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Safety

Instructions

1.6

Symbols

The following marks and symbols are attached on the product and this User's Guide. Be

familiar with the meanings of each mark and symbol, and follow their instructions.

Symbols

Description

Symbols

Description

Manufactured date

Manufacturer

Device Complies With The
Requirements Of The EC Di

rective 93/42/EEC.

Caution

A CF type pump.

Serial Number

IP32

Protection from dust and d

ropping water

Reference Number

Authorized EU representativ

WEEE

See instructions for use

Содержание DI-6000

Страница 1: ......

Страница 2: ...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...

Страница 3: ...Yeoksam ro Gangnam gu Seoul Korea Phone 82 2 558 1711 Fax 82 2 554 0317 Website http www daiwha com mdi Europa GmbH Langenhagener Str 71 D 30855 Hannover Langenhagen Germany Copyrights Copyrights for...

Страница 4: ...splay 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 powe...

Страница 5: ...k 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...

Страница 6: ...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...

Страница 7: ...njury 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...

Страница 8: ...re 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...

Страница 9: ...er 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 occlus...

Страница 10: ...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 followi...

Страница 11: ...mark and symbol and follow their instructions Symbols Description Symbols Description DC AC Manufactured date Manufacturer Device Complies With The Requirements Of The EC Di rective 93 42 EEC Caution...

Страница 12: ...n it indicates that injection is stopped in standby mode 3 AC DC power connecti on LED Orange LED turns off when battery power is used LED turns on when the AC power is connected 4 Buttons See details...

Страница 13: ...ensor Connector 4 USB port used for maintenance 5 DC power port 6 Docking Station Connector To connect an optional Docking Station 7 Fuse 8 AC power port Caution Open the Cover of Docking Station Conn...

Страница 14: ...on To Save the adjusted setting push BOLUS SAVE or JOG to set OK POWER When the POWER button is pressed the power of the product immediately turns on The power of the product turns off by pressing and...

Страница 15: ...nfusion is being made 5 BOL Indicates that BOLUS infusion is being made 6 LOCK Indicates that KEYS are Lock Unlock 7 Battery Indicates remaining battery 8 F Rate Indicates Flow Rate setting value 9 I...

Страница 16: ...aution When the DC power is connected the product operates without charging 2 5 Alarm icon display unit The Alarm Icon Display unit checks each sensor and displays the state of the pump No Name Descri...

Страница 17: ...ation display unit Displays the I V Set installed in the pump and the set drug No Name Description 1 I V Set Displays name of the fluid set I V Set R Time is displayed during infusion 2 Drug Displays...

Страница 18: ...Names and Functions 12 No Name 1 I V Set Holder 2 Air Sensor 3 Slide Clip home 4 Manual Clamp 5 Down Occlusion Sensor 6 Door Latch 7 Pumping Unit 8 Up Occlusion Sensor...

Страница 19: ...Names and Functions 13 2 8 Components No Name Image 1 Power cable 2 User Manual 3 Drop Sensor sold separately...

Страница 20: ...the power 1 Connection the I V Pole stand Turn the pole handle of the pole clamp to fix to the I V Pole stand Caution Use the product in a horizontal position The product can be used in a vertical po...

Страница 21: ...DC LED orange color on the Front turns on 2 Press the POWER button on the front of the product Then the Power LED on the front display turns on and self checks internal functions After self checking...

Страница 22: ...time do not place the I V container at a place 1 m or higher from the patient s heart 3 Pull the door clamp to open the front part 4 Grab the detector for Upstream Occlusion by hand and firmly press...

Страница 23: ...ing or twisting Incorrect installation may keep it from reaching the set rate Use the clamp to lock the I V Set before opening the door or removing the I V set Failure to close completely may cause wa...

Страница 24: ...d the fluid surface in the chamber 3 Attach the drop sensor to be perpendicular to the chamber If tilted it may not operate smoothly Do not attach it near the surface of the fluid It can detect splash...

Страница 25: ...the drop sensor always keep the chamber surface of the I V Set that is located between the drop sensors in a clean condition Be careful not to get dirt on the chamber The number of drops may not be c...

Страница 26: ...infusion Drug Injection Mode Drug setting Drug is selected Concentration Dose mcg kg min Weight kg Dosage mg and T Vol ml is set for the infusion Dosage Infusion Mode Dosage setting Drug is not select...

Страница 27: ...d press the JOG in standby mode 2 The flow rate setting appears in red with the cursor F Rate is active in injection standby mode If F Rate is inactive select F Rate by using the JOG 3 Turn the JOG di...

Страница 28: ...total volume are set 6 Press the START button to start injection 4 2 2 Setting the remaining time 1 First Set the values for F Rate and T Vol as above Setting the flow rate and total volume The settin...

