Amsino AMSure User manual

File Name
IFU of AMSure® Enteral Feeding
Pump and Feeding Set
REF#
L10196_US
Version
B
Page 1of 81
AMSINO Confidential
AMSure®Enteral Feeding Pump IFU
Name
Printed
Job
Title/Function
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

File Name
IFU of AMSure® Enteral Feeding
Pump and Feeding Set
REF#
L10196_US
Version
B
Page 2of 81
AMSINO Confidential
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...............................................................................................................................................7
1.5 Complications............................................................................................................................... 98
2. Glossary of Terms............................................................................................................... 98
3. Introduction and Application Scope.................................................................................9
3.1 Device Description.........................................................................................................................9
3.2 Indication for Use.......................................................................................................................109
3.3 Model Naming.............................................................................................................................109
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 Preparation before Use............................................................................................................. 19
7.1.1 Pump Installation................................................................................................................. 19
7.1.2 Connect to AC Power Supply......................................................................................... 20
7.1.3 Switch on and Self-Testing............................................................................................. 22
7.1.4 Feeding Set Identification System................................................................................ 23
7.1.5 Load Feeding Set................................................................................................................ 26
7.2 Feeding Operation Guidance................................................................................................. 27

File Name
IFU of AMSure® Enteral Feeding
Pump and Feeding Set
REF#
L10196_US
Version
B
Page 3of 81
AMSINO Confidential
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........................................................................................................................ 31
7.2.5 Stop Feeding and Start a New Feeding..................................................................... 32
7.2.6 Interval Waiting.................................................................................................................... 34
7.2.7 Feeding Complete and Switch Off............................................................................... 35
7.2.8 KTO.......................................................................................................................................... 36
7.2.9 Screen Lock.......................................................................................................................... 39
7.2.10 Parameter Out of Range............................................................................................... 40
7.2.11 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 25 mL/hr. Rate under -13.3kpa..................................................... 68
10.5 Accuracy Curve at 25 mL/hr. Rate under -0.5m........................................................... 70
11. Internal Battery Maintenance....................................................................................... 71
12. Product Maintenance and Warranty.......................................................................... 71
12.1 Technical Maintenance........................................................................................................... 71
12.2 Cleaning........................................................................................................................................ 71
12.3 Disinfection.................................................................................................................................. 72
12.2 Warranty....................................................................................................................................... 73

File Name
IFU of AMSure® Enteral Feeding
Pump and Feeding Set
REF#
L10196_US
Version
B
Page 4of 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

File Name
IFU of AMSure® Enteral Feeding
Pump and Feeding Set
REF#
L10196_US
Version
B
Page 5of 81
AMSINO Confidential
1. Symbols, Marking Instructions and Warnings
1.1 Description of Graphics and Symbols
Caution
Refer to instruction
manual/booklet
BF type equipment
Class II equipment
Date of manufacture
WEEE
Signifies waste 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 by or on the order of a
physician.
Catalog #: Indicates the manufacturer's catalog # so that the medical device
can be identified.