SK-600Ⅰ

(This Operator's Manual is also applicable to the

SK-600ⅠB Infusion Pump)

Infusion Pump

Operator’s Manual
© 2011-2013 Shenzhen Shenke Medical Instrument Technical Development Co.,
Ltd. All rights reserved.

The issue date for this Operator’s Manual is October 2013.

Version:2.0

I
Intellectual Property Statement
SHENZHEN SHENKE MEDICAL INSTRUMENT TECHNICAL DEVELOPMENT CO.,
LTD (hereinafter called SK Medical) owns the intellectual property rights to this SK
product and this manual. This manual may refer to information protected by copyright or
patents and does not convey any license under the patent rights or copyright of SK
Medical, or of others.

SK Medical intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the
written permission of SK Medical is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any

other derivative work of this manual in any manner whatsoever without the written
permission of SK Medical is strictly forbidden.

, and are the trademarks, registered or otherwise,

of SK Medical in China and other countries. All other trademarks that appear in this
manual are used for informational or editorial purposes only. They are the property of
their respective owners.

II
Responsibility of the Manufacturer

SK Medical reserves the final interpretation for this Operator’s Manual.

SK Medical reserves the right to modify the Operator’s Manual without further notice.
The modified parts will be present in the new edition of Operator’s Manual.

SK Medical is not responsible for any software and devices supplied by companies
other than SK Medical or supplied by distributors.

SK Medical is responsible for the safety, reliability and performance of the product
on condition that all the following conditions are satisfied:

 Installation, expansion, readjustment, improvement and maintenance must be

conducted by professionals authorised by SK Medical.
 All maintenance involving replacement of spare parts, accessories and
consumables should use the original sets or sets authorised by SK Medical.
 Relevant electrical equipment meets national standards and the requirements
of this Operator’s Manual.
 Please operate the product as per the Operator’s Manual.

WARNING
 The device must be operated by professional clinicians or under the
guidance of professional clinicians. The users must receive adequate
product training. No unauthorised or untrained personnel should carry out
any operation.

III
Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions
SK Medical's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product or
the use of parts or accessories not approved by SK Medical or repairs by people
other than SK Medical authorised personnel.

This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified
or unauthorised service people.
 Malfunction of an instrument or part whose serial number is not fully legible.
 Other malfunctions not caused by an instrument or part itself.

IV
Company Contact

Manufacturer: Shenzhen Shenke Medical Instrument Technical

Development Co., Ltd
Address: 5th,6th Floor, Block A, Tempus Building, 1st Qingshuihe
Road, Luohu District 518023 Shenzhen China
E-mail Address: http://www.skmedica.com
Service Hotline: +86 400 700 5652
Tel: +86 755 82402696
Fax: +86 755 82438567

EC-Representative: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg，Germany

Tel: +49-40-2513175
Fax: +49-40-255726

V
Preface

Purpose of the Manual

This Operator’s Manual describes the product’s application, function and operation
in detail. Please read this Operator’s Manual carefully and understand the content
before use, in order to ensure the proper usage and guarantee the safety of the
patient and the user.
This Operator’s Manual describes the product as per the most complete
configuration. Some content of this manual may not be applicable for the product
you are handling. Please contact us if you have any questions.
Please store this Operator’s Manual with the infusion pump in order to consult it at
your convenience.

Intended Audience
This Operator’s Manual is only applicable to use by suitably qualified clinicians.

Illustrations
All illustrations in this Operator’s Manual are used for reference only. Settings or
data shown may not be entirely consistent with the actual information displayed on
the product.

Conventions
 Italic text is used in this manual to quote referenced chapters or sections.
 The terms “Danger”, ”Warning”, and “Caution” are used throughout this manual
to point out hazards and to designate a degree or level of severity.

VI
Contents
1 Safety .................................................................................................................. 1-1
1.1 Safety Information ............................................................................................. 1-1
1.1.1 DANGER ............................................................................................... 1-2
1.1.2 WARNING ............................................................................................. 1-2
1.1.3 CAUTION .............................................................................................. 1-3
1.1.4 NOTE .................................................................................................... 1-5
1.2 Equipment Symbols .......................................................................................... 1-6

2 Overview ............................................................................................................. 2-1

2.1 Product Introduction .......................................................................................... 2-1
2.1.1 Scope of Use ........................................................................................ 2-1
2.1.2 Contraindications .................................................................................. 2-1
2.1.3 Product Structure, Composition and Performance ................................ 2-1
2.2 Product Exterior ................................................................................................ 2-3
2.2.1 Front View ............................................................................................. 2-3
2.2.2 Rear View.............................................................................................. 2-5
2.3 Screen Display .................................................................................................. 2-6
2.4 Battery............................................................................................................... 2-6
2.4.1 Overview ............................................................................................... 2-6
2.4.2 Battery Guidelines ................................................................................. 2-7
2.4.3 Battery Maintenance ............................................................................. 2-8
2.4.3.1 Battery Optimization ..................................................................... 2-8
2.4.3.2 Checking the Battery .................................................................... 2-9
2.4.4 Battery Recycling .................................................................................. 2-9

3 Installation and Maintenance ............................................................................ 3-1

3.1 Installation ......................................................................................................... 3-1
3.1.1 Out of Box Audit (OOBA) ...................................................................... 3-1
3.1.2 Environmental Requirements ................................................................ 3-2
3.1.3 Power Supply Requirements ................................................................. 3-2
3.1.4 Fixing the Infusion Pump....................................................................... 3-3
3.1.5 Installing the Power Cord ...................................................................... 3-4
3.1.6 Installing the Drop Sensor (optional) ..................................................... 3-4
3.2 Maintenance ..................................................................................................... 3-6
3.2.1 Inspection .............................................................................................. 3-6
3.2.2 Cleaning and Disinfection ..................................................................... 3-7
3.2.3 Periodic Maintenance............................................................................ 3-8
3.2.4 Pollution-Free Disposal and Recycling.................................................. 3-9

4 Operation Guide ................................................................................................. 4-1

1
4.1 Operation Flow Chart ........................................................................................ 4-1
4.2 Operating Steps ................................................................................................ 4-2
4.2.1 Turning on the Infusion Pump ............................................................... 4-2
4.2.2 Installing the Infusion Tube.................................................................... 4-3
4.2.3 Setting the Infusion Parameters ............................................................ 4-4
4.2.4 Clearing the Accumulated Volume ........................................................ 4-5
4.2.5 Starting the Infusion .............................................................................. 4-5
4.2.6 Infusion Finished ................................................................................... 4-5
4.2.7 Turning off the Infusion Pump ............................................................... 4-5

5 Function and Interface....................................................................................... 5-1

5.1 Main Interface and Parameters ......................................................................... 5-1
5.2 Bolus Function .................................................................................................. 5-2
5.3 Drop Rate Function and Setting (Optional) ....................................................... 5-2
5.3.1 Starting the Drop Rate Function ............................................................ 5-3
5.3.2 Setting the Drop Rate for the Infusion Tube .......................................... 5-3
5.3.3 Viewing the Drop Rate Interface ........................................................... 5-4
5.4 Using a Different Brand of Tube ........................................................................ 5-5
5.4.1 Selecting the Infusion Tube ................................................................... 5-5
5.4.2 Accuracy Calibration ............................................................................. 5-7
5.4.3 Pressure Adjustment ............................................................................. 5-7
5.5 Setting the Occlusion Level............................................................................... 5-9
5.6 Setting the Air Bubble Filter Level ..................................................................... 5-9
5.7 Automatic Pressure Release Function (Anti-Bolus) ........................................ 5-10
5.8 KVO Function.................................................................................................. 5-10

6 Alarms ................................................................................................................. 6-1

6.1 Overview ........................................................................................................... 6-1
6.2 Alarm Levels and Methods ................................................................................ 6-1
6.3 Pausing the Alarm Tone .................................................................................... 6-2
6.4 Alarm Countermeasures ................................................................................... 6-2

A Product Specifications ..................................................................................... A-1

A.1 Safety Specifications ........................................................................................ A-1
A.2 Environmental Specifications ............................................................................ A-1
A.3 Power Specifications ........................................................................................ A-1
A.4 Hardware Specifications ................................................................................... A-2
A.5 Basic Infusion Pump Parameters ..................................................................... A-3
A.6 Occlusion Alarm Pressures, Maximum Delays for Alarm Times and Maximum
Permissible Dose Volumes ..................................................................................... A-4
A.7 Infusion Accuracy Table .................................................................................... A-5

B EMC ................................................................................................................... B-1

2
C Alarm Information............................................................................................. C-1
C.1 Alarm Information ............................................................................................ C-1
C.2 Prompt Messages ........................................................................................... C-6

D Symbols and Terms.......................................................................................... D-1

D.1 List of Units ...................................................................................................... D-1
D.2 List of Terms .................................................................................................... D-2

3
FOR YOUR NOTES

4
1 Safety
1.1 Safety Information
The safety statements presented in this chapter refer to basic safety information that
the operator must pay attention to and abide by when using the infusion pump.There
are additional safety statements in other chapters or sections, which may be the
same as or similar to the following, or specific to particular operations.

