MEDIFUSION DS-3000 User Manual - fmfeed.eu · 3) Charge the battery at least once a month to...

MEDIFUSIONⓇ

DS-3000

User Manual

DAIWHA

Copyright © 2010, DAIWHA Corporation. All rights reserved. Manual No: DW-DS3000-OP-KR (Rev 0.5)

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Contents

1. Precautions ................................................................................................................... 5

1.1 Overview .............................................................................................................................. 5

1.2 Warnings .............................................................................................................................. 5

1.3 Caution................................................................................................................................. 6

1.4 Symbols ............................................................................................................................... 9

2. Specifications ............................................................................................................. 10

2.1 Specifications ..................................................................................................................... 10

2.2 Occlusion Detection Characteristics .................................................................................. 12

2.3 Usable Syringes ................................................................................................................. 12

2.4 Memory Function ............................................................................................................... 12

2.5 Classification ...................................................................................................................... 12

2.6 EMS Issues ........................................................................................................................ 13

2.7 Characteristics Curves ....................................................................................................... 14

3. Names and Functions ................................................................................................ 15

3.1 Keys ................................................................................................................................... 15

3.2 LCD Display ....................................................................................................................... 16

3.3 LED Display ....................................................................................................................... 16

3.4 Others ................................................................................................................................ 17

3.5 External Interface Area ...................................................................................................... 17

3.6 Accessories ....................................................................................................................... 17

4. Installation .................................................................................................................. 18

4.1 Installing DS-3000 and Connecting the Power .................................................................. 18

4.2 Installing the Syringe ......................................................................................................... 20

4.3 Syringe Select .................................................................................................................... 21

4.4 Syringe Change ................................................................................................................. 22

5. Infusion Mode ............................................................................................................. 23

5.1 Normal Infusion .................................................................................................................. 23

5.2 Drug Infusion ..................................................................................................................... 25

5.3 Dosage Infusion ................................................................................................................. 26

5.4 Dosage Infusion(Manual)................................................................................................... 27

6. Settings ....................................................................................................................... 29

7. Operation .................................................................................................................... 34

7.1 Infusion Ready (Before Operation) .................................................................................... 35

7.2 Start Infusion (Start Operation) .......................................................................................... 35

7.3 Stop and Pause ................................................................................................................. 36

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7.4 Viewing the Infused Volume and Time Remaining ............................................................ 36

7.5 Key Lock Function ............................................................................................................. 36

7.6 History Log Function .......................................................................................................... 36

8. User's Settings ........................................................................................................... 37

8.1 Menu Tree .......................................................................................................................... 37

8.2 Special Functions .............................................................................................................. 37

8.2.1 Syringe Selection ................................................................................................... 37

8.2.2 Drug Selection ........................................................................................................ 37

8.2.3 Dosage Setting ....................................................................................................... 37

8.2.4 Calibration .............................................................................................................. 38

8.2.5 Infusion Relay ......................................................................................................... 38

8.3 Options............................................................................................................................... 38

8.3.1 Bolus F.rate............................................................................................................. 38

8.3.2 Bolus Volume ......................................................................................................... 38

8.3.3 Standby Time ......................................................................................................... 38

8.3.4 Near Complete Alarm ............................................................................................. 38

8.3.5 Pressure Level ....................................................................................................... 38

8.3.6 Nurse Call ............................................................................................................... 38

8.3.7 Auto Save On/Off ................................................................................................... 38

8.3.8 AC/DC Removal Alarm ........................................................................................... 39

8.3.9 K.V.O Set ................................................................................................................ 39

8.3.10 Auto Bolus Check ................................................................................................... 39

8.3.11 Anti-Bolus On/Off ................................................................................................... 39

8.4 Config Mode ...................................................................................................................... 39

8.4.1 Sound Volume ........................................................................................................ 39

8.4.2 Key Sound Volume ................................................................................................. 39

8.4.3 Occl Sensitivity ....................................................................................................... 39

8.4.4 Alarm Log ............................................................................................................... 39

8.4.5 Event Log ............................................................................................................... 39

8.4.6 Date Set .................................................................................................................. 40

8.4.7 Time Set ................................................................................................................. 40

8.4.8 Factory Reset ......................................................................................................... 40

8.4.9 Contrast .................................................................................................................. 40

8.4.10 Contrast(Standby) .................................................................................................. 40

8.4.11 Language................................................................................................................ 40

8.5 Service Mode ..................................................................................................................... 40

9. Alarms ......................................................................................................................... 41

9.1 Occlusion Alarm ................................................................................................................. 41

9.2 Low Battery Alarm .............................................................................................................. 42

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9.3 Empty Battery Alarm .......................................................................................................... 42

9.4 Infusion Complete Alarm.................................................................................................... 42

9.5 AC Power Removal Alarm ................................................................................................. 42

9.6 DC Power Removal Alarm ................................................................................................. 43

9.7 Removal Power Alarm ....................................................................................................... 43

9.8 Standby Alarm ................................................................................................................... 43

9.9 Time Out Alarm .................................................................................................................. 43

9.10 Near Complete Alarm ........................................................................................................ 44

9.11 Near Empty Alarm .............................................................................................................. 44

9.12 Clamp Alarm ...................................................................................................................... 44

9.13 Clutch Alarm ...................................................................................................................... 44

9.14 Detect Alarm ...................................................................................................................... 44

9.15 Error Codes ....................................................................................................................... 45

9.16 Checklists for Alarms ......................................................................................................... 45

10. Precautions during Use ............................................................................................. 47

10.1 Life-span of Replaced Parts .............................................................................................. 47

10.2 Maintenance ...................................................................................................................... 47

10.3 Cleaning and Disinfecting .................................................................................................. 47

10.4 Disposal ............................................................................................................................. 47

10.5 Storage .............................................................................................................................. 48

11. Document History ....................................................................................................... 49

12. <Supplement> ............................................................................................................. 50

12.1 Calibration Process ............................................................................................................ 50

12.1.1 Preparation ............................................................................................................. 50

12.1.2 Calibration preparation ........................................................................................... 50

12.1.3 Calibration Start ...................................................................................................... 51

12.2 Infusion Relay .................................................................................................................... 52

12.2.1 Preparations ........................................................................................................... 52

12.2.2 Infusion Relay ......................................................................................................... 52

12.2.3 Preparation for Infusion Relay ................................................................................ 52

12.2.4 Set for Infusion Relay ............................................................................................. 53

12.2.5 Cancellation of Infusion Relay ................................................................................ 54

12.2.6 Cancellation of Infusion Relay ................................................................................ 54

12.2.7 Start Infusion Relay( Automatic ) ............................................................................ 55

12.2.8 Infusion Relay Start(Hand-operate) ....................................................................... 56

12.2.9 Other messages ..................................................................................................... 57

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1. Precautions

1.1 Overview

◎ This manual describes how to use the infusion pump (Model: DS-3000) manufactured by DAIWHA Corporation, and its technical specifications.

◎ This pump is designed to meet the requirements for delivering drugs in general wards, to new-born babies, and to emergency rooms.

◎ Please ensure that only clinical doctors and nurses who are familiar with the operation of this pump can use this pump. You can set the range of flow rate from 0.01 ml/h to 1500 ml/h.

◎ This pump allows you to set Normal Infusion mode and Dosage mode. ◎ Repair or circuit alteration of this equipment can only be carried out by personnel authorized by

DAIWHA. The warranty shall not apply to defects or damage caused by repairs or disassembly by anyone other than personnel authorized by DAIWHA, and safety shall not be assured.

◎ Parts or circuits which are used for this equipment can be replaced to improve the safety and performance of this equipment.

◎ Read this manual carefully before using the pump, and understand its functions and how to use it for safe use.

◎ Contact DAIWHA if you have any questions regarding the equipment or the User Manual. ◎ This manual is only applicable to pumps with Program Version v1.xx or above.

Safety precautions are classified as below in accordance with the expected danger, seriousness of damage or urgency.

