1.HealFusion Syringe Pump User Manualv1.0

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HealFusion

Syringe Pump User Manual


(s7, sp-3)

HEDY Medical Device Co., Ltd.


Product Information
Congratulations on your purchase of HealFusion Syringe Pump. Before using
this product, please read this manual carefully for proper use of the product.
Please keep this manual after reading so that you can access at any time when
needed.

Manufacturer: HEDY Medical Device Co., Ltd.


Address:No.286, Science Avenue, Guangzhou High and New Tech
Development Zone, 510663, P. R. China
Tel: +86-20-8307-0896
Fax: +86-20-8307-0817
Mail: [email protected]

REVISION HISTORY:

VER DATE
v1.0 May, 2015
v2.0 Dec.,2015
v3.0 Jun.,2016
Contents

Chapter 1 Safety Precaution ..........................................................1-1

1.1 Safety Signs ................................................................................ 1-1

1.2 Safety Information ...................................................................... 1-2

1.3 Electric Safety Preventive Measurements ................................... 1-4

1.4 Contraindications ........................................................................ 1-5

1.5 EMC ........................................................................................... 1-5

1.6 Environment Safety Preventive Measurements .......................... 1-5

Chapter 2 Brief Introduction ..........................................................2-1

2.1 Brief Introduction of the User Manual ........................................ 2-1

2.2 Brief Introduction of the Pump ................................................... 2-2

2.3 Device Features and Intended Use .............................................. 2-3

2.4 Overview .................................................................................... 2-3

2.5 Daily Use Procedures ............................................................... 2-12

Chapter 3 Operation ......................................................................3-1

3.1 Before the Operation................................................................... 3-1

3.2 Operation Procedure ................................................................... 3-1

3.2.1 Turn On ...................................................................................... 3-1

3.2.2 Basic Settings ............................................................................. 3-1

3.3 Modes ......................................................................................... 3-8

3.3.1 Rate Mode .................................................................................. 3-8

3.3.2 Dosage Mode .............................................................................. 3-9

3.3.3 V-T Mode ................................................................................. 3-12

3.3.4 R-T Mode ................................................................................. 3-14

I
3.3.5 Trapezia Mode .......................................................................... 3-14

3.3.6 Intermittent Mode ..................................................................... 3-16

3.3.7 Loading Dose Mode ................................................................. 3-17

3.3.8 Sequence Mode......................................................................... 3-18

3.4 Relay Mode ............................................................................... 3-20

3.5 Settings ..................................................................................... 3-20

3.5.1 VTBI Finish Setting .................................................................. 3-21

3.5.2 Manual Bolus Setting ............................................................... 3-23

3.5.3 Push Volume Setting ................................................................ 3-23

3.5.4 Default Settings ........................................................................ 3-24

3.5.5 Volume &Brightness ................................................................ 3-25

3.5.6 Auto-Lock Setting .................................................................... 3-26

3.5.7 Cap Rate setting ........................................................................ 3-27

3.5.8 Syringe Type Setting ................................................................ 3-28

3.5.9 Day & Night Mode ................................................................... 3-28

3.5.10 System Time setting ................................................................. 3-29

3.5.11 Add Extended Syringe .............................................................. 3-30

3.5.12 System Version ......................................................................... 3-31

3.6 Logs .......................................................................................... 3-31

3.6.1 Operation Logs ......................................................................... 3-32

3.6.2 Alarm Logs ............................................................................... 3-33

3.6.3 infusion Logs ............................................................................ 3-33

3.7 Drugs ........................................................................................ 3-34

3.8 Service ...................................................................................... 3-35

Chapter 4 Technical Data ...............................................................4-1

II
4.1 Infusion Accuracy ....................................................................... 4-1

4.2 KVO Mode ................................................................................. 4-3

4.3 Blocking Threshold .................................................................... 4-3

Chapter 5 Alarm and Tips ...............................................................5-1

5.1 Alarm Function ........................................................................... 5-1

5.2 Alarm Priority ............................................................................. 5-1

5.2.1 High-level Alarm ........................................................................ 5-2

5.2.2 Intermediate-level Alarm ............................................................ 5-4

5.2.3 Low-level Alarm......................................................................... 5-5

5.2.4 Alarm acknowledgement reference table .................................... 5-6

5.3 Tips ............................................................................................. 5-7

Chapter 6 Maintenance .................................................................6-1


6.1 Cleaning/Disinfection ................................................................. 6-1

6.2 Maintenance................................................................................ 6-2

6.3 Safe Use and Maintenance of the Rechargeable Batteries .......... 6-2
Appendix A Start-up Curves and Trumpet Curves .................... A-1
Appendix B EMC Information ..................................................... B-1
Appendix C Parameters Default Value ........................................ C-1
Appendix D Abbreviations ............................................................ D-3

III
Preface
Statement

HEDY Medical Device Co., Ltd. (hereinafter referred to as the manufacturer)


has the copyright of this non-publication manual. This manual is for reference
only while operating, maintaining and repairing the manufacturer’s products.
Other persons have no right to disclose the content of this manual to any other
persons.

This manual contains the proprietary data and information which are protected
by the copyright law. All rights reserved. No part of this Manual is
photographically reproduced, copied or translated to other languages without
prior written permission from the manufacturer.

All contents of this manual are considered correct. The manufacturer has no
legal liability and responsibility for the accidental or inevitable damage caused
by improper installation and operation. The manufacturer doesn’t give the
concessions granted by the copyright law to any other parties. For the legal
consequences caused by the infringement of copyright law and any third
party’s rights, the manufacturer has no legal liability and responsibility.

Contents contained in this manual are subject to change without prior notice.

Manufacturer’s Responsibility

The manufacturer should be responsible for the safety, reliability and


performance of this machine only under the following conditions, i.e.:

 The assembling operation, extension, readjustment, improvement and


maintenance are done by the qualified personnel approved by the
manufacturer.

 The related electrical devices conform to national standards.

IV
 The machine is used according to the conditions and requirements
described in this manual.

User Notice

 To ensure operation safety and long-term stable performance of the


system, it’s strongly recommended reading this manual to get a full
knowledge on the function, operation and maintenance before operating the
system.

 Pay special attention to contents of ―Warning‖, ―Caution‖ and ―Note‖ in


this manual.

 The manufacturer takes no responsibility for any damage or harm


caused by incorrect operation or maintenance inconsistent with instructions of
the manufacturer or its agent thereof.

 The Dosage Mode, Drugs, WiFi and some other functions are optional,
the user can choose to have these functions or not.

Warranty

 The manufacturer guarantees 12months of warranty for the main unit


and its material and technology. During warranty period, the manufacturer
provides free repairing and damaged part replacement.

 The warranty only applies to faults occurred in operation under


conditions specified by this manual. So, please make sure the system is used
within the application scope recommended by this manual.

 The warranty doesn’t apply to damage caused by accidents, misuse,


abuse, falls, modification or alteration to any part or component of the system.

 Surface damage is not included in the free repair or replacement range.


Battery replacement, training material supply, etc. are not free, either.

V
 The manufacturer takes no responsibility for any damage caused by
other system or unauthorized connection to other systems.

 The manufacturer takes no responsibility for any loss, damage or harm


caused by delayed service request.

 Please report to the manufacturer after-sale service department if the


system has any malfunction. Model number, series number and a brief
description of the malfunction are supposed to be provided in the report.

VI
Chapter 1 Safety Precaution

1.1 Safety Signs

The following messages can be read throughout this manual, they are
supposed to be paid special attention to.

A WARNING label applies to information that may


cause severe personal injury, death or actual property loss
WARNING! if neglected.

A CAUTION label applies to information that may cause


mild personal injury or property loss if neglected.
CAUTION!

A NOTE label applies to information on installation,

NOTE! operation or maintenance, which is very important but


poses no risk potential.

Table1-1 Equipment Symbols


Num. Symbol Description

1 Defibrillation-proof type CF applied part

2 Refer to the instruction manual/booklet

Labeling of electric and electronic devices


3
according to directive 2002/96/EC(WEEE)

1-1
4 Serial number

5 Manufacture date

6 Manufacture information

7 European community representative

8 General warning sign

9 Non-ionizing radiation

10 IPX3 Waterproofing grade

1.2 Safety Information

Safety of the operator or the examinee, and reliability of the system are
generally considered during designing and manufacturing. However the
following safety preventive instructions should be followed.

1. The system should be operated by qualified personnel or under the


guidance of qualified personnel.

2. The system belongs to type CF, class I system,defibrillation recovery


time for 5s.

3. When there is any equipment failure, please turn off the pump and
contact the manufacturer or its authorized agent immediately.

4. Avoid operation or storage in the following environments:

1-2
 Sharp temperature variance.
 Rather high humidity, poor ventilation.
 Water vapor exposure, do not operate the system with wet hands.
 Near heat-emitting systems.
 Direct solar irradiation.
 Violent shakes or vibration.
 Near chemical materials or explosive gas.
 Do not let dust or metal articles fall into the system.
 Do not disassemble or open the system. The company won't shoulder
any responsibility for any result caused thereby.
 Take the plug rather than the wire for pulling out the power line.

5. Environmental specifications

 Transport & Storage Temperature: -30℃~70℃.


 Transport & Storage Relative Humidity: 10%~90%.
 Transport & Storage Atmospheric Pressure: 22kPa~106kPa.
 Operating Temperature: 5℃~40℃.
 Operating Relative Humidity: 10%~90%.
 Operating Atmospheric Pressure: 70kPa~106kPa.
 Maximum elevation of 3000 meters.

6. Power supply

 AC: 100-240VAC 50/60Hz 35VA.


 DC: 10-15VDC 2.5A.

7. Pump mobile condition

 When handling equipment (especially the stairs), care must be taken.


 If the pump fall or bump, it must be inspected and tested by service
personnel.

1-3
 After selecting the location to place the equipment, before installing this
system, please make sure the power supply is normal.

8. The emergency measure and corrective action during use

 If there are any errors or equipment failure during use, the user should
immediately stop operation and take care of the wounded. Contact the
manufacturer or its authorized agent immediately.
 Users are not permitted to repair any components of the equipment
without authorization. Please put all the maintenance tasks to qualified
maintenance personnel.

