ENMIND EN-S7 INSTRUCTION MANUAL. Manufactured by - Shenzhen Enmind Technology Co., Ltd. ENMIND PDF
ENMIND EN-S7 INSTRUCTION MANUAL. Manufactured by - Shenzhen Enmind Technology Co., Ltd. ENMIND PDF
ENMIND EN-S7 INSTRUCTION MANUAL. Manufactured by - Shenzhen Enmind Technology Co., Ltd. ENMIND PDF
INSTRUCTION MANUAL
Manufactured by:
ENMIND
Preface
1 Application Scope of the User Manual
Applicable to EN-S7/EN-S7 Smart syringe pumps of our company.
This User Manual describes the product of most complete configuration, the accessories and functions may
not be equipped in the product of the user, for more detailed information, please contact our company.
3 Use Instructions
This User Manual covers the basic information on the safety and effectiveness of the product for guiding
the operator to correctly install, test, operate, use and maintain the product. Please read this manual
thoroughly before use and use the product in a correct way. Please carefully keep the User Manual for
future use.
Our company is responsible for the reliability and performance of the equipment only all following
conditions are met:
The equipment can only be disassembled, assembled, replaced, tested, improved and repaired by the
professional technicians of our company.
All components and accessories as well as consumables for repairing are provided by our company.
● Relevant electric devices meet the international standard IEC/EN 60601-1 and this User Manual.
4 Paraphrase
【】 means mechanical button
『』 means touch button
() further Information
- means inapplicable
√ means accordant
→ means operation steps
KVO: low predetermined rate(s) to which the syringe pump reverts under specified conditions with
the object of keeping the patient line open .
1
IrDA: infrared communication
Warning /Attention: it may possibly cause physical injury or death if the cautions covered in the Warning
are not obeyed.
Caution: it may possibly cause physical injury or property loss if the cautions are not obeyed.
Note: in case fails to follow the supplementary or prompt information on the operation instructions may
possibly cause physical injury the equipment fault or property loss if it is not obeyed.
Accessories: the optional components which are necessary and (or) suitable for using with the equipment in
order to achieve the expected purpose, or provide convenience for achieving the expected purpose, or
improve the expected purpose, or increase the additional functions of the equipment.
The copyright of this User Manual belongs to Shenzhen Enmind Technology Co., Ltd. Without the
approval of our company, any unit or individual is not allowed to copy, modify or translate the contents
speculated in this User Manual.
This User Manual may be revised subject to product improvement, laws updating or instructions improving
basing on the preconditions of meeting related laws and regulations, and all revised records will be stated in
the new version.
2
Content
Chapter1 Safety Instructions...................................................................................................................7
1.1 Warnings...........................................................................................................................................7
1.2 Cautions............................................................................................................................................ 8
1.3 Prompt Information...................................................................................................................... 10
1.4 Symbols........................................................................................................................................... 11
Chapter2 Overview.................................................................................................................................12
2.1 Application Scope.......................................................................................................................... 12
2.1.1 Expected Purpose.................................................................................................................... 12
2.1.2 Expected Working Environment............................................................................................. 12
2.1.3 Suitable object......................................................................................................................... 12
2.2 Contraindications.......................................................................................................................... 12
2.3 Working Principle..........................................................................................................................12
2.4 Structure and Performance.......................................................................................................... 12
2.4.1 Structure and Performance...................................................................................................... 12
2.4.2 Accessories.............................................................................................................................. 12
2.4.3 Description on Model.............................................................................................................. 13
2.4.4 Product Specification...............................................................................................................13
Chapter3 Appearance.............................................................................................................................16
3.1 LEFT Front View...........................................................................................................................16
3.2 RIGHT FRONT VIEW................................................................................................................. 17
3.3 OPERATION PANEL................................................................................................................... 18
3.4 Display Screen................................................................................................................................ 19
3.4.1 Title Bar................................................................................................................................... 19
3.4.2 Typical Interface...................................................................................................................... 20
3.4.2.2 Input Method Interface..................................................................................................................21
3.5 Rear View........................................................................................................................................22
Chapter4 Installation..............................................................................................................................23
4.1 Unpacking and Checking..............................................................................................................23
4.2 Installation......................................................................................................................................23
4.2.1 Install the syringe Pump.......................................................................................................... 24
Chapter5 Use Preparation and Cautions............................................................................................. 25
5.1 Use Preparation............................................................................................................................. 25
5.1.1 Operation Cautions.................................................................................................................. 25
Chapter6 Basic Operation......................................................................................................................26
6.1 Operation Flow.............................................................................................................................. 26
6.2 Infusion Operation........................................................................................................................ 26
6.2.1 Equipment Installation.............................................................................................................26
6.2.2 Starting and Self-test............................................................................................................... 26
3
6.2.3 Loading a Syringe....................................................................................................................27
6.2.4 Set Infusion Parameters...........................................................................................................27
6.2.5 Purge Air..................................................................................................................................27
6.2.6 Start Infusion........................................................................................................................... 28
6.2.7 Changing the Rate During infusion.........................................................................................28
6.2.8 Bolus Application.................................................................................................................... 28
6.2.9 Infusion Completion................................................................................................................29
6.2.10 Stop Infusion............................................................................................................................29
6.2.11 Remove the syringe................................................................................................................. 29
6.2.12 Power OFF or Standby............................................................................................................ 29
Chapter7 Set Infusion Parameters........................................................................................................30
7.1 Introduction to Infusion Parameters Setting..............................................................................30
7.2 Infusion Parameters Setting Range............................................................................................. 30
7.3 Infusion Mode Setting................................................................................................................... 31
7.3.1 ml/h Mode................................................................................................................................32
7.3.2 Body Weight Mode..................................................................................................................32
7.3.3 TIVA mode...............................................................................................................................33
7.3.4 Loading dose mode..................................................................................................................33
7.3.5 Ramp up/down mode...............................................................................................................34
7.3.6 Sequence Mode........................................................................................................................34
7.3.7 Relay Mode..............................................................................................................................34
Chapter8 System Setting........................................................................................................................ 35
8.1 Parameter Set.................................................................................................................................35
8.1.1 KVO Rate................................................................................................................................ 35