Danger

A precaution which can result in critical personnel injury or immediate loss of life if instructions are not followed.

Warning

A precaution which could result in critical personnel injury or loss of life if instructions are not followed.

Caution

A precaution which could result in minor personnel injury or damage to the product if instructions are not followed.

1.2 Warnings

1. Do not operate the DS-3000 syringe pump in the presence of flammable anesthetics, flammable liquids, or explosive gases (danger of fire or explosion).

2. Do not touch the inlet section with a wet hand or get it wet (danger of electric shock or short-circuit).

3. Do not operate the pump in an area where strong sources of high frequency waves and electromagnetic fields are present or where high pressure oxidation ignites (cause of failure or low performance).

4. Ensure that the syringe is installed correctly.

5. Check the infusion volume, flow rate, time and settings carefully prior to infusion. Infusion differences or critical errors may occur, since this pump does not have a device to determine infusion.

6. Check the functions and infusion differences of the pump if the pump has been severely impacted. This pump does not have a device to detect force of impact automatically.

7. Do not use the pump where radiation and MRI equipment are used or where high pressure oxidation could ignite. (It can cause product failure, breakage, degradation or explosion.)

8. Do not leave the syringe pump in a damp environment or where there is active gas (comprehensive disinfecting gas). (These environments may affect internal electrical parts and cause degradation of or damage to the equipment.)

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9. Do not keep or use the infusion pump in the presence of flammable liquid or gas. (Doing so may cause ignition or explosion.)

10. Do not use the infusion pump in an environment, e.g., an extracorporeal circuit, where positive pressure and negative pressure occur. (Infusion may not be accurate and the occlusion alarm function may not work properly.)

1.3 Caution

1. Only designated personnel (trained, experienced) are permitted to operate the pump for safe use.

2. Operate the pump using the correct procedure.

3. The following must be ensured when installing the pump.

1) Be mindful of safety procedures, e.g. vibration, impact (including transport). 2) The location for installation must not be affected by temperature, humidity and pressure. 3) Ensure that the pump is always clean. 4) The correct electric power has to be provided. 5) The location must be securely grounded. 6) Avoid strong direct sunlight.

4. The following must be ensured when operating the pump with an external power source.

1) The power plug has to be plugged into a grounded outlet in the hospital, and check the rated voltage and the frequency beforehand.

2) Do not use an extension cord containing two wires without it being grounded. 3) Check the power plug prior to use. 4) Do not connect the DC power and AC power to the pump simultaneously. 5) Be careful of the polarity and voltage when using the DC power.

5. The following must be ensured when operating the pump with a battery.

1) Be careful of the usage time when operating the pump with a battery. (The battery can support a running rate of 5 ml/h for up to 4 hours with a 50 ml syringe when fully charged.)

2) Connect the power cord to the pump to charge the battery if the “Low Battery” lamp on the LCD display blinks or if the alarm goes off.

3) Charge the battery at least once a month to prevent its life-span from being reduced if it is not being used for an extended period of time.

4) If possible, fully recharge the battery after it has been completely discharged. 5) The battery capacity is indicated on the LCD display while the battery charges. Charge the

battery fully. 6) Replace the battery if the battery usage time drastically decreases after being fully charged.

(Contact the supplier you purchased the product from when replacing the battery.)

6. The following must be ensured during infusion.

1) Check the operating conditions of the pump and the patient’s condition regularly. 2) Check if there is any damage to the syringe, e.g. a leakage or a broken extension tube. 3) Use the Lock function to prevent the settings from being altered, even if some keys are pressed

while the pump is in use.

7. The following must be ensured when using the syringe.

1) Only use the designated syringe, otherwise the flow rate may differ from the desired rate and cause malfunction of the occlusion alarm. Contact a Daiwha vendor or the head office if you cannot use the Daiwha designated syringe or the User mode.

2) Do not reuse the syringe. If you reuse the syringe, it may result in the malfunctioning of the infusion volume or sensors.

3) Install the syringe properly. Incorrect installation may result in an incorrect flow rate and infusion volume.

4) Free flow or leakage may occur if the syringe is not installed correctly. 5) Do not link and use other devices or products to infuse a drug into a patient who is connected to

the extension tube (Patient Line). It may result in an incorrect flow rate and infusion volume, and may affect the alarm functions.

8. Please note that infusion volume may differ in the following conditions.

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1) The activation time of the occlusion alarm is long when infusing the drug at a low speed and infusion does not happen,

2) The pump is operated in an environment other than the ambient temperature (10℃ ~ 40℃), relative humidity (20% ~ 90%) and atmospheric pressure (70 kPa ~ 106 kPa).

9. The following must be ensured when cleaning the pump.

1) Do not disinfect the pump with Ethylene Oxide gas or by autoclaving. 2) Do not wipe the pump with thinner, solvents, benzene, ammonia or acetone. Wipe the pump

down with damp gauze and then dry with a smooth, dry cloth. 3) Do not operate the pump in wet conditions. 4) Do not submerge the pump in water or dry the pump forcibly.

10. Do not open or disassemble the pump.

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Sales &

Service Center

Address:

Tel :

Fax :

Website:

Daiwha B/D, 733-18 Yeoksam-dong, Gangnam-gu, Seoul, Korea

+82-2-558-1711∼6

+82-2-554-0317

www.daiwha.com

Address:

Tel:

mdi Europa Gmbh Langenhagener Str. 71 30855

Hannover-Langenhgener, Germany

+49-511-39 08 95 30

This is medical equipment.

DAIWHA Corporation 1656-2 Dongwha-ri, Munmak-eup, Wonju city, Kangwon, Korea

Product Name Syringe Pump

Model DS-3000

Approval No.

Packaging Unit 1 Set

Purpose Consistent infusion of medicine

Storage Store at room temperature

Usages and Precautions See the User Manual

http://www.daiwha.com/

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1.4 Symbols

Power On (main power On) Power Off (main power Off)

AC DC

Down Key

Up Key

BOLUS (Fast Infusion)

Serial Number

Start Key (Start Infusion)

STOP/CLEAR (Stop motor and delete infusion volume)

Date of Manufacture

Manufacturer

Device Complies with the Requirements of the EC Directive 93/42/EEC.

Attention (Read the User Manual carefully prior to use.)

Type CF

IPX1 Protected against dripping water

Reference Number

Authorized European Representative

Recycle electrical and electronic equipment

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2. Specifications

2.1 Specifications

Product Name Syringe Pump

Model DS-3000

Pumping Mechanism The stepping motor drives the drive shaft.

Flow Rate 0.01 - 1500 ml/h

Accuracy

±2% (Dedicated Syringe) Measure every hour at room temperature (25 ℃) using water or saline solution (above 1.00 ml/h of flow rate). * Accuracy may differ depending on the type of medical fluid and

syringe.

Infusion Range

Total Vol. 0.01 - 9999 ml or infinity

0.01 - 99.99 ml (in 0.01 ml increments) 100.0 – 999.9 ml (in 0.1 ml increments) 1000 – 9999 ml (in 1 ml increments)

Infused Vol. 0.00 - 9999 ml 0.01 - 99.99 ml (in 0.01 ml increments) 100.0 – 999.9 ml (in 0.1 ml increments) 1000 – 9999 ml (in 1 ml increments)

Bolus Rate (Purge)

700 ml/h (default) * 5ml Syringe: 200 ml/h * 10ml Syringe: 300 ml/h * 20ml Syringe: 400 ml/h * 30ml Syringe: 500 ml/h * 50/60ml Syringe: 1500 ml/h

Bolus Volume (Purge) 0.01 - 99.99 ml (in 0.01 ml increments)

Occlusion Pressure 60 - 850 mmHg

Display Mono Graphic LCD (Resolution: 240 x 64)

Alarms

* Occlusion alarm (detection capacity: 60 - 850 mmHg) - Nine adjustable steps for downstream occlusion * Low Battery and Empty Battery alarms * AC/DC Power Removal alarm * Near Complete alarm * Standby alarm (at an interval of 2 minutes when not infusing) * Delivery Complete alarm * Near Empty alarm * The pump stops operating when alarms go off except for the Low

Battery and Start Reminder alarms. * Malfunction The status of the pump is displayed and an alarm goes off.