DANGER
 Indicates an imminent hazard that, if not avoided, could result in death,
serious injury or damage to product/property.

WARNING
 Indicates a potential hazard or unsafe practice that, if not avoided, could
result in death, serious injury or damage to product/property.

CAUTION
 Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury, product malfunction or damage to
product/property.

NOTE
 Provides application tips or other useful information to ensure that you
get the most out of the product.

1-1
1.1.1 DANGER

DANGER
 The infusion tube must be installed straight and level in the bottom of
the groove on the infusion pump.

1.1.2 WARNING

WARNING
 This infusion pump is intended to be used for clinical intravenous
infusion. It is not intended to be used for enteral and endogastric
nutrition infusion. It can only be used by professional clinicians, medical
electrical experts, or suitably trained nurses on specific occasions.
 The infusion pump and its accessories must be inspected before use to
guarantee their normal and safe operation.
 Avoid using this infusion pump in a flammable or explosive atmosphere
in case of fire outbreak or explosion.
 Infusion alarms must be set based on the actual situation of the
patients.Do not rely too heavily on the audible alarm system during
infusion supervision. Pay close attention to the actual clinical situation
of the patient.
 Keep monitoring the remaining liquid volume in the infusion bags (or
infusion bottles) and check that there are no air bubbles in the infusion
tubes during the infusion. Do not rely solely on the alarm function of the
infusion pump.
 The pressure detector may not work normally in high-pressure
environments, especially in hyperbaric oxygen therapy.
 Make sure the blood vessel is well protected before infusion.
 In the infusion tube, occlusion caused by tube knots and filter
coagulation or intubations may cause the pressure inside the infusion
tube to rise.If this occurs, the effort to eliminate the occlusion may
cause an excessive dose of liquid to be infused into the patient’s
body.Appropriate measures should be taken to prevent this
situation.For example,clamp the infusion tube before eliminating the

1-2
 occlusion.
 This infusion pump should be used 120 cm above or below the patient’s
heart.
 Avoid using the infusion pump when an alarm is sounding.
 When another set of infusion systems or accessories is connected to
the infusion tube used in this infusion pump, the operation of this pump
may not meet its specifications.
 Only standard components, connectors and disposable products can be
used with this pump.Subsidiary items must not be attached to the pump
and its accessories. Modification of the pump is prohibited and may lead
to unexpected consequences.
 The pump's accuracy will not be maintained when it is used with a
non-standard infusion tube or the parameters of the infusion tube are
not set accurately. The maximum deviation may reach 40% or above.
 Disposable accessories must be disposed of after use in accordance
with the relevant hospital regulations.
 This infusion pump belongs to Class II (type of electric shock
protection); the supplied Type I power cord PE earth terminal should not
be used as ground protection and functional earthing.
 Do not open the casing of the infusion pump, as you may suffer an
electric shock.The infusion pump must be maintained or updated by
maintenance staff trained and authorized by our company.
 The packaging materials must be disposed of in compliance with local
laws and regulations or the hospital policy on waste management.They
must be kept out of the reach of children.
 The double thickness of the infusion tube should be between 0.8
mm–1.2 mm. The outer diameter should be between 3.5 mm–4.5 mm.
 Otherwise, its accuracy cannot be guaranteed, and may cause serious
injury to patients.

1.1.3 CAUTION

CAUTION
 Please use the accessories specified in this Operator’s Manual to
guarantee the patient’s safety.
 Cables must be connected carefully to reduce the possibility of the

1-3
 patient choking or getting caught in them.
 Disposable accessories can only be used once. Repeated use may lead
to deterioration in performance or cross-infection.
 After installation of the infusion tube and before infusion, check for
leakages. If any are found, they should be rectified as soon as possible.
 Adjust the fixing site of the infusion tube every 4 hours after infusion
begins, in order to guarantee its accuracy.Replace the infusion tube
after the infusion has been running for 24 hours.
 When this infusion pump and its accessories exceed their service life,
they must be disposed of in accordance with local statutes or hospital
regulations.If you have any queries, please contact your distributor or
the manufacturer.
 Electromagnetic fields may influence the performance of the infusion
pump. Therefore, equipment or devices used in the vicinity of the
infusion pump must meet the EMC standard.Mobile phones, X ray and
MRI equipment are all potential interference sources because of their
high-intensity electromagnetic radiation.
 Avoid direct sunshine, high temperatures and humidity.
 Avoid exposing this infusion pump to high-pressure sterilization or
chemical materials.
 Check the built-in battery before use to make sure it has sufficient
power.Recharge the battery if necessary.
 Before the infusion pump is connected to the power supply, make sure
the voltage and frequency of the power supply comply with the label on
the pump or the specific requirements outlined in this Operator’s
Manual.
 Please install and carry the infusion pump appropriately to protect the
pump from being dropped, knocked, violently shaken, or suffering other
damage caused by forces external to the machine.
 Use a piece of soft cloth dampened with warm water to wipe the surface
of the infusion pump if any liquid is spilled on it.
 If the surface tension, specific gravity and viscosity of the infusion
solution are different from saline (for example, a kind of solution mixed
with surfactant), the infusion accuracy may be different from the
accuracy listed in the specifications table.
 When the infusion rate is high (≥ 1000 ml/h), high-quality silicone tubes
with 0.9 mm transfusion needles must be used with the pump in order to
maintain infusion accuracy.
 If the infusion pump fails to work as specified in the Operator’s Manual
and the cause is uncertain, stop the infusion and report the situation

1-4
 (including infusion accessories used with the pump, infusion volume,
infusion rate, serial number, liquid type, etc.) to your distributor or the
manufacturer.
 The drop sensor is not applicable to light-proof medicine infusions.
Adopting light-proof IV sets on the pumps might cause the drop sensor
to fail and result in serious injury to patients.

1.1.4 NOTE

NOTE
 Keep this Operator’s Manual near to the infusion pump for ease of future
reference.
 Install the infusion pump where convenient for its supervision, operation
and maintenance.
 This Operator’s Manual describes all the settings and functions of the
infusion pump in its most complete functional configuration. The
infusion pump you are handling may not have some of the settings or
functions described herein.
 Do not insert devices that are not specified by our company into the data
interface.

1-5
1.2 Equipment Symbols

Attention! Refer to the Manual Class II equipment

Type BF applied parts Splash-proof

IP21
Alternating current power Direct current power supply
supply (AC) (DC)
Batch number Serial number

Date of manufacture Manufacturer

Dispose of using a Wireless transceiver

pollution-free method
Up or increase value Down or decrease value

Confirm Settings

Stop Silence

Start Bolus

Clear Select

ON/OFF Protect from rain during

transport

Fragile item, handle with care Keep upright during transport

Similar packaging stacked up Package should be kept

to 5 layers only between 10%–95% humidity
during transport

Package should be kept Package should be kept

between 50–106 kPa during
transport
Authorised Representative in
the European Community.
between -20–55°C during
transport
This product complies with the
EU Medical Device Directive
93/42/EEC and the basic
requirements of Directive
Appendix I, hence it carries the
CE mark.

1-6
2 Overview
2.1 Product Introduction
2.1.1 Scope of Use
This infusion pump is for use in wards, operating theaters, and observation rooms for
accurate and continuous infusion to patients.It does not apply to enteral or
endogastric nutrition infusion.

This infusion pump is expected to be used in institutes or units with healthcare

capabilities, such as hospital outpatient departments, accident and emergency
departments, wards, operating theaters, observation rooms, clinics, nursing homes,
etc.

WARNING
 The infusion pump and its accessories must be inspected before use to
guarantee their normal and safe operation.

CAUTION
 The operating environment and power supply of this infusion pump
must meet the requirements specified in A. Product Specifications.