Страница 29: ...s 23 3 Turn the JOG dial or use the MENU left MUTE right button to set the time The R Time setting screen appears in red with the cursor 4 Press the JOG or SAVE to set ok 5 Press the START button to s...

Страница 30: ...ing 2 Select Drug Library Use and then press the JOG to move to the sub menu Then the LIST screen appears with the alphabet initials 3 Turn the JOG to select the drug index and then press the JOG to s...

Страница 31: ...tration and Dose value by using the JOG and the KEYPAD 1 Press the MENU button in the injection standby screen Then the MENU screen appears Select Flow Rates Calculation 2 Press the JOG to move to the...

Страница 32: ...right corner and press the JOG to apply the setting Then it returns to the Standby screen 6 Press the START button to start injection 4 5 Secondary injection mode The secondary injection mode is requ...

Страница 33: ...screen It is set to modify F Rate and T Vol of the primary and secondary drug 4 Set Secondary Drug in Auto Mode Select the Modify button to set the F Rate and T Vol of the Secondary drug 5 Set Primar...

Страница 34: ...ns injection with the slave pump when the mater pump injection is completed Relay can be set to Auto and Manual Relay only operates in Docking Station The company provided syringe pump DS 5000 and inf...

Страница 35: ...o 2 screen appears 5 Enter the Master slot number and press the JOG 6 Master and Slave in green above F Rate will appear on screen in standby mode Press Start button when it is ready 7 Cancel Infusion...

Страница 36: ...on 2 Keep on pressing the POWER button for 3 seconds to turn off the power 3 In case of the I V Set is not installed The warning screen will appear and then the power will be turned off 4 In case of t...

Страница 37: ...andby alarm rings and the red LED blinks See 7 14 Standby alarm If you press the BOLUS button injection is performed with the preset BLOUS flow rate and volume Caution If you press the BOLUS button in...

Страница 38: ...If you press the JOG button while in injection you can change the flow rate See 5 4 Operation Status Titration function When the current injected volume is within 5 minutes until total amount the Nea...

Страница 39: ...conds during infusion T Vol appears on the pop up screen Manual Bolus Bolus injection stops and infusion mode starts by unpressing the BOLUS button Caution If you press the BOLUS button in standby mod...

Страница 40: ...on When you press the LOCK button on the rear for 3 seconds the Key Lock icon on the LCD display lights and all buttons except START STOP POWER and LOCK buttons are deactivated 5 7 History function Th...

Страница 41: ...me of the pump is not recorded The history logs are initialized when using the factory reset or installing a new firmware See 6 4 Device Setting Alarm Volume Alarm Log 5 8 Standby time function This f...

Страница 42: ...Operation 36 The VTBI function can be used after setting in the Infusion Setting menu See 6 2 Infusion Setting K V O F Rate...

Страница 43: ...Bolu sF Rate Bolus Volume K V O F Rate Secondary Mode and Infusion Relay 2 Dosage Setting You can set for F Rate calculation drug library and drug registration 3 Device Setting You can set for standb...

Страница 44: ...Custom Settings 38...

Страница 45: ...Rate is 1ml h or higher the rate can be set from 1 to 20 ml h The K V O F Rate cannot exceed the current F Rate If it is set to OFF the K V O function will not operate 5 Secondary Mode Can set the pr...

Страница 46: ...container more than 50 cm higher than the patient s heart Do not use an I V Set in the same location for more than 12 hours Prolonged use at the same location may cause deformation of the tube and in...

Страница 47: ...Auto Save System Check Caution Set the accurate date and time for the product The alarm and event log times are set depending on the specified date and time 6 4 1 Alarm Volume 1 Standby Alarm If you...

Страница 48: ...et Level Air Bubble Check OFF No detection Large 15 mm or above Medium 10 mm or above Small 5 mm or above 4 Drop Sensitivity Used to set the drop sensor s sensitivity You can set the sensitivity to Hi...

Страница 49: ...llation and the occlusion level value Advances or retracts the motor to inspect the checker 4 Brightness Used to adjust the LCD brightness Setting range is 1 10 steps 5 Language Used to change the lan...

Страница 50: ...Rate 700 ml h Bolus Volume 5 ml K V O F Rate 0 1 ml h Device Setting Standby Alarm OFF Near Complete Alarm OFF AC DC Remove Alarm ON Alarm Volume 5 Key Volume 1 UP Occlusion Level 9 Down Occlusion Lev...

Страница 51: ...Air Drop sensor and Door sensor 5 Key View the names of pressed keys except the CLEAR and P OWER keys 6 F W View the firmware version and perform firmware updates 7 Date Set the current date and time...