The Syringe pump is not a raw material, and the device is


not supposed to be used as a portable device.
WARNING!

The hospital&agent which have the right to use the pump,


are responsible for the proper use of the system, otherwise
WARNING! it may cause abnormal fault and damage the patients’ life.

1.3 Electric Safety Preventive Measurements

The pump meets the requirement of IEC 60601-1:2005,IEC 60601-2-24:2012,


IEC 60601-1-8:2007. In addition, the following points should be paid
attention to.

 The power cable should conform to the power cable of the system. The
system should be well grounded (otherwise, noise may be produced).

To avoid the risk of electric shock, this equipment must


only be connected to supply mains with protective earth.
WARNING!

1-4
 Do not open the enclosure without permission. Do not change any other
parts of the pump without permission.
 In case of any equipment failure, cut off the power supply immediately
and contact the manufacturer or its authorized agent.
 The fuse is manufactured by Littelfuse, Inc. The specification is 392 T1
AL 250 V.

1.4 Contraindications

1.5 EMC

The EMC-limits (electro-magnetic compatibility) according to IEC/EN


60601-1-2 and IEC/EN 60601-2-24 are maintained. If the equipment is
operated in the vicinity of other equipment which may cause high levels of
interference (e.g. HF surgical equipment, nuclear spin tomography units,
mobile telephones etc.) maintain the recommended protective distances from
these devices.

 Refer to Appendix B for more information.

1.6 Environment Safety Preventive Measurements

 The waste must be treated follow the local laws timely (especially the
disposable Syringe device).

 Equipment and accessories probably cannot be normal used at the end of


life, ensure to replace the equipment or accessories timely to decrease the risk
to the minimum. The battery inside the device is not replaceable.

 Harmful substances and the content in the product:

1-5
Table1-2Harmful Material and Its Content

Hazardous Substance

Component Pb Hg Cd Cr6+ PBB PBDE

Host ○ ○ ○ ○ ○ ○

Cable ○ ○ ○ ○ ○ ○
○indicates that the concentration of the hazardous substance in all
homogeneous materials in the parts is below the relevant threshold of the
RoHS Directive (2011/65/EU Directive), the system is fully in compliance
with RoHS requirements in terms of component selection and application,
production process control, overall testing, appearance and labeling.

╳indicates that the concentration of the hazardous substance in all


homogeneous materials in the parts is beyond the relevant threshold of the
RoHS Directive (2011/65/EU Directive), the system is fully in compliance
with RoHS requirements in terms of component selection and application,
production process control, overall testing, appearance and labeling.

1-6
Chapter 2 Brief Introduction

2.1 Brief Introduction of the User Manual

 This user manual introduced the HealFusion Syringe Pump. It applies


enough information for the user to operate and storage the pump. Please read
it carefully before using.

 This User manual applies enough information for the user to operate the
pump safety. It contains the system’s basic function, security features, operate
mode, how to care and maintenance the pump. Please read it carefully before
using.

 In daily operations, we can refer to fast operation card to make quick


access.

 This manual consists of several independent chapters. Partial contents in


some chapters are identical. All chapters are compiled to provide the user with
reading convenience and content consistency.

 Any query on operation of this system, please turn to the manufacturer’s


service engineer or its authorized distributor for support.

The User manual describes the operation of the pump,


before using, the user must be familiar with the
operation and precautions, in order to avoid
NOTE! unnecessary losses.
Also, medical equipment used in the room must
conform to the relevant regulations (such as IEC,
VDE0100 or VDE0107).

2-1
2.2 Brief Introduction of the Pump

 Product name: Syringe Pump

 Product type: s7/sp-3, The differences between two types are as follows:

 s7 has gray panel, and can support up to 2000 logs.


 sp-3 has purple panel, and can support up to 1500 logs.

 This system consists of the following parts: Syringe pump enclosure,


drive system, input system, storage system, control system, display system,
sensor monitoring system, alarm system, internal rechargeable battery.

 Congratulations on your purchase of HealFusion Syringe Pump. This


system is a high quality system which is stable and convenient to operate. It is
suitable for all qualified doctors, this pump consists of the following modes:

 Rate Mode
 Time Mode(include V-T Mode and R-T Mode)
 Dosage Mode(optional)
 Trapezia Mode(optional)
 Intermittent Mode(optional)
 Loading Dose Mode(optional)
 Sequence Mode(optional)
Note: Mean Time to power down from fully charged @ 5ml/h under normal conditions is

more than 6 hours, and need less than 4 hours to be charged full.

 Classification

 Class I / Internally powered equipment;


 Type CF applied part;
 IPX3– Protected against vertically falling drops of water;
 No sterilization requirement;
 Not Category AP / APG equipment;

2-2
 Mode of operation: Continuous;

2.3 Device Features and Intended Use

 Intended use: working with the syringe. The pump is suitable for the
hospital operating room, ICU, outpatient and general wards and other places,
which is used to control the flow of liquid injected into the patient. The
injection site support for intravenous.

 The pump is an advanced device for treatment, which is used for


infusion. It can accurately control the infusion velocity, and input the liquid to
the patient timely and accurately. It can guarantee the accuracy of the dose
rate and work safely into the patient, making it especially suitable for the
situation that requires liquid flow rate and dosage controlled strictly.

Since the Syringe pump is a kind of life support


NOTE! equipment, ensure to enter the correct inject rate and
volume, otherwise it may damage the patients’ life.

2.4 Overview

1. Features of the Pump

Figure 2-1Pump Closed

2-3
Figure 2-2Pump Open

Figure 2-3 Rear View

Table2-1Equipment Parts Description Table


Num. Symbol Description
1 Connect button Fixed stacked syringe pump, infusion pump
3.5 inch color Display menus and submenus, can be operated
2
display using touch
ALARM indicator indicates the alarm status,
3 Indicator
POWER indicator indicates the power status
4 Operation panel ON/OFF button, RUN/STOP button,

2-4
MUTE/BACK button, PUSH/ BOLUS button,
Arrow keys, ENTER/OK button, indicators
5 Syringe holder Fixed syringe
6 Drive unit Push the syringe, fixed syringe
Extension set
7 Fixed the infusion tube
hook
8 Magnet
Fixed pump door
9 Magnetic iron
10 Door /
Press to open the Positive Plunger Grippers to
11 Finger grips
hold the syringe
AC power connector(12(a)), RS232
12 Back interface
Connector(12(b))

 SIP/SOP function

12(b) is RS232 Connector, it provides:

External DC voltage input function.

RS232 Connector: RS232 interface can be used with a two-way


communication, please ask our Customer Service Department to obtain an
interface protocol if necessary, RS232 communication cable need to use
shielded cable. The device which is connected to the RS232 interface should
conform to the standard of IEC60950.

Staff call: RS232 Connector generated high.

The plug is used as disconnect to the mains supply, do


not to position the pump to make it difficult to operate
the disconnection device when an appliance coupler or
WARNING!
mains plug or other separable plug is used as isolation.

2-5
2. Operation Panel

Figure 2-4Operating Panel Diagram

Table2-2Description Table
Symbol Name Description

ON/OFF button Press to turn pump ON/ OFF.

RUN/STOP button Press to start/stop infusion.

Press to silence alarm for two


minutes (configurable). Or cancel
MUTE/BACK button
the operation and return to the
previous menu.

Press to access PUSH or


PUSH/BOLUS button
BOLUS.

Press to access optional features.


The backlight of the Arrow keys
Arrow keys
alternately lit counterclockwise
during infusion.

Open certain functions and press


ENTER/OK button
to confirm values/settings/alarms.

2-6
Flashing red: high level alarm.
ALARM indicator
Yellow: low level alarm.

Flashing green: battery charged.


BATTERY indicator Steady green: battery full.
Steady red: battery error.

Lit up when the pump is


AC POWER indicator
connected to an AC power supply

Note: BOLUS function details:

 Press PUSH/ BOLUS button twice(within 1s)

1. At the very beginning of infusion, enter manual PUSH.


2. During an infusion, or already have an infusion, enter manual BOLUS.
3. Bolus will continue until the button released in the second long-press.
The volume is displayed.

 Press PUSH/ BOLUS button once

1. At the very beginning of infusion, enter Automatic PUSH. Press to


start PUSH.
2. During an infusion, or already have an infusion, enter Automatic

BOLUS, Press to confirm BOLUS dose and time.

3. Screen Interface

2-7
01/01 08:00 Boon 50ml
1 2

Infu. 150.0 ml/h

3
5
00:08:30 5000 135 kPa
4
Time h:m:s VI ml 18
6
Figure 2-5Screen Interface

Table2-3Screen Interface Description Table

Number Description

1 Display system time, Format: ―MM/DD HH:MM‖

Display syringe brand and type(optional). Infusion mode


2
alternately, display charging status / battery remaining capacity
Display infusion status (through doll’s states), rate, and can press
3 MENU to enter the submenu: MENU button hidden during
infusion
Display Time and Volume during infusion alternately, others
4
VTBI

5 Display total volume, press to clear

6 Display current pressure, press to set pressure class

Details
 Charging status / battery remaining capacity:

2-8
A battery icon displayed when only battery-powered. A battery charging
animation icon and the external power icon displayed when there is an
external power supply and the battery is not fully charged. A fully charged
battery icon and the external power icon displayed when there is an external
power supply and the battery is full.

 Display VTBI in the infusion pause status, Time and the Volume
displayed alternately during infusion.

 Doll status: conventional infusion walking, BOLUS running, KVO


walking slowly, standing scratching in a pause. Press the doll, enter the
standby time setting interface, set standby time, confirmed and enter standby
mode, the interface shows standby time countdown.

 Pressure status box displays obstruction pressure icon, occlusion


pressure and real-time pressure, when real-time pressure accounting for less
than 70% occlusion pressure, 71% -90%, 91%-100%, the color of the
real-time pressure were green, yellow, red. Press the box to enter the pressure
class setting interface, the user can set the current pressure class and its unit.

Simple operation
 To select an option, the user can press directly on the screen to enter (the
background changes to yellow when selected), or press the arrow keys and
OK button to enter (appear yellow box when selected).