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Safety Features

* Infusion is unavailable when the syringe clamp is open. * Key Lock: Only the START/STOP and ON/OFF keys work. * Occlusion Sensor: Detects clogging of the extension tube. * Nurse Call: Monitoring is possible if an alarm goes off. * Breakage of the stepping motor or gear is detected by monitoring the

movements of the drive shaft.

Other Functions

* Time Mode: Calculates the flow rate by setting the infusion time. * Dosage Mode: Calculates the flow rate by setting the dosage. * Titration: Flow rate can be altered during infusion

(available only when the time remaining for infusion is more than 5 minutes).

* Low, Empty Battery: Alarms go off 30 minutes and 3 minutes before the battery goes flat.

* Date and Time: The date and time can be checked without a power supply, since a designated clock is installed.

* Standby (Pause) Mode: Pauses the operation of the pump. 1 - 999 min (in 1 min increments)

* Event History: Saves up to 2000 event logs. * Alarm Log Event: Saves 50 alarm logs. * All records of infusion events will be stored automatically and

permanently after power off.

Power

* AC 100 - 240 VAC, 50 - 60 Hz (Fuse: 250V, T3.15A) * DC 12V (1A) * Ni-MH Rechargeable Battery - 2000mAh, AA type, 1.2 V, 8 ea - Operating time: approx. 6 hours at a flow rate of 5 ml/h - Recharging time: approx. 5 hours

Power Consumption 34 VA

Protection Type

* Protection from electric shock: Class Ⅰ * Protection capacity for electric shock: Type CF * Protection from liquid infiltration: IPX 1 (drip-proof)

Dimensions (D×W×H) 260×130×91mm

Weight Approx. 1.8 kg

Operating Environment Temperature: 10 - 40 ℃, Humidity: 20 - 90% Atmospheric Pressure: 70 - 106 kPa (525 - 795 mmHg)

Storage Environment Temperature: -10 - 60 ℃, Humidity: 10 - 95% Atmospheric Pressure: 65 - 120 kPa (487 - 900 mmHg)

Accessories

User Manual 1 ea (Manual No.: Refer to the front cover of the manual.) Pole Clamp 1 ea (Model: Pole Clamp-A) Medifusion Station 1 ea (Optional)

AC Power Cable 1 ea (4 m, 0.75 ㎟ x 3C,

KS C IEC 60227-5 300/500V 60227KSIEC 53)

Communication USB

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2.2 Occlusion Detection Characteristics

1. Occlusion pressure and anti-bolus pressure were measured at a 500 ml/h flow rate, using a 50 ml syringe.

2. Syringe used for measurement: Korea Vaccine (at ambient temperature 25℃)

NOTE: The following table is for reference. (Measurement Instrument: FLUKE IDA4 PLUS)

Flow Rate Occlusion

Level (Setting)

Occlusion Pressure (mmHg)

Anti-bolus Pressure (mmHg)

500 ml/h

1 77 65

2 144 125

3 220 160

4 317 170

5 402 175

6 487 184

7 601 193

8 707 202

9 849 205

2.3 Usable Syringes

1. Korea Vaccine, JMS

2. Various syringes will be available through continuous product updates.

The infusion volume may differ depending on the type of syringe.

2.4 Memory Function

1. Recent flow rates and intended infusion volume are stored in the internal memory even after the power is turned off, and the data saved in the memory is stored permanently.

2. The date, time, infusion volume and status are stored, and you can view the data on the LCD display, or via USB.

2.5 Classification

- Class I internally powered equipment - Type CF - IPX1 - Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen

or nitrous oxide. - Continuous operation

Caution

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2.6 EMS Issues

This equipment has been tested and found to comply with the limits for medical devices in EN 601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

- Reorient or relocate the receiving device. - Increase the separation between the equipment. - Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. - Consult the manufacturer or field service technician for help.

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2.7 Characteristics Curves * The following characteristics curves were achieved in the same conditions as those of IEC 60601-2-24. 1. Start-up curve: This curve shows an infusion every 30 seconds within 2 hours of measurement

time. This start-up curve shows the characteristics of the infusion when the ratio becomes stable after the onset of infusion.

2. Trumpet curve: This curve shows the fluctuation ratio through the maximum and the minimum differences in the flow rate on the horizontal and the vertical axes. (The smaller the gaps get, the fewer fluctuations occur.)

NOTE: The following figures are only for reference. (Measurement Instrument : METRON QA-IDS MKII)

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3. Names and Functions

3.1 Keys

① LOCK Key ( ) - When you press the LOCK key, the corresponding icon appears on the LCD

display. At this time, only the START/STOP and ON/OFF keys work.

② BOLUS Key ( ) - When you press the BOLUS key while paused or during infusion, the pump infuses at the flow rate and volume set in the Setting Mode (BOLUS volume and rate).

③ MENU Key ( ) - Allows you to set sub functions. (This key does not work during infusion.)

④ CANCEL Key ( ) - Allows you to cancel changing from the sub menu to the root menu or settings.

You can also use this key when you reset the input values in the Settings window.

⑤ RIGHT Key ( ) - Used when moving the menu.

⑥ LEFT Key ( ) - Used when moving the menu.

⑦ UP Key ( ) - Used when moving the menu. When you press this key in the Settings window, you

can also increase the set values. The settings information is displayed on the infusion screen.

⑧ DOWN Key ( ) - Used when moving the menu. When you press this key in the Settings window,

you can also decrease the set values. The settings information is displayed on the infusion screen.

⑨ OK Key ( ) - Allows you to move from the sub menu to the root menu. This button allows you to

move to the root menu when the settings on the Settings screen are complete.

⑩ INFO Key ( ) - When you select I.VOL and then press the INFO key on the infusion screen, the

time remaining displays. Press the INFO key ( ) to clear an alarm sound.

⑪ START/STOP Key ( ) - If you press this key after completing the infusion settings on the infusion

screen, infusion will start. If you press this key once again, the infusion will stop.

⑫ POWER Key ( ) - The pump turns on when pressing the ON/OFF key, but when pressing and

holding the ON/OFF key, it turns off.

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3.2 LCD Display

ⓐ Alarm display ⓑ Status display ⓒ Pressure display ⓓ Lock/Unlock display ⓔ Battery display ⓕ T.VOL (Total Volume) ⓖ I.VOL (Infusion Volume) ⓗ F.RATE (Flow Rate) ⓘ Information display <Battery level display based on the battery capacity>

No. Battery Status Battery Capacity LCD Display Remarks

１ 75 - 100%

２ 50 - 75 %

3 20 - 50%

4 7 - 20% Battery Low alarm

5 Below 7% Battery Empty Battery Empty alarm

6 Charging Shows the current battery status

7 Charging Complete

The battery does not charge when DC power is supplied.

3.3 LED Display

Ⓐ Infusion LED (Green) - When the pump is infusing, this LED blinks. When the pump is paused, this LED turns off.

Ⓑ Alarm LED (Red) - When an alarm goes off, this LED turns on. When the alarm is cleared, this LED turns off.

Ⓒ AC/DC LED (Amber) - When the battery is working, this LED turns off. When the AC power is connected, this LED turns on.

Caution

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3.4 Others

Ⓓ Clamp - Holds the syringe in position and is used when checking the type of syringe. Ⓔ Clutch - Holds the syringe in position when infusion starts and the drive head moves. Ⓕ Drive Arm - Holds the syringe in position during infusion, and is used for checking for occlusion. Ⓖ Drive Shaft - The drive arm is driven by the drive shaft.

3.5 External Interface Area

① LAN Port ② USB Port ③ DC Power Inlet ④ Nurse Call Port ⑤ Drop/PCA Port ⑥ AC Power Inlet ⑦ Fuse

External Interface must be separated when the pump is used with Rack system. But, for single pump use, do not separate the External Interface from the pump.