2.1.2 Contraindications
None

2.1.3 Product Structure, Composition and Performance

SK-600Ⅰ/600ⅠB Infusion Pumps mainly comprise a housing assembly, pump
component, board and battery.

SK-600I/600IB Infusion Pumps contain the following parts:

2-1
 Microcomputer System:the core of the whole system, which provides intelligent
control and management over the whole system and processes detection signals.
In this system, two single-chip Micyoco (SCM) systems are adopted for mutual
backup copy and supervision.When one SCM fails, the other one will give a
timely warning signal and cut the power of the host computer to stop the pump
with the purpose of ensuring the patient’s safety.
 Pump Device:the power source of the infusion, employs a step motor to drive the
continuous extrusion of the pump tablets upon the infusion tube, in order to
achieve infusion.
 Detection Device:the device mainly includes various types of sensor, including
an air bubble sensor (detects air bubbles inside the infusion tube), a pressure
sensor (detects the pressure inside the infusion tube), etc.
 Alarm Device:the device mainly includes audible alarms and information alarms,
drawing the user’s attention to the correct operation.
 Input and Display Device:the input device is used for setting infusion parameters,
such as flow rate, etc.The display device shows all the parameters and the
current operating status on the screen.
 Battery:the battery sustains the operation of the infusion pump when there is no
AC power supply.

SK-600I/600IB Infusion Pump Performance:

 Accurate control of flow rate
 Accurate control of infusion volume
 Alarms for Air Bubble, Finish, Occlusion, Battery Empty, System Error (Err 1),
Motor Error (Err 2), Drops Error (Err 3), Handle Open（Err 4), Reminder (Err 5),
Low Battery, AC Disconnect etc.

2-2
2.2 Product Exterior
2.2.1 Front View

1. Alarm indicator lamp

 Flashing red light for high-level alarm;
 Flashing amber light for medium-level alarm;
 Steady amber light for low-level alarm.
2. AC indicator lamp
This light illuminates steady green when the AC power supply is connected.
3. Run indicator lamp
This light illuminates steady green after the infusion tube is correctly installed, and
flashes during infusion.
4. Quick operating instructions
Guidance for easy operation.
5. Tube fixing groove

2-3
Used to secure the infusion tube.
6. Display
Displays infusion parameters and running status.
7. UP key
Moves cursor up or increases value in increments of100, 10 or 1.
8. Handle
 Pull up the handle:to install or remove the infusion tube.
 Push down the handle:to tightly clamp the tube and prevent the handle from
protruding at the side.If the infusion tube is correctly installed, the running
indicator light will illuminate when the handle is pushed down. Otherwise,
reinstall the tube.
9. DOWN key
Moves cursor down or decreases value in increments of100, 10 or 1.
10. STOP key
 During infusion, press this key to stop infusion;when an alarm is on, press this
key to silence the alarm (except battery alarms).
 In the Accuracy Calibration and Pressure Adjust interfaces, cancels saving the
current setting and exits the interface.
11. START/BOLUS key
 In stop status, if the infusion tube is correctly installed, pressing this key starts
infusion.
 During infusion, by keeping your finger on this key as long as you need, the
pump will start the bolus function (flow rate ≤ 600 ml/h). After removing your
finger from the key, it will return to the original infusion rate.
12. SET key
In stop status, press this key to enter the Infusion Parameters setting interface.
13. Power
 To turn on the machine:press the key and then release it.
 To turn off the machine:press and hold until the display flashes for two seconds,
then release.
 Backlight:after powering on the machine, press this key to switch the display
backlight on/off.
14. POWER ON indicator light
This light illuminates steady green in Power On mode.
15. SELECT key
In the setting interface for the infusion parameter, press this key to select Rate,
Preset volume limit and Bed No. in turn.
16. CLEAR/SILENCE key
 In the Infusion Stop interface, press this key to clear the accumulated amount;
 In value inputting status, press this key to clear the input value to the minimum
value;
 When an alarm occurs in the Run interface, press this key to pause the alarm
tone for 2 mins (except battery alarms).

2-4
2.2.2 Rear View

1.AC power supply port

2.Handle
3.Product label
4.Vent
5.Speaker
6.Retaining clamp
Secures the infusion pump to the stand.
7.Clamp knob
Used in conjunction with the fixing clamp to secure the infusion pump to the stand.
8.Drop sensor port (drop sensor is an optional purchase accessory)

2-5
2.3 Screen Display
This infusion pump has a built-in LCD screen. The display information comprises four
main parts:

1. Power information area

Displays the AC power icon and battery icon.
2. Information area
Displays the infusion parameters.
3. Alarm information area
Display alarm information, such as Air Bubble, Occlusion, Empty and Finish.
4. Value area
Displays the specific values of the infusion parameters.
5. This area displays the current infusion tube A, B, or C, for infusion tubes of Brand A,
Brand B and Brand C respectively.

2.4 Battery
2.4.1 Overview
This infusion pump uses a built-in rechargeable battery to guarantee the normal use of the
pump during patient transfers or power outages in the hospital. The battery will
automatically charge itself when the pump is connected to the AC power, both in Power
On and Power Off mode. The pump will operate with its battery in the event of a sudden
power failure.

The battery can only provide power for the pump to operate normally for a certain length
of time .Once the battery reaches its minimum charge, the pump will emit an alarm tone
every few seconds to notify the user;after a certain length of time, the pump will emit a

2-6
rapid beeping alarm tone and the alarm indicator light will flash to alert the user that the
battery is nearly empty. If the pump is running at this time, it will automatically stop the
infusion and will not operate until it is connected to the AC power. The battery empty alarm
will only stop sounding after the pump is connected to the AC power.

The alarm indicator light, AC indicator light, AC icon and battery icon all indicate the
battery's current status:

 When the battery is empty, the red alarm light flashes.

 When the battery is low, the amber alarm light flashes.
 When not connected to the AC power supply, the amber alarm light glows
steady and the battery symbol is displayed in the upper-left corner of the
screen.
 When charging, the AC indicator light glows steady amber and the battery
charging icon is displayed in the upper-left corner of the screen.

NOTE

 8-14 hours are required to fully charge an empty battery.

 Please discharge the battery every 3 months to prevent damage to the
battery if the product is not in regular use.
 The battery is a consumable part. Please replace it when it no longer
holds adequate charge.
 If you have any queries, please contact your distributor or the
manufacturer.

2.4.2 Battery Guidelines

The lifespan of the battery depends on its usage frequency and environment. If it is used
and maintained correctly, its lifespan is 3 years. Otherwise, its lifespan will be shortened.
The battery will need to be replaced every 3 years.

For safe use and longer battery life, please adhere to the following battery guidelines:

 The battery should be checked annually. Before the pump is sent for
maintenance or if you suspect the battery to be the cause of a problem, the
battery should be checked.
 Optimize the battery every 3 months of use (or storage), or once the battery
running time is significantly shortened.

2-7
 WARNING

 Use the battery specified by the manufacturer.

 Please replace the battery immediately if it is damaged or leaking.
 Damaged batteries must not be used.
 Used batteries must be returned to your supplier or the manufacturer, or
disposed of in accordance with applicable laws and regulations.

2.4.3 Battery Maintenance

2.4.3.1 Battery Optimization
Optimize the battery when it is used for the first time. A complete optimizing cycle
entails the following: charge continuously until the battery is fully charged, then
discharge the battery until the pump powers off automatically, then charge the battery
continuously again until fully charged. During usage, regularly optimizing the battery
performance will extend its lifespan.

NOTE
 The actual battery capacity will reduce after the battery has been used for
some time.If the battery capacity is obviously shortened during
optimization, please replace the battery.

Please follow the steps below during optimization:

1. Disconnect the infusion pump from the patient, and stop the infusion.
2. Connect the infusion pump to the AC power, charging continuously for 12 hours.
3. Disconnect the infusion pump and the AC power, using the battery as the power
supply until the infusion pump powers off automatically.
4. Connect the infusion pump to the AC power, charging continuously for 12 hours.
5. Battery performance optimization is complete.

2-8
2.4.3.2 Checking the Battery
Regular battery checks are required because battery function will reduce as it is used.

NOTE
 If the battery’s usage time is too short after a full charge, the battery may
be damaged.The battery’s power supply time depends on the usage
frequency of the pump and its setting parameters. For
example:extended use of the display backlight.
 If the battery has obvious damage (e.g. misshapen, dented, leaking) or
cannot hold charge, it should be replaced and recycled.

