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Immunity test

IEC 60601

test level

Compliance

level

Electromagnetic environment -

guidance

Conducted RF
IEC 61000-4-6

3Vrms

150kHz to 80MHz

3Vrms

Portable and mobile RF
communications equipment should
be used no closer to any part of
the DTS-3000, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.

Recommended separation distance

Radiated RF

IEC 61000-4-3

3V/m

80MHz to 2.5GHz

3V/m

80MHz to 800MHz

800MHz to 2.5GHz

Where is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and is the
recommended separation distance in
meters (m).

Field strengths from fixed RF
transmitters, as deter-mined by an
electromagnetic site survey

a

should

be less than the compliance level in
each frequency range.

b

9-3. Guidance and manufacturer’s declaration
– electromagnetic immunity

The DTS-3000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the DTS-3000 should assure that it is used in such an environment.

41

UserManual_DTS-3000_170223_인증용.indd 41

2017-02-23 오후 2:06:10

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Содержание DTS-3000

Страница 1: ... safety use Read this manual carefully This manual is for user s safety and previewing any property loss Before using our device please read this manual inevitably This product is medical device using under doctor s instructors UserManual_DTS 3000_170223_인증용 indd 1 2017 02 23 오후 2 06 03 ...

Страница 2: ...eaning conditions 3 Product package 3 1 Device part 3 2 Cuff part 3 3 LOP Sensor 4 Product description 4 1 Device specifications 4 2 Device views 4 3 Cuff specifications 4 4 Names and Functions of Parts 4 5 Names and Functions of Control Panel 4 6 LCD Screen 5 Product use and procedure 5 1 Before using a device 5 2 Use and install 5 3 LOP Application 5 4 Cuff connection 5 5 LOP connection 6 Troubl...

Страница 3: ...anufacturer s declaration electromagnetic immunity 9 4 Recommended separation distances between portable and mobile RF communications equipment and the DTS 3000 10 Symbols Information 10 1 Symbols Information Device 10 2 Symbols Information Set Box 10 3 Symbols Information EPS 10 4 Symbols Information Cuff Box 10 5 Symbols Information Cuff 10 6 Symbols Information Out Box 10 7 Symbols Information ...

Страница 4: ...re range of 20 to 700mmHg Even in case of power failure due to blackout or contingencies this device can be used in Emergency Mode for up to Max 6 hours using the embedded battery when it is fully charged This User Manual contains the information related to application storage and maintenance It is strongly recommended to thoroughly read and understand the contents in this User Manual including co...

Страница 5: ...ypoxia hypercarbia and acidosis of the tissues occur and become significant after about one and a half hours of tourniquet use Symptoms of tourniquet paralysis are motor paralysis and loss of sense of touch pressure and proprioceptive responses Intraoperative bleeding may be caused By the slight impeding effect exerted by an unpressurized cuff and its padding if used which prevents venous return a...

Страница 6: ... objects on the device During operation these objects may drop from the device and cause a fire or physical injury to the user Do not turn on the power switch before applying cuff to a patient Connect the hoses after the cuff are applied to the patient Turn the power on to the device after connecting the hoses to the air socket at front of device to ensure self check Do not put or pull out a power...

Страница 7: ...ms electric shock fire physical damage or property loss Do not attempt to open repair or modify this device Doing so may lead to a risk of fire electric shock or injury to the user 2 2 Indications for use Use this device under the supervision or instruction by a doctor Thoroughly read and understand the instruction to use this device including connection and operating method before application Che...

Страница 8: ...of a patient during hemostasis When using two double cuffs connect one cuff with the red hose and grey hose to ports of 1CH red first and then another double cuff with blue hose and grey hose to 2CH blue If Change button is pressed the cuff bladder connected with gray hose is activated For using LOP sensor trim the nails or toenails of a patient If a patient has a nail polish remove it because it ...

Страница 9: ... heat sources including heaters or direct sunlight It may cause breakdown distortion or fire Be cautious to prevent any sharp objects around including scissors from making a hole in a cuff or an air hose The damage of an air chamber in a cuff or an air hose may cause improper operation of this device Do not make oil benzene alcohol gasoline or chemicals touch a cuff It may reduce the durability of...