 Set infusion rate: press directly on the screen, or press the arrow keys
and OK button to set infusion rate in the submenu.

 VTBI: press directly on the screen, or press the arrow keys and OK
button to set VTBI in the submenu.

2-9
 Clear accumulated volume: press directly on the screen, or press the
arrow keys and OK button to choose whether to clear accumulated volume or
not in the submenu.

 Set pressure class: press directly on the screen, or press the arrow keys
and OK button to select pressure class in the submenu.

 Press MENU on the screen directly, or press the arrow keys and OK
button to select MENU and enter the submenu.

 Change infusion rate: press the rate displays on the screen directly to
input new infusion rate in the submenu.

Note: The above operations can be taken place only when there is a response pressing the

screen, if no response, this parameter cannot be set.

4. Submenu

Drugs
3
1
Modes Service
5

Logs 6
Settings
4

Figure 2-6Submenu

Table2-4Submenu Description Table

Num. Name Description

1 Modes Select different modes

2-10
2 Drugs Select Drug’s name

3 Service Maintenance the equipment(password needed)

4 Settings Select and set user parameters

Include Operation Logs, Alarm Logs, Infu.


5 Logs
Logs

6 return key Back to the previous menu

1、 Press MENU to enter.

2、 Use Arrow keys and ENTER/OK button to select and enter the
submenu, or press directly on the screen to enter.

3、 If the option is still under the sub menu, then repeat the above steps 2.

4、 Repeat steps 2 and 3 to adjust other parameters. The user can press CLR
or press on the display to return to the previous submenu.

2-11
2.5 Daily Use Procedures

Press ON/OFF button

Syringe installation

Syringe selection

PUSH

Parameters setting

Connect patient

Start injection

End injection

Figure 2-7 Conventional Procedures


1. Press ON/OFF button to turn the pump on.

2. Select proper syringe and infusion tube. Push the syringe to discharge
air bubbles (an alternative way is using the PUSH function).

Please choose the accurate Syringe produced by the


Provide manufacturers, the use of other company's
Syringe may cause inaccurate infusion rates, pressure
NOTE! false alarm and so on. For a given Syringe, we only
consider its form factor size, biochemistry, physics,
metrology and other indicators get the relevant
supervision departments’ Testing Approval.

2-12
3. Syringe installation

Refer to the dynamic installation prompts figure to install the Syringe.


Note: Refer to 3.2.2 for more information.

4. Syringe selection

The syringe selection interface pop up, please choose the right Brand and
Type.
Note: Refer to 3.2.2 for more information.

5. PUSH

Press to start PUSH, to stop PUSH, or automatically stop after the


pre-set volume completed.
Note: Refer to 3.2.2 for more information.

6. Use last settings

The user can choose ―Yes‖ or ―No‖.


Choose ―Yes‖, enter the Screen Interface which has last parameters.
Choose ―No‖, enter the Screen Interface which has no parameters. Different
mode has different parameter setting interface. Please refer to the 3.2.3 Mode
Selection for more information.

The parameters like infusion fluids, volume and rate


NOTE!
should be set by medical professionals.

7. Discharge air bubbles inside the Syringe.

Note: Refer to 2.4 for more information.

Note: Please use PUSH to discharge air bubbles inside the Syringe.

2-13
8. Connect the patient

Only after turning on the pump can patient be


connected. In order to prevent inaccurate value input,
NOTE!
please interrupted the connection during the parameter
setting period.

The parameters like Infusion fluids, volume and rate


NOTE!
should be set by medical professionals.

9. Make sure the rate is correct, press ON/OFF button to start infusion.

10. Replace the Syringe

10.1. Press ON/OFF button to stop infusion.


10.2. Disconnect the patient.
10.3. Open the pump door, remove the syringe.
10.4. Replace the syringe, discharge the air bubbles inside it.
10.5. Connect the patient.
10.6. Make sure the rate is correct.
10.7. Press ON/OFF button to start infusion.

Note: Syringes and disposable components should not be used longer than 8 hours.

If the pump needs to be moved during the infusion,


NOTE!
ensure security and stability.

11. Stop infusion

11.1. Press ON/OFF button to stop infusion. Disconnect the patient.


11.2. Remove the syringe. Close the pump door.

2-14
Please take good care of the infusion rate and the
NOTE! patient's response, if there are any abnormal situations,
treat timely.

12. Turn off the pump

Press ON/OFF button long, to turn the pump off.

11.1 Before the countdown reach 1, loosen the ON/OFF button, return to the
previous interface.

11.2 After the countdown reach 1, the system turned off.

Note: More information, refer to the following chapters.

2-15
FOR YOUR NOTE

2-16
Chapter 3 Operation

3.1 Before the Operation

 Ensure the pump is properly positioned and secured(a maximum of 3


pumps can be stacked together). The pump must be positioned on a level
surface if used in combination with the short stand. Do not position the pump
above the patient. And the pump should place in front of the operator.

 Prior to administration, visibly inspect the pump for damage, missing


parts or contamination. If staff call is used we recommend checking the
equipment carefully after connecting the pump.

 Make sure the power cord can be used normally.

3.2 Operation Procedure

3.2.1 Turn On

 Press ON/OFF button to turn the pump on.

Note: If the pump fails to start and display ―Device Failure!‖, please turn the pump off and

connect our service.

3.2.2 Basic Settings

For the first time using the pump, after boot animation, the pump enters the
touch calibration interface automatically.

3-1
3.2.2.1 Touch calibration
The Syringe pump has four calibration points, respectively press on the screen
according to the instructions, until the calibration is successful.
Note: Once enter the touch calibration interface, only after successful calibration can the user
skip this interface.

3.2.2.2 Power initialization


After the calibration, the pump enters power initialization automatically and
checks audible and visible alarms during self-test.
In the process of self-test,the horn and buzzer rang, the alarm light first on a
red, and then light yellow. If the above function is normal, the alarm self-test
finished and function normal.

HealFusion R
Version:1.00

Figure 3-1 Power initialization

3.2.2.3 System Time Setting


After the power initialization, the pump enters system time setting
automatically:

Note: more information, please refer to 3.5.10.

After system time setting, users can press the return key to reset date, or press
OK to enter the following steps.

3-2
3.2.2.4 Syringe installation
After system time setting, the pump enters ―install syr.‖ interface
automatically.

Be sure to use the sterile syringes produced by regular manufacturers, check


the validity sterilized and packaging for leaks and other anomalies before use
carefully.

Install the syringe according to the following steps:

1. Open the syringe holder, release and pull out the drive unit.

Figure 3-2 Syringe installation 1


2. Open the pump door, Insert the syringe such that the grip and the pressure
plate reach the guide.

3. Lock syringe holder again. If the syringe has been "correctly" placed the
release catch will snap back on its own.

3-3
Figure 3-3 Syringe installation 2
Note: If the syringe has been incorrectly placed, there will be dynamic figure installation

prompts to install the syringe in the display.

4. Close the pump door.

Note: To reinstall the syringe, repeat the above steps.

3.2.2.5 Syringe selection


After the syringe installation, the pump enters ―Syr. Type‖ interface
automatically.

If this is the first time using the pump, the syringe type displayed in the screen
is similar to the type which the pump detected. Please select the right type.

If not, and in the ―Default Settings‖ select ―Enable pop-ups for Syringe
option‖, the syringe type displayed in the screen according to the following
rules:

1. The type of the syringe inserted is similar to the type last used, regardless of
whether the type is selected , it will be ranked in the first place.

2. The type of the syringe inserted is different from the type last used, the
pump will check the type selected, and ranked the similar syringe.

3-4
3. The type of the syringe inserted is different from the type last used, the
pump will check the type selected, when it finds no one similar to the syringe
inserted, all the syringes in the same type will be ranked.

Syr. Type
BOON 20ml

BD 20ml √
XINHua 20ml √
Extend A 20ml

Extend B 30ml

Figure 3-4 Syringe Selection 1


Another case:

Syr. Type
Unidentified Syr. √

Figure 3-5 Syringe Selection 2


The user need to reinstall the syringe, or define a new type.

Confirm the type of the syringe by pressing ENTER/OK button. The type
displayed must match the inserted syringe.

Note: Any interface (except Turn on and syringe installation interface), whenever it detects a

syringe reinstall, syringe selection interface will pop up.

3-5
3.2.2.6 Push
If this is not the first time using the pump, and in the ―Settings-Default
Settings‖ interface, ―Pop up push UI‖ is selected, then after the Syringe
selection, the pump enters PUSH interface automatically.

PUSH Rate is 60ml/h, it can be set in ―MENU-Settings-Manual Bolus


Rate‖.

PUSH Volume can be set in ―MENU-Settings- Push Volume Setting‖, four


values are optional: 0.5 ml, 1.0ml, 1.5ml, 2.0ml.

Note: The blocking alarm is disabled when the PUSH is operated. The
maximum blocking threshold alarm value automatically to the P11 during
bolus, more than the threshold will trigger alarm.

Press to start PUSH:

Push

Rate:500ml/h
Vol. :0.0ml

Figure 3-6 PUSH 1

Press to stop PUSH during PUSH:

3-6
Push

Rate:500ml/h
Vol. :0.8ml

Figure 3-7 PUSH 2


Or it will stop automatically after the pre-set volume completed.

The PUSH volume will be reset when next PUSH process starts.

3.2.2.7 Use last settings


If it is not the first time using the pump, and in ―Settings-Default Settings‖
we select ―Pop up Last Setting UI‖ option, then after PUSH, press , the
pump enters ―Use last settings‖ interface automatically:

Figure 3-8 Use last settings


The user can choose ―Yes‖ or ―No‖.

In addition to involving parameters, other parameters which are within range


(such as BOLUS rate) will follow the previous value.

Note: No matter whether the user use last parameter or not, the mode is the same as the last

infusion mode.

3-7
Note: It will not appear for the first time.

Till now, all the basic settings completed, enter screen interface.

3.3 Modes

The Default Setting mode is Only Rate Mode.

Press ―MENU-Modes‖ to enter mode selection interface.