2.4.4 Battery Recycling

If the battery has obvious damage (e.g. misshapen, dented, leaking) or the battery
capacity is used up, it should be replaced and recycled. Please follow the applicable
laws on recycling.

WARNING
 The battery must not be disassembled, thrown onto fire or
short-circuited.The burning, explosion or leakage of the battery may
result in personal injury.

2-9
FOR YOUR NOTES

2-10
3 Installation and Maintenance
3.1 Installation

WARNING
 The software copyright of this infusion pump belongs to our company.
Any infringement such as falsification, reproduction or exchange by any
means or in any form by any organization or individual is prohibited
without permission.

3.1.1 Out of Box Audit (OOBA)

Before opening the box, please check the packaging carefully for any damage to the
products during transportation. If there is any damage, please contact the distributor
or our company immediately.

If the packaging is intact, please open it immediately, carefully remove the infusion
pump and its accessories, and inspect them against the packing list. Examine the
pump for any mechanical damage and ensure that the box includes all items on the
packing list. Please contact our customer service department immediately if you
have any queries.

WARNING
 Please keep the packaging materials out of the reach of children.The
packaging materials must be disposed of in compliance with local laws
and regulations or the hospital policy on waste management.

NOTE
 Please keep the packing case and packaging materials for future
transport or storage.
 Please contact your distributor or the manufacturer if any of the spare
parts are missing when you open the box.

3-1
3.1.2 Environmental Requirements
The operating environment of this infusion pump must meet the requirements in A.2
Environmental Specifications.

The operating environment of this infusion pump should also be appropriately

protected from noise, vibration, dust, and corrosive, inflammable or explosive
substances. There should be a 2-inch (5 cm) gap around the infusion pump to
ensure that air can circulate freely.

When the infusion pump is transferred from one place to another, the difference in
temperature and humidity may cause condensation to form in the infusion pump. If
this is the case, do not switch on the pump until the condensation has gone.

3.1.3 Power Supply Requirements

The power supply for this infusion pump must meet the requirements in A.3Power
Specifications.

WARNING
 Ensure that the operating environment and power supply meet
environmental requirements and the power supply requirements
specified above. Otherwise, the infusion pump will not meet the
technical specifications outlined in A. Product Specifications, and this
may also cause unexpected consequences such as damage to the
device.
 The power supply must be selected in accordance with the settings for
the system power voltage.Otherwise, it may cause severe damage to the
system.

3-2
3.1.4 Fixing the Infusion Pump

Fig. 3-1
Instructions for fixing the infusion pump as shown in Fig. 3-1:
1. Steel tube of infusion pump stand
2. Clamp knob

Fig. 3-2 Fig. 3-3

Procedure for installing infusion pump onto infusion pump stand:

1. As shown in Fig. 3-2, for convenience, rotate the clamp knob counter-clockwise
and make enough room for the installation of the pump on the stand.
2. As shown in Fig. 3-3, place the stand in line with the clamp, and then turn the
clamp knob clockwise until the infusion pump is securely installed on the stand.

3-3
 NOTE

 The infusion pump must be installed horizontally.

 Please ensure the stand is stable before installation.

3.1.5 Installing the Power Cord

Plug the power cord into the socket on the machine.

NOTE

 Applicable power supply range is: 100–240 V, 50/60 Hz.

 The AC power cable should be inserted correctly and tightly.
 When the infusion pump is not connected to the AC power, it will emit a
pip sound every few seconds to remind the user to connect the AC
power.

3.1.6 Installing the Drop Sensor (optional)

NOTE
 This section should be used with the optional drop sensor. The user may
skip the instructions in this section if a drop sensor is not included with
the infusion pump.
 The drop sensor function can only be started when the rate ≤ 400 ml/h.

3-4
 Fig. 3-4 Fig. 3-5

1. Firmly insert the drop sensor power plug into the connecting port on the rear
panel; at the same time, the volume of the liquid in the filter must be less than 1/3
that of the filter volume;
2. As shown in Fig. 3-5, clip the drop sensor to the liquid filter (by manually applying
pressure as shown in Fig. 3-4), making sure that the drop sensor is above the
surface of the liquid.

NOTE

 The surface of the liquid in the filter must be lower than the drop sensor,
and splashing of the liquid inside the filter should be avoided.
 The positioning block of the filter must be inserted vertically through the
positioning groove on the drop sensor.
 The infusion tube must be replaced once it has operated continuously
for over 24 hours.
 Do not tilt the drop sensor, or expose it to direct sunlight during
infusion.
 Make sure that the medicine liquid filter is not clamped too tightly by the
drop sensor.

3-5
3.2 Maintenance

WARNING
 The hospital or medical facility using this infusion pump must set up a
comprehensive maintenance plan. Failure to do so may result in device
failure or other unexpected consequences, and may even jeopardize
personal safety.
 All safety inspections or maintenance work involving the disassembling
of the pump must be conducted by professional maintenance personnel.
Action by unqualified persons may result in device failure and even
jeopardize personal safety.
 Please contact your distributor or the manufacturer immediately if you
discover any problem with the pump.

3.2.1 Inspection
The pump must be given an overall inspection before use, after it has been in
continuous use for over 6 months, or after maintenance or updating, so as to ensure
that it is operating and functioning normally.

The inspection criteria are:

 The environment and power supply meet requirements
 The battery performance is good
 The power cord is not damaged and has sufficient electrical insulation
 Current leakage meets requirements
 The infusion pump and accessories have no mechanical damage
 The accessories used with the pump are specified accessories
 The alarm system functions correctly
 Leakage after installation of the infusion tube
 Pump operates well in all infusion modes

If any pump damage or abnormal circumstances occur, please do not use the
infusion pump, and contact your distributor or the manufacturer immediately.

3-6
3.2.2 Cleaning and Disinfection
The pump must be cleaned or disinfected using the materials and methods listed in
this chapter. Otherwise, our company will not be responsible for any damage or
accident caused by cleaning and disinfection using other materials and methods.

Our company shall not be held responsible for the efficacy of infection control using
the following chemicals or methods. Please contact the hospital's infection
prevention department or epidemic experts regarding infection control methods.

Please keep the infusion pump and accessories free of dust, and comply with the
following provisions to prevent damage to the pump:

 Dilute all cleaning agents and disinfectants in accordance with the

manufacturer’s instructions, or use as low a concentration as possible.
 Do not submerge the pump in liquid.
 Do not pour liquid onto the device or its accessories.
 Avoid liquid entering the pump body.
 Do not use abrasive materials (such as steel wool or silver polishing agent) or
any strong xylene or acetone-type solvent, in order to prevent damage to the
outer casing.

WARNING
 Turn off the power and disconnect the AC power supply before cleaning
the infusion pump.

CAUTION
 If liquid is accidentally spilled on the infusion pump or its accessories and
causes the infusion pump to stop working, please contact your distributor
or the manufacturer.

The infusion pump should be cleaned regularly. The cleaning frequency should be
increased in areas with serious environmental pollution or in very windy or sandy
areas.Before cleaning, please consult or refer to the hospital's specific regulations
concerning medical device cleaning.

3-7
 The recommended cleaning agents and disinfectants are:

 Warm water
 Diluted soapy water
 Diluted aqua ammonia
 Sodium hypochlorite (bleaching powder for washing)
 Hydrogen peroxide (3%)
 Ethanol (70%)
 Isopropanol (70%)

Recommended procedure for cleaning and disinfection:

1.Turn off the power and disconnect the power cord.

2.Use a piece of soft cloth dampened with warm water to wipe the surface of the
infusion pump if any liquid is spilled on it.
3.Wipe the surface of the pump with a soft cloth soaked in 70% ethanol.
4.Keep the pump in a cool and ventilated environment to dry.
The above steps are for reference only. The effects of disinfection should be
checked according to the relevant method.

CAUTION

 Do not use ethylene oxide (EtO) gas or formaldehyde for disinfection.

3.2.3 Periodic Maintenance

1. Checking the Infusion Flow Volume
Check the infusion flow volume every 6 months using a measuring cylinder and
stopwatch.

WARNING

 Operators should not rely solely on the infusion pump detection

function, but should also use their clinical experience to determine
whether the infusion flow rate is normal.

2.Maintaining Battery Performance

Refer to 2.4.3 Battery Maintenance.

3.Routine Maintenance

3-8
 Interval Routine Maintenance Procedures

Thoroughly clean the infusion pump casing before or

According to hospital policy
after long storage periods.