Страница 10: ...ser Check a battery on a regular basis and replace it if it is not normal status Abnormal battery may prevent the device from operating for a long time in emergency situations Fully charge up the battery for more than 8 hours when using the device for the first time Low temperature below 0o C may interrupt proper charge of the battery by reducing the battery function Excessively high temperature b...

Страница 11: ... new battery from the manufacturer Do not disassemble the device for replacing a battery Do not use any battery from other manufacturers It may cause fire by the error of the device or overheating of the battery Warranty is not applied to the device using any batter from other manufacturers or for other models In case of the disposal of the device separate the battery and dispose it in accordance ...

Страница 12: ... careful not to enter into the skin or eyes If any foreign material gets on the hose use a soft cloth to wipe the hose with a bit of water or a neutral detergent Be careful of any liquid doesn t go into the hose It may cause the durability of the hose if water is inside of the hose it could also break and cause a fire if and when water goes into the device from the hose Do not spray water directly...

Страница 13: ...r use with a volage rating not exceeding 1000 volts for alternating current and 1500 volts for derect current Exemption of equipment desinged to be sent into space large scale stationary industrial tools and etc Cunsumers have to actively contribute to the success of such collection and should be encouraged to return WEEE 2 7 1 Correct Disposal of this product Waste Electrical Electronic Equipment...

Страница 14: ... apply to batteries containing more than a given amount of these substances Lead acid batteries recycle cadmium as far as technically feasible and recycle a minimum of 75 of batteries by average weight Nickel cadmium batteries recycle cadmium as far as technically feasible and recycle a minimum of 75 of batteries by average weight Other batteries recycle a minimum of 50 of batteries by average wei...

Страница 15: ...3 1 Device part Product package 3 Air Hose Blue 1EA Air Hose Red 1EA Air Hose Gray 2EA Main device Power code User manual 15 UserManual_DTS 3000_170223_인증용 indd 15 2017 02 23 오후 2 06 04 ...

Страница 16: ...ne Double Cuff Select and purchase the cuffs depending on user s status or application areas Cone Single Cuff The cuff is a consumable product The cuff is defined as the mounting part in IEC 60601 1 16 UserManual_DTS 3000_170223_인증용 indd 16 2017 02 23 오후 2 06 05 ...

Страница 17: ...3 3 LOP Sensor The LOP sensor is defined as the mounting part in IEC 60601 1 17 UserManual_DTS 3000_170223_인증용 indd 17 2017 02 23 오후 2 06 05 ...

Страница 18: ...00mmHg 4mmHg Unit 1 5mmHg Setting Time 1 240min Unit 1min 5min Dimension 180 W x 200 D x 260 H mm Weight 3Kg Rated Voltage of Battery DC 14 4V Current Consumption of Battery 2600mAh Working Hours of Battery About 6 Hours varying on the battery status Certification SAFETY IEC60601 1 EMC IEC60601 1 2 Setting pressure should be operated under doctor s instructions 4 1 Device specifications 18 UserMan...

Страница 19: ... 10cm CUFF DTC S07 SINGLE 86 X 10cm CUFF DTC CD26 CONE DOUBLE 90 X 12cm CUFF DTC S08 SINGLE 107 X 10cm CUFF DTC CD27 CONE DOUBLE 107 X 14cm CUFF DTC C25 CONE SINGLE 70 X 10cm CUFF DTC SA01 AC SINGLE 30 X 11cm CUFF DTC C26 CONE SINGLE 90 X 12cm CUFF DTC SA02 AC SINGLE 46 X 11cm CUFF DTC C27 CONE SINGLE 107 X 14cm CUFF DTC SA05 AC SINGLE 61 X 11cm CUFF DTC D04 DOUBLE 57 X 10cm CUFF DTC SA06 AC SINGL...

Страница 20: ...le cuff 4 LOP Socket Socket to connect LOP Sensor 5 Alarm LED LED indicating the operating status and errors Green Standby operating status Red Errors 6 SD Card Slot Slot to insert SD Card to save the operating status by a user 7 Hose Holder Holder for the air hose 8 Holder fixing pin Handle Pin to fix the device on the holder Use the handle when moving the device 9 Battery Cover Battery mounted o...

