Daiwha DI-6000 User manual

Medical Device Guide
This is a medical device.
Product Name: Infusion Pump
Model Name: DI-6000
Product license: 14-1443
Product life span: N/A

Foreword
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Foreword
Thank you for choosing Daiwha DI-6000.
DI-6000 is an infusion pump manufactured by Daiwha Corporation.
This manual contains standard specifications. Contents may vary according to the specifications of
the product purchased. The contents of this manual are subject to change without notice after
performance improvements.
Please contact us if you have questions about this manual or the product purchased.
 Manufacturer: Daiwha Corporation
 Address: Daiwha Building, 33-gil 3 (Yeoksam-dong), Yeoksam-ro, Gangnam-gu, Seoul, Korea
 Phone: [phone]
 Fax: [phone]
 Website: http://www.daiwha.com
 mdi Europa GmbH (Langenhagener Str. 71, D-30855 Hannover-Langenhagen
Germany)
Copyrights
Copyrights for all contents of this manual belong to Daiwha Corporation.
Reproduction and distribution of this manual without consent of Daiwha Corporation is strictly
prohibited and punishable as intellectual property rights infringement.
All information included in this manual has been verified by Daiwha Corporation to be true and
accurate. Daiwha Corporation is not responsible for any conditions arising from inaccuracy of
information or typographical errors.
ⓒ 2017 DAIWHA CORPORATION Co., Ltd. All rights reserved.

Contents
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Contents
1. Safety Instructions ................................................................................................ 1
1.1 Indications of signal words.............................................................................................. 1
1.2 Warning ........................................................................................................................ 1
1.3 General Caution ............................................................................................................. 2
1.4 Responsibilities of manufacturer ...................................................................................... 4
1.5 User obligations ............................................................................................................. 4
1.6 Symbols ........................................................................................................................ 5
2. Names and Functions ............................................................................................. 6
2.1 Front panel .................................................................................................................... 6
2.2 Rear panel ..................................................................................................................... 7
2.3 Names and functions of each button ................................................................................ 8
2.4 LCD screen display region ............................................................................................... 9
2.5 Alarm icon display unit ................................................................................................. 10
2.6 Information display unit ................................................................................................ 11
2.7 I.V Set installation unit ................................................................................................. 11
2.8 Components ................................................................................................................ 13
3. Installation ........................................................................................................... 14
3.1 Mounting the product and connecting the power ............................................................ 14
3.2 Connecting the external power ...................................................................................... 15
3.3 Mounting I.V Set .......................................................................................................... 16
3.4 Mounting the drop sensor (optional) .............................................................................. 18
4. Injection Modes ................................................................................................... 20
4.1 Settings for each injection mode ................................................................................... 20
4.2 Normal Infusion ........................................................................................................... 21
4.2.1 Setting the flow rate and total volume .............................................................. 21
4.2.2 Setting the remaining time ............................................................................... 22
4.3 Drug Infusion .............................................................................................................. 24
4.4 Dosage Infusion ........................................................................................................... 25
4.5 Secondary injection mode ............................................................................................. 26
4.6 Infusion relay mode ..................................................................................................... 28

Contents
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5. Operation ............................................................................................................. 30
5.1 Power on/off ................................................................................................................ 30
5.2 Standby status (before operation) .................................................................................. 31
5.2.1 Setting the I.V. Set Code .................................................................................. 31
5.3 Infusion start (operation started) and stop ..................................................................... 32
5.4 Operation status ........................................................................................................... 32
5.4.1 Initializing Infusion Information and I.Vol .......................................................... 32
5.4.2 Bolus (Purge) Injection Mode ........................................................................... 33
5.4.3 Titration-normal injection mode ........................................................................ 33
5.5 Viewing the infused volume and remaining time .............................................................. 34
5.6 Key Lock button function ............................................................................................... 34
5.7 History function ............................................................................................................ 34
5.8 Standby time function ................................................................................................... 35
5.9 VTBI (Volume to be Infused) function ............................................................................ 35
6. Custom Settings ................................................................................................... 37
6.1 Menu list ..................................................................................................................... 37
6.2 Infusion Setting ............................................................................................................ 39
6.3 Dosage Setting ............................................................................................................. 40
6.4 Device Setting .............................................................................................................. 41
6.4.1 Alarm & Volume .............................................................................................. 41
6.4.2 Sensor ............................................................................................................ 42
6.4.3 History ........................................................................................................... 42
6.4.4 Etc 42
6.5 Default value ............................................................................................................... 44
6.6 Service Mode ............................................................................................................... 45
6.6.1 Access Service Mode ........................................................................................ 46
7. Alarms and Actions .............................................................................................. 47
7.1 Alarm devices .............................................................................................................. 47
7.2 Alarm priorities ............................................................................................................. 48
7.3 Down Occlusion alarm .................................................................................................. 48
7.4 Up occlusion alarm ....................................................................................................... 49
7.5 Air bubble alarm ........................................................................................................... 49
7.6 Door open alarm .......................................................................................................... 50
7.7 Drop sensor alarm ........................................................................................................ 50
7.8 Battery Overheating Alarm ............................................................................................ 51