1. Check the AC power plug and power cord.

Check the pump at least
once a year.
2. Run the machine until it emits a low battery alarm.
Then charge the battery to ensure it works and
recharges fully.
3. Check for leakage after correct installation of the
infusion tube.

3.2.4 Pollution-Free Disposal and Recycling

For more relevant information about pollution-free disposal and recycling, please
contact your distributor or the manufacturer.

You can dispose of the pump and accessories as follows:

1. Pumps that have been scrapped can be sent back to your distributor or the
manufacturer for proper recycling.
2. Used batteries can be sent back to your distributor or the manufacturer for
disposal, or disposed of in accordance with applicable laws and regulations.

3-9
FOR YOUR NOTES

3-10
4 Operation Guide
4.1 Operation Flow Chart

Fill the infusion bags (bottles) with the prepared liquid

Prepare Infusion
medicine, remove any air bubbles, and turn off the
infusion tube flow rate regulator;

Turn on the machine

Press the key;

Install the Infusion Set Referring to 4.2.2 Installing the Infusion Tube

Set the parameters, referring to 4.2.3 Setting the

Set the infusion parameters Infusion Parameters;

Observe whether there are any residual bubbles in the

extension tube. If there are, press the key to start

Check and remove any air
the infusion pump. Press the key again and hold it down
bubbles
to rapidly discharge the bubbles from the infusion tube,

then press the key;

Clear the accumulated
amount
Press the key;

Connect the patient and the

pump Connect the infusion tube to the patient;

Start Infusion Press the key;

Infusion Finished Press the key;

Make sure that the infusion has stopped, then

Disconnect the infusion tube
between patient and the pump disconnect the infusion tube from the patient and
remove the infusion tube;

Turn off the Infusion Pump

Press and hold the key.

4-1
4.2 Operating Steps

NOTE
 Part of this section covers the Drop Sensor function. If the user needs to
use this function, the drop sensor should be purchased as an accessory to
the infusion pump. For more details, please consult your distributor or the
manufacturer.

4.2.1 Turning on the Infusion Pump

After installing the infusion pump, turn on the device by referring to the following
steps:

1. Perform a safety inspection referring to 3.2.1 Inspection before turning on the

pump.

2. Press the key. The pump will start self-checking and will display the
power-on interface.
3. After a few seconds, the pump will finish self-checking and enter the main
interface.
4. Now the user can operate the pump by means of the operating panel.

NOTE
 When the AC indicator light is illuminated, this means that the pump is
running on AC power.
 In Power On mode, you can turn the display backlight on/off by pressing

the key.

4-2
4.2.2 Installing the Infusion Tube

①Pull out the handle as shown by the ② Pull the infusion tube straight
arrow

Install the two ends of the infusion tube

into the bottom of the infusion groove

③ Install the infusion tube straight and ④ Push down the handle after
level in the bottom of the groove on the installation
infusion pump

4-3
 WARNING

 Push down the handle after correct installation of the infusion tube when
the pump is in Power On mode. If the running indicator light illuminates,
it means that the infusion tube is correctly installed. If it does not
illuminate, the infusion tube needs to be reinstalled.
 When using the same infusion tube, change the part of the tube that is
clamped in the groove of the machine every 4 hours.The infusion tube
must be replaced once it has operated continuously for over 24 hours.
 If the infusion tube is loose or pulled too tightly, this may cause an
abnormal infusion volume.
 The double-layer thickness of the infusion tube should be between 0.8
mm–1.2 mm. The outer diameter should be between 3.5 mm–4.5 mm.
Otherwise, its accuracy cannot be guaranteed, and may cause serious
injury to patients.

 CAUTION

 After installation of the infusion tube and before infusion, check for
leakages. If any are found, they should be rectified as soon as possible.

4.2.3 Setting the Infusion Parameters

1. Press the key to place the pump in stop status.

2. Press the key to enter the setting interface for the infusion parameters. Press

the key to select Rate, Preset volume limit and Bed No. in turn.The parameter will

keep flashing when it is selected. Press the key or key to adjust the value;

press the key to save the newly set parameter.

4-4
4.2.4 Clearing the Accumulated Volume

In stop status, press the key to clear the accumulated volume.

NOTE

 The accumulated volume can only be cleared when the infusion pump is
in stop status.

4.2.5 Starting the Infusion

After setting all the parameters and installing the infusion tube correctly, press the

key. The motor will begin to run and the pump will start infusing. The running
indicator light will flash during infusion.

NOTE

 The pump will stop working automatically once the critically low battery
alarm sounds during infusion.

4.2.6 Infusion Finished

When the accumulated volume reaches the preset volume limit, the LCD will display
“Finish” and emit an audible alarm to alert the user that the infusion is finished. Press the

key to stop the infusion.

4.2.7 Turning off the Infusion Pump

Follow the steps below to turn off the infusion pump:

1. Disconnect the infusion tube between the patient and the pump.

2. Press and hold the key until the backlight blinks for 2 seconds, then release
the key and the pump will power off.

4-5
NOTE

 The flow rate and other parameters will reset to the default values after
the machine is turned off.

4-6
5 Function and Interface
5.1 Main Interface and Parameters
The infusion pump enters the main interface by default after it is switched on by pressing

the key. Press the key to enter the setting interface for the infusion

parameters, then press the key to select Rate (Fig. 5-1), Preset volume limit (Fig.
5-2) and Bed No. (Fig. 5-3) parameters in turn.For details on how to set parameters see
4.2.3 Setting the Infusion Parameters; for the parameter ranges see Table 1.

Fig. 5-1 Fig. 5-2 Fig. 5-3

Parameter Parameter Range and Description

Flow rate range for SK-600Ⅰ:1–600 ml/h

Rate
Flow rate range for SK-600ⅠB:1–2000 ml/h

PreS 1–9999 ml

Bed No. 1–100

Table 1

NOTE

 Rate setting range for SK-600Ⅰ:1–600 ml/h.

 Rate setting range for SK-600ⅠB:1–2000 ml/h.

5-1
5.2 Bolus Function
During the infusion, if you need to accelerate the infusion when the current flow rate is

below the bolus rate (600 ml/h), keep pressing the key to increase the flow rate to

600 ml/h, and release the key to return to the original flow rate.

NOTE

 The bolus function should be used under normal infusion conditions.

 The bolus function does not affect any of the alarm functions.
 The flow rate for the bolus function is 600 ml/h, and is not adjustable.

5.3 Drop Rate Function and Setting (Optional)

NOTE

 The Drop Rate Function described in this section requires software

support. For more details, please consult your distributor or the
manufacturer.
 The pressure adjust and accuracy calibration interfaces do not monitor
drop rate.
 The drop rate function can only be started when the rate ≤ 400 ml/h.

WARNING
 The drop sensor is not applicable to light-proof medicine infusions.
Adopting light-proof IV sets on the pumps might cause the drop sensor to
fail and result in serious injury to patients.

5-2
5.3.1 Starting the Drop Rate Function

In the main interface, press the 100-decrement key and the 1-increment key

simultaneously to enter the drop rate interface.When the rate value is 1 and the
drop rate unit is /ml, as shown in Fig. 5-4, it means that the drop rate monitoring
function is on.When the rate value is 0 and the drop rate unit is ml/h, it means that the

drop rate monitoring function is off.Finally, press the key to save the setting.

Fig. 5-4

NOTE

 The drop rate activation interface is only accessible on infusion pumps

equipped with the drop rate function. Otherwise, it is not possible to
enter this interface.

5.3.2 Setting the Drop Rate for the Infusion Tube

The tube drop parameters will be different for different brands. Please refer to the
parameter descriptions on the packaging of each tube for details.

On the infusion pump start display, select the infusion tube (i.e. Brand A infusion tube)

that the system needs, as shown in Figure 5-5. Press the key and the

1-decrement key simultaneously to enter the parameter setting interface for

“drop/ml”. Then set the system parameter the same as the drop rate parameter, and

finally press the key to save the parameter.

5-3
 NOTE

 Setting range for infusion tube: 10–60 drop/ml. Default: 20 drop/ml.

Fig. 5-5

5.3.3 Viewing the Drop Rate Interface

As shown in Fig. 5-6, with the infusion pump switched on and in stop status, press the

key to enter the setting interface for the infusion parameters. Press the key

and the 1-decrement key simultaneously to convert the flow rate unit between
/ml and ml/h.