3.6 Accessories

① AC power cable ② Pole clamp ③ User Manual ④ Medifusion Station (optional)

AC power cable Pole clamp User Manual Medifusion Station(Optional)

Caution

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4. Installation

4.1 Installing DS-3000 and Connecting the Power

Installing DS-3000 on the infusion stand

1. Mount the DS-3000 onto the infusion stand by fastening the ① knob of the pole clamp.

<Before installation>

<After installation>

1. Using the pump should be used in horizontal position. In an emergency or depending on the circumstances, you may also use the pump vertically.

Caution

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Connecting external power

1. Plug the power cord into the AC power cord inlet at the back of the pump.

2. The orange AC/DC LED on the front turns on.

3. Press the POWER key ( ) on the front.

4. The display on the front turns on and the functions of the pump are checked automatically.

Using the battery power

1. Press the POWER key ( ) on the front.

2. The display on the front turns on and the functions of the pump are checked automatically.

3. When the self-test is complete, the infusion settings are displayed on the LCD display and then the pump switches to the Infusion Ready Mode

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4.2 Installing the Syringe

1. Turn on the pump and lift the clamp. The drive arm moves backward and the pump returns to the initial state.

2. The clutch is open.

3. When you install the syringe and push the clamp down, the drive arm automatically moves forward.

4. Hold the syringe in place by moving the clutch when the drive arm makes contact with the syringe plunger.

5. To start infusion, set the infusion mode with the

keypad, and then press the START key ( ).

6. When infusion starts, the LCD display shows the Infused Volume, Time Remaining and Occlusion.

1. Only use the designated syringe, otherwise the flow rate may differ from the desired rate and cause malfunction of the occlusion alarm. If you cannot use a syringe designated by Daiwha, contact the store you purchased the pump from or use the User mode.

2. Install the syringe correctly. Incorrect installation may result in an incorrect flow rate and infusion volume.

3. Do not reuse the syringe. If you reuse the syringe, it may result in the malfunctioning of the infusion volume or sensors.

Caution

21

4.3 Syringe Select

After installing the syringe, size will automatically

recognized by pump itself.

Display pre-use syringe size and manufacturer and then

Display will ask the message “what we should use it”.

If current syringe and pre-use syringe is same. Press OK

key and move to infusion standby mode.

If current syringe and pre-use syringe is not

Same, then Press CANCEL key and move to

manufacturer selection window.

Select the current manufacturer and Press OK

key, and then move to infusion standby mode.

If current syringe size and pre-use syringe size

is not the same, in the manufacturer selection window,

Press CANCEL key and move to size selection

window.

Select the current manufacturer and Press

OK key, and then move to infusion standby mode.

1. Install the syringe correctly. Incorrect installation may cause an incorrect flow rate and infusion

volume.

2. Ensure to check correct manufacturer and size of a syringe, before to use.

Caution

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4.4 Syringe Change

When infusion standby mode, Lift the clamp and then LCD

will Displayed popup of "Syringe Change?"

Press OK key, then clutch will open and the drive arm

moves backward and the pump will return to the initial

state.

Press CANCEL key, then pull the clamp down and pump

will return to the infusion standby mode.

1. Remove or replace a syringe is prohibited during infusion. Note that excessive liquid may be

infused abruptly depending on the syringe.

Caution

23

5. Infusion Mode

5.1 Normal Infusion

Set the T.VOL, R.TIME and F.RATE with the keypad.

Total Volume Setting

Press OK key.

Press Up/down key

to change the total.

Set Flow Rate. Press Start key to

start infusion.

Flow Rate Setting

Press OK key.

Press Up/down key

to change flow rate.

Press Start key

to start infusion.

Press OK key.

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※Make sure to set the T.Vol first, and then set the R.Time.

Remain Time Setting

Press Start key to

start infusion.

Press INFO key.

Press Up/down

key to change

the remaining.

Press OK key.

Press OK key.

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5.2 Drug Infusion After Drug name setting, set the Total Volume and Flow Rate with the same steps of Normal Infusion Mode.

Drug Infusion

Press MENU key.

Press OK to move to sub-title menu bar.

Press Up/down key to select the Drug Select bar and press OK key.

Select the drug name and press OK key.

Press MENU key to move to main window. Set the Total Volume and Flow Rate and press Start key to start infusion.

Press Up/Down key to select the alphabet index and press OK key.

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5.3 Dosage Infusion

Set the Drug, Weight and T.VOL with the keypad.

Dosage Setting (Drug)

After setting, press MENU key to move to Main Window.

Press the Up/Down to set the Weight, Total volume, Flow rate.

Press Up/Down key to select the Drug Select bar and press OK key.

Press MENU key .

Select the drug name and press OK key.

Press Up/Down key to select the alphabet index and press OK key.

Select Dosage Set menu and press OK.

Press OK key to move to sub-title menu bar.

Press Start key to start infusion.

27

5.4 Dosage Infusion(Manual) In case Drug setting is not used, user can change the setting of concentration, dose, unit of measurement.

In case of the initial setting for Dosage, make sure to Clear Therapy first, and then start Dosage setting.

Dosage Setting (Manual)

Complete Settings. Press Start key.

1. Choose a Dosage Set using UP and DOWN keys and press OK key.

1. Press the menu key on standby display. 2. Choose a Special function using UP and DOWN keys and press OK key.

1. Choose Concentration set using UP and DOWN keys and press OK

key.

1. Press Cancel key to be a setting display for Dose measure.

1. Choose a Dose measure by UP and DOWN keys and press OK key.

1. Input Dose value using UP and DOWN keys and press OK key.

1. Input weight value using UP and DOWN keys and press OK key to be a Dose display.

1. You can check current set mode. 2. Press T.Vol and move to standby display by pressing Menu key.

1. After choosing Drug by pressing OK key to set Drug amount and press OK Key.

2. After choosing Amount and pressing OK key to set dilution amount and press OK key.

Weight Setting weight not setting

28

The above steps are about initial setting. In case of reset and change of Dosage. move to Dosage Set menu and

the setting information of current setting of Dosage.

T.Vol, Dose, Weight are changed in Dosage Set menu. But, the process of changing Concentration is the same

as the initial setting.

1. Choose a Dosage Set using UP and DOWN keys and press OK key to move to Dosage set display.

1. Press the Menu key in standby display. 2. Choose Special Function using UP and DOWN keys and press OK key.

Dosage Setting (Manual)

29

6. Settings

1. You can set Infusion Mode 1 (Normal) or Infusion Mode 2 (Drug), Infusion Mode 2 (Manual Dosage) as below:

1) In Infusion Mode 1 (Normal), you can set the infusion flow rate and time. 2) In Infusion Mode 2 (Drug), you can set the Dosage (mcg/kg/min), Weight (Kg) and T.Vol (ml). 3) In Infusion Mode 3, you can set Dosage measure, Concentration, Dose without selecting Drug.

● Changing infusion mode

Category Mode

LCD Display Description Remarks

Infusion Mode 1 (Normal)

You do not need to select a drug.

Infusion Mode 2

(Drug)

You need to select a drug.

Infusion Mode 3

(Manual Dosage)

You can set Dosage

measure, Concentration, Dose without selecting Drug

30

● Setting the infusion mode

Category Mode

Display Description Remarks

Infusion Mode 1 (Normal)

Setting the flow rate

Set the flow rate (ml/h) and the total volume (ml).

See Chapter 5. Infusion Mode

(Normal) - Setting the Flow Rate

Setting the infusion time

Set the infusion time, flow rate (ml/h), and the total volume (ml).

See Chapter 5. Infusion Mode

(Normal) - Setting the Infusion Time

Infusion Mode 2 (Drug)

Setting the drug

After Set the drug, Set the flow rate (ml/h) and the total volume (ml).

See Chapter 5. Setting the

Infusion Mode (Drug)

Setting the dosage (Drug)

After Set the drug, Set the dosage (mcg/kg/min), weight (kg), dosage (mg), and total volume (ml).