Contents
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7.9 Empty battery alarm ..................................................................................................... 51
7.10 Low battery alarm ........................................................................................................ 52
7.11 AC/DC removal power alarm ......................................................................................... 52
7.12 K.V.O alarm ................................................................................................................. 52
7.13 Complete Alarm ........................................................................................................... 53
7.14 Near complete alarm .................................................................................................... 53
7.15 Standby alarm ............................................................................................................. 54
7.16 Time out alarm ............................................................................................................ 54
7.17 Error codes .................................................................................................................. 55
8. Maintenance and Storage .................................................................................... 57
8.1 Inspection ................................................................................................................... 57
8.2 Cleaning and Disinfection .............................................................................................. 57
8.3 Storage ....................................................................................................................... 58
8.4 Replacement cycle ....................................................................................................... 58
8.5 Product disposal .......................................................................................................... 58
9. Technical Specification ........................................................................................ 59
9.1 Specifications .............................................................................................................. 59
9.2 Functional specifications ............................................................................................... 61
9.3 Occlusion detection properties....................................................................................... 62
9.4 Compatible I.V Sets ...................................................................................................... 62
9.5 Memory Function ......................................................................................................... 63
9.6 Classification ............................................................................................................... 63
9.7 Electromagnetic information .......................................................................................... 63
9.8 Drop sensor functions ................................................................................................... 64
9.9 Characteristic curves .................................................................................................... 64
10. Appendix .............................................................................................................. 66
10.1 EMC declaration ........................................................................................................... 66
10.2 Document History ....................................................................................................... 70

Safety Instructions
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1. Safety Instructions
Cautions to be exercised for safe use of this device are described in this section.
Inspect and service the device regularly for long-term safe use of this device.
Caution
 For more information how to operate the product, refer to User’s Manual.
 Only the service staff authorized by the Daiwha Corporation can service
the product or modify its circuits.
1.1 Indications of signal words
Safety precautions are classified as the following categories according to the degree and
urgency of the expected risk or damage. Be sure to read the following precautions before use
of the product Use the product only according to the operation procedures in this manual.
Signal Word Meaning
Danger If violated, it can result in death or serious injury.
Warning If violated, it may result in death or personal injury.
Caution If violated, it may result in minor injury or property damage
(e.g. damage to the product).
1.2 Warning
 Be careful not to soak or touch the inlet part connected to the external power with wet
hands.
 Electric shock or short circuit may occur.
 Do not store or use the product near flammable anesthetics, liquids, or gases.
 There is risk of fire or explosion.
 Do not use the pump in an area where radiation or MRI equipment is used or high-pressure
oxidation occurs.
 There is possibility of malfunction, damage, product degradation, or explosion.
 Do not store or use the pump near flammable liquids or gases.
 There is risk of fire or explosion.
 Do not use the product in areas where strong high frequency and magnetic fields are
generated or areas where high pressure oxidation occurs.
 This may cause malfunction or performance degradation.
 Do not use the pump in the environment where excessive positive or negative pressure
occurs such as extracorporeal circulation circuit.
 Infusion accuracy check and lock alarming may not work properly.