8.1.2 Occlusion Pressure.................................................................................................................. 35
8.1.3 VTBI Infused Pre-Alarm.........................................................................................................36
8.1.4 Reminder Alarm...................................................................................................................... 36
8.1.5 Weight Unit..............................................................................................................................37
8.1.6 Setting Pressure Unit............................................................................................................... 37
8.1.7 Setting Micro Mode.................................................................................................................37
8.1.8 Brand........................................................................................................................................37
8.1.9 Reset Total Volume..................................................................................................................38
8.2 General............................................................................................................................................38
8.2.1 Changing the Sound Volume................................................................................................... 38
8.2.2 Setting Date and Time............................................................................................................. 38
8.2.3 Screen Lock............................................................................................................................. 38
8.2.4 Brightness................................................................................................................................ 39
8.2.5 Night Mode..............................................................................................................................39
8.2.6 Touch Screen Calibration........................................................................................................ 39
8.2.7 Nurse call................................................................................................................................. 39
4
8.3 NetWork..........................................................................................................................................39
8.3.1 Connection Mode.................................................................................................................... 40
8.3.2 WLAN..................................................................................................................................... 40
8.4 System Information....................................................................................................................... 40
8.4.1 Setting Language..................................................................................................................... 40
8.4.2 Factory Data Reset...................................................................................................................40
8.4.3 Serial Number(SN).................................................................................................................. 40
8.4.4 Maintenance.............................................................................................................................41
8.4.5 Version..................................................................................................................................... 41
Chapter9 Other Functions..................................................................................................................... 42
9.1 Drug library................................................................................................................................... 42
9.1.1 Introduction to Drug library.................................................................................................... 42
9.1.2 Setting Drug library................................................................................................................. 42
9.2 Patient Information System..........................................................................................................42
9.2.1 Patient Information.................................................................................................................. 42
9.2.2 Doctor’s Order......................................................................................................................... 42
9.3 Therapy Record............................................................................................................................. 43
9.4 History Records............................................................................................................................. 43
9.5 Anti-bolus....................................................................................................................................... 43
9.6 Electronic Memory Function........................................................................................................43
9.7 Data Export.................................................................................................................................... 43
Chapter10 Alarm Prompt and Troubleshooting................................................................................... 44
10.1 Introduction to Alarm Level.........................................................................................................44
10.2 Multilevel Alarm Rules................................................................................................................. 45
10.3 Alarm Treatment........................................................................................................................... 45
10.4 Fault Analysis and Solution.......................................................................................................... 45
Chapter11 Maintenance........................................................................................................................... 46
11.1 Cleaning, disinfecting and sterilizing...........................................................................................46
11.1.1 Cleaning...................................................................................................................................46
11.1.2 Disinfecting..............................................................................................................................46
11.2 Periodical maintenance................................................................................................................. 47
11.2.1 Check the Appearance............................................................................................................. 47
11.2.2 Performance Check..................................................................................................................47
11.2.3 Maintenance Plan.................................................................................................................... 48
11.3 Calibration......................................................................................................................................48
11.4 Repair..............................................................................................................................................49
11.4.1 Normal Repair Process............................................................................................................ 49
11.4.2 Maintenance for Long Term Store.......................................................................................... 49
11.5 Equipment Components/Accessories...........................................................................................50
11.6 Production Date............................................................................................................................. 50
5
11.7 Recycling.........................................................................................................................................50
Chapter12 Battery.................................................................................................................................... 51
12.1 Check the Battery Performance...................................................................................................51
12.2 Replaced the Battery..................................................................................................................... 51
Chapter13 After Sale Service...................................................................................................................52
Chapter14 Appendix.................................................................................................................................53
Appendix A Start Up Graphs and Trumpet Curves.................................................................................. 53
Appendix B Occlusion Response Property..................................................................................................55
Appendix C Alarm and Solution.................................................................................................................. 56
Appendix D Electro Magnetic Compatibility declaration.........................................................................58
Appendix E Wireless Module Information................................................................................................. 63
Appendix F Factory Default Data Set..........................................................................................................64
6
Chapter1 Safety Instructions
1.1 Warnings
Before using, please check the equipment, connecting wire and accessories to ensure that it can work
normally and safely. If there’s anything abnormal, immediately stop working and contact our after sale
service department. Additionally, the adhesion or intrusion of fluid/drug may possibly cause the
equipment fault and malfunction. Therefore, please clean the equipment after use, and store it
correctly.
It is not allowed to put and use the equipment in the environment with anesthetic and other
inflammable or explosive articles to avoid fire or explosion.
It is not allowed to store or use the equipment in the environment with active chemical gas (including
gas for disinfecting) and moist environment since it may influence the inside components of the
syringe pump and may possibly cause performance drop or damage of the inside components.
The operator shall guarantee that the set infusion parameters of this equipment are the same as the
medical advice before starting infusion.
Please do not only depend on information prompt during use, please periodically check it to avoid
accident.
Tightly fix this equipment on the infusion stand and ensure the stability of the infusion stand. Be
careful when moving the infusion stand and this equipment to avoid the equipment dropping and
infusion stand falling or knocking the surrounding objects.
If the syringe extension tube is twisted, or the filter or needle is obstructed, or blood in the needle
which may obstruct the syringe, the pressure in the tube will rise. When removing such occlusion, it
may possibly cause “bolus injection” (temporary excess infusion) to the patient. The correct method is
to tightly hold or clamp the extension tube near the puncturing position, then loosen the tube, solve the
reason of occlusion, and restart infusion. If infusion is restarted when the occlusion reason exists, then
it may cause occlusion alarm persistently, and the pressure in the syringe tube may keep rising, and
may break or cut off the tube, or hurt the patient.