Infusion Mode -Dosage(Drug)

Setting the dosage (Manual)

It starts infusion

after setting

Dosage mode.


Infusion Mode -Dosage(Manual)

● Changing values in Infusion mode

Category Mode

Button Operation Remarks

Infusion Setting Mode , ,

,

Change digits and values. See the menu for

each setting.

31

● You can set the additional functions as below.

Function LCD Display Description

Clear the input value

If there is the existing setting value in display,

Press CLEAR( ) key to change the setting

value to “0”. *Caution: If placed “0” for setting value, it won’t be saved.

Clear the total set value

In Main Window, press CLEAR( ) key and

OK( ) key to clear all setting values. (T.Vol, F.Rate, R.Time, Drug, I.Vol.)

Viewing set values

In Infusion mode, press the UP ( ) and Down ( ) keys to view the set

values.

e.g.) Syringe: KOVAX 30 The current syringe is a 30 ml KOVAX

syringe.

e.g.) Drug: No Drug Infusion Mode 1 (Normal) is set, and this

is displayed when selecting Drug Library. See Infusion Mode (Drug).

e.g.) T.Vol: 30.00 ml The total volume (ml) is displayed.

e.g.) I.Vol: 0.00 ml The infused volume (ml) is displayed.

e.g.) R.Time: 0:04 The time remaining for the completion of

infusion is displayed.

e.g.) F.Rate: 500 ml/h The flow rate (ml/h) is displayed.

EX) NO SLOT

Slot No. is displayed when a station installed.

“NO SLOT” is displayed when a station is not

installed.

1. To reset a set value, press the CLEAR ( ) key and the OK ( ) key on the Settings screen.

2. To reset all the set values, press the CLEAR ( ) key and the OK ( ) key on the Infusion

Ready Window.

32

● Resetting the Accumulated Volume (ml) – Infusion Mode 1 (Normal) You can reset the accumulated volume (ml) as below:

No. LCD Display Description

1

In Infusion Ready window, select I.Vol (ml) by

pressing the left ( ) and right ( ) keys. When

you press the OK key ( ), the accumulated

volume displays.

2

To reset the value on the I.Vol (ml) display, press

the CLEAR ( ) and OK ( ) keys.

3

When you press the OK key ( ), the Infusion

Ready window appears.

1. Press the START key ( ) to start infusion.

* The accumulated infusion volume is displayed as follows: 0.01 - 99.99 ml (in 0.01 ml increments) 100.0 – 999.9 ml (in 0.1 ml increments) 100 0- 9999 ml (in 1 ml increments)

33

● Titration Function – Infusion Mode 1 (Normal) You can set the titration function as below:

No. LCD Display Description

1

In Infusion Status, When you press the OK key

( ), the flow rate input display appears.

2

3

Press UP( ), DOWN( ) key to set the Flow

Rate.

4

When you press the OK key ( ), infusion

resumes at the changed flow rate.

1. This function allows you to change the flow rate during infusion.

* Extra care is required since this function allows you to change the flow rate during infusion.

34

7. Operation

1. Operation states can be categorized as follows.

● Types of operation states

Mode Category

Display Description Remarks

Main Window

The syringe pump can be operated immediately after pressing the START

key ( ).

Infusion State

The START key ( )

was pressed, and infusion has started.

Standby

After set infusion Value,

The POWER key( ) was pressed.

Purge Infusion

Press the BOLUS key

( ) in the Infusion

Ready Status.

Bolus Infusion

Press the BOLUS key

( ) in the normal

infusion state.

Pause

When the STOP key

( ) is pressed in the

normal infusion state, infusion will stop.

Infusion Mode 1

(Normal)

You do not need to select a drug in this mode.

Infusion Mode 2

(Dosage)

You need to select a drug in this mode.

35

7.1 Infusion Ready (Before Operation)

1. The syringe pump can be operated immediately after pressing the START key ( ) in the Infusion

Ready Status.

2. You can access any mode in the standby mode. However ensure that the Key Lock switch is on. (See Chapter 7.5 Key Lock Function.)

3. The Standby alarm goes off if no keys are pressed within the configured time in the Infusion Ready window. The red LED will blink. (See Chapter 9. Setting the Standby Alarm.)

4. When you press the BOLUS key ( ), infusion starts at the set BOLUS F.Rate with the set bolus

infusion volume.

When you press the BOLUS key ( ) in infusion Ready window, occlusion is detected in Purge

Mode. Note that excessive liquid may be infused abruptly.

7.2 Start Infusion (Start Operation)

1. Press the START key ( ) on the front to start the pump.

2. The infusion volume on the I.Vol display increases as the pump keeps running.

3. When pressing the Up/Down keys, you can view information such as the Drug, R.Time, T.Vol, I.Vol, F.Rate and Syringe.

4. When pressing the BOLUS key ( ), infusion starts at the set bolus flow rate with the set bolus

volume.

When pressing the BOLUS key ( ) during operation, occlusion is detected in the bolus state.

Note that excessive liquid may be infused abruptly.

5. Press the OK key ( ) to change the flow rate during infusion. See Chapter 6.1.4 Titration

Function.

6. If you press the STOP key ( ) during operation and no keys are pressed within the configured

pause time, the Standby alarm will go off and the red alarm LED will blink.

7. The Near Complete alarm is triggered if the infusion completion time is within 5 minutes in accordance with the set total volume and the infused volume. See Chapter 9. Setting the Near Complete Alarm.

8. If the Save function is on, the infusion volume and flow rate are saved. When the power is turned off and turned on again, the previous data is displayed.

※ If the Save function is not set, the infusion volume and flow rate are not saved. Therefore when the power is turned off and turned on again, the infusion volume and flow rate are displayed as "0".

1. Before you start infusion, ensure that the syringe is installed correctly, and the flow rate and intended volume are set properly.

2. Press the START key ( ) and monitor the infusion for a while to ensure that it is working

properly.

Caution

Caution

Caution

36

Opera

7.3 Stop and Pause

1. If the STOP key ( ) is pressed during normal infusion or bolus infusion, infusion stops and the

green LED turns off.

2. If infusion does not start within the preset pause time after pressing the STOP key ( ), the

standby alarm goes off and the red LED blinks.

7.4 Viewing the Infused Volume and Time Remaining

1. Press the UP ( ) and DOWN ( ) keys to view the information on the Drug, R.Time, T.Vol, I.Vol,

F.Rate and Syringe.

7.5 Key Lock Function

1. This function is used to prevent malfunctioning of the keys during infusion.

2. When you press the Lock key ( ) on the keypad, the Key Lock icon on the LCD display appears.

At this time, only the START/STOP ( ) and ON/OFF ( ) keys will work.

7.6 History Log Function

1. The History Log function saves the events of the equipment in the memory.

2. Up to 2,000 events can be saved, and when there are more than 2,000 events, the oldest ones are overwritten.

3. Events are saved when starting, completing and stopping infusion, and when alarms occur.

4. Events contain the Date & Time (the date and time when an event occurred), Operation Mode, Total Volume, Flow Rate, Infused Volume and Types of Alarms.

1) Date & Time: Year, Month, Day, Hour, Minute, Second

2) Operation Modes: Ready, Normal, Bolus, Purge and Pause modes

3) Total Vol: 0.00 - 9999

4) Flow Rate: 0.00 - 1500

5) Infused Vol: 0.00 - 9999

6) Types of alarms

5. You can view event logs on the LCD display. See the service manual for detailed information.

6. The 50 most recent alarm logs are saved in the History Log and other memory. You can view the alarm logs on the LCD display. See the service manual for detailed information.

37

8. User's Settings

8.1 Menu Tree

8.2 Special Functions

1. Change the status or the set values using the directional keys, and press the OK key ( ) to

finish setting.

8.2.1 Syringe Selection 1. When you have installed a defined syringe from another manufacturer, you can change the

manufacturer.