Fig. 5-6

5-4
 NOTE

 Regardless of whether the infusion pump is equipped with the drop rate
function, you can view the drop rate interface to convert the flow rate
unit between //ml and ml/h.

5.4 Using a Different Brand of Tube

This infusion pump is calibrated and factory set with the IS-G-V3(1) model of the “Dragon
Heart”brand of disposable infusion tube. If you use any other brand of feeding tube with
the pump, then a new accuracy calibration and pressure adjustment must be carried
out.To do this, proceed as follows:

Step 1:prepare a new infusion tube;

Step 2:switch on the infusion pump;
Step 3:install the infusion tube as normal, referring to 4.2.2 Installing the Infusion
Tube;
Step 4:select the infusion tube (A, B, C), referring to 5.4.1 Selecting the Infusion Tube;
Step 5:carry out accuracy calibration, referring to 5.4.2 Accuracy Calibration;
Step 6:carry out pressure adjustment, referring to 5.4.3 Pressure Adjustment.

NOTE

 Accuracy calibration and pressure adjustment should be carried out

after changing the infusion tubes used with this infusion pump, prior to
first use, after 6 months of continuous use or after maintenance or
upgrading.

5.4.1 Selecting the Infusion Tube

This infusion pump can save the parameters (occlusion level and accuracy) of 3 different
brands of infusion tube.If using multiple brands of infusion tube, the different brands of
tube can be represented by the letters A, B and C and the parameters corresponding to
each brand can be saved to facilitate selection during use of the pump. To select the
infusion tube, proceed as follows:

As shown in Figure 5-7, press the key and the key simultaneously in the
main interface to enter the infusion tube selection interface.

5-5
 Fig. 5-7

In the infusion tube selection interface, you can switch the type of infusion tube as shown

below. When finished, select the button to save and exit to the main interface.

Tube A

Tube B

Tube C

Fig. 5-8

5-6
5.4.2 Accuracy Calibration
1. Set the calibration flow rate (recommended value 300 ml/h) in the main
interface;

2. Press the 100-decrement key and the 10-decrement key

simultaneously to enter the accuracy calibration interface as shown in Fig. 5-9;
3. Install the infusion tube as normal, insert into a measuring cup and press the

key to start calibrating. The interface will display the progress of the
calibration;
4. Measure the amount of liquid in the measuring cup once the infusion pump has
stopped running;enter the actual measured volume on the second line;

5. Press the key to exit and save.Note:press the key to exit without
saving;

Fig. 5-9

NOTE
 Infusion accuracy of the infusion pump is ±5%.
 In order to reduce accuracy testing errors, fill the tube with liquid and
ensure there are no air bubbles before testing.
 When changing the brand of infusion tube, it is necessary to recalibrate
the accuracy (or reset the accuracy value).

5.4.3 Pressure Adjustment

1. Set the calibration flow rate (recommended value 100 ml/h) in the main
interface;

2. Press the 100-decrement key and the 10-decrement key

5-7
 simultaneously to enter the pressure adjustment interface as shown in Fig.
5-10;
3. Install the infusion tube as normal and connect it to a pressure gauge;

4. Press the key to start adjustment;

5. Press the 100-decrement key to stop the motor when the pressure

gauge pointer reads 100 kPa and then the 10-decrement key to save the
result of the adjustment and exit the interface.

Fig. 5-10

WARNING
 The Pressure Adjust interface has no occlusion alarm. In order to avoid
causing any serious harm to patients, do not perform the infusion
operation.

NOTE

 The pressure factor ranges from 40 to 150. If the pressure factor is not
within this range after adjustment, you will not be able to exit the
adjustment interface normally.If you force the Pressure Adjust interface
to exit, the adjustment factor will revert to the previous value.
 The Pressure Adjust interface cannot be powered off.
 The pressure should be adjusted when the material of the infusion tube
is too hard or soft.

5-8
5.5 Setting the Occlusion Level

Press the key and the key simultaneously in the main interface to enter the
infusion tube selection interface.The first line value is the occlusion level, The occlusion
level ranges from 1-3, The lower the occlusion level, the higher the occlusion

sensitivity.When the parameter is flashing, press the 1-increment key or

1-decrement key key to adjust the value, then press the key to save and
exit.Setting is now complete.

Fig. 5-11

NOTE

 The lower the occlusion level, the higher the occlusion sensitivity.

5.6 Setting the Air Bubble Filter Level

Press the key and the key simultaneously in the main interface to enter the
setting interface for the bubble filter level as shown in Fig. 5-12. The filter level ranges
from 0-3, with 0 indicating that the air bubble filter is closed and no air bubbles are

allowed to pass.Press the 1-increment key or 1-decrement key to set the

appropriate level, then press to save and exit.Setting is now complete.

5-9
 Fig. 5-12

NOTE

 The higher the filter level, the larger the capacity of air bubble allowed
through the filter.
 Only the rate of 60ml / h to carry out the air bubbles filtering.

5.7 Automatic Pressure Release Function (Anti-Bolus)

If occlusion occurs during infusion, an occlusion alarm will be triggered. The motor will
reverse and pressure will be released automatically.The motor will remain in reverse until
the pressure limit is reached.

5.8 KVO Function

When infusion is finished, the system automatically enters KVO mode, continues running
at a flow rate of 1 ml/h, and displays the infusion finished report and KVO Rate.

If no operation is performed and no alarm is triggered after entering KVO mode, the
system automatically stops after running at the KVO rate for half an hour. Otherwise, it
will stop during this process.

5-10
 6 Alarms
6.1 Overview
Alarms refer to the use of both sound and information displays to alert health care
workers to any abnormalities in the infusion circuit or any faults occurring with the
infusion pump itself during the infusion process, affecting the pump's ability to
provide smooth infusion to the patient.

WARNING
 It is potentially hazardous to use the same or similar equipment with
different alarm presets within the same area.

6.2 Alarm Levels and Methods

When an alarm occurs, the infusion pump will use both visual and auditory methods
to alert the user:
 Visual alarm
 Audible alarm
 Alarm Information
The visual alarm and audible alarm will vary in order to identify the different alarm
types.
Alarm Visual alarm Audible alarm Message display
method
Prompt
Alarm Color On Off Sound Continuous Intermittent Text display
type
level
 Air Bubble
 Finish
 Occlusion Single
 Battery alarm
dididi-didi
High-level 250 250  Empty flashing;
Red …… 3000 ms 10 s
alarms ms ms (not displayed) multiple
dididi-didi
 SystemError:Err 1 alarms
 Motor Error:Err 2 displayed
 Drops Error:Err 3 alternately;
 HandleOpen:Err 4 information
dididi  Reminder:Err 5 switching
Mid-level 500 500
Yellow …… 1500 ms 15 s  Low Battery frequency
alarms ms ms
dididi (not displayed) is 1 s
Low-level  AC Disconnect
Yellow Steady / di…… 500 ms 20 s
alarms (not displayed)

6-1
6.3 Pausing the Alarm Tone

After a pump alarm is triggered during infusion, press the key to pause the
alarm tone for 2 mins (except battery alarms). If the source of the alarm has not
been eliminated after 2 mins, the alarm tone will continue to sound.

6.4 Alarm Countermeasures

WARNING
 Please check the patient’s condition first when an alarm occurs.

When an alarm is triggered, please refer to the following steps and take appropriate
measures:

1. Inspect the patient;

2. Confirm the parameters or type of alarm;
3. Determine the reason for the alarm;
4. Eliminate the reason for the alarm;
5. Check whether the alarm has cleared.

NOTE
 Please refer to C - Alarm Information for the specific handling measures
for each alarm.

6-2
A Product Specifications
A.1 Safety Specifications
Parameter Specifications
China SFDA Classification Ⅱ

Type of shock protection Ⅱ, including internal power supply equipment

Degree of shock protection Type BF - non-defibrillation proof applied parts

Liquid ingress protection IP21

Operating mode Continuous running

Mobile level Portable equipment

A.2 Environmental Specifications

Parameter Specifications

Operating temperature 5–40ºC

Operating humidity 20–80%, non-condensing

Operating atmospheric pressure 86–106 kPa

Transport and storage -20–55ºC
temperature
Transport and storage humidity 10–95%, non-condensing
Transport and storage 50–106 kPa
atmospheric pressure
Description of storage conditions In a room with no corrosive gases and good
ventilation

A.3 Power Specifications

Parameter Specifications
Alternating current power supply (AC)

Input voltage 100–240 V

A-1
Input current 0.25–0.11 A

Frequency 50/60 Hz

Battery

No. of batteries 1

Battery type Rechargeable battery

Rated battery voltage DC 7.4 V

Capacitance 1600 mAh（2400 mAh Optional）

SK-600Ⅰ: 25 VA. Able to run normally for at least 4 hours

Maximum power and at a rate of 25 ml/h after charging（2400 mAh）.
operating time SK-600ⅠB: 25 VA. Able to run normally for at least 2
hours at a rate of 25 ml/h after charging（2400 mAh）.

