for Calibration 1 Enter the calibration page Select the rate range that needs to be calibrated by touching the For the selected ones t...

Страница 52: ...age 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 V M ρ M electronic balance reading g ρ distill water density 0 998 g cm3 V real volume ml ...

Страница 53: ...ct tubing for the pump there is a separate password for RFID switch function Only authorized person can switch on off the RFID identification 7 3 5 3 Sensor Enter the Sensor page to check the sensor real time return values which may help technicians diagnose the issues of pump Note The threshold of each sensor cannot be adjusted 7 3 5 4 Self test The self test has been performed during pump start ...

Страница 54: ...3 End time 7 00AM 4 Brightness 1 5 Alarm volume 1 7 KTO KTO between meals Switch on Caution 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...

Страница 55: ...er voltage to judge whether the motor is faulty Downstream Tube Occlusion Alarm Sensor Input Downstream Pressure Sensor Voltage The pump determines downstream tube alarm based upon voltage value levels it receives from the Downstream Pressure Sensor Air in Line Alarm Sensor Input Downstream Ultrasonic Sensor Voltage The pump determines Air in line alarm based upon the voltage values it receives Th...

Страница 56: ...eding 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 When an occlusion occurs in the tubing on the fluid supply side of the pump rotor fl...

Страница 57: ...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 The pump never changes the priority of alarms based on situational or environmental conditions Alarm priority of the pump remains fixed Additionally the pump does not change Alarm Signal Generation Delay or Alarm Condition delay as a result ...

Страница 58: ...ng event no longer exists Recoverable alarm sound automatic recovery time is 2 mins since alarm muted Alarm Messages and Corrective Actions No Display Alarm Solutions 8 1 Upstream Tube Alarm Stops the feeding Potential Cause Formula bag empty Air bubble in the upstream tube Upstream tube occlusion Check whether the roller clamp of the enteral delivery set is open Release upstream occlusion Check w...

Страница 59: ...4 Air in Line Stops the feeding Potential Cause Air bubble in the tubing To remove air bubbles in the feeding set disconnect the set from the patient s gastric tube and prime the feeding set 8 5 Feeding Complete Stops the feeding Potential Cause A feeding task has completed Caution To unload the tubing close the roller clamp disconnect the tubing from the patient s enteral access and then unload t...

Страница 60: ... turned on and not running there is not any other operations within 1min50s 2min the alarm will be generated Any operations can eliminate this alarm 8 7 Low Battery Doesn t stop the feeding Pump keeps running 30 mins Potential Cause When the remaining capacity of battery is low 20 the alarm is triggered Touch Mute a prompt page will pop up with detail information Connect the pump to AC power suppl...

Страница 61: ...f battery is almost exhausted 5 the alarm is triggered Connect the pump to AC power supply immediately 8 9 Battery Error Stops the feeding Potential Cause System error for battery Please contact customer service 8 10 Battery Degradation Doesn t stop the feeding Use time 7 hours 120mL hr Potential Cause Battery degrades Touch Mute a prompt page will pop up with detail information Contact customer s...

Страница 62: ...er Failure Stops the feeding Pump turns off Potential Cause Battery and power adapter failure Connect the pump to AC power supply immediately and restart the pump 8 12 Motor Error Stops the feeding Potential Cause The motor is malfunction Please contact customer service 8 13 Communication Fault Stops the feeding Potential Cause System error for processor Please contact customer service ...

Страница 63: ... 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 Recommended list of AMSure enteral delivery sets No REF Description 1 ENF500K Enteral feeding set with 500mL bag 2 ENF1004K Enteral feeding set with spike 3 ENF1200K Enteral feeding set with 1200mL bag 4 ENF500K2 Enteral feeding set with 500mL ...

Страница 64: ... Set REF L10196_US Version B Page 64 of 81 AMSINO Confidential 10 Accuracy Graphs 10 1 Accuracy Curve at 1 mL hr Rate Hours 0 2 Accuracy Curve at 1 mL hr Rate Hour 0 2 Accuracy Trumpet Curve at 1 mL hr Rate Flow Rate Time Percentage Error Observation Window ...

Страница 65: ...Feeding Set REF L10196_US Version B Page 65 of 81 AMSINO Confidential Hours 23 24 Accuracy Trumpet Curve at 1 mL hr Rate 10 2 Accuracy Curve at 25 mL hr Rate Hours 0 2 Accuracy Curve at 25 mL hr Rate Percentage Error Observation Window Flow Rate Time ...

Страница 66: ...and Feeding Set REF L10196_US Version B Page 66 of 81 AMSINO Confidential Hours 0 2 Accuracy Trumpet Curve at 25 mL hr Rate Hours 23 24 Accuracy Trumpet Curve at 25 mL hr Rate Percentage Error Observation Window Percentage Error Observation Window ...

Страница 67: ...96_US Version B Page 67 of 81 AMSINO Confidential 10 3 Accuracy Curve at 25 mL hr Rate under 13 3kpa Hours 0 2 Accuracy Curve at 25 mL hr Rate under 13 3kpa Hours 0 2 Accuracy Trumpet Curve at 25 mL hr Rate under 13 3kpa Flow Rate Time Percentage Error Observation Window ...