2. When you have installed an undefined syringe, you can set the manufacturer and syringe size.

8.2.2 Drug Selection 1. Set the drug infusion mode.

See Chapters 5.2 Dosage Infusion and 6.4 Infusion Mode (Drug).

8.2.3 Dosage Setting 1. Change detailed settings in the Drug Infusion mode. See Chapter 6.4 Infusion Mode (Drug)

38

8.2.4 Calibration 1. A calibration function is available so as to increase the accuracy of the pump.

2. Make sure to set the syringe to the specified size, and then perform calibration.

3. When the calibration is complete, the pump switches to the Infusion Ready Status.

4. Please refer detailed information to <Supplment – Calibration Process>

1. Ensure that you check for the manufacturer and size of a syringe prior to use. 2. If you use an undefined syringe, set the manufacturer and size prior to its calibration.

8.2.5 Infusion Relay 1. 2pumps are connected by automatic/hand-operate for infusion. 2. Infusion relay is only possible to operate when there is an additional Medifusion or Station. 3. Infusion relay operates only one time at a setting. If you want Infusion relay again, it needs reset for

it. 4. Please refer detailed information on< Supplment - Infusion relay.>

8.3 Options

1. Change the status and the set values using the directional keys, and press the OK key ( ) to

finish setting.

8.3.1 Bolus F.rate

1. Press the BOLUS key ( ) to change the bolus flow rate.

8.3.2 Bolus Volume

1. Press the BOLUS key ( ) to change the bolus volume.

8.3.3 Standby Time 1. If there isn’t any input to any keys for 2 minutes, Standby alarm occurs.

2. Standby alarm can be turned On/Off.

8.3.4 Near Complete Alarm 1. The Near Complete alarm goes off when the infusion approaches the preset infusion completion

time in accordance with the preset total volume and the infused volume.

2. You can change the time when the Near Complete Alarm will go off.

3. You can set the time to a minimum of 1 minute and a maximum of 24 hours.

8.3.5 Pressure Level 1. You can change the occurrence level of the occlusion alarm.

2. If the pressure measured in real-time is greater than the preset pressure level, the occlusion alarm will go off.

8.3.6 Nurse Call 1. You can turn the Nurse Call mode on or off when the alarm goes off.

8.3.7 Auto Save On/Off 1. You can turn the Save function on and off.

2. If the Save function is on, the infusion volume and flow rate are saved. When the power is turned

Caution

39

off and turned on again, the previous data is displayed.

3. If the Save function is not set, the infusion volume and flow rate are not saved. Therefore when the power is turned off and turned on again, the infusion volume and flow rate are displayed as "0".

8.3.8 AC/DC Removal Alarm 1. You can turn this alarm on or off when connecting or disconnecting the AC/DC power.

8.3.9 K.V.O Set 1. You can set the K.V.O (Keep Vein Open) flow rate and turn it on or off.

8.3.10 Auto Bolus Check 1. Bolus confirmation message can be turn On/Off.

2. After Auto Bolus Check Turn on, pump will display Popup message of bolus operation confirmation.

3. Press OK key to Bolus Infusion or Press Cancel key to normal infusion

8.3.11 Anti-Bolus On/Off 1. In order to cancel the pressure when Occlusion alarm, you can set whether to retreat the drive or

not. 2. If Anti-Bolus is on when Occlusion alarm, the Drive removes pressure with retreating Drive. 3. If Anti-Bolus is off when Occlusion alarm is set, Drive does not retreat. But be careful it may occur

excessive bubbles. 4. Set as Anti-Bolus is on during infusion.

8.4 Config Mode

1. Change the status and the set values using the directional keys, and press the OK key ( ) to

finish setting.

8.4.1 Sound Volume 1. Allows you to adjust the volume of the alarms and sound effects.

8.4.2 Key Sound Volume 1. Allows you to adjust the volume of the keys when they are pressed.

8.4.3 Occl Sensitivity 1. It may occur occlusion alarm frequently during infusion due to syringe characteristic. 2. Sensitivity value is step of pressure level. 3. If you increase pressure level or occlusion sensitivity adjusts to downward, it prevents occurring

frequent alarm. 4. Even though it occurs excessive alarm with no occlusion alarming, you can check whether

occlusion alarm occur or not with adjusting sensitivity to downward.

8.4.4 Alarm Log 1. You can view the alarm logs.

2. Sorted by recent logs.

8.4.5 Event Log 1. You can view the event logs.

2. Sorted by recent logs.

40

8.4.6 Date Set 1. Allows you to set the date.

8.4.7 Time Set 1. Allows you to set the time.

8.4.8 Factory Reset 1. Allows you to set the pump back to the factory settings.

2. Enter the password to set the pump back to the factory settings.

3. The password is provided separately.

8.4.9 Contrast 1. You can control Contrast of LCD.

8.4.10 Contrast(Standby)

1. You Can Control Contrast of Standby Window

8.4.11 Language 1. English, Italian, Spanish, French, Dutch

2. Allows changing the language of pump.

3. Add Language of other nations through continuous product updates.

4. Select Language and press the OK key to set the language of nations.

1. Set the date and time on the pump correctly. 2. The date and time set on the pump apply to the alarm and event logs.

8.5 Service Mode

1. Change the status and the set values using the directional keys, and press the OK key to finish setting.

2. The sub-menu is a service menu, and thus it will be available later.

Caution

41

9. Alarms

The following describes the alarms and corrective action when the pump is not working properly. Stop the infusion immediately if the pump is not working properly. For the patient’s safety, there are many safety alarms. Alarms go off and the user is notified of each state by the triggering of alarms and the status LEDs and the LCD displays. The operator can identify the pump status within a meter of the pump, and within three meters of the pump with the status LEDs and alarms.

1. Alarm LED - Red LED ON: An alarm is activated. - Red LED OFF: The alarm is deactivated.

9.1 Occlusion Alarm

1. The occlusion alarm is triggered and infusion stops when the syringe is installed incorrectly, or when its needle is clogged.

2. The following alarm goes off and the corresponding LED turns on when the occlusion alarm is triggered.

- Alarm sound. - Alarm icon displays. - LCD status indicator: “Occl" blinks.

3. Press the OK key ( ) to clear the occlusion alarm and to switch to the standby mode.

1. Before you start infusion, ensure that the syringe is installed correctly, and that the flow rate and intended volume are set properly.

Alarms

Caution

42

9.2 Low Battery Alarm

1. The Low Battery alarm is triggered 30 minutes before the pump stops working if the pump is operating on battery power without an external power source.

2. The following alarm goes off and the corresponding LED turns on when the Battery Low alarm is triggered.

- Alarm sound.

- Alarm icon displays.

- LCD status indicator: “Low Battery" blinks.

3. When external power is supplied to the pump, the Low Battery alarm is cleared.

9.3 Empty Battery Alarm

1. If the pump is operating on battery power without an external power source, the Empty Battery alarm is triggered 3 minutes before the remaining battery shuts down the pump.

2. The following alarm goes off and the corresponding LED turns on when the Empty Battery alarm

is triggered.

- Alarm sound.


- LCD status indicator: “Empty Battery" blinks.

3. When external power is supplied to the pump, the Empty Battery alarm is cleared.

4. When the Empty Battery alarm occurs, you cannot clear it with the CLEAR key ( ).

5. After the Empty Battery alarm occurs, the pump stays on for 3 minutes, and then shuts down.

6. If you turn the pump on when the battery is empty, the following alarm goes off and the corresponding LED turns on, and then the pump shuts down.

- Alarm sound.


- LCD status indicator: “Empty Battery" blinks.

9.4 Infusion Complete Alarm

1. When the set infusion volume is complete, infusion stops and the pump switches to the standby mode.

2. The Infusion Complete alarm is triggered, and the green LED turns off. - An alarm goes off and the green LED turns off.

9.5 AC Power Removal Alarm

1. The AC Power Removal alarm is triggered if AC power stops being supplied.

- Alarm sound. - AC/DC power connection LED: Off - Alarm icon display. - LCD status indicator: "AC Reject Alarm" blinks.