This equipment has the occlusion detection function for detecting and alarming when the syringe
needle deviates the position in the vein or the needle is not correctly punctured in the vein. However, it
only alarms when the occlusion pressure has reached certain numerical value, and the puncturing part
may possibly have become reddish, swelling or bleeding, additionally, it is possible that the device
7
doesn’t alarm for a long period if the actual occlusion pressure is lower than the alarm threshold value,
therefore, please periodically check the puncturing part. If there’s any abnormal phenomenon for the
puncturing part, please timely take suitable measures, such as puncturing again.
Only those sterile hypodermic syringes for single use and other medical components that meet the
local laws and regulations and the requirements covered in and this User Manual can be adopted, it is
suggested to adopt the syringe with same brand as this equipment. It can’t ensure the infusion
accuracy if the unsuitable syringe line is adopted. Please use the syringe and the extension tube with a
screw, or may be because of the pipeline pull to cause damage to the patient.
It is not allowed to disassemble or refit this equipment or use it for other purposes except normal
infusion.
No one is allowed to repair this equipment except our company or the authorized repair technician of
our company.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protecti
-ve earth
1.2 Cautions
Before its first use after purchase, or this equipment is not used for a long period, please charge the
equipment with AC power supply. If it is not fully charged, under power failure, the equipment can’t
continue working with built-in battery power supply.
This equipment can be used in the places with radiological installation or magnetic resonance
equipment as well as the places with high pressure oxygen therapy.
Other devices near this equipment must meet corresponding EMC requirements, otherwise, it may
influence the performance of this equipment.
Under general conditions, please use AC power supply as much as possible since it can prolong the
service life of the battery at a certain degree. When using AC power supply, ensure that the grounding
wire is reliably connected with the ground, and only the AC power wire attached with this equipment
shall be adopted. The built-in battery can only be used as the assistant power supply when the AC
power supply can’t reliably connected with the ground and is not under normal conditions (power
failure or moving infusion).
Before connecting this equipment with power supply, please keep the power socket and plug dry, and
the power voltage and frequency meet the requirements listed in the equipment label or this User
Manual.
The equipment is equipped with the audible and visual alarm system, and the red and yellow alarm
indicators will light on by turn to check if the alarm system can work normally, and the speaker makes
8
the “beep” sound.
Please keep the equipment away from the AC power socket for a certain distance to avoid fluid/drug
splashing or dropping in the socket, otherwise, it may possibly cause short circuit.
Please use the fluid/drug after it has reached or nearly reached room temperature. When the fluid/drug
is used at low temperature, the air which is dissolved in the fluid/drug may cause more air bubbles and
result in frequent air bubble alarm.
It is not allowed to press and operate the button with sharp object (such as pencil tip and nail),
otherwise, it may possibly cause early damage to button or surface film.
Under the condition of low flow rate infusion, please pay special attention on occlusion. The lower the
infusion flow rate, the longer the time of detecting occlusion, and it in turn may possibly cause a long
time infusion stop during this period.
If the equipment suffered from dropping or impacting, please immediately stop using it, and contact
our after sale service department, because the inside components of the equipment may be possibly
damaged even the appearance is not damaged and abnormality is not occurred when working.
9
1.3 Prompt Information
It is displayed on the screen with information prompt box, mainly the contents such as operation
confirmation, parameters setting error and so on. For example:
10
1.4 Symbols
Not all of the below symbols are equipped in the equipment you have purchased.
Table:1.4-1
Lot Number
Class I Equipment
Attention, consult
Alternating Current
accompanying documents
environment-friendly use
Non-ionizing radiation
period (20 years)
Unlock Lock
11
Chapter2 Overview
2.2 Contraindications
No
2.4.2 Accessories
None
12
2.4.3 Description on Model
This equipment has two models: EN-S7, EN-S7 Smart, the main function differences are shown in table
below.
Function /Model EN-S7 EN-S7Smart
ml/h mode √ √
Body weight mode √ √
TIVA mode - √
infusion mode Loading dose mode - √
Sequence mode - √
Ramp up/down mode - √
Relay mode - √
Drug name display √ √
Drug Library Drug dose upper and lower limit - √
Drug names 30 2000
IrDA - √
IrDA and workstation communication - √
WIFI module Optional Optional
Occlusion alarm level 4 levels 12 levels
This User Manual describes the most configuration and most complete functions, due to model
difference or optional components, not all functions are equipped in the product you purchased.
Electric protection
Class I
Type
Electric protection
Defibrillation proof type CF applied Part
Level
Protection against
IP24
fluid ingress
Specification Parameters
14
When the sound is set at lowest level, alarm signal sound pressure level
Alarm signal sound ≥50dB(A)
pressure level When the sound is set at highest level, alarm signal sound pressure level
≤80dB(A)
VTBI near end, Syringe near empty, VTBI infused, Syringe empty,Pressure high
Alarm information , Battery nearly empty, Battery empty, No battery inserted, No power supply,
Check syringe,Reminder alarm, Standby time expired, KVO finished
Environment
Non AP/APG type Do not use it in the environment with inflammable anaesthetic gas mixed with
equipment air, and inflammable anaesthetic gas mixed with oxygen or nitrous oxide
(1) temperature: 5-40℃
Operating (2) humidity: 15-95%, non-condensable
(3) atmospheric pressure: 57-106kPa
(1) temperature: -20-60℃
Transport & Storage (2) humidity: 10-95%, non-condensable
(3) atmospheric pressure: 50-106kPa
Safety Standard
IEC 60601-1:2005+A1:2012
Medical Electrical Equipment, Part 1: General Requirements for basic safety and
essential performance
IEC60601-2-24:2012
Medical electrical equipment – Part 2-24: Particular requirements for the safety o
f syringe pumps and controllers
IEC60601-1-8:2006
+A1:2012
Main Safety
Medical electrical equipment –Part 1-8: General requirements for basic safety an
Standards
d essential performance –Collateral Standard: General requirements, tests and gui
dance for alarm systems in medical electrical equipment and medical electrical sy
stems
EN60601-1-2:2007+AC:2010
Medical Electrical Equipment - Part1-2: General requirements for basic safety an
d essential performance-Collateral standard:Electromagnetic compatibility-Requi
rements and tests
15
Chapter3 Appearance
1 ——Clutch
Control syringe pump push-pull sliding box screw and clip opening.