Страница 21: ...ng the Pressure button Press for about 3 seconds The pressure can be adjusted during operation Unit 5mmHg Long push 1mmHg Short push Furthermore SET is displayed on the pressure value before pressure is applied SET is changed to RUN when pressure is supplied and the current pressure value is displayed 4 5 Names and Functions of Control Panel 12 6 11 5 10 4 9 3 8 2 7 1 13 14 21 UserManual_DTS 3000_...

Страница 22: ...n 4 1CH Deflate Button Deflate the cuff of 1CH For deflating a cuff press the Deflate button long 3seconds LCD displays during deflating 5 1CH Cuff Change Button Change the hemostasis area while using double cuff of 1CH When operation continues for a long time change the hemostasis area while using double cuff to prevent damage of skin nerve or muscle Press the Cuff Change button long 3 seconds wh...

Страница 23: ...e value before pressure is applied SET is changed to RUN when pressure is supplied and the current pressure value is displayed 8 2CH Inflation Button Inflation of the cuff of 2CH Press the Inflate button long 3 seconds to apply preset pressure to a cuff When pressure is applied to a cuff LCD displays When pressure reaches to the preset value is displayed 9 2CH Time Setting Button Time setting of 2...

Страница 24: ...Cuff A to the Cuff B at the bottom of the screen 12 2CH LOP Button Set LOP of 2CH LOP notifies the proper pressure for hemostasis by measuring of a patient s LOP For using LOP press the LOP button long 3 seconds after putting a cuff on and LOP measurement starts Then LOP automatically estimates and notifies the proper pressure for a patient To start press the Inflate button to activate The icon be...

Страница 25: ...n to the product In the use of DOUBLE CUFF the compression is through CUFF A CUFF B when the CHANGE button is pressed Indication of current date and time 1 LCD Information AC CordIndication Screen Battery Remaining Icon Error Indication Icon Channel 1 Pressure Indication Channel 2 Pressure Indication Screen Channel 1 Time Indication Screen Channel 2 Time Indication Screen Channel 1 Operation Statu...

Страница 26: ...pen the battery cover at the back of the device and separate the connector connected to the battery For replacement of battery contact the service center of your seller The battery is consumable The warranty for battery is 6 months from the date when you purchase Full Charge External power connection Medium Charge Charge Required Supply Power External power Cutt off No Power Supply Power 26 UserMa...

Страница 27: ...on the application area of a patient and put the cuff on it 3 Connect the power cord to the device 4 Push the ON OFF switch at the back of the device to ON Touch the Power button on the front 5 Set the pressure and time in accordance with a patient s status and operation area 6 Touch the Inflate button long 3 seconds to apply the pressure to the cuff 7 When OK message is displayed on the LCD scree...

Страница 28: ...s the top to open it with the sound click For separating the air hose from the device pull the air hose as pressing the top of air socket and the air hose is easily removed Connect the single cuff to the other end of the air hose until you hear the click sound Use the device after checking the proper connection 28 UserManual_DTS 3000_170223_인증용 indd 28 2017 02 23 오후 2 06 07 ...

Страница 29: ... top to open it with the sound click For separating the air hose from the device pull the air hose as pressing the top of air socket and the air hose is easily removed Connect the double cuff to the other end of the air hose until you hear the click sound Use the device after checking the proper connection 29 UserManual_DTS 3000_170223_인증용 indd 29 2017 02 23 오후 2 06 07 ...

Страница 30: ...nails where the LOP Sensor is applied Put the LOP Sensor to the index finger or the second toe of the limb where the cuff is applied Put a finger or a toe deep into the sensor Use the LOP function after checking the proper connection 5 5 LOP connection 30 UserManual_DTS 3000_170223_인증용 indd 30 2017 02 23 오후 2 06 08 ...

Страница 31: ...the connection of a cuff and a hose contact your vendor Voltage error while using the battery Charge the battery by supplying AC power When the battery is used continuously without AC power supply it may reduce the life span of device due to battery discharge Errors during LOP operation Check the connection of LOP Sensor If the error persists even checking LOP connection contact your vendor Troubl...