2. The alarm goes off for 2 seconds when the AC Power Removal alarm is triggered.

3. If AC power is supplied again, the AC Power Removal alarm is cleared and it goes off for two seconds.

43

9.6 DC Power Removal Alarm

1. The DC Power Removal alarm is triggered if DC power stops being supplied.

- Alarm sound. - Alarm icon displays. - LCD status indicator: "DC Reject Alarm" blinks. - AC/DC power connection LED: Off

2. The alarm goes off for 2 seconds when the DC Power Removal alarm is triggered.

3. If DC power is supplied again, the DC Power Removal alarm is cleared and it goes off for two seconds.

9.7 Removal Power Alarm

1. If AC/DC Power is removed, "Removal Power" alarm occurs for 3 minutes.

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Removal Power" blinks. - Power LED Off

2. "Removal Power" alarm sounds for 3 minutes.

3. "Removal Power" alarm can be turned off by pressing INFO( ).

4. If AC/DC Power is re-connected during "Removal Power" alarm period, alarm will be automatically off. And then, the injection alarm occurs for 2 seconds.

9.8 Standby Alarm

1. If there isn’t any input to any keys for 2 minutes, Standby alarm occurs.

2. In "Standby“ alarm period, following symptom appears:

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Standby" blinks.

3. "Removal Power" alarm can be turned off by pressing any keys.

4. If there isn’t any input to any keys for 2 minutes, Standby alarm occurs.

9.9 Time Out Alarm

1. “Time Out” alarm occurs if there isn’t any input to POWER( ) key for the set time in Standby

mode. 2. In "Time Out“ alarm period, following symptom appears:

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Time Out" blinks.

3. "Time Out” alarm can be turned off by pressing any keys.

44

9.10 Near Complete Alarm

1. The Near Complete alarm is triggered if the infusion completion time is 5 minutes away, in accordance with the set total volume and the infused volume.

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Near Complete" blinks.

2. When infusion is complete, the Near Complete alarm is cleared. The Infusion Complete alarm goes off and then the pump switches to the standby mode.

9.11 Near Empty Alarm

1. “Near Empty” alarm occurs when liquid inside the syringe reaches under the 10mm during infusion operation.

2. In "Near Empty“ alarm period, following symptom appears:

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Near Empty" blinks.

3. If the infusion is completed, “Near Empty“ will be off and “Complete” alarm occurs.

9.12 Clamp Alarm

1. If you open the Clamp or uninstall syringe during infusion operation, “Clamp” alarm occurs and operation automatically stops.

2. In "Clamp“ alarm period, following symptom appears:

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Clamp" blinks.

3. "Clamp” alarm can be turned off by pressing any keys.

4. If you want to restart infusion, re-install the syringe.

9.13 Clutch Alarm

1. If the Clutch is in malfunction or the syringe is installed improperly, the “Clutch” alarm occurs and infusion operation stops.

2. In "Clutch“ alarm period, following symptom appears:

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Clutch" blinks.

3. "Clutch” alarm can be turned off by pressing any keys.


9.14 Detect Alarm

1. During the infusion operation, if plunger of syringe is detached from the Detector due to Free flow, “Detect” alarm occurs and infusion operation stops.

2. In "Detect“ alarm period, following symptom appears:

- Alarm sound. - Alarm icon displays. - LCD status indicator: "Detect" blinks.

3. "Detect” alarm can be turned off by pressing any keys.


45

9.15 Error Codes

1. If an error occurs while using the pump, the pump displays an error code on its LCD display.

2. Turn the power switch at the back of the pump off, and turn it back on when an error occurs. If the same error code persists, stop using the pump and contact the vendor you purchased the pump from.

Error Code Cause

E001 Motor Check Error

E002 System Error

9.16 Checklists for Alarms

When an alarm goes off, infusion stops automatically (in accordance with the priority).

Check the alarm message, LED and alarm on the LCD display. Press the STOP key ( ) to stop the

alarm. Refer to the inspection items for the corresponding alarm and press the START key ( ) to

resume the infusion. Check the alarm. ※ The operator must be present at a location where he/she can identify the pump status while the

pump is running.

Alarm Status Cause Corrective Action Inspection

Near Empty Alarm

Liquid inside the syringe reaches under the 10mm during infusion operation.

Alarm will be automatically off after infusion is completed.

Occlusion Alarm Inside of syringe or connected tube is over-pressured more than set pressure limit.

Check the inside of syringe and tube, and remove the cause of occlusion.

Start the infusion operation and block the syringe inlet to check the occlusion.

Low Battery Alarm The remaining battery time is no longer than 30 minutes.

Connect AC power to charge the battery.

Keep running the pump until Low Battery Alarm is indicated.

Empty Battery

Alarm

The remaining battery time is no longer than 5 minutes.

Connect AC power to charge the battery.

Keep running the pump until Empty Battery Alarm is indicated.

Complete Alarm Finish of set infusion operation.

Press START/STOP key to remove alarm.

Set the infusion operation mode temporary and wait until operation is done.

AC/DC Power

Removal Alarm AC/DC power is disconnected.

Press START/STOP key to remove alarm.

Disconnect the AC/DC adapter.

Standby Alarm There is no input to any keys for 2 minutes.

Press any key to remove the alarm.

Turn on the Standby Alarm and wait for 2 minutes without any input.

46

Near Complete

Alarm

The infusion completion time is 5 minutes away from completion of infusion operation.

Alarm will be automatically off after infusion is completed.

Clamp Alarm

The Clamp is opened during infusion. Syringe is not installed properly.

Press any keys to remove alarm and re-install the syringe.

Open the Clamp during infusion operation.

Clutch Alarm

The Clutch is in malfunction or the syringe is installed improperly.


Hold the clutch during detecting syringe.

Detect Alarm

Plunger of syringe is detached from the Detector during infusion operation.


Detach the Plunger from Detector during infusion operation.

Error code

Malfunction of Motor

Turn on the pump again. If the same symptom shows continuously, then request for A/S.

"Error 001"

System Error

Turn on the pump again. If the same symptom shows continuously, then request for A/S.

"Error 002"

Install the syringe on the product properly prior to use.

Contact the vendor you purchased the product from for other error codes or problems with the product.

Caution

47

10. Precautions during Use

Perform regular inspection and maintenance of the pump to use it safely for an extended period of time.

Do not use the pump if the pump is found to be abnormal during inspection, and contact the vendor you purchased the pump from. Do not use the pump if it has any external signs of impact or is dropped, and contact the vendor you purchased the pump from. The sensors inside the pump or their accuracy may deteriorate, even if there were no external issues.

10.1 Life-span of Replaced Parts

1. Batteries – Check the usage times of the batteries, since the batteries' life-spans could be reduced if the batteries are used for more than a year. It is highly advisable to replace the batteries every year. ▪ Battery life-span may differ depending on the environment and the frequency of use. ▪ Contact the vendor you purchased the pump from when replacing the batteries.

10.2 Maintenance

It is essential to inspect the pump regularly for safe and correct use. Contact the vendor you purchased the pump from if it is found to be abnormal.

1. Accuracy Inspection – Monitor infusion volume regularly. Contact the vendor you purchased the pump from if there is a large difference in infusion volume.

2. Occlusion Alarm Inspection – Completely block the syringe by hand to prevent the influx of liquid, and monitor if the occlusion alarm is triggered.

10.3 Cleaning and Disinfecting

1. Clean and store the pump properly after use. If the pump is not stored properly or is stored without cleaning, it may cause malfunctioning of the pump. ※ Precautions 1. Disconnect the pump from any external power source when cleaning. 2. Do not disinfect the pump with Ethylene Oxide gas or by autoclaving. 3. Do not wipe down the pump with thinner, solvents, benzene, ammonia or acetone. Use a damp

cloth. 4. Dry the pump after cleaning.

10.4 Disposal

When the pump reaches the end of its life-span, dispose of or recycle the pump and the batteries (Ni-MH) in accordance with local regulations, or contact the nearest vendor.