Страница 52: ...the same time to access Service Mode from the main menu screen Access to the sub menus under Service Mode requires a password Enter the password as follows 1 Enter the password 1711 2 Press the JOG to...

Страница 53: ...are various alarm devices to ensure patient safety Depending on the alarm these devices send beep sounds display alarm lamps and notify the current status Alarm LCD Red LCD ON High level of Severity...

Страница 54: ...z LOW Near Complete Alarm Complete Alarm Standby Alarm Time Out Alarm Yellow No flickering 7 3 Down Occlusion alarm Item Description Cause When the injection pressure between the pump and a patient ex...

Страница 55: ...rm and switch to standby mode Action Check for occlusion in the I V Set and release the pressure Caution If an occlusion alarm occurs due to locking of the manual roller clamp do not open the roller c...

Страница 56: ...lay Door Alarm clearing method Press any buttons to clear the door open alarm Action Make sure the door remains closed during injection 7 7 Drop sensor alarm Item Description Cause The drop sensor ala...

Страница 57: ...ry overheating alarm Action Make sure to use after the battery cools down Caution If the problem keeps happening stop using the pump and contact your dealer 7 9 Empty battery alarm Item Description Ca...

Страница 58: ...ction Charge the battery by connecting to the AC power 7 11 AC DC removal power alarm Item Description Cause When the AC DC power is disconnected the AC DC removal power alarm occurs Indicators Alarm...

Страница 59: ...standby screen appears When K V O is set to ON an injection K V O alarm occurs Indicators Alarm sounds Alarm screen appears in yellow on the LCD display LCD state display Complete Alarm clearing meth...

Страница 60: ...is not started for 2 minutes in injection standby state a standby alarm occurs Indicators Alarm sounds Alarm screen appears in yellow on the LCD display LCD state display Standby Alarm clearing method...

Страница 61: ...jection standby screen appears 7 17 Error codes When an error occurs while in operation of the product the error code screen appears in red on the LCD display When an error occurs press the POWER butt...

Страница 62: ...Alarms and Actions 56 Err Code Display Cause Screen E004 Battery Error Note Make sure the I V Set is properly installed Caution Contact your dealer regarding any malfunction or error...

Страница 63: ...o the tube when the air bubbles are passing the air sensor check if an air alarm occurs Occlusion Alarm Use the roller clamp or hands to completely stop the flow in the tube between the product and a...

Страница 64: ...ons for the pump are as follows Ambient temperature 10 60 relative humidity 10 95 atmospheric pressure 65 kPa 120 kPa 8 4 Replacement cycle Battery performance may diminish after a year Check its life...

Страница 65: ...ml or infinite amount 0 01 99 9 ml 0 01 ml step 100 999 9 ml 0 1 ml step 1000 9999 ml 1 ml step Infused Vol 0 00 999 0 ml Bolus Rate Purge 700 ml h default adjustable from 1 to 1500 maximum flow rate...

Страница 66: ...el TYPE CF Liquid ingress protection IP32 Dimension W D H 207 130 80 mm Weight Approx 1 95 kg Operating environment Temperature 10 40 C Humidity 20 90 RH Atmospheric pressure 70 106 kPa 525 795 mmHg S...

Страница 67: ...k UP DOWN occlusion sensor Detects occlusion in the I V Set Nurse Call Allows monitoring upon alarms Air Sensor Detects air bubbles Drop Sensor Detects infusion drops Others Time Mode Calculates the f...

Страница 68: ...UKE IDA4PLUS Flow Rate Occlusion Level Setting Occlusion Pressure mmHg Accuracy mmHg Time to Alarm min sec 25 ml h 1 120 200 0 44 2 247 200 1 15 3 307 200 1 30 4 394 200 1 40 5 472 200 1 50 6 645 200...

Страница 69: ...mable anesthetic mixture with air or with oxygen or nitrous oxide Continuous operation 9 7 Electromagnetic information This equipment has been tested and found to comply with the limits for medical de...

Страница 70: ...llation Caution Do not mount or dismount the drop sensor during injection It causes operation to stop 9 9 Characteristic curves The following characteristic curves present the results of test under IE...

Страница 71: ...Technical Specification 65...

Страница 72: ...ns Group 1 Infusion Pump DI 6000 uses RF energy only for their int ernal function Therefore their RF emissions are very lo w and are not likely to cause any interference in nearby electronic equipment...

Страница 73: ...mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and Voltage variation...

Страница 74: ...the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propa...

Страница 75: ...ommunications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation di...

Страница 76: ...vised of BOLUS Key when setting injection information 6 5 I V Set code setting Added item 6 12 Revised of Bolus function and image 6 13 Revised of Purge function and image 6 17 History function Added...

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