2 ——Slider
3 ——Slider hook
4 ——Leadscrew
5 ——Clamp
7 ——wire Clamp
16
3.2 RIGHT FRONT VIEW
1 ——loudspeaker
2 ——Slit
17
3.3 OPERATION PANEL
Install the syringe and set the parameters of the infusion, press this button to start the infusion.
The alarm indicator indicates the alarm Level with different colors and frequencies, please refer to 10.1 for
detailed information
Press the Power button to enter into the OFF Setting interface, the user may set OFF, standby (duration) or
cancel.
Hold the Power button till the screen is off, the pump stops.
⑨--- AC indicator
syringe apparatus /
indication icon
It displays only the equipment has accessed the EN-D7 Smart
Workstation access
infusion workstation correctly, please refer to “infusion workstation
icon
User Manual” for details
Lock screen
Unlock state icon is
indication icon
Display the pressure change of the current infusion line at real time.
Pressure indication When the infusion line pressure changes, the pointer turns
icon clockwise, when the line pressure reaches or exceeds the set
occlusion level default pressure value, it alarms for occlusion.
Battery charging Display the current battery charging state
indication icon
The percentage numerical value at the left side of the icon displays
the remained battery.
Battery status
Since the remained battery may change, it may possibly show the
indication icon
following states:
19
3.4.2 Typical Interface
During infusion preparation and during infusion, the typical interface will display the following interfaces:
main interface, working interface, alarm interface, prompt interface, control panel, parameters setting, input
method, standby interface and so on.
Table:3.4.2.1-1
X/Y Page indication Arabic numerals mean, X is the current page, Y is the total page
In the infusion parameters setting interface, click this icon to turn to the
Left
left page
In the infusion parameters setting interface, click this icon to turn to the
Right
right page
Single selection
Mean that this parameter is selected
box-1
20
3.4.2.2 Input Method Interface
The input method interface composes of the title bar, input box, editing box.
The main button area composes of the numerical value, letters and icons, click it continuously to change the
sequence.
21
3.5 Rear View
4 --- IrDA
Using for communicating with EN-D7 Smart workstation made by our company
7 --- Slider
9 --Battery Compartment
10 --Handle
22
Chapter4 Installation
2) Please carefully open the package to avoid damaging the equipment and relevant accessories.
3) After unpacking, please check the objects according to the packaging list, if there’re insufficient or
damaged accessories, please contact our company as soon as possible.
5) Please keep the packing case and packing materials for future transportation or storage.
Warning: Please put the packing materials out of reach of children. Please obey local laws and
regulations or the hospital waste treatment system to handle the packing materials.
4.2 Installation
Warning:
All devices that connect with this equipment must pass the designated IEC standards (for example:
IEC60950 information technology equipment safety and IEC60601-1 medical electric device safety)
certification, and all devices must be connected according to the valid version of IEC60601-1-1
system. The technician who takes charge of connecting to additional devices with the equipment
interface is responsible for meeting the IEC60601-1-1 standard. Please contact our company if you
have any enquiry.
When connecting this equipment with other electric devices to form the combination with special
function, if the combination can’t be confirmed dangerous or not, please contact our company or the
electric expert of hospital to ensure that the necessary safety of all devices in the combination won’t be
destroyed.
This equipment must be used and stored in the environment regulated by our company.
23
4.2.1 Install the syringe Pump
24
Chapter5 Use Preparation and Cautions
The equipment appearance is clean and under good condition without crack and leakage.
The moving components are smooth and effective , the button is effective.
The power wire is installed tightly and won’t be easily damaged when pulling.
Set and check the system time to ensure that the history records will be correctly recorded.
In case only built-in battery is adopted for supplying power, please charge it to full before
using, and ensure that the battery keeps at the effective working conditions.
Carefully read the Warnings, Cautions and Operation Steps listed in this User Manual.
Cautions:
Avoid direct sunlight, high temperature or high humidity.
The equipment shall be put at the position less than 0.65m to the heart of the patient.
The parameters can only be set or changed by the trained and professional personnel.
Avoid the equipment working with fault so as to avoid medical negligence, which may hurt
the health and even life of the patient.
It may possibly drop the infusion accuracy or abnormal work of the equipment if the working
environment temperature exceeds the designated range.
The viscosity and specific gravity of infusion fluid will influence the infusion accuracy.
25
Chapter6 Basic Operation
¤Loading a syringe
¤ Start infusion
3) After passing self-test, it directly enters into ml/h mode parameters setting interface;
Warning: ● If it fails to pass the self-test, please contact our company and do not continue
using this equipment.
26
6.2.3 Loading a Syringe
(1)Press the slider clutch and move the slider fully to the right.
(3) Insert the flange of the syringe into slit. Turn the clamp left 90 degrees , and lower it slowly to
hold the syringe securely.
(4)Press the clutch and move the slider until the contact pin of the slider hits the syringe plunger.
Release the clutch, and the slider hooks hold the plunger.
(5)Hang the extension tube of the syringe on the hook and insert the tube inside the wire clamp.
Warning:
● It is suggested to use the syringe of the brand attached with this system.
● Please confirm that the syringe brand and specification displayed in the display screen is
accordant with the actual one.
● Although this equipment supports user-defined syringe apparatus function, in order to ensure
the infusion accuracy, the user is strongly suggested to contact our company, and ask the
professional technician of our company to set and test the user-defined syringe apparatus.