The battery will charge automatically when the infusion

Charging time pump is connected to an AC power source (it takes 8-14
hours to fully charge the battery).

A.4 Hardware Specifications

Parameter Specifications

Overall

Size 120 mm×140 mm×195 mm (L × W × H)

Weight ≈1.7 kg

LCD (Liquid Crystal Display)

Type LCD

Size 2.7 inches

Indicator lamp

No. 4
Fuse

Pressure resistance, flow T 2 A 250 V～

Interfaces

Power source 1 AC interface

Data ports 1 drop rate sensor interface

A-2
A.5 Basic Infusion Pump Parameters
Parameter Specifications

Tube standards and In compliance with "GB 8368-2005 Disposable Infusion Sets,
requirements Gravity Feed"

Infusion pump Peristaltic mechanism

mechanism

Range of infusion rates SK-600Ⅰ:1–600 ml/h

SK-600ⅠB:1–2000 ml/h

Rapid infusion rates 600 ml/h

Drop rate setting Drop rate:1–400 drops/min（The maximum value is limited by drip
parameter infusion tube parameter values.）

Drops/ml Tube specifications and parameters, i.e. the number of drops

contained in 1ml of the drug. Please see tube packaging for
values.Range: 10-60 drop/ml. Default: 20 drop/ml.

Increments 1, 10 or 100

Step 1ml

KVO rate 1 ml/h (start KVO after infusion has finished)

Range of preset infusion 1–9999 ml

volumes

Display accumulated 0–9999 ml

volume

Infusion accuracy ±5%

Displayed and indicated Battery symbol, AC power symbol, infusion set symbol, flow rate,
information flow rate value and unit, preset volume limit, preset volume limit
and units, accumulated volume, accumulated volume value and
unit, finish, occlusion, air bubble, bed no, etc.

Status indicator Stop, infusion, bolus, KVO

Alarm function Air Bubble, Finish, Occlusion, Battery Empty, System Error (Err 1),
Motor Error (Err 2), Drops Error (Err 3) , Handle Open (Err 4),
Reminder (Err 5), Low Battery, AC Disconnect

Air bubble measurement The minimum detectable volume for air bubbles at a rate of 600
ml/h is 0.005 ml

Infusion pressure The maximum pressure that can be generated is 160 kPa. The
pressure threshold range in which the occlusion alarm will sound is
40–160 kPa. The time of occlusion alarm please refer to A.6.

A-3
A.6 Occlusion Alarm Pressures, Maximum Delays for
Alarm Times and Maximum Permissible Dose
Volumes
Reference
Actual test Large dose
occlusion Rate Alarm time
pressure volumes
value (ml/h) (Min)
(kPa) (ml)
(kPa)
5 68.00 00：04：09 0.172

70±30 100 72.00 00：00：13 0.176

600 65.07 00：00：02 0.192

5 100.20 00：08：01 0.254

100±30 100 102.90 00：00：21 0.237

600 100.20 00：00：03 0.203

5 130.60 00：10：21 0.282

130±30 100 133.30 00：00：28 0.253

600 126.50 00：00：03 0.191

NOTE

 Test conditions for the above data:

 FLUKE IDA4 PLUS tester.
 Infusion set brand:“Dragon Heart”.
 Occlusion alarm pressures, maximum delays for alarm times and possible
dose volumes are all affected by test conditions.
 The data above are only typical values under the testing conditions, and
the actual data may vary against different testing conditions. Please rely
on data obtained from the testing on the product you buy. The bigger the
measured pressure under the same reference clogging value and the same
flow velocity is

A-4
A.7 Infusion Accuracy Table
The following infusion accuracy table expresses performance after infusion has
started and infusion fluctuations occurring within a certain period of time after normal
infusion flow volumes have been reached.

A.7.1 Accuracy Curve

Plotted on the basis of data collected over a two-hour measurement period.

Sampling rate:25 ml/h

Sampling interval:△t =0.5 min
Test period:T=120 min
Infusion rate:Q (m/h)

A-5
A.7.2 Bell-shaped Curve
Short-term infusion rate errors (p△t)

Sampling rate:25 ml/h

Sampling interval:△t =0.5 min
Continuous observation window times:p△t =2, 5, 11, 19, 31 min
Maximum observation window error within a specified continuous time:EPmax (%)
Minimum observation window error within a specified continuous time:EPmin (%)
Overall average percentage for measured rate errors:A (%)

NOTE

 Infusion accuracy does not reflect clinical criteria, such as patient age and
weight and the specific drug used.
 Infusion accuracy may be affected by the infusion pump environment
(such as pressure, temperature, humidity and any infusion accessories
used).

A-6
 B EMC
This infusion pump complies with EMC standard EN 60601-1-2.

NOTE

 Use of accessories, sensors or cables outside of the specified scope of

this pump may increase electromagnetic emissions and/or lower the
electromagnetic immunity of the pump.
 This infusion pump may not be used in close proximity to or stacked
with other equipment.If necessary, closely observe the pump to ensure
that it is able to operate normally under the current configuration.
 Special protection must be given to the electromagnetic compatibility of
the infusion pump. Installation and maintenance must be carried out in
an environment that satisfies the following EMC information.
 The infusion pump should not be used at the same time as any MRI
(Magnetic Resonance Imaging) or other similar equipment, to avoid the
possibility of the pump malfunctioning or crashing due to
electromagnetic interference.
 Even if other equipment is compliant with CISPR emission requirements,
it may still cause interference and affect how the pump operates.
 If the infusion signal amplitude is lower than the minimum amplitude
stipulated in the technical specifications, it may result in inaccurate
measuring.
 Portable and mobile RF communications equipment can affect the
performance of monitoring devices.

Guidance and statements regarding electromagnetic emissions

This infusion pump should be used in the stipulated electromagnetic environments. The
customer or user should guarantee that the infusion pump is used in an electromagnetic
environment that complies with the following regulations:
Emission test Conformity Electromagnetic environment - guidance
RF emission Group 1 The infusion pump only uses radio frequency
CISPR 11 energy when running internal functions. The
pump's radio frequency emissions are therefore
very low and will not cause any electromagnetic
interference in nearby electronic equipment.

B-1
RF emission Class B
CISPR 11
Harmonic emission Class A
IEC61000-3-2
Voltage fluctuations and Compatible
scintillation
IEC 61000-3-3

Guidance and statements regarding electromagnetic immunity

This infusion pump should be used in the stipulated electromagnetic environments. The
customer or user should guarantee that the infusion pump is used in an electromagnetic
environment that complies with the following regulations:
Immunity test IEC60601 test level Level of conformity Electromagnetic
environment - guidance
Electrostatic ±6 kV contact ±6 kV contact Flooring must be wood,
discharge (ESD) discharge discharge concrete or ceramic
IEC 61000-4-2 ±8 kV air discharge ±8 kV air discharge tile.If the floor is lined
with synthetic materials
there must be a relative
humidity of at least
30%.
Electrical fast ±2 kV power cord ±2 kV power cord The network power
transient ±1 kV I/O cable source must be of
(EFT) typical commercial or
IEC 61000-4-4 hospital quality.
Surge ±1 kV differential mode ±1 kV differential
IEC 61000-4-5 ±2 kV common mode mode
±2 kV common
mode
Voltage drops, ＜5% UT(drop＞95% ＜5% UT(drop＞ The network power
short interruptions UT) 0.5 cycles 95% UT) 0.5 cycles source must be of
and changes typical commercial or
IEC 61000-4-11 40% UT(drop 60% UT) 40% UT(drop 60% hospital quality.If the
5 cycles UT) 5 cycles infusion pump needs to
run continuously we
70% UT(drop 30% UT) 70% UT(drop 30% recommend using an
25 cycles UT) 25 cycles uninterruptible power
supply UPS in case of
＜5% UT(drop＞95% ＜5% UT(drop＞ interruptions in network
UT) 5 seconds 95% UT) 5 seconds power.