Modes
Rate Mode

Dosage Mode

V-T Mode

R-T Mode
Trapezia Mode

Figure 3–9 Modes 1


The user can press to enter the next page.
Modes
Intermittent Mode

Loading Dose Mode


Sequence Mode

Figure 3–10 Modes 2

3.3.1 Rate Mode

Press ―Rate Mode‖, enter Rate setting interface.

3-8
Rate Setting (ml/h)

12 09.10

Figure 3–11 Set Rate

 Press to increase values, to decrease values.

 Or press arrow keys to select and increase / decrease values.

 Press to confirm.

Press START/STOP button, the pump work in the certain rate.

3.3.2 Dosage Mode

Press ―Dosage Mode‖, enter the following interface:

剂量计算模式
Dosage Mode
药名:胰岛素
Drug: Insulin

体重:50.0kg
Weight: 50.0kg

浓度:20.0IU/20ml
Concentration:
=1.00IU/ml
速率:4.0IU/h
Rate: √
Dosage=4.00ml/h
Mode

Figure 3–12 Dosage mode


The Drug, Weight, Concentration, rate are adjustable. Press the corresponding

item, input the correct data and press to confirm. The relevant
parameters of dosage mode are as follows:

 Drug: select from drugs;

3-9
 Weight: 0.1~ 300kg;

 Concentration: Dose Unit Setting, Dose Setting and Dilution Volume


Setting are adjustable. The adjustable range of Dose Setting is
0.1~99999.9, the Dilution Volume Setting is 1~9999;

 Rate: Dose Rate Unit and Dose Rate Setting are adjustable. The
adjustable range of Dose Rate Setting is 0.1~9999.9.

Note: There was a ―Parameters Error‖ prompt character when the parameter is out of range.

The formula: Rate=Dose Rate/Concentration.

The detail steps to set concentration are as follows:

1) Press Concentration item, enter the Dose Unit Setting interface:


药量单位设置(20.0IU/20ml)
Dose Unit Setting
mg

mcg
u

mmol

mEq

IU √
Figure 3–13 Dose Unit Setting
2) Click the target unit, such as the virtual box back of ―mg‖ to select mg,

then press to enter Dose Setting and Dilution Volume Setting


interface:

3-10
药量设置(---mg/---ml)
Dose Setting

00000.0

Figure 3–14 Dose Setting

配液用量设置(20.0IU/---ml)
Dilution Volume Setting

0000

Figure 3–15 Solvent Setting


3) Click other dosage units will enter the above Settings interface, only the

unit is different. Press to confirm and return the dosage mode


interface.
The detail steps to set rate are as follows:

1) Press Rate item, and enter the Dose Rate Unit interface. The different
dosage units corresponding to different dose rate unit, such as the
dosage units for mg, press the Rate enter into the following interface:

3-11
选择剂量速率单位
Dose药物库
Rate Unit

mg/kg/min √ mg/min

mg/kg/h mg/h ug
mg

mg/kg/24h mg/24h √
Figure 3–16 Dose Rate Unit

2) Press to enter Dose Rate Setting interface. Note shall not exceed
limit setting rate, otherwise there will be "Out of Range" prompt

character. Click the return key will not save this set and return
previous interface. Click the key can select other dose rate unit,
such as ug.

Press the key in the dose mode interface after finished setting, and return
the screen interface, and then work with this rate.

3.3.3 V-T Mode

Press ―V-T Mode‖, enter the following interface:

预置量时间模式
V-T Mode
输液时间:
Infu. Time: 1min
VTBI:
预置量: --.--ml

注射速率:--.--ml/h
Infu. Rate:

Figure 3–17 V-T Mode
Press the corresponding item, enter Infusion Time setting and VTBI setting
interface.

3-12
Infu. Time Setting(h:m)

12 :09

Figure 3–18 Set Infusion Time
VTBI Setting(ml)

12 34.56

Figure 3–19 Set VTBI

 Press to Increase values, to decrease values.

 Or press arrow keys to select and increase / decrease values.

 Press to confirm, enter V-T mode.

Press key in the V-T Mode interface, then enter VIBI Finished Entry
interface. The user can select Continue, Stop or Enter KVO Mode after
finished.

After confirmed, enter the screen interface, the system can work under V-T
Mode.

The user can enter Preset volume setting and Time setting interface directly by
press VTBI in the screen menu.

3-13
3.3.4 R-T Mode

Press ―R-T Mode‖, enter the following interface:


预置量时间模式
R-T Mode
Infu. Rate: 1ml/h
VTBI:
Infu. Time: --.-- min

注射速率:--.--ml/h
VTBI: --.-- ml

Figure 3–20 R-T Mode
Press the corresponding item, enter Infusion Rate setting and Infusion Time
setting interface. The detail setting steps can refer to V-T Mode.
The user can enter Infusion Rate setting and Infusion Time setting interface
directly by press the rate in the screen menu.

3.3.5 Trapezia Mode

Press ―Trapezia Mode‖(gradient model), enter the following interface:


剂量计算模式
Trapezia Mode
VTBI:---

Platform Rate:---

Rising Time:0s

Falling Time:0s

Dosage Mode
Platform Time:---

Figure 3–21 Trapezia Mode


The VTBI, Platform Rate, Rising Time and Falling Time are adjustable, Press

the corresponding item, input the correct data and press to confirm. The

3-14
Platform Time will update and display according to each parameter. The
relevant parameters of gradient mode are as follows:
 VTBI: 0.01~9999.99ml;
 Platform Rate: 0.01~9999.99ml/h;
 Rising Time: 0.01s~99h59min59s;
 Falling Time: 0.01s~99h59min59s;
Note: There was a ―Parameters Error‖ prompt character when the parameter is out of range.

The detail setting steps can refer to Dosage Mode. After confirmed, enter the
Trapezia Mode ,the interface shows as follows:
Trapezia Mode

R=1.00ml/h V1=0.0013ml
V2=9.9960ml
v1 v2 v3 V3=0.0027ml
t1 t2 t3
t1=00:00:10
Vt=10.00ml
Tt=10:00:15
t2=09:59:45
t3=00:00:20

Figure 3–22 Trapezia Mode Infusion
Note: v: VTBI, t1: Rising Time, t2: Maintain Time, t3: Falling Time.

Check formula: (t1+t2)/2<V/R,(R: maintenance rate).

Press to confirm, return the main infusion interface, enter into Trapezia
Mode.
1. It is forbidden for any Bolus during Trapezia Mode
process.
2. Rising and falling stages are not allowed to change the
rate, only in the maintenance phase rate of change and
NOTE! change to follow the principle. The fulling time and
residual fluid volume remains the same, no more than the
limits of the pump (department, the drug library, etc.).
3. If occur alarm lead to motor stalling during process,
remove after the alarm, press start again, and then

3-15
continue the last time breakpoint running. The rest of the
alarm does not affect the infusion. Returns the last
regular mode after the end of three stages.

3.3.6 Intermittent Mode

Press ―Intermittent Mode‖(discontinuous model), enter the following


interface:
剂量计算模式
Intermittent Mode
Total VTBI:---

Number:---

Interval Time:---

Rate:---ml/h

V=---
Dosage t=---
Mode

Figure 3–23 Intermittent Mode


The Total VTBI, Number, Interval Time and Rate are adjustable, Press the

corresponding item, input the correct data and press to confirm. The
Single VTBI will update and display according to each parameter. The
relevant parameters of gradient mode are as follows:
 Total VTBI: 0.01~9999.99ml;
 Number: 1~50;
 Interval Time: 1s~99h59min59s;
 Rate: 0.01~9999.99ml/h;
Note: There was a ―Parameters Error‖ prompt character when the parameter is out of range.

The detail setting steps can refer to Dosage Mode. After confirmed, enter the
Intermittent Mode, start infusion.
Change rate during infusion process, it will effective immediately, and the
VTBI remain unchanged, the infusion time adjustment. In the interval
adjustment rate, the next sequence to take effect.

3-16
1. It is forbidden for any Bolus during intermittent Mode
process.
2. If occur alarm lead to motor stalling during process,
NOTE!
remove after the alarm, press start again, and then
continue the last time breakpoint running. The rest of the
alarm does not affect the infusion.

3.3.7 Loading Dose Mode

Press ―Loading Dose Mode‖, enter the following interface:


剂量计算模式
Loading Dose Mode
药名:胰岛素
Weight:50.0kg

Concentration:10.0mg/10ml
Loading Dose:1.00mg
= 1.00ml
st
1速率:4.0IU/h
st
Stage Time:1min √
1Dosage Mode
Stage=4.00ml/h
Rate:60.00ml/h

Figure 3–24 Loading Dose Mode


The Weight, Concentration, Loading Dose, 1st Stage Time and 1st Stage Rate
are adjustable, Press the corresponding item, input the correct data and press

to confirm. The relevant parameters of loading dose mode are as follows:


 Weight: 0.1~300kg;
 Concentration: Dose Unit Setting, Dose Setting and Dilution Volume
Setting are adjustable. The adjustable range of Dose Setting is
0.1~99999.9, the Dilution Volume Setting is 1~9999;
 Loading Dose: Loading Dose Unit and Loading Dose Setting are
adjustable. The adjustable range of Loading Dose Setting is
0.1~9999.99ml;
 1st Stage Time and 1st Stage Rate : 1st Stage Time is adjustable.

3-17
 2nd Stage Rate: Dose Rate Unit and Dose Rate Setting are adjustable.
The adjustable range is 0.1~9999.99ml;
 2nd Stage Dose: Dose Rate Unit and Dose Rate Setting are adjustable.
The adjustable range is 0.1~9999.99;
Note: There was a ―Parameters Error‖ prompt character when the parameter is out of range.

The detail setting steps can refer to Dosage Mode. After confirmed, enter the
following interface:
剂量计算模式
Loading Dose Mode

Weight:50.0kg
Concentration:1000.0mg/10ml
浓度:---/---ml
Loading Dose:100.00mg(1.00ml)
1st Stage Rate:1.0mg/01:00:00
维持速率:---
=1.00ml/h
= ---
2 Stage Rate:100.00mg/min
st

=60.0ml/h
速率:4.0IU/h
2st 维持期剂量:---
Stage Dose:100mg(1.00ml)

= ---
Dosage=4.00ml/h
Mode

Figure 3–25 Loading Dose Mode

Press to confirm, enter loading dose mode.