Caution :
Check and confirm that no bubbles are contained in the syringe.
Ensure that the syringe is installed in place, otherwise not only can not guarantee the
accuracy, there may be even no output of the fluid/drug or a siphon which is caused by high
dose output, causing harm to the patients.
select 『Yes』, after removing air from the infusion line, click 『Stop』 .
27
The flow rate from purge is not calculated in the Total Volume Infused.
Cautions:
● Purge air from the syringe tube under non infusion state and the infusion line is not connected
with the patient.
● The air purge rate is the max rate of the syringe size, when the single air purge volume ≥5ml,
it automatically stops purge.
Note: ● Only the ml/h mode and body weight mode support rate modification function
during infusion.
(1) Manual bolus: hold the 【Bolus】 button, the equipment will work according to the default
max flow rate of the syringe apparatus system (please refer to this User Manual Chapter 2.5),
loosen it to recover the original infusion rate.
(2) Automatic bolus: in the infusion interface, click『Bolus』 , set any two parameters of the
bolus infusion value, rate and time, click 『 Bolus start 』 . After bolus infusion, the equipment
recovers to the original infusion rate. To finish bolus infusion in advance, please click『Stop』.
28
6.2.9 Infusion Completion
When the remaining fluid/drug infusion time in the fluid/drug container reaches the set time for
pre-alarm, it will activate preset value nearly completion alarm. If it is not handled, the system
will keep alarming till finishing infusion, and then transfer to preset value completion alarm. The
time for pre-alarm is adjustable, please refer to Chapter 8.1.4 for detailed information.
After VTBI completed, it activates VTBI infused alarm, if KVO function is ON, the equipment
automatically starts KVO function, click 『OK』 in the alarm interface to stop KVO and eliminate
alarm.
The default working time of the KVO system is 30min, after reaching the time, it will activate
KVO completion alarm and stop infusion.
(1) Turn off the equipment: click 『Power off』icon, the equipment is turned OFF.
(2) Standby: click『Standby』icon to enter into standby time setting interface, set the standby time.
Under standby state, the screen brightness will be lowest, after standby, the screen brightness will
be recovered.
(3) Cancel: click『Cancel』, return to the interface before OFF setting.
Note: ● The equipment has standby function only under the non-working state.
29
Chapter7 Set Infusion Parameters
30
Acti agentia(Drug mass),
Agentia unit(Drug Unit)
Volume(Fluid amount)
Weight, Loading rate,
TIVA mode Loading rate Unit. The same as Body Weight mode
Loading time,
Maintain dose,
Maintain dose unit,
Dose Unit,
VTBI The same as ml/h mode
Maintain rate
Loading dose mode
Loading rate
Loading time
VTBI The same as ml/h mode
Ramp up/down Rate
mode Rising time
Falling time
Rate The same as ml/h mode
Sequence mode
Time
parameters setting interface, to select other mode, click 『Menus』 icon to enter into the main
interface, click 『Select Mode』 icon to enter into the mode selection menu interface, and select
preset infusion mode.
31
7.3.1 ml/h Mode
Under this mode, it allows to set three parameters: Rate, VTBI (Volume to be infused) and Time,
set any two of the three parameters, and the system will automatically calculate the third
parameter, if the VTBI is 0, then the equipment works at the set rate till stop with alarm.
Under this mode, set the Weight(body weight), Acti agentia(drug mass), Agentia unit(drug unit),
Volume(fluid volume), Dose rate, Dose unit, VTBI.
The system will automatically calculate the flow rate from the specified dose rate (ug/kg/min,
mg/kg/min, ug/kg/h, mg/kg/h,…etc) according to related formula {dose rate × weight}/{Acti
agentia(drug mass)/Volume(fluid volume)}, and automatically calculate the time according to
(VTBI) /(flow rate).
Under this mode, firstly, set the basic parameters of the Acti agentia(drug mass), Agentia Unit(drug
unit), Volume(fluid volume), Weight, and then set the Loading stage: set Loading dose rate and unit,
Loading time. Set maintenance stage: set Maintain dose rate and units, the system will automatically
calculate the fluid rate, start running, first run the Loading dose rate after the end of the Loading time
change to works at the Maintain dose rate which automatically calculate by system until manually stop
or stop with alarm.
The Loading dose mode means to infusion with the Loading flow rate according to the Loading
time, after reaching the Loading time, it works at the Maintain rate till complete the
VTBI( Volume to be infused).
Loading dose VTBI =Loading rate ×Loading time
Maintain time = (VTBI -Loading VTBI) /Maintain rate
Under this mode, set the VTBI, Maintain rate, Loading rate, Loading time, system
automatically calculate Loading dose VTBI and Maintain time.
Note: ● VTBI must be greater than the Loading dose VTBI otherwise, when setting exceeds
the limit, the excess part can’t be set.
33
7.3.5 Ramp up/down mode
Ramp up/down mode means to automatically increase the flow rate till reaching stable flow rate
within the set rising time of the equipment through setting the rising time and falling time, after
holding for a period, it automatically drops the flow rate within the set dropping time. The rising
or dropping stage is implemented in 9 stages.
Under this mode, set VTBI, rate in the stable stage, rising time and falling time, the system will
automatically calculate the rising and dropping rate.
Sequence mode means to perfuse according to the set sequence after setting the rate and time of
different sequence groups. At most 5 sequence can be set in this mode.
34
Chapter8 System Setting
Warning:
When adopting fluid/drug of high viscosity and the occlusion pressure is set at low level, it is
possible that the system will report occlusion alarm even when the line is not obstructed,
under this condition, please carefully observe the pressure indication icon in the display
screen and infusion line, and rise the occlusion pressure if needed.
When the blocking pressure is set to high grade, the larger pressure inside the pipeline is
likely to be washed away from the extension tube connected to the syringe. Please confirm
that the extension tube is securely attached to the syringe.