B-2
Power frequency 3 A/m 3 A/m The power frequency
magnetic field magnetic field must be
(50/60 Hz) at a typical level for
IEC 61000-4-8 typical commercial or
hospital environments.
NOTE:UT refers to the voltage of the exchange network before voltage testing

Guidance and statements regarding electromagnetic immunity

This infusion pump should be used in the stipulated electromagnetic environments. The
customer or user should guarantee that the infusion pump is used in an electromagnetic
environment that complies with the following regulations:
IEC 60601 Level of
Immunity test test level conformity Electromagnetic environment - guidance
Conducted 3 Vrms 3V Portable and mobile radio frequency
immunity 150 k–80 MHz communications devices must be used at the
IEC61000-4-6 stipulated distance away from the infusion
Radiated 3 V/m 3 V/m pump or any system components (including
immunity 80 M–2.5 GHz the cables).This isolation distance is
IEC61000-4-3 calculated using appropriate formulas
selected on the basis of the frequency of the
transmitter.Recommended calculation
formulas for isolation distance are:

d = 1.2 P

d = 1.2 P 80 M–800 MHz

d = 2.3 P 800 M–2.5 GHz

where P is the rated maximum output power
of the transmitter, in W.d is the recommended
distance, in m.
The field strength of the radio frequency
transmitter obtained by measuring the
electromagnetic field a must be within
compliant levels for every frequency range b.
May cause interference if used in close
proximity to equipment with the following
symbols:

B-3
Note 1:Between 80 MHz–800 MHz, use a formula for higher frequency bands.
Note 2:The above guidance is not suitable for use in all conditions. Material structures, objects
and people can absorb and reflect electromagnetic waves, affecting electromagnetic
propagation.
a
Field strengths for radio (honeycomb and wireless) handset base stations and terrestrial
mobile radio receiving apparatus, antenna reception apparatus, and FM and AM radio/television
broadcasts cannot be accurately estimated using a purely theoretical approach.
The use of electromagnetic field measuring methods should be considered when estimating the
electromagnetic environment produced by a fixed radio frequency transmitter. If the measured
field strengths in the environment in which this infusion pump is used exceed stipulated RF
levels, the infusion pump must be observed to check whether normal operation is
possible.Relevant measures must be taken as soon as abnormalities are discovered, such as
changing the position of the infusion pump or moving it to another environment.
b
In a frequency range of between 150 k–80 MHz, field strength should be less than 3 V/m.

It is recommended that the infusion pump be kept away from portable/mobile RF communications
equipment
The infusion pump can be used in electromagnetic environments in which RF interference is
controlled.In order to avoid electromagnetic interference, the customer or user should maintain
the minimum recommended distance between the infusion pump and portable/mobile RF
communication equipment.The following recommended isolation distances are calculated on the
basis of the maximum output power of the communications equipment.

Transmitter ratings Calculate isolation distances on the basis of transmitter frequencies (m)
Maximum output 150 k–80 MHz 80 M–800 MHz 800 M–2.5 GHz
power
(W) d = 1.2 P d = 1.2 P d = 2.3 P

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

If the rated maximum output power of the transmitter is not included above, the isolation distance
may be estimated by using the formula in the corresponding column.In the formula, P is the rated
maximum output power of the transmitter as provided by the manufacturer, in W.
Note 1:Between 80M-800MHz, use a formula for higher frequency bands.
Note 2:The above guidance is not suitable for use in all conditions. Material structures, objects
and people can absorb and reflect electromagnetic waves, affecting electromagnetic propagation.

B-4
 C Alarm Information
C.1 Alarm Information
NOTE:column A shows whether the alarm can be completely cleared;column B
shows whether the sound and light can be cleared;column L shows the alarm level.

Alarm
Display A B L Reason Countermeasure
Information
Air Bubble Yes Yes High Air bubbles in the
infusion tube Press the
key to stop infusion
and turn off the
alarm. Eliminate
the air bubbles
from the infusion
tube and press the

key to
restart infusion.
Infusion tube is Reinstall the
incorrectly installed infusion tube,
referring to 4.2.2
Installing the
Infusion Tube.
Infusion pump Contact the
sensor malfunction manufacturer.

Finish Yes Yes High Preset infusion

volume has been Press to
reached stop infusion and
turn off the alarm.

Press to
clear the
accumulated
volume, then press

to restart
infusion.

C-1
 Alarm
Display A B L Reason Countermeasure
Information
Occlusion Yes Yes High Infusion circuit
blocked Press to
stop infusion and
turn off the alarm.
Eliminate the
blockage in the
circuit, then press

again to
restart infusion.
Increase the
Occlusion occlusion level,
sensitivity is too referring to 5.5
high Setting the
Occlusion Level.
Infusion pump Contact the
sensor malfunction manufacturer.
Battery Empty No No High Low battery, battery Connect an AC
icon is flashing and power source to
emitting rapid recharge the
alarm sound. It will battery.
stop infusion
automatically if
under infusion and
it cannot continue
infusion until
connected to the
AC power
Battery old or pump Contact the
charging circuit manufacturer.
malfunction

C-2
 Alarm
Display A B L Reason Countermeasure
Information
SystemError Yes Yes High Internal data
communication Press to
(Err1)
error stop infusion and
turn off the alarm.

Press again
to restart infusion.
If this alarm
reoccurs, please
contact the
manufacturer for
repair.

Hardware fault
Press for
direct shutdown,

then press
again to restart the
infusion pump. If
this alarm
reoccurs, please
contact the
manufacturer for
repair.
Motor Error Yes Yes High Infusion pump
(Err2) motor is operating Press to
abnormally stop infusion and
turn off the alarm.

Press again
Improper to restart infusion.
installation of If this alarm
hardware, or reoccurs, please
hardware fault contact the
manufacturer for
repair.

C-3
 Alarm
Display A B L Reason Countermeasure
Information
Drops Error Yes Yes High Error with the drop Reset the drop rate
(Err3) (requires rate parameter parameters
optional drop settings correctly.
rate sensor) Accuracy is not Recalibrate tube
calibrated accuracy.
Running the pump Shake the water
for long periods droplets off the
causes water funnel walls.
droplets to form on
the funnel walls,
affecting the
monitoring
capability of the
drop rate sensor

Liquid not flowing Eliminate blockage

freely within the in the infusion
tube circuit.

Drop rate sensor is Contact the

faulty manufacturer.

Liquid medicine Lower the liquid

level in the funnel level of the funnel
is above the drop appropriately to
rate sensor keep it below the
drop rate
sensor.The liquid
medicine in the
medicine filter
must be less than
1/3 of its volume.

Handle Open Yes Yes High Handle open

(Err4) during infusion Press to
stop infusion and
turn off the alarm.
Close the handle

and press to
restart infusion.

C-4
 Alarm
Display A B L Reason Countermeasure
Information
Reminder Yes No Mid-level Infusion pump
(Err5) does not start Press to
within 2 mins after start the infusion
the infusion tube is pump and
properly installed, commence
and prompts the infusion.
user for further
action.

Low Battery No No Mid-level Low Battery Connect an AC

power source and
power on to
recharge the
battery.
Battery old or pump Contact the
charging circuit manufacturer.
malfunction

AC Disconnect No No Low Power cord not Check that the

supplying the power cord is
infusion pump with plugged in and fully
AC power seated.

Problem with the Contact the

infusion pump manufacturer.
power supply
circuit

C-5
C.2 Prompt Messages
None

C-6
D Symbols and Terms
D.1 List of Units

Abbreviation English Chinese

min Minute 分钟

h Hour 小时

Hz Hertz 赫兹

mg Milligram 毫克

g Gram 克

kg Kilogram 千克

kPa Kilopascal 千帕

ml Milliliter 毫升

D-1
D.2 List of Terms

Abbreviation English meaning Chinese meaning

AC Alternating current 交流电

DC Direct current 直流电

EMC Electromagnetic compatibility 电磁兼容性

KVO Keep vein open 保持静脉通畅流速

ERROR Error 错误的，出错

LED Light emitting diode 发光二极管

SN Serial Number 序列号

EtO C2H4O (ethylene oxide) 环氧乙烷

Bolus (Discrete quantity of liquid 短时间内输送液体的离散量（即快

BOLUS
delivered in a short time) 进）

D-2
P/N：046-004730-00（2.0）