Страница 68: ...6_US Version B Page 68 of 81 AMSINO Confidential 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 Hours 0 2 Accuracy Curve at 25 mL hr Rate under 13 3kpa Percentage Error Observation Window Flow Rate Time ...

Страница 69: ...t REF L10196_US Version B Page 69 of 81 AMSINO Confidential Hours 0 2 Accuracy Trumpet Curve at 25 mL hr Rate under 13 3kpa Hours 23 24 Accuracy Trumpet Curve at 25 mL hr Rate under 13 3kpa Percentage Error Observation Window Percentage Error Observation Window ...

Страница 70: ...L10196_US Version B Page 70 of 81 AMSINO Confidential 10 5 Accuracy Curve at 25 mL hr Rate under 0 5m Hours 0 2 Accuracy Curve at 25 mL hr Rate under 0 5m Hours 0 2 Accuracy Trumpet Curve at 25 mL hr Rate under 0 5m Flow Rate Time Percentage Error Observation Window ...

Страница 71: ...ge the battery every 3 months to avoid batter degradation 2 Do not disassemble or install the battery contact customer service for battery replacement 3 For detailed battery replacement method refer to L10201 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 recommend...

Страница 72: ...ft cloth 5 Power Adapter Cleaning Refer to General Cleaning Directions before starting The power adapter normally does not require cleaning If soiling of the power adapter is observed unplug from outlet and wipe the exterior surfaces of the power adapter with a non abrasive dry or slightly damp cloth Allow excess moisture to evaporate from the power adapter prior to use 6 Rotor Cleaning Refer to G...

Страница 73: ...ring the pump to avoid electrical shock hazard fire hazard or damage to electrical components Do not submerge the AMSure Enteral Feeding Pump or its accessories in water or cleaning solutions 6 The device cannot be sterilized 7 Make sure the power adapter is completely dry before plugging into an electrical outlet 12 2 Warranty The AMSure Enteral Feeding Pump warranty covers technical faults occur...

Страница 74: ... it is noted on the courier s paperwork 13 Characteristics of ALARM SIGNALS Alarm light indicator characteristics Alarm type Indicator Color Flashing Frequency Duty Cycle High priority alarm signal Red blinked 2Hz 50 Medium priority alarm signal Yellow blinked 2Hz 50 Low priority alarm signal Solid Yellow Normally open 100 Volume of auditory alarm signals Unit dB A Alarm Condition Volume level set...

Страница 75: ...Y ALARM CONDITIONS 2 Including maximum and minimum settings 3 Position selected based on STATIONARY ME EQUIPMENT Illustration of temporal characteristics of auditory ALARM SIGNALS Characteristic High Priority Alarm Signal Medium Priority Alarm Signal Low Priority Alarm Signal Number of PULSES in BURST a e 10 3 tr ms 17 24 21 25 td ms 112 123 167 182 tf ms 10 20 68 81 ts ms 119 143 122 146 329 119 ...

Страница 76: ...0Hz 4000Hz Pulse frequency f0 384 Hz 7 harmonic components in the range 300Hz 4000Hz Pulse frequency f0 288Hz 6 harmonic components in the range 300Hz 4000Hz Pulse frequency f0 528Hz 4 harmonic components in the range 300Hz 4000Hz Low priority Alarm Pulse frequency f0 528Hz 6 harmonic components in the range 300Hz 4000Hz Pulse frequency f0 288 Hz 6 harmonic components in the range 300Hz 4000Hz Pul...

Страница 77: ...ic performance Item Description Internal power operation Start normal operation at 25mL h the feeding accuracy error is within 10 and the operation is normal during the process there should be no abnormal phenomena and malfunctions Grid power connection operation Start normal operation at 25mL h the feeding accuracy error is within 10 and the operation is normal during the process there should be ...

Страница 78: ...the power cord NA The grid power supply should have the quality used in a typical commercial or hospital environment Surge IEC61000 4 5 1 KV Wire to wire 2 KV Wire to ground 1 KV Wire to wire NA The grid power supply should have the quality used in a typical commercial or hospital environment Voltage dip IEC61000 4 11 5 UT continued 0 5 period UT 95 Suspended 40 UT continued 5 period UT 60 Suspend...

Страница 79: ...ncy transmitter is determined by surveying the electromagnetic field c and in each frequency range d should be lower than the compliance level Interference may occur near equipment marked with the following symbols Note 1 At 80 MHz and 800 MHz frequency points the higher frequency band formula is used Note 2 These guidelines may not be suitable for all situations Electromagnetic propagation is aff...

Страница 80: ...uman bodies 16 Anti Static Precautions When using this equipment users should not touch the pins of connectors marked with electrostatic discharge warning symbols and should not connect to these connectors unless electrostatic discharge precautions are used Users should note 1 Unless the following appropriate precautions have been taken do not touch the accessible connector contacts marked with el...

Страница 81: ...et 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 AMSure is a registered trademark of GEDSA The symbol indicates the trademark is registered in the U S Patent and Trademark Office and certain other count...

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