Страница 32: ...izontally or fixed the screw hard locking Check that there is nothing laying on top of the device or underneath 4 No air in the hose Hose connection alarm Check that the hose is inserted correctly into the device Bent hose Check that the hose is not bent No Problem Cause Solution 1 Weak air injection Air hose damage Contact the seller if there is a defect in the inner hose or cuff connection Air h...

Страница 33: ... Power button with long key to quit Maintenance mode DTS 3000 uses both Main board and Sub board in general Main board It is mainly controls Drive that manipulate LCD display Button input control LOP control SD DATA SAVE Sub board It is the board that will proceed for the order coming from Main board after giving command using UART communication If there is communication error between Main board a...

Страница 34: ...n Maintenance mode while AC cord is connected then check if battery connection condition works on display correctly Verify if battery is in the acceptable coverage area Check if battery is recharged with AC connection If the rest of battery bar is lower than 13 3 Voltage it is necessary to be recharged Battery is recognized Battery capacity indication and Acceptance coverage indication Check the s...

Страница 35: ...ay Status Check completion with good condition Check failure Error condition Condition that Check is not proceeded Power goes out after power button is pressed for 3 seconds Connect 4 Cuffs into CH 1 CH2 before testing Press the Alarm Power button altogether then Sensor Solenoid Leak check mode will show Test will be proceeded 1 to 4CH accordingly Press the PRESSURE UP BUTTON red button in order t...

Страница 36: ...lay Test method It tests if pressure can reach to the cuff for 30 seconds in case the pressure sensor is recognized pressure If the pressure reach to the specific pressure figures that selected by user within 30 seconds then it stops motor and stay It stays 30 seconds and it decides if there is any leak It stop testing and test next chamber in case there is some problem Display Test method After c...

Страница 37: ...Hennock Road East Exeter EX2 8RU UK Tel 44 1392 829500 Fax 44 1392 823232 298 24 Gongdan ro Gunpo si Gyeonggi do 15809 Korea Tel 82 31 459 7211 Fax 82 31 459 7215 E mail info dsmaref com www dsmaref com 모델명 Label Specification Part name Code 2017 02 22 Date DTS 3000 LABEL 손동영 AN 70 DTS W41 01 Designer Reviewe Approve Revision Rev 01 하정훈 김국한 Labels 8 1 Label for main device Label location and descr...

Страница 38: ... KEEP POWER CORD PLUGGED IN BATTERY ONLY FOR USE DURING POWER EMERGENCY OR TEMPORARY PATIENT TRANSPORT ATTENTION UNIT SHOULD BE PLUGGED IN 24 HOURS BEFORE USE TO PROPERLY CHARGE BATTERIES 38 UserManual_DTS 3000_170223_인증용 indd 38 2017 02 23 오후 2 06 10 ...

Страница 39: ...agnetic immunity The DTS 3000 is intended for use in the electromagnetic environment specified below The customer or the user of DTS 3000 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagneticenvironment guidance Electrostatic discharge ESD IEC 61000 4 2 6kV contact 8kV air 6kV contact 8kV air Floors should be wood concrete or ceram...

Страница 40: ...0 UT 30 dip in UT for 25cycles 5 UT 95 dip in UT for 5sec Mains power quality should be that of a typical commercial or hospital environment If the user of the DTS 3000 requires continued operation during power mains interruptions it is recommended that the DTS 3000 be powered from an uninterruptible power supply or a battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 3A m 3A m Power fre...

Страница 41: ...z to 800MHz 800MHz to 2 5GHz Where is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and is the recommended separation distance in meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey a should be less than the compliance level in each frequency range b 9 3 Guidance and manufacturer s declaratio...

Страница 42: ... radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the DTS 3000 is used exceeds the applicable RF compliance level above the DTS 3000 should be observed to verify normal operation If abnorma...