1. It is forbidden for any Bolus during loading dose phase.
Can manual end of 1st Stage ahead of time. Access to 2nd
Stage directly, at this stage can change rate for Bolus or
online.
NOTE!
2. If occur alarm lead to motor stalling during process,
remove after the alarm, press start again, and then
continue the last time breakpoint running. The rest of the
alarm does not affect the infusion.

3.3.8 Sequence Mode

Press ―Sequence Mode‖ ,enter the following interface:

3-18
剂量计算模式
Sequence Mode
体重:50.0kg
药名:胰岛素
ID VTBI V Time t Rate R
浓度:---/---ml
1 1ml 00:03:00 20.00ml/h
2首剂量速率:---
--- --- --- 1
= ---

速率:4.0IU/h
首剂量:---
Total VTBI:1ml
= ---
Dosage=4.00ml/h
Mode
Total Time:3min √
Figure 3–26 Sequence Mode
The VTBI and Time are adjustable, Press the corresponding item, input the

correct data and press to confirm. The Rate, Total VTBI and Total Time
will update and display according to each parameter. The next sequence will
automatically arrange after setting up a sequence. The relevant parameters of
sequence mode are as follows:
 VTBI: 0~9999.99ml;
 Time: 1s~99h59min59s;
Note: There was a ―Parameters Error‖ prompt character when the parameter is out of range.

Click the sequence can change its VTBI and time, the whole period of
sequence mode can change rate. Change of rate effective immediately during
infusion process. Can only change the rate at which the current sequence, do
not affect other rate.
After confirmed, in the case of setting the VTBI and time for each sequence
can enter sequence mode infusion.
1. It is allowed for manual Bolus during Sequence Mode
process. The quantity of Bolus calculation to the infusion
quantity.
NOTE! 2. If occur alarm lead to motor stalling during process,
remove after the alarm, press start again, and then
continue the last time breakpoint running. The rest of the
alarm does not affect the infusion.

3-19
3.4 Relay Mode

Press ―Relay Mode‖, enter the following interface:

时间速率模式
Relay Mode
Send Relay
输液速率: --.--ml/h
输液时间:
Clear Relay 1min

预置量: --.--ml

Figure 3–27 Relay Mode


The equipment can continuously launch relay. This mode needs to be used
with infusion information collection system manufactured by HEDY Medical
Device Co., Ltd.

3.5 Settings

Press ―MENU-Settings‖, enter user setting interface.

Settings

VTBI Finish Setting


Manual Bolus

Cap Rate

Push Volume Setting

Syr. Type Setting

Figure 3-28 Settings 1


The user can press to enter the next page.

3-20
Settings

Auto -Lock Setting


Default Setting

Volume & Brightness

Day & Night Mode

System Time Setting

Figure 3-29 Settings 2


Press each individual in the menu, the user can enter the submenu to set all the
parameters in user setting.

We have set the password for Settings of some items to improve the safety of
device, the password is: 520512, please enter the password into the
corresponding interface when you need.

Setting alarm limits to extreme values that can render

the alarm system useless.


WARNING!

3.5.1 VTBI Finish Setting

Press ―VTBI Finish Setting‖, enter the submenu, the user can choose any one
of the next three ways to continue working after the VTBI is completed.

3-21
VTBI Finish Setting
Continue
Stop

Enter KVO Mode

KVO Settings

Dosage Mode

Figure 3-30 VTBI Finish Setting


If Enter KVO Mode is selected, the user should choose when to enter KVO
Mode and the KVO Rate.

 KVO Rate must be limited in 0.10-5.00ml/h.

 The user can choose to enter KVO Mode when the remaining volume is

1%, 2% or 3% of the VTBI.


Set the KVO Rate, KVO Rate must be limited in 0.10-5.00ml/h.

If the user choose 2 or 3 of the options, after the preset value isset, the ―After
VTBI Completed Entry‖ interface will pop up, the user can choose a way to
continue(You can choose only one option).

VTBI Finish Setting

Continue

Stop √
Enter KVO Mode


Figure 3-31 Continue working options
Note: During operation, after the user make a choice in the pop up, the next pop will contain

only the ways the user selected last time, if the user select only one way, the next time will not

pop up.

3-22
3.5.2 Manual Bolus Setting

Press ―Manual Bolus Setting‖ to enter the Manual Bolus setting interface.

Manual Bolus Setting

手动快推速率:150ml/h
Bolus Rate:
Bolus Volume:
手动快推液量:5.00ml


Figure 3–32 Manual Bolus Setting
The Bolus Rate and Bolus Volume are adjustable, Press the corresponding

item, input the correct data and press to confirm.


 Bolus Rate: 0.10-2000.00ml/h;
 Bolus Volume: 0.01~100ml.
Note: There was a ―Parameters Error‖ prompt character when the parameter is out of range.

Manual Bolus Rate limit is the same as the infusion rate limit, and related to the type of the

Syringe. The default value is 500.00ml/h.

3.5.3 Push Volume Setting

Press ―Push Volume Setting‖, enter push Volume setting interface. There are
four parameters can be set: 0.5 ml. 1.0 ml. 1.5 ml. 2.0 ml (You can choose
only one option).

3-23
Push Volume Setting
0.5ml

1.0ml √
1.5ml

2.0ml

Figure 3-33 Push Volume Setting

3.5.4 Default Settings

Press ―Default Setting‖, enter ―Please Enter Password‖ interface.

Please Enter Password

5661

, 1 2 3 X

. 4 5 6 0

7 8 9 Abc

Figure 3-34 Enter Password


If the password is incorrect, there will be a reminder ―Password Error‖.

Password Error

, 1 2 3 X

. 4 5 6 0

7 8 9 Abc

Figure 3-35 Password Error

3-24
If the password is correct, enter ―Default Setting‖ interface. The user can
choose to pop up these UIs:

Default Settings
Pop up Last Setting UI
Pop up Push UI

Pop up Syr. Select UI


Dosage Mode

Figure 3-36 Default Settings


Press the virtual key to turn on/off the options, if this option is turned on, it
will pop up automatically when the pump turned on, otherwise it will not.

Note: These options above are optional, the user can choose none, one or some of them.

3.5.5 Volume &Brightness

Press ―Volume &Brightness‖, enter ―Please Enter Password‖ interface. If


the password is correct, enter Volume & brightness setting interface.

Volume & Brightness

Volume: 2

Brightness: 3

Figure 3-37 Volume & Brightness

1. Alarm volume has 5 grades, press to decrease the volume, to


increase the volume, when adjust the volume, it is accompanied with voice
prompt.

3-25
2. Screen brightness has 10 grades, press on the left side to weaken

screen brightness, on the right side to enhance screen brightness, when

adjust the screen brightness, it is accompanied with brightness display prompt.

3. Press to confirm the setting.

The auditory alarm signal sound pressure levels, which

are less than ambient levels, can impede OPERATOR

recognition of alarm conditions and the alarm system


WARNING!
provides.

3.5.6 Auto-Lock Setting

Press the up key on the panel + CLR more than 1s at the same time, the panel
and the screen can be locked or unlocked. When it is locked, there has no
response pressing the screen or pressing the panel, after unlocking, their
functions recovery. When an alarm occurs, the lock canceled automatically
(except Remainder Alarm).

The user can choose to auto-lock or not, and can set auto-lock time, the pump
provide four auto-lock time: 2min, 5min, 10min, 20min(You can choose only
one option).

Auto-lock Setting
2min

5min √
10min

20min

Disable Auto-Lock Funtion

Figure 3-38 Auto-Lock Setting

3-26
Note: Auto-lock time represent how long will the pump auto-lock without operation, it will

not auto-lock if the pump continue being operated.

3.5.7 Cap Rate setting

Press ―Cap Rate‖, enter ―Please Enter Password‖ interface. If the password
is correct,enter the Cap Rate setting interface.

Cap Rate(ml/h)

1500.00 √

Figure 3-39 Set Cap Rate

 Press to Increase values, to decrease values.

 Or press arrow keys to select and increase / decrease values. If the


parameter is out of range, there will be a reminder“?Out of range”.
?Out of Range

1500.00 √

Figure 3-40 Out of Range

 Press to confirm.
Note: Rate upper limit can be set in the range of 100-1500.00ml / h, the default value is

1500.00ml / h, in the trace mode this value can be set to 100.00ml / h.

3-27
3.5.8 Syringe Type Setting

Press ―Syr. Type Setting‖ to enter Bubble Class setting interface.


Syr. Type Selection
BD
BOON

√ 5ml 10ml

20ml 30ml √
50ml

Figure 3-41Syringe Type Setting


The syringe recommended by the manufacturer displays here:

 BD: TYPE 5ml. 10ml. 20ml. 30ml. 50/60ml.


The specifications list of BD syringe has been tested. And the accuracy has
been evaluation.
The administration set (including needle and pipe ) are treated as the applied
part, which are not intended to deliver heat, during normal user, the maximum
temperature at applied part maybe up to 42°C

3.5.9 Day & Night Mode

Press ―Day & Night Mode‖, enter ―Please Enter Password‖ interface. If the
password is correct, enter Day & Night mode setting interface. The user can
set the start time of the day, and the volume & brightness during the day, the
start time of the night, the volume and brightness during the night.

3-28
Day & Night Mode
Day Time Start: 05:00
Day Volume & Brightness

Night Time Start: 18:00

Night Volume & Brightness

Figure 3-42 Day & Night Mode


The start time of the day and night can be set freely, press the virtual key to
enter submenu.

The volume & brightness during the day and night can be set freely according
to users’ own habits. The volume & brightness change according to the mode.

The user can also choose to close Day & Night mode.

3.5.10 System Time setting

Press ―System Time Setting‖, enter time setting interface.

1. Date setting, format: ―YY-MM-DD‖:

 Press to Increase values, to decrease values.

 Or press arrow keys to select and increase / decrease values.

 Press to confirm.

3-29
Date (YY/MM/DD)

15/07/10

Figure 3-43 Date Setting


2. After confirm date setting, enter time setting interface.

3. Time setting format ―HH:MM:SS‖, refer to date setting procedures to set


values.