When the occlusion pressure is set at high level, it may possibly cause the patient
uncomfortable, after rising the occlusion pressure, please carefully observe the condition of
the patient, and immediately take measure if there’s any abnormality.
Under the equipment fault state, the max pressure generated by the infusion line is 300kPa.
Under single fault state, the max infusion volume is 2ml.
35
(Table 8.1.2-1 Relation of Occlusion level and Pressure)
Click 『VTBI infused pre-alarm』 to enter into the time for pre-alarm setting interface, click the
preset time option, then the corresponding icon of this option changes into .
The adjustable range of time for pre-alarm is: 2min, 5min, 10min, 15min, 20min, 30min.
36
Reminder alarm means that the system will activate “Reminder alarm” if no button is operated
when the syringe is loaded within the preset time for “Reminder alarm” when the equipment is
under no infusion no alarm state.
Note: ● Please carefully confirm when changing the current pressure unit.
Unit Mark Unit Conversion
kPa 1 kPa=7.5mmHg=0.145psi=0.01bar
PSI 1psi=51.724mmHg=6.897kpa=0.069bar
Bar 1bar=750mmHg=14.5psi=100kPa
8.1.8 Brand
For the built-in syringe brand of the system, after installing the syringe, click『Brand』to enter into
the syringe brand selecting interface, and click the preset brand option.
The system built-in syringe brand: Double-Dove, GSYJX (Authorization) No.[2013]3151615.
● The syringe of different brand may possible cause flow rate deviation, when use, please
37
confirm if the displayed information in the interface is accordant with the actual working syringe
brand.
Click 『Reset total volume 』, the interface displays the operation confirming prompt box, click
『Yes』to confirm reset, otherwise, please click『No』
8.2 General
In the main interface, click『General』to enter into the equipment setting interface.
Click『Sound』 to enter into the sound parameters setting interface, the volume has 10 levels. The
lowest volume is ≥50dB, and the highest volume is ≤80 dB. Move the long box to the preset value,
after confirming, click『OK』.
When setting date and time, directly input the numerical value in the input method interface. For
example, to preset one date “2015-08-31”, input “20150831”; to preset the time “13: 34”, input
“1334”.
The time is displayed in 24h format or 12h format, the date is displayed in British type, American
type or Chinese type, please set according to the requirement.
Automatic lock screen time can be set at 15s, 30s, 1min, 2min, 5min, 10minor 30min and so on,
38
which means that the equipment will automatically lock the screen if it is not touched or the
button is pressed within corresponding time after starting.
Note: ● The equipment will automatically unlock if there’s high Level alarm.
8.2.4 Brightness
Click『Brightness』to enter into display brightness setting interface. The brightness has 10 levels.
The equipment has the function of automatic brightness adjustment if external power supply is
unavailable. When there is no external power supply, and the power is supplied by battery, if it is
not operated within 3min, the system will automatically adjust the brightness to the lowest level,
when it is touched or button is clicked by user or when there’s alarm, it will automatically recover
the brightness.
Note: ● The nurse call function must be used with special cable.
● The user shall not only depend on the nurse call function as the main alarm notice mode, and
shall identify according to the equipment alarm and the patient state.
8.3 NetWork
This equipment supports wireless or wire interconnection, when it is equipped with wireless
module and connects with the Internet through WIFI, the equipment screen displays icon.
39
Click『NetWork』in main interface to set the response.
Note: ● This function shall be set by the professional equipment maintenance technician.
● After activating the interconnection function, the equipment can periodically transmit the
equipment data to outside, and the data is only for displaying and doesn’t provide any suggestion
on therapy.
8.3.2 WLAN
When WIFI function is in use, turn on the WLAN switch of the equipment, set the name and
password of access point, and configure the TCP/IP parameters.
Note: ● The wireless access must be set by the professional technician recognized by our
company.
● The transmitted data of this equipment doesn’t provide any suggestion on therapy, and this data
shall not be used for calculating the therapeutic schedule.
● When the data is adopted by the third party’s equipment or software, it is only for displaying,
and shall not be used for alarming or calculating.
40
8.4.4 Maintenance
This function is not open to general user. It is suggested to contact our company or local dealer,
and customize and calibrate it by professional technician, otherwise, it can’t guarantee the infusion
accuracy.
8.4.5 Version
Check the software version in this interface.
41
Chapter9 Other Functions
(1) EN-S7Smart supports over 2000 medicines, which can be imported with external tool, and
has the functions such as upper and lower limit, concentration, color and so on.
Select medicine and then import the medicine parameters, the user may change the parameters
including the concentration and dosage rate, but the parameters won’t be saved.
When working, the background color of the medicine name shall be accordant with the set color.
(2) EN-S7 supports 30 drugs, and allows to edit the medicine name, save the names after turning
off the machine, but the upper and lower limit function is unavailable.
BMI index (means body mass index, also named as body weight) is the number produced with
height (m) after divided by body weight (kg), and is the common standard in the world to measure
the obesity degree and health conditions.
(2) The system can save 20 medical records at most, when it is full, the new records will cover the
old records by turn.
9.5 Anti-bolus
When the line occlusion activates occlusion alarm, the system will automatically drop the line
pressure to avoid additional impact bolus to the patient after contacting the occlusion.
43
Chapter10 Alarm Prompt and Troubleshooting
If there’s alarm, the system will display the alarm interface. Click 『 OK 』 to exit the alarm
interface.
Click『Mute』to mute, if alarm is not eliminated, the alarm sound will be sent out 2min later.
Warning: ● Some alarm threshold values of this equipment can be set by the user, for
example: occlusion pressure, reminder alarm, VTBI infused pre-alarm, alarm
sound volume and so on, the user shall confirm the parameters when set the
alarm threshold value, otherwise, it may possibly influence the alarm function
or infusion safety.
44
10.2 Multilevel Alarm Rules
When there’re several alarms, the system will alarm according to the following rules:
Warning: ●When there’s alarm, please check the conditions of the patient, remove the
reason of alarm and then continue working.