Страница 43: ...y of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 117 0 117 0 233 0 1 0 369 0 369 0 738 1 1 167 1 167 2 333 10 3 689 3 689 7 379 100 11 667 11 667 23 333 For transmitters rated at a maximum output power not listed above the recommended separation distance in metres m can be estimated using the equation applicable to the frequency of the transmitter where is the maxim...

Страница 44: ...electrical and electronic components which must be collected separately EN 50419 The official mark of Europe Certificate CE logo Type of applied part IEC 60878 5333 Refer to instruction manual ISO 7010 M002 Alternating current IEC 60878 5032 Alarm off Button Custom Symbol Increase Button Custom Symbol Decrese Button Custom Symbol Inflation Button Custom Symbol 44 UserManual_DTS 3000_170223_인증용 ind...

Страница 45: ...er IEC 60878 5007 OFF power IEC 60878 5008 Power Button IEC 60878 5009 General warning Caution ISO 7010 W001 Symbols Explanation Reference The official mark of Europe Certificate CE logo Humidity limitation ISO 7000 2620 This way up ISO 7000 0623 Do not hang on hooks in the box ISO 7000 0622 45 UserManual_DTS 3000_170223_인증용 indd 45 2017 02 23 오후 2 06 11 ...

Страница 46: ...perature limitation EN 980 5 17 3 Load Limitation ISO 7000 2403 Fragile handle with care ISO 7000 0621 Keep dry EN 980 5 21 Symbols Explanation Reference Symbol recommending the recycling of polluting components IEC60878 1135 10 3 Symbols Information EPS 46 UserManual_DTS 3000_170223_인증용 indd 46 2017 02 23 오후 2 06 11 ...

Страница 47: ...mitation ISO 7000 2403 Do not hang on hooks in the box ISO 7000 0622 Fragile handle with care ISO 7000 0621 Keep dry EN 980 5 21 Temperature limitation EN 980 5 17 3 Humidity limitation ISO 7000 2620 The official mark of Europe Certificate CE logo 47 UserManual_DTS 3000_170223_인증용 indd 47 2017 02 23 오후 2 06 11 ...

Страница 48: ...tion Out Box Symbols Explanation Reference The official mark of Europe Certificate CE logo Humidity limitation ISO 7000 2620 This way up ISO 7000 0623 Do not hang on hooks in the box ISO 7000 0622 Load Limitation ISO 7000 2403 Fragile handle with care ISO 7000 0621 48 UserManual_DTS 3000_170223_인증용 indd 48 2017 02 23 오후 2 06 11 ...

Страница 49: ...Custom Symbol Symbols Explanation Reference General warning Caution ISO 7010 W001 General prohibition sign ISO 7010 P001 Do not take to pieces CustomSymbol Symbol that indicates electrical and electronic components which must be collected separately EN 50419 10 7 Symbols Information User Manual 49 UserManual_DTS 3000_170223_인증용 indd 49 2017 02 23 오후 2 06 11 ...

Страница 50: ...C 62133 The official mark of Europe Certificate CE logo Manufacturer EN 980 5 12 European Representative EN 980 5 13 Temperature limitation EN 980 5 17 3 Humidity limitation ISO 7000 2620 Atmospheric pressure limitation ISO 7000 2621 50 UserManual_DTS 3000_170223_인증용 indd 50 2017 02 23 오후 2 06 11 ...

Страница 51: ...ngs even though warranty period 1 Disorder happened by strong impact 2 In case user repair or reproduce internal part arbitrarily 3 In case of using the device in prohibited place 4 In case of against our How To Use 5 Cuff is articles of consumption Warranty DESCRIPTION MODEL NAME WARRANTY Digital Pneumatic Tournique system DTS 3000 Device 1 year UserManual_DTS 3000_170223_인증용 indd 51 2017 02 23 오...

Страница 52: ...2010 Anvisa in Brazil 2007 Authentication of Merit certificate 2006 Innovation management awards 2006 KOTRA B2B e Trade awards 2006 KFDA awards by Prime minister 2006 KGMP registration 2004 The 34 precious Technique bronze awards 2004 Korean World class products award 2004 Vice president award 2004 SFDA in China 2003 Success Design product 2002 ISO9001 EN13485 2002 CE marks DL series MK series DL1...

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