Time (HH:MM:SS)

15:07:10

Figure 3-44 Time Setting
4. Time setting completed, press to reset date, or to return to the user
setting menu interface.

3.5.11 Add Extended Syringe

Press ―Add Extended Syr.‖, enter add extended syringe interface, user can

define syringe following the Interface prompt. For example:

1. Press ―Extend A‖.

3-30
2. Press the type you defined, such as: 5ml. 10 ml. 20 ml. 30 ml. 50 ml.

3. Enter submenu, enter the syringe length, press to confirm.

Note: the syringe length is the length between 0 to the selected syringe type scale. For

example: the syringe type is 50ml, then the syringe length is the length between syringe

graduation 0ml to 50ml on the syringe housing.

4. Load the empty syringe properly to the syringe pump, press to

confirm.

5. Push the Screw to the far left, till it could not be pushed any more, press

to confirm.

Note: if the drive unit has not be pushed to the far left, when you press to confirm, a

warning ―Detect Failed‖ may occurs, and you cannot enter the next step.

6. Lock syringe holder, press to confirm.

Note: If the syringe holder unlocked, when you press to confirm, a warning ―Detect

Failed‖ may occurs, and you cannot enter the next step.

7. Add Extended Syr. Completed.

3.5.12 System Version

Press ―System Version‖ to view system version. The version is V02.00.00.

3.6 Logs

If the user needs to check operation logs, alarm logs, infusion logs. Press
―MENU-Logs‖ to enter the interface.

3-31
Logs
Operation Logs
Alarm Logs

Infu. Logs

Figure 3-45 Logs


The contents of the log are not going to disappear after the alarm system has

experienced a total loss of power for a finite duration.

The pump will eliminate the earliest log as it reaches capacity.

3.6.1 Operation Logs

Operation log shows the operate time and date, and what the user set.

Press ―Operation Logs‖ to enter the interface.

Operation Logs
2015/04/02 11:30:51
Set rate : 8.00 ml/h
2015/04/02 11:26:05
Set current mode: R-T Mode
2015/04/02 11:08:20
Cfm. battery low
2015/04/02 10:30:19
Shutdown

Figure 3-46Operation Logs


The format is:

Date and time[yyyy/mm/ddhh:mm:ss]


Operation string: value[optional]+unit/auxiliary string[optional]

3-32
3.6.2 Alarm Logs

Alarm log shows the time and date when alarm occurs, and why the alarm
occurred.

Press ―Alarm Logs‖ to enter the interface.

Alarm Logs
2015/04/05 11:30:19
!!! Battery Empty
2015/04/02 16:39:33
? Out of range
2015/04/02 11:30:19
! External power off
2015/04/01 10:30:19
? Password error
Figure 3-47 Alarm Logs
The format is:
Date and time [yyyy/mm/ddhh:mm:ss]
Alarm string

3.6.3 infusion Logs

infusion log shows the start and stop time of each infusion, and the rate during
this time.

Press ―Infu. Logs‖ to enter the interface.

3-33
Infu. Logs
Time Interval Drug Info. Infu. Logs
04/12-08:00:13 XXX 50ml/h
04/12-09:25:13 5mg/50ml 1.01ml
16:39:33

Figure 3-48infusion Logs


The format is:

time Drug information Log

Start time —— Rate (ml/h)

Stop time —— Volume (ml)

3.7 Drugs

Press ―MENU-Drugs‖, enter the drugs interface:


药物库
药物库
Drugs

!!! Battery Empty


肌松药
Anesthesia common
2015/04/02 16:39:33drugs
? Out of range
降血糖药
Hypertension drug
11:30:19
降压药
ICU common drugs
2015/04/01 10:30:19
局麻药
Obs&Gyn common drugs

Figure 3–49 Drugs


The user can press the drugs folder to enter drug list, select the target drug. Or
click the search box and input keyword to search.
Press the drug’s name to enter the following interface view drug information
after searched the target drug.

3-34
药物库
胰岛素
Insulin

!!!Concentration:
Battery Empty
药物浓度:
20.00IU/20ml
=1.00IU/ml
1
默认速率:
Default Rate:
4.00IU/h

Figure 3–50 Drug’s information

Press the number key on the right, such as to check out other
information page. All the information parameters including Concentration,
Default Rate, Dose Rate Hard Limit, Manual Bolus Vol. , Manual Bolus Vol.
Hard Limit, Default Manual Bolus Rate, Bolus Rate Hard Limit, Code.

Press back key to return previous interface, press to confirm drug


information.
Note: this function is optional.

3.8 Service

Please use the syringe the manufacturer recommended. When the syringe

pump leave factory, it has default calibration coefficients corresponding the

syringe inside. Under normal circumstances, it doesn’t need to re-calibration

coefficients. In case of other factors, the user can enter ―Accuracy

Calibration‖ interface to enter Calibration factor.

Note: Set a target VTBI, using standard measuring instruments to measure the actual infusion

quantity. The quotient of the two is the calibration factor.

3-35
FOR YOUR NOTE

3-36
Chapter 4 Technical Data

4.1 Infusion Accuracy

 Under normal circumstances, the infusion precision of the Syringe pump


is as the following:

Table4-1infusionControl Parameters

Infusion Control Parameter Rate Range

50/60ml syringes 0.1~1500 ml/h

30 ml syringes 0.1~800 ml/h

Rate 20ml syringes 0.1~600 ml/h

10 ml syringes 0.1~300 ml/h

5/6ml syringes 0.1~150 ml/h

0.1-99.99ml/h 0.01ml/h
Infusion Rate Step
100.0-999.9ml/h 0.1 ml/h
Resolution
1000-1500 ml/h 1 ml/h

VTBI 0.1-9999ml

0.1-99.99ml 0.01ml
VTBI Step
100.0-999.9ml 0.1ml
Resolution
1000-9999ml 1ml

4-1
Infusion Precision (Solution: Ⅲ grade water, ±2%

Test temperature:23±2℃)

Mechanical Precision ±0.5%

Note: the infusion precision is ±2%. It means that, infusion after the rate and the VTBI is set,

the liquid error range is less than ±2%.

Under the single fault condition, the system has over-infusion and under-infusion caused

precision error range is ±10%.

If the Syringe used is untested varieties, or used under


other unusual circumstances, such as too short circle
time, abnormal transfusion characteristic, Inadequate
protection under harsh environmental conditions, tube
WARNING!
plugging and backflow, the pump may unable to
maintain the accuracy.
 The Bolus infusion Performance meets the following requirements:

Table4-2Bolus Infusion Control Parameters

Bolus Infusion Control Parameter Parameter Range

50/60ml syringes 0.1~1500 ml/h

30 ml syringes 0.1~800 ml/h

Bolus Rate 20ml syringes 0.1~600 ml/h

10 ml syringes 0.1~300 ml/h

5/6ml syringes 0.1~150 ml/h

4-2
4.2 KVO Mode

KVO mode can switch on/off, the system can switch automatically when there
is a trigger, others can be switched via an infusion pause.

 KVO(keep vein open)Mode

In the end of the pre-set time, or when the VTBI completed, the Syringe pump
will transfuse automatically with a very low rate, in order to prevent the blood
from blocking the needle. KVO rate is a minimum rate to keep vein open.

 When the infusion completed, the pump enters KVO mode


automatically, KVO can be turned off.

 KVO protection performance meets the following requirements:

Table4-3 KVO Protection Performance

KVO Protection Control Parameters Parameter Range

KVO Rate 0.1~5.0 ml/h

4.3 Blocking Threshold

In order to ensure the safety of the patients, the pump has Occlusion alarm
function, when the pressure in the infusion tube is greater than the blocking
threshold, it will alarm.

 Under the condition of patients’ pipe end completely blocked, the


maximum injection pressure generated by the pump is 240kPa.

 The blocking alarm threshold means the physical quantity value when
the blocking alarm is triggered. The blocking alarm threshold is highly
affected by the environment temperature, injection pipe quality. The test
temperature is 23±2℃ and the length of infusion connective tube is less

4-3
than 1.2 meters.

 The pump will release pressure automatically to entrapped unintended


bolus before occlusion release.

 The following table shows the typical values for time to alarm (BD):

Table4-4Typical Values for Time to Alarm

Syringe Rate Pressure Occlusion Time to


Bolus(ml)
TYPE (ml/h) class pressure (kPa) Alarm(s)

P1 7.07 00:21:19 0.008


0.1 P6 55.2 02:25:12 0.129
P11 115.74 07:18:24 0.096
P1 7.33 00:04:41 0.015

1 P6 59.07 00:18:16 0.123


5ml
P11 145.20 01:21:47 0.261

P1 10.93 00:00:27 0.006

5 P6 58.13 00:02:36 0.147

P11 123.60 00:06:14 0.180

P1 7.47 02:15:02 0.01


0.1 P6 57.2 12:45:15 0.067
P11 129.8 24:41:01 0.124
P1 6.80 00:16:14 0.03
50ml
P6 62.14 01:10:08 0.219
1

P11 142.27 03:55:22 0.54

5 P1 10.00 00:03:00 0.028

4-4
P6 56.00 00:21:34 0.250

P11 134.00 00:37:18 0.113

 due to equipment’s pressure release function, when the pump operate in


the middle speed, and the pressure up to maximum occlusion alarm
threshold, the pump will release the system pressure automatically,
therefore the liquid flowing through after the release is negligible.

 The liquid flowing through under single fault conditions is 0.54ml


(Pressure class is P11).

Note: the Occlusion pressure and Occlusion alarm time are related to the Syringe brand,

infusion tube, pressure calibration coefficients and the test equipment. So the data above are

only for reference.

 Blocking pressure has 11 classes, its units are: kPa, mmHg.

Press the pressure blocking box in the lower right corner of the interface, enter
submenu to set the pressure class.

Pressure Class Range(kPa) Pressure Class Range(kPa)

P1 12.5±7.5 P7 70±15

P2 20±10 P8 85±15

P3 30±10 P9 100±15

P4 40±10 P10 115±20

P5 50±10 P11 135±20

P6 60±10

4-5
FOR YOUR NOTE

4-6
Chapter 5 Alarm and Tips

5.1 Alarm Function

1. Alarm function’s operating environment is the same as the equipment’s


operating environment.