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48

10.5 Storage

1. Avoid direct sunlight when storing the pump. Do not leave the pump in wet and humid conditions.

2. Avoid areas with a possibility of falling.

3. Transport & storage condition:

- Temperature : -10℃~45℃

- Humidity : 10%~95%

- Pressure : 65KPa ~ 120KPa

49

11. Document History

Change Code Revised Description

Rev 0.19 2012.03.30 Release

Rev 0.20 2012.08.17 Add Function

Rev 0.3 2013.01.08 Add Function

Rev 0.4 2013.01.15 Add Image

Rev 0.5 2013.06.07 Black LCD & Image

Rev 0.51 2013.06.13 Modify Image

50

12. <Supplement>

12.1 Calibration Process

12.1.1 Preparation 1. Syringe, Electronic scale, Pump, Extension Tube, Distilled Water

12.1.2 Calibration preparation

No. Pictures Explanation

1

1. Connect the power cord to the AC connector on back side and press

POWER( ) for 3 seconds to turn on Pump. 2.Open the Clamp to move Drive to the right for syringe insertion.

2

1. Fill the distilled water into the syringe for Calibration.

3

1. Install the syringe with pump and close Clamp to fix the syringe. . 2. Drive moves forward automatically and pump recognize the syringe size.

4

1. Check whether the size of the installed syringe is same as the size in display Select USER for the syringe name and

press OK( )key.

5

1.Connect the extension tube to the syringe.

2. Press Bolus key( ) to remove air in extension tube

6

1. Connect the extension tube to a needle and position the needle above the beaker in the electronic scale. <Refer to IEC 60601-2-24 >

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12.1.3 Calibration Start


1

1.Position the left end of Plunger in the gradation of the maximum syringe size. (EX) syringe size 50 : 50ml syringe size 30 : 30ml syringe size 20 : 20ml syringe size 10 : 10ml syringe size 5 : 5ml

2

1.Reset the scale as zero(0).

3

1. Select MENU > Special Function >

Calibration and press OK( )key to start Calibration.

4

1 When calibration is completed, new calibration result is applied.

5

1.In case difference between the setting volume and the infused volume is over 2%, do calibration again. 2. Check out the amount of distilled water and air bubble inside extension tube to ensure accuracy of infusion.

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12.2 Infusion Relay

12.2.1 Preparations 1. Syringe, 2 Pumps, Medifusion Station

12.2.2 Infusion Relay 1. Infusion Relay function is used for infusion of multiple drug bags by two pumps. 2. With the Master-Slave structure, after Master pump completes the first infusion, Slave pump automatically starts the second infusion. 3. Infusion Relay has both of Automatic type and Manual type in operation. 4. Daiwha’s Infusion pump models(DI-4000) are compatible for the Infusion Relay function. 5. Infusion Relay function is for single using only and not repeatable with a setting.. 6. Please reset the Infusion Relay for the new operation.

12.2.3 Preparation for Infusion Relay


1

1.Each slot of Station has its slot number as seen in the left picture. In case Pump is installed, the slot number is automatically assigned to the Pump.

2

1.Install Pump onto Station and connect AC power, and press POWER

key( ) to turn on Pump. . 2.Install the syringe and select the syringe name.

3

1.You can check the assigned slot

number with ( , ) keys in standby display.

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12.2.4 Set for Infusion Relay - For explanation as below, the setting is arbitrarily as Slot no.1 for Master pump and Slot no.2 for Slave pump. For your clinical using, please set it with the actually assigned Slot number.

No. Pictures Pump Explanation

1

Master Pump (Slot 1)

1.Press the Menu key of Master pump(slot no.1) and select Special Function Infusion Relay Master Start and press OK( ) key.

2


1. Select the Slot number of Slave pump(slot no.2) with

Up/Down( , ) key and press OK key.

3


1.It moves to the status of Slave pump connection. . 2.When Slave pump is connected, the message on the top of display is changed as seen in the left picture.

4

Slave Pump (Slot 2)

1.Press the Menu key of Master pump(Slot no.2) and select Special Function Infusion Relay Master Start

and press OK( ) key.

5

Slave Pump (Slot 2)

1.Select the Slot number of Master pump (Slot no.1) with

Up/Down( , ) key and

press OK( ) key.

6

Slave Pump (Slot 2)

1.It moves to the status of Master pump connection. 2.When Slave pump is connected, the message on the top of display is changed as seen in the left picture.

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12.2.5 Cancellation of Infusion Relay In case you clear Infusion Relay mode in any of Master pump or Slave pump, the Infusion Relay mode of the other pump is automatically cleared.


1


1. Once Infusion Relay mode is set, the menu of Master Start is automatically changed to Master Stop.

2. Press OK( ) key after choosing Master stop. Select Master Stop and press

OK( ) key.

2


1.It gives the message to confirm the cancellation. Press

OK( ) to clear Infusion Relay mode.

3


Wait for answering on the top of display.

4


1.When Master pump receives answering from Slave pump, it turns to the standby display. 2.If Slave pump is not set or not installed, it moves to standby display after 3~5 seconds.

12.2.6 Cancellation of Infusion Relay - In case you clear Infusion Relay mode in any of Master pump or Slave pump, the Infusion Relay mode of the other pump is automatically cleared. - It has the same procedure as the Master pump.

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12.2.7 Start Infusion Relay( Automatic ) - To use Automatic Infusion Relay, Near Complete Alarm of Master Pump must be OFF then start to infuse.


1

Master Pump

(Slot 1)

1.Install the syringe into Master pump. After completing infusion setting, press

START( ) key.

2

Master Pump

(Slot 1)

1 .Once infusion starts, display is changed as seen in the left picture. . 2. Once infusion is completed, Master pump allows Salve pump to start infusion automatically and stops Infusion Relay mode and moves to standby mode.

3

Slave Pump

(Slot 2)

1.Master pump automatically starts Infusion Relay after receiving the signal from Master pump. 2.If there is no syringe or no syringe setting, it does not start to infusion with alarm.

4

Slave Pump

(Slot 2)

1. Once infusion starts, the display is changed as seen in the left picture. 2. Once infusion is completed, Infusion Relay mode stops and it moves to standby display.

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12.2.8 Infusion Relay Start(Hand-operate) - Hand-Operated Infusion Relay can be used in case of using Master Pump with setting Near Complete Alarm. And when the rest of infusion time (R.Time) is lower than Near Complete Alarm, user can start to infuse Slave Pump hand-operatedly


1

Master Pump

(Slot 1)

1. Select Near Complete Alarm

and press OK( )key.

2. Press MENU( ) to move to standby display.

2

Master Pump

(Slot 1)

1. Install the syringe into Mater pump and complete infusion setting and press

START( )key.

3

Master Pump

(Slot 1)

1. Once infusion is completed, Master pump allows Salve pump to start infusion automatically and stops Infusion Relay mode and moves to standby mode.

4

Master Pump

(Slot 1)

1. When the R.Time is less than the setting time of Near Complete Alarm, display shows pop-up window as seen in the left picture.

2. Press OK( )key to start infusion of Slave pump.

If you Press CANCEL( ) key, it operates at Auto Infusion Relay mode.

5

Slave Pump

(Slot 2)

1. Master pump automatically starts Infusion Relay after receiving the signal from Master pump. . 2. If there is no syringe or no syringe setting, it does not start to infusion with alarm.

6

Slave Pump

(Slot 2)

1. Once infusion is completed, it moves to standby display.

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12.2.9 Other messages

- If user set incorrectly during setting Relay mode, the picture below could be shown.


1

1. In case you make Salve setting in the Master pump, the warning window as the left picture comes on. 2. In case you make Master setting in the Slave pump, the warning window as the left picture comes on.

2

1. When the pump is not installed in the Station. 2.When the pump is installed incorrectly in the Station. *If “NO SLOT” window still comes on the display when you reinstall the pump in Station, please contact the supplier or manufacturer.

3

1. If you set the Infusion Relay in the above cases, warning window comes on as seen in the left picture.

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