If the equipment is on fire/burns for unknown reason, or has other abnormal conditions, the user
shall immediately cut off power supply and contact our customer service department.
45
Chapter11 Maintenance
Warning: ● Please cut off power supply and unplug the DC /AC power wire before
cleaning the equipment.
● During cleaning and disinfecting, please keep the equipment horizontal and
upwards to protect the equipment and accessories from fluid.
11.1.1 Cleaning
(1) The daily maintenance is mainly to clean the housing and pump body. It is inevitable that
fluid/drug may flow in the equipment during infusion. Some fluid drug may corrode the
pump and cause working fault. After infusion, please timely clean the equipment, wipe it
with moist and clean soft fabric, and then naturally dry it.
(2) When cleaning the equipment interface, please wipe it with dry and soft fabric, confirm the
interface is dry before using.
(3) Please do not soak the equipment in water. Although this equipment has certain waterproof
function, when fluid splashes on the equipment, please check if it works normally, perform
insulation and electric leakage test if needed.
11.1.2 Disinfecting
(1) Disinfecting may possibly cause harm of certain degree to the equipment, it is suggested to
disinfect the equipment if it is needed.
Please disinfect the equipment with common disinfecting agent such as 50% sodium
hypochlorite, 10% hypochlorous acid, 3% hydrogen peroxide, aerodesin 2000 (mainly
containing alcohol disinfecting solution), cidex 2% glutaraldehyde + activating agent, virex
disinfecting based on organic ammonium chloride, betadine sterilizing agent (povidone
iodine solution), 70% ethanol, 70% isopropyl alcohol, 10% physiological saline and so on.
Please follow the instructions of the disinfecting agent.
(2) After disinfecting, wet the soft fabric with warm water, dry the fabric and then wipe the
equipment with it.
(3) Do not sterilize the equipment with high pressure steam sterilizer, do not dry the equipment
46
with dryer or similar product.
Warning: ● Please do not adopt Cidex OPA orthophthalaldehyde, methyl ethyl ketone or
similar solvent, otherwise, it may corrode the equipment.
Notes: ● The medical mechanism shall set up complete maintenance plan, otherwise, it
may possibly cause the equipment malfunction or fault, and may possibly hurt
the physical safety.
● In order to ensure the safe use and prolong the service life of the equipment, it is
suggested to periodically maintain and check it once every 6 months. Some
items shall be maintained by the user, and some items shall be maintained by the
dealer of the equipment.
(1) The appearance of the equipment shall be clean and under good condition without crack and
water leakage.
(2) The buttons are flexible and effective without invalid phenomenon; the sensitivity of the
touch screen is normal,
(3) The slider of the syringe pump is flexible in movement, and the clamp is ok.
(4)The power wire is under good condition and installed tightly.
(5) After connecting with external power supply, check if the AC indicator of the equipment AC
indicator lights on normally.
(6) Adopt the accessories designated by our company.
(7) The environment meets the requirements.
47
11.2.3 Maintenance Plan
The following check/maintenance items must be performed by the professional technician
recognized by our company. If the following maintenances are necessary, please contact our
company. Please clean and disinfect the equipment before testing or maintaining.
11.3 Calibration
In the 『System Info』menu, enter into 『Maintenance』 interface, click 『Brand』 to enter into
brand setting interface, create the consumables brand, delete and calibrate the brand.
Warning: ● It is suggested to contact our company or local dealer, and customize and
calibrate it by professional technician, otherwise, it can’t guarantee the infusion accuracy.
(1) New
If the actual using syringe brand is not listed in the system built-in brand, please create the syringe
brand in this interface.
Input the name and specification of syringe brand.
(2) Delete
Enter into 『Delete』 interface, click it to delete user-defined syringe brand.
(3) Calibrate
Please calibrate the syringe apparatus when using the built-in brand syringe for the first time, or
the first user-defined syringe brand, or after periodical maintenance.
Please prepare the following materials before calibrating:
Unused new syringes, 10,20,30,50 ml specified brands
Calibrating Steps:
1) Install the syringe according to the requirements and remove the air bubbles;
48
2) Put the needle into the measuring cup for collecting fluid;
3) Start calibrating according to the interface prompt, the equipment starts infusion;
4) After working for 10min, the equipment will automatically stop, read the fluid amount in the
measuring cup or calculating the fluid volume by weighing;
6) After exiting the calibration interface, select the calibrated brand as the current brand, and then
verify the infusion accuracy with 25ml/h and 150ml/h flow rate respectively.
11.4 Repair
1. Verify the flow rate accuracy to avoid unconformity between the syringe apparatus parameters
in the equipment and the actual parameters after it hasn’t be used for a long period or caused by
other reasons, otherwise, it may cause infusion error, influence the therapeutic effects and even
cause medical negligence.
3. Test the battery discharging and charging duration to confirm that the battery is also usable.
49
11.5 Equipment Components/Accessories
Warning: ● Only the components and accessories designated by our company shall be
adopted, otherwise, it may possibly damage the equipment or drop the
equipment performance.
11.7 Recycling
The normal service life of this equipment is 5 years, and depends on the use frequency and
maintenance. The equipment must be rejected after reaching the service life, please contact the
manufacturer or the dealer to get more detailed information.
50
Chapter12 Battery
This equipment is equipped with charging lithium-ion polymer battery to ensure the normal
infusion when the equipment is moved or the external power supply is cut off.
When connecting external power supply, no matter the equipment is started or not, it can charge
the battery. When charging, the equipment screen displays the battery charging indication icon
. In case only built-in battery is adopted for supplying power, and when the remained battery
is less than 20%, please connect the equipment with external power supply to charge the battery.
The performance of the built-in battery may drop according to the using duration, it is suggested
to check the battery once a month.
(1) Disconnect the equipment from the patient, and stop all infusion.
(2) Supply public power to the equipment to charge the battery for 5h at least.