2. Alarm Silence: the user can press CLR to silence the alarm for 2
minutes.

3. Alarm Acknowledge: All the alarms can be confirmed by pressing OK.


Only after acknowledging alarm can message be cleared and back to the
previous interface(except the Install syringe installation interface).

4. Audible alarm will exist in all alarm conditions. Alarm meets the
following requirements: Audible alarm can produce sound levels, the sound
pressure produced by the maximum sound level is more than 65dB(A) when
the user stand 1m away from the source, by the minimum is more than
45dB(A).

5. The device has real-time detection through encoder and hardware circuit,
and produce device fault alarm to prevent the patient from over-infusion and
under-infusion.

6. The alarm produced by the system can output through nurse call. The
alarm delay no more than 10ms. Associated with the alarm Settings, such as
blocking alarm threshold, automatic save by hardware permanently.

5.2 Alarm Priority

Alarm is sound and light alarm that has sound and light signals. Syringe
pump’s alarms in priority order are divided into: high-level alarm,

5-1
intermediate-level and low-level alarm. Different priority alarms have
different sound and light signals. All alarms are technical type.

This section will detail the cause of the alarm and the corresponding solutions.
If there is more than one alarm occurring at the same time, high priority Alerts
appear first depending on the alarm priority.

5.2.1 High-level Alarm

Device failure and cannot work properly when the high-level alarm occurs. At
this moment the infusion immediately stopped and the device will emit the
high alarm sound, the red alarm light is blinking and the screen displays
relevant information. High-level alarm includes the following types:

High-level Alarm Alarm Cause Solution

!!! Device Caused by the hardware Please turn the pump off

Fault and etc. and connect our service.

In the process of the First, press OK to confirm

infusion, the drive unit or the alarm. Second, refer to


!!! Syr.
syringe holder is not in the correct interface
Loading Error
place. animation prompted to

install syringe.

In the case of no external First, press OK to confirm

power supply, the the alarm. Second,

!!! Battery remaining capacity can connect the external

Empty support the pump continue power supply.

working only 3 more

minutes.

5-2
In the process of the First, press OK to confirm
!!! Clutch
infusion, the clutch loose. the alarm. Second, press
Status Abnormal
the finger grips to move

the clutch to clamp.

The velocity /BOLUS rate Press OK to confirm the

exceed the limit value of alarm. The


!!! Rate Out of
Range the new syringe when a velocity/BOLUS rate

new syringe reloaded, and automatically changes to

the user chose to use last the maximum value of the

parameter. new syringe.

In the process of infusion, Syringe pump

syringe empty is detected. automatically stop


!!! Syr. Empty
infusion, please press OK

to confirm the alarm.

In the process of infusion, Syringe pump

when the pre-set infusion automatically stop

time come to an end, or infusion, please press OK

VTBI completed, to confirm the alarm.


!!! Infu.
including KVO finished, is
Finished
detected (When the preset

value is reached, select to

stop infusion), this alarm

occurs.

!!! KVO In the process of infusion, Press OK to confirm the

5-3
Actived the VTBI completed is alarm. The infusion

detected (select to enter continues. The user can

KVO when VTBI stop the infusion after

completed). confirming the alarm.

In the process of infusion, First, press OK to confirm

!!! IV set infusion tube pressure the alarm. Second, anti -

Occluded exceeds the limit value. bolus to pressure back to

normal.

5.2.2 Intermediate-level Alarm

The intermediate-level alarm occurs when there are some bad effects in the
normal work, it means that the device’s work has been done, and the medical
personnel need to do the next step. When the intermediate-level alarm occurs,
the device will emit the medium alarm sound, the yellow alarm light is
blinking and the screen displays relevant information. Intermediate-level
alarm includes the following types:
High-level Alarm Alarm Cause Solution

In the process of infusion, Press OK to confirm the

the VTBI completed is alarm. The infusion


!!! KVO
detected (select to enter continues. The user can
Actived
KVO when VTBI stop the infusion after

completed). confirming the alarm.

5-4
5.2.3 Low-level Alarm

The low-level alarm refers to the alarm which does not affect the normal work
and does not require the medical personnel to do the next step. Its main
function is to prompt the medical personnel prepare to enter the next operation.
In addition, the low-level alarm won’t interrupt the infusion. When the low
alarm occurs, the device will emit the low alarm sound, the yellow alarm light
is on and the screen displays relevant information. Low-level alarm includes
the following types:

High-level Alarm Alarm Cause Solution


! Battery Low In the case of no First, press OK to
external power confirm the alarm.
supplied, and the Second, connect the
remaining capacity can external power supply.
support the pump
continue working only
30 more minutes.
! Near Empty In the infusion process, Press OK to confirm
the syringe will soon be the alarm. The infusion
empty is detected. will be continued. The
user can stop the
infusion after
confirming the alarm.
! Infu. Near In the infusion process, Press OK to confirm
Finished the infusion time or the the alarm. The infusion
VTBI is nearly continues. You can stop
completed. the infusion after
confirming the alarm.
! Forget Operation When the screen Press OK to confirm
unlocked, and the user the alarm.

5-5
has no operation
staying on the main
screen or the setup
interface for more than
2 minutes.
! External power The status of external Press OK to confirm
supply interruption power supply changes the alarm. If no human
from connected to factors, reconnect the
disconnected. external power supply.
! VTBI Finished, In the process of Press OK to confirm
Continue Infu. transfusion, VTBI
completed is detected
(select to continue
infusion when VTBI
completed).
Note: The following alarms are non-latching alarm signal, and others are
latching alarm.
 Battery Low
 External power supply interruption
 Infu. Near Finished

5.2.4 Alarm acknowledgement reference table

optical signal
Alarm Audible Staff
Red Yellow User confirmation
Type signal Text call
LED LED

Press CLR to
High Such as
silence the alarm.
Yes Blink Off ―!!!Battery Yes
Alarm Press OK to
Empty‖
confirm.

5-6
Press CLR to
Low Such as ―!
silence the alarm.
Yes Off Blink Remainder Yes
Alarm Press OK to
Alarm‖
confirm.
Note: If the current alert was not lifted, touch screen and hardware buttons (except the button

of OK/CLR/POWERON) shall be void.

5.3 Tips

In addition to the alarm, in order to facilitate user action, the Syringe pump
has some relevant tips. The contents of tips mainly refers to the input
parameter is incorrect. Such as the velocity exceeds the allowed range, cannot
change the parameters, and so on. When then tips appear, does it make a
sound. Tips including the following types:

Tips Tips Cause


KVO Vol. Invalid The liquid is too little to enter KVO.
Out Of Range In the parameter setting interface, the value is
set out of the allowed range.
Password Error The password input is not correct, including
service password, user password and WiFi
password.
Door Unclosed The door of device is unclosed.
Screen Locked Success to lock the device.
Screen Unlocked Success to unlock the device.
Please Unlock! Success to lock the device.
Parameter Error Parameters cannot be changed.
Cumulative Vol. up to Out of cumulative volume.
9999ml, Set Zero
Communication Failure Communication failure.
Infu. Forbidden The syringe is forbidden.

5-7
Pressure not calibrated Pressure not calibrated.
Calibration Unfinished Accuracy or pressure calibration unfinished.
Calibration Finished Accuracy or pressure calibration finished.
Device as Main Pump Device as main pump.
Relay Select Unfinished Relay select unfinished.
No Matching Main Pump No matching main pump.
All Main Pump Denied All main pump denied.
Relay Select Time Out Relay select time out.
No Syr. Was Detected No syringe was detected.
Note: If the user does not have operations, the above tips will disappear automatically.

5-8
Chapter 6 Maintenance

6.1 Cleaning/Disinfection

Power off and unplug the system before cleaning the


equipment.
CAUTION!
The system should be wiped with the following liquids dipped soft cloth at
least once every month for cleaning.

 50% NaClO
 10% HClO
 3% H2O2
 70% Alcohol
 70% Isopropyl Alcohol in water
 10% NaCl and water
 T-Spary I (Pharmaceutical Innovations)
 T-Spary I (Pharmaceutical Innovations)
 PROTEXTM DISINFECTANT SPRAY
 MetriZyme

After equipment cleaning / disinfection completed, store in a cool dry place.


Please refer to the equipment component’s User manual to get the limit of
temperature, pressure, humidity and time that the equipment components can
with stand in detail.

Never:

 Let any liquid enter the device.


 Sterilize the equipment by heating or with gas.

6-1
6.2 Maintenance

 Equipment should store at the specified temperature, humidity and other


external conditions.
 Observe the pump’s statue to find and solve problems timely.

No modification of this equipment is allowed.


WARNING!

This equipment shall not be serviced or maintained while in

use with the patient.


WARNING!

6.3 Safe Use and Maintenance of the Rechargeable Batteries

 Rechargeable batteries cannot be replaced.


Battery Type: KMP-BAT-01.
Size: 7.4V-2600mAh.
 Ensure the safety of the battery, please avoid overcharge and keep the
battery maintains a certain amount of electricity all the time.
 Under the suitable external condition, if the device will be stored for
longer than six months, please charge the device.

6-2
Appendix A Start-up Curves and Trumpet Curves
The following are the Start-up Curves and Trumpet Curves @different
infusion speeds

Infusion time: 2h.


Syringe type:5ml、10ml、20ml、30ml、50/60ml.
Solution: Ⅲ grade water.
Test temperature: 23±2℃.