Safety Instructions
2
 Do not place the pump in a humid place or where active gas (inclusive disinfection gas)
exists.
 This environment may affect the internal electrical part and can cause function
degradation or damage.
 Accurately check the infusion volume, infusion speed, infusion time, and settings before
injection.
 This product has no infusion control device so any injection problem or fatal error may
occur.
 Always check for injection problem or functions of the product if the pump receives a
strong impact.
 This product has no device to determine those errors.
 Check if I.V Set is properly installed to the product.
 If the JOG dial has come off, stop using the pump.
1.3 General Caution
Installing the product
 Be careful of vibration or shock when transporting or moving the product.
 Install in a place where the product is not affected by temperature, humidity, and
atmospheric pressure.
 Always keep the product clean.
 Avoid a place with direct sunlight.
Using the external power
 The power cord must be plugged into a grounded outlet for hospital use and check the
flow rated voltage and frequency in advance.
 Do not use 2-wire extension cables that have not been grounded.
 Always check if there is no problem in the power connection before use.
 Do not connect the product with AC and DC powers together.
 Check for polarity and voltage when using the DC power.
Use with battery
 Pay attention to the time of use when using the product with battery power.
 Can be used for approximately 10 hours in a flow rate of 25 ml/h after fully charged.
 Connect the power cord to the product for charging when an alarm rings and Low Battery
appears on the front LCD.
 When battery power is not used for a long time, charge the battery at least one time a
month to prevent battery life reduction.
 Fully recharge the battery if possible, since the battery charging lasts for approx. 6 hours
after being completely discharged.
 The battery capacity is indicated on the battery capacity display bar.

Safety Instructions
3
 Replace the battery if its usage time significantly decreases even in full charge condition.
 Contact the dealer to replace the battery.
Using for other purposes
 Do not use product if it is wet.
 Do not open or disassemble the product.
 To prevent errors, check if the labels are attached on the infusion pump and tube.
 Check the infusion pump setting and monitor the patient to check for extremely high or low
dose.
 Be sure to plan and prepare for failures of the infusion pump in advance.
 All possible actions must be taken to prevent and cope with pump issues.
 Pressure is eliminated when the Occlusion alarm occurs because the Anti-Bolus function is
automatically activated in which unintended infusion does not occur. Be careful not to inject
medication before discharging pressure
 The maximum infusion pressure is 1050 mmHg.
 Injection is immediately stopped in failure status so unintended infusion does not occur.
When the failure continuously occurs, contact the dealer or headquarters.
 Check for infusion difference in the following situation.
 In case of using fluid of high viscosity such as Dextrose 50 %.
 When infusion is not made because the active time of the occlusion alarm is long
due to low flow rate of the infusion.
 When using in the environment other than ambient temperature of 10-40 ℃,
relative humidity of 20-90 %, and atmospheric pressure of 70-106 kha.
Cleaning the product
 Do not sterilize device with autoclave or EO (Ethylene Oxide) gas.
 Do not use thinner, solvent, benzene, ammonia, or acetone to clean the product. Use wet
gauze and wipe out moisture with smooth dry fabric.
 Do not soak the product in water or dry it by force.
When injecting drug
 Regularly check for product operation and patient status.
 Use the Lock function for safe use for settings not to be changed even though pressing any
buttons during operation.
 Inspect to prevent I.V Set damage such as leakage or filter burst.
Using I.V Set
 Use I.V Set exclusive for drug infusion pump.
 The intended flow rate may not be satisfied if the designated I.V Set is not used and
this may cause air or occlusion alarms. If the designated I.V Set cannot be used,
inquire the dealer or headquarters.

Safety Instructions
4
 Do not reuse I.V Set.
 If I.V Set is used again, this may cause failures of sensors and infusion volume.
 When using for a long time (more than 12 hours), change the location of I.V Set
Tube by 15 cm or more. Use it within the error range as instructed.
 Do not mount I.V Set with extended.
 Error may occur in flow rate or infusion volume.
 Mount I.V Set in place.
 Free flow or leakage may occur if not accurately mounted.
 Do not connect other devices that can inject drugs in the I.V Set line (Patient Line).
 It may affect the flow rate, infusion volume, and alarming.
1.4 Responsibilities of manufacturer
This product is a medical device. The manufacture or dealer has responsibility for normal
operation and safety in the following cases:
 If genuine parts approved by the company
 If serviced or repaired by the company or an agency delegated by the company
 If properly used as instructed
 If the product is damaged not by user fault
1.5 User obligations
The user must regularly maintain the product for electrical and mechanical safety (Common
electrical and mechanical standards (Ministry of Food and Drug Safety No. 2015-115) / IEC
60601- 1:2012). The owner of the product must guarantee the maintenance or repair work.
For more information, see 8. Maintenance and Storage.