(3) Supply power for the syringe pump only with battery, perfuse at the rate of 5ml/h, test the
time till the battery runs down and the equipment is turned off.
- If the infusion time exceeds 10h, the battery keeps at good state.
- If the infusion time exceeds 7h but less than 10h, the battery starts deterioration, but it can be
used temporarily.
- If the infusion time is less than 7h, the battery is reaching the service life, please replace the
battery.
It is better to replace the battery once every 2 years, it is suggested to replace the battery by the
dealer or manufacturer.
The steps of replacing battery are shown as below:
⑴ Cut off the power supply of the equipment, disconnect the power wire. Open the cover of
battery chamber and take out the battery.
⑵ Push the new battery into the battery chamber, and insert in the battery fastener.
⑶ After replacing the battery, install the battery cover, and check the battery.
Warning: ● When replace the battery, please do not touch the 12V DC plug inside of the
batter Chamber.
51
Chapter13 After Sale Service
This product enjoys 1-year free warranty after purchase. The warranty period is from the
installation date listed on the “Warranty Card”. The “Warranty Card” is the only voucher for
calculating the warranty period, in order to maintain your benefit, please carefully fill into and
keep the “Warranty Card”, and hand over the copy for the company to the installation technician.
The damages of the equipment caused by the following shall not enjoy free warranty service.
2. The damages caused by incorrect operation during the transportation process after purchase.
3. The fault and damages caused by fire, salt injury, toxic gas, earthquake, windstorm, flood,
abnormal voltage and other natural disasters.
For the damages or faults mentioned above, our company provides repair services but chargeable
according to the repair cost.
Address of Registrant/ Manufacturer: Rm. 201, Block A, No. 1, 1st Qianwan Rd., Qianhai
Shenzhen-Hong Kong Cooperation Zone, Shenzhen
After Sale Service Unit: Customer Service Department of Shenzhen Enmind Technology Co.,
Ltd.
Address of After Sale Service: 5/F, Block A, Defengsheng Building, o. 41, Dabao Rd., 23 Bao’an
District, Shenzhen
52
Chapter14 Appendix
Graph 1 Start-up graph: Flow rate 1 (ml/h) against time (min) plotted from data gathered
during the first 2 h of the test period
Graph 2 Start-up graph: Flow rate 5 (ml/h)against time (min) plotted from data gathered
during the first 2 h of the test period
53
Appendix A.2 Trumpet Curves
Brand: Double-Dove Size:50ml
Flow Rate: 1ml/h
Measurement Interval: ∆ t = 0.5min
Measurement duration: T = 2h
54
Appendix B Occlusion Response Property
Notes: The alarm pressure intensity error for EN-S7Smart is ±15% or ±100mmHg, the higher
value shall be taken;
The alarm pressure intensity error for EN-S7 is ±20% or ±150mmHg, the higher value shall be
taken.
Notes: ● Conditions for testing above data: Syringe Brand: Double-Dove Size:50ml
● The occlusion alarm pressure, alarm delay time and bolus are influenced by the
test conditions.
● The above data is the typical value under the test conditions, please see the test
data of the product for the actual data, the data may be different if the test
conditions are different.
55
Appendix C Alarm and Solution
56
Alarm Type Alarm Level Reason Solution
When power is supplied by
the built-in battery only, Immediately connect with
under low battery, the alarm external power supply.
Battery empty High duration is >30min
2. Battery ageing or the
Please contact the dealer or
equipment charging circuit
manufacturer for repair.
is fault.
Keep connecting with
No battery
Middle Battery is removed external power supply,
inserted
reinstall the battery
Under ON state, AC power
The alarm automatically
No power supply is adopted, but the
Low eliminates after connecting
supply AC power wire is dropped
the external power supply.
during the process
Note: When alarm rings, click the 『Mute』 icon on the screen to temporarily stop sound alarm
for 2min.
57
Appendix D Electro Magnetic Compatibility
declaration
This product needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided, and this unit can be affected by portable and
mobile RF communications equipment.
Caution:
This unit has been thoroughly tested and inspected to assure proper performance and
operation!
This machine should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, this machine should be observed to verify normal
operation in the configuration in which it will be used.
Warning:
The use of ACCESSORIES, transducers and cables other than those specified, with the exception
of transducers and cables sold by the MANUFACTURER of the Syringe pump as replacement
parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of
the Syringe pump.
The Syringe pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the Syringe pump should assure that it is used in such an environment.
RF emissions
Class A The Syringe pump is suitable for use
CISPR 11
in all establishments, including
Harmonic emissions domestic establishments and those
Not applicable
IEC 61000-3-2 directly connected to the public
low-voltage power supply network
Voltage fluctuations/ flicker
that supplies buildings used for
emissions Not applicable domestic purposes.
IEC 61000-3-3
58
Guidance and manufacture’s declaration – electromagnetic immunity
The Syringe pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the Syringe pump should assure that it is used in such an environment.
Electrical fast ±2 kV for power ±2kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical
commercial or hospital
IEC 61000-4-4 +1 KV for
environment.
input/output lines
<5% UT <5% UT
59
Power frequency 3 A/m 400A/m Power frequency magnetic
(50Hz/60Hz) magnetic fields should be at levels
field IEC 61000-4-8 characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
The Syringe pump is intended for use in the electromagnetic environment specified below. The
customer or the user of Syringe pump should assure that it is used in such an environment.
Compliance Electromagnetic
Immunity test IEC 60601 test level
level environment - guidance
Recommended separation
distance
d = 1.167 P
d = 2.333 P 800
60
distance in metres (m).
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Syringe pump is used
exceeds the applicable RE compliance level above the Syringe pump should be observed
to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Syringe pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
61
Recommended separation distances between
The Syringe pump is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Syringe pump can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Syringe pump as recommended below,
according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
62
Appendix E Wireless Module Information
63
Appendix F Factory Default Data Set
64