Figure A–6-1Start-up Trend. BD 5ml@1ml/h

Figure A–6-2Trumpet Curve. BD 5ml@1ml/h

A-1
Figure A–6-3 Start-up Trend. BD [email protected]/h

Figure A–6-4 Trumpet Curve. BD [email protected]/h

A-2
Figure A–6-5Start-up Trend. BD10ml@1ml/h

Figure A–6-6Trumpet Curve. BD10ml@1ml/h

A-3
Figure A–6-7Start-up Trend. BD10ml@5ml/h

Figure A–6-8Trumpet Curve. BD10ml@5ml/h

A-4
Figure A–6-9Start-up Trend. BD20ml@1ml/h

Figure A–6-10Trumpet Curve. BD20ml@1ml/h

A-5
Figure A–6-11Start-up Trend. BD20ml@5ml/h

Figure A–6-12Trumpet Curve. BD20ml@5ml/h

A-6
Figure A–6-13Start-up Trend. BD30ml@1ml/h

Figure A–6-14Trumpet Curve. BD30ml@1ml/h

A-7
Figure A–6-15Start-up Trend. BD30ml@5ml/h

Figure A–6-16Trumpet Curve. BD30ml@5ml/h

A-8
Figure A–6-17Start-up Trend. BD50ml@1ml/h

Figure A–6-18Trumpet Curve. BD50ml@1ml/h

A-9
Figure A–6-19Start-up Trend. BD60ml@5ml/h

Figure A–6-20Trumpet Curve. BD60ml@5ml/h


The graphs show the accuracy/uniformity of flow in relation to time. They
allow for the following:

The delivery behavior or delivery precision is essentially influenced by the


type of the disposable used. Deviations from the technical data of the pump
cannot be excluded if lines (disposables) other than those stated in the order
data are used.

A-10
The above graphs show the test’s results, which can be used as an important
symbols of comprehensive characteristic of the pump.

The above data is tested by the same syringe pump, and each test using new
syringe, a total of 10 syringes.

 Trumpet Curves

All measured values for second hour in each case.

Measurement interval △t = 0.5 min

Observation interval p x △t [min]

 Start-up Curves

Measurement interval △t = 0.5 min

Measurement duration T = 120 min

Flow Qi (ml/h)

A-11
FOR YOUR NOTE

A-12
Appendix B EMC Information

Accompanying Documents:

1. Instructions for use

 Model s7/sp-3 needs special precautions regardingEMC and needs to be


installed and put into service according to the EMC information provided in
the ACCOMPANYING DOCUMENTS;
 Portable and mobile RF communications equipment can affect model
s7/sp-3.

2. Technical description

 Warning that the use ofaccessories, transducers and cables other than
those specified with the exception of transducers and cables sold by the
manufacturer of the model s7/sp-3 as replacement parts for internal
components, may result in increased EMISSIONS or decreased IMMUNITY
of the models7/sp-3.
 Warning that the model s7/sp-3 should not be used adjacent to or
stackedwith other equipment.

B-1
3. Normative references:

Guidance and manufacturer’s declaration – electromagnetic immunity


The models7/sp-3 is intended for use in the electromagnetic environment
specifiedbelow. The customeror the user of the model s7/sp-3 should ensure
that it is used in such an environment.
Electromagnetic
Immunity IEC 60601 Compliance
environment –
test test level level
guidance
Floors should be wood,
Electrostatic concrete orceramic tile. If
discharge ±8 kV floors are covered
±8 kV contact
(ESD) contact withsynthetic material,
±15 kV air
IEC ±15 kV air the relative
61000-4-2 humidityshould be at
least 30 %.

Electrical fast Mains power quality


±2 kV for ±2 kV for
transient/burst should be that of atypical
power power
IEC commercial or
supply lines supply lines
61000-4-4 hospitalenvironment.

±1 kV
line(s) and ±1 kV line(s) Mains power quality
Surge
neutral and neutral should be that of atypical
IEC
±2 kV ±2 kV line(s) commercial or
61000-4-5
line(s) to to earth hospitalenvironment.
earth
Voltage dips, <5 % UT <5 % UT Mains power quality
short (>95 % dip (>95 % dip in should be that of atypical
interruptions in UT) UT) commercial or
and for 0,5 cycle for 0,5 cycle hospitalenvironment. If

B-2
voltage the user of themodel
variations 40 % UT 40 % UT s7/sp-3requirescontinued
on power (60 % dip in (60 % dip in operation during
supply UT) UT) powermains
input lines for 5 cycles for 5 cycles interruptions, it is
IEC recommendedthat the
61000-4-11 70 % UT 70 % UT model s7/sp-3 bepowered
(30 % dip in (30 % dip in from an uninterruptible
UT) UT) powersupply or a battery.
for 25 cycles for 25 cycles

<5 % UT <5 % UT
(>95 % dip (>95 % dip in
in UT) UT)
for 5 sec for 5 sec
Power
Power frequency
frequency
magnetic fieldsshould be
(50/60 Hz)
at levels characteristic of
magnetic 3 A/m 3 A/m
atypical location in a
field
typical commercialor
IEC
hospital environment.
61000-4-8

NOTEUT is the a.c. mains voltage prior to application of the test level.

B-3
4. Normative references (Continued)

Guidance and manufacturer’s declaration – electromagnetic immunity


The model s7/sp-3 is intended for use in the electromagnetic environment
specified below. The customer orthe user of the model s7/sp-3 should ensure
that it is used in such an environment.
Immunity IEC 60601 Compliance Electromagnetic environment –
test test level level guidance

Portable and mobile RF


communications
equipmentshould be used no
closer to any part of themodel
s7/sp-3, including cables, than
Conducted
therecommended separation
RF 3 Vrms
distance calculated fromthe
IEC 150 kHz to
equation applicable to the
61000-4-6 80 MHz 3V
frequency of thetransmitter.
Radiated 3 V/m 3 V/m
RF 80 MHz to
Recommended separation
IEC 2,5 GHz
distance
61000-4-3
d=1.2√P
d=1.2√P 80MHz to 800MHz
d=2.3 √P 800MHz to 2.5
GHz
Where P is the maximum output

B-4
power rating of thetransmitter in
watts (W) according to the
transmittermanufacturer and d is
the recommended
separationdistance in metres (m).
Field strengths from fixed RF
transmitters, as determinedby an
electromagnetic site
survey,ashould beless than the
compliance level in each
frequencyrange.bInterference may
occur in the vicinity of equipment
marked with the following
symbol:

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 absorptionand reflection from structures, objects
and people.
a
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and landmobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted
theoreticallywith accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic sitesurvey should be
considered. If the measured field strength in the location in which the
model s7/sp-3 isused exceeds the applicable RF compliance level above,
the model s7/sp-3 should be observed to verifynormal operation. If
abnormal performance is observed, additional measures may be

B-5
necessary, such as reorientingor relocating the model s7/sp-3.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.

B-6
5. Normative references (Continued)

Guidance and manufacturer’s declaration – electromagnetic emissions

The model s7/sp-3 is intended for use in the electromagnetic environment


specified below. Thecustomer or the user of the model s7/sp-3 should ensure
that it is used in such an environment.
Electromagnetic environment –
Emissions test Compliance
guidance
The model s7/sp-3 uses RF energy only
for itsinternal function. Therefore, its RF
RF emissions
Group 1 emissions are verylow and are not likely
CISPR 11
to cause any interference innearby
electronic equipment.
RF emissions
Class A
CISPR 11
The model s7/sp-3 is suitable for use in all
Harmonic
Class A establishments, but if used in domestic
emissions
establishments and those directly
IEC 61000-3-2
connected to the public low-voltage power
Voltage
supply network that supplies buildings
fluctuations/
used for domestic purposes, whatever
flicker Complies
additional measures are necessary.
emissions
IEC 61000-3-3

B-7
Recommended separation distances between
portable and mobile RF communications equipment and themodel
s7/sp-3
The model s7/sp-3 is intended for use in an electromagnetic environment in
which radiated RF disturbancesare controlled. The customer or the user of
theModel s7/sp-3 can help prevent electromagnetic interferenceby
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and themodel s7/sp-3 as
recommended below, according to the maximum output power of the
communicationsequipment.
Separation distance according to frequency of
Rated
transmitter(m)
maximum
150 kHz to 80 MHz to 800 MHz to 2,5
outputpower of
80 MHz 800 MHz GHz
transmitter
W

0,01 0.12 0.12 0.23


0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d inmeters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is
themaximum 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 andreflection from structures, objects
and people.

B-8
Appendix C Parameters Default Value
User Parameters Default
Only Rate
Syringe Mode
Mode
Rate --
VTBI --
Drop Rate Display
Close
Front Switch
Only Rate
Drop Rate Drop Rate Display
Mode Close
Display Back Switch
Parameters Drop Rate --
Drop Rate
20 drops/ml
Coefficient
Weight 50 kg
Treatment Dose --
Dosage
Parameter Solvent --
Mode
Dosage Rate --
VTBI --
Drug --
Cap Rate 2000 ml/h
After VTBI
Completed Stop
Common Entry
VTBI Finished
Parameter Continue Open
Parameters
Stop Open
Enter KVO
Open
Mode
Manual BOLUS Bolus Rate 150 ml/h

C-1
Parameters Bolus Volume 5 ml
Auto BOLUS Bolus Rate 150 ml/h
Parameters Bolus Volume 1 ml
Single PUSH Limit Volume 1ml
KVO Rate 0.1 ml/h
IV. Set Type Boon
Pressure Class 85 kPa
Daytime Start 5:00
Daytime Daytime Volume 5
& Brightness 9
Nighttime Daytime Start 18:00
Setting Nighttime Volume 1
Brightness 2
Pop up Last
Close
Power on Setting UI
pop up
Setting Pop up PUSH
Close
UI
User
Auto-Lock Setting Close
Parameter
Uncalibrate
s Calibration Mark
d
Touch X Migration --
calibration Y Migration --
X Coefficients --
Y Coefficients --
Extended Syr. Set Optional Not
Extended Syr.
state Optional
Set
Accuracy Calibration Mark Calibration
Calibration
Pressure Calibration Mark Calibration
Language English

C-2
Appendix D Abbreviations
AC Alternating Current
Cap Rate The upper limit of the rate
CLR Clear
DC direct current
EMC Electromagnetic Compatibility
Syr. Syringe
KVO Keep vein open
RF Radio frequency
RS232 recommend standard 232
R-T Mode Rate-Time Mode
SIP /SDP Signal Input Port/Signal Output Port
UI User Interface
VTBI Volume To Be Infused
V-T Mode VTBI-Time Mode
WEEE Waste Electrical and Electronic Equipment

D-3

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