Page 1
Digital Pneumatic Tourniquet system
USER MANUAL
ISO 9001
EN ISO 13485
Read this manual carefully. This manual is for user's safety
Indications
for safety use
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and previewing any property-loss. Before using our device,
please read this manual inevitably.
This product is medical device using under doctor's
instructors.
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1. Information
1-1. DTS-3000 Introduction
4
1-2. Intended use
4
1-3. Target treatment group and diseases
4
1-4. Expected except group of treatment
5
1-5. Side effect
5
2. Information on Safety and Handling
2-1. Operation of the device
6
2-2. Indications for use
7
2-3. Cuff safekeeping and maintenance
9
2-4. Device Safekeeping and Maintenance
10
2-5. Cautions for Battery safety
10
2-6. Cleaning
12
2-7. WEEE marking
13
2-8. Operating, storage and cleaning conditions
14
3. Product package
3-1. Device part
15
3-2. Cuff part
16
3-3. LOP Sensor
17
4. Product description
4-1. Device specifications
18
4-2. Device views
18
4-3. Cuff specifications
19
4-4. Names and Functions of Parts
20
4-5. Names and Functions of Control Panel
21
4-6. LCD Screen
25
5. Product use and procedure
5-1. Before using a device
27
5-2. Use and install
27
5-3. LOP Application
27
5-4. Cuff connection
28
5-5. LOP connection
30
6. Troubleshooting
6-1. Alarm messages
31
6-2. General troubleshooting
32
6-3. Troubleshooting
32
CONTENTS
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33
33
41
43
43
45
47
48
49
50
51
52
52
53
7. Maintenance and safety instructions
7-1. Test Methods and Calibration
7-2. Explanation of each test
8. Labels
8-1. Label for main device
9. Information on EMC
9-1. Guidance and manufacturer’s declaration - electromagnetic emissions
9-2. Guidance and manufacturer’s declaration – electromagnetic immunity
9-3. Guidance and manufacturer’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 (User manual)
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1
Information
1-1. DTS-3000 Introduction
Thank you for purchasing DTS-3000. DTS-3000 is the surgery device blocking blood flow by
wrapping the limbs with cuff and inflating the cuff. Thus, this device shall be applied under
the instruction of a doctor.
This device has two channels with 4 ports that can connect two double cuffs at the same
time. A double cuff prevents muscles, skin or blood vessels in the area stopping the bleeding
from being damaged during the surgical operation taking long time.
During the surgical operation, the area to stop bleeding can be changed using the
“Cuff Change” button.
Furthermore, the pressure can be adjusted depending on the areas to stop bleeding or
patient’s status in the pressure 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 control and connection method before using for successfully completing surgical
operations and preventing failure of this device.
1-2. Intended use
A device intended to occlude the blood flow to obtain hemostasis field during limb(s) surgery.
1-3. Target treatment group of disease
- Kirschner wire removal
- Nerve injuries
- Tendon repair
- Bone grafts
- Amputations
- Replantations
- Reduction of certain fractures
- Tumor and cyst excisions
- Subcutaneous fasciotomy
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- Total wrist joint replacement
- Replacement of joints in the fingers
- Knee joint replacements
1-4. Expected except group of treatment
- Open fractures of the leg
- Post-traumatic lengthy hand reconstruction
- Severe crushing injuries
- Elbow surgery (where there is excess swelling)
- Severe hypertension
- Skin grafts in which all bleeding points must be readily distinguished
- Compromised vascular circulation, e.g.peripheral artery disease.
- Diabetes mellitus
- The presence of sickle cell disease is a relative contraindication
1-5. Side effect
- A dull aching pain (tourniquet pain) may develop throughout the limb following use.
- Pathophysiologic changes due to pressure, hypoxia, 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 at the beginning of the operation.
By blood remaining in the limb because of insufficient exsanguination.
By inadequate tourniquet pressure (between systolic and diastolic blood pressure of
the patient), or slow inflation and deflation, all of which allow arterial blood to enter
while preventing venous return.
By blood entering through the nutrient vessels of the long bones, such as the
humerus.
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2
Information on Safety and Handling
2-1. Operation of the device
- In case of any abnormal smell, stop using this device. Turn off the power
immediately and pull the power plug out of the outlet. And contact the
Service Center. Continuing application may cause fire or electric shock.
- Unplug out the device in case of thunder, lightning, or power failure.
- The device is for indoor use only. Do not use the device in highly humid
places, e.g., sauna or, bathroom.
(Humid environment may result in mechanical defect or physical damage
caused by an electric shock or scald.)
- When using or transporting this product please take care not to shake
or drop this device as it may cause the device to malfunction or fail to
operate.
- Do not put any 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 line from a socket with wet hands.
(Fire or electric shock may occur.)
- Do not damage, process, bend, twist or heat the power cord. It may
damage the cord and cause fire or electric shock.
- Do not change the fuse.
(It may be dangerous. Ex. An electric shock or possible burn.)
- Install the power plug in a place where it can be easily removed.
- Remove the power plug immediately if a malfunction occurs.
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- This Product is used to connect to a power source that is grounded. If
you are connecting to a power source that is not grounded, it may occur
to malfunction and problems protection circuit works when the device
shorted.
- Do not use oil, benzene, alcohol, or any other chemicals to clean the
device or cuff.
- Be cautious to prevent water or other foreign substances from getting into
the inside of device.
(It may cause failure, electric shock or fire.)
- Do not use the device in places with temperatures over 40
0oC.
(Otherwise, it may cause mechanical problems, 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.
o
C or under
- Thoroughly read and understand the instruction to use this device including
connection and operating method before application.
- Check the cuffs before using. Air leakage from a cuff due to any reasons
including damage may cause incorrect operation including insufficient
hemostasis.
- Put a cuff after putting a bandage around the application area.
- Do not use the air hose toward a nose, a mouth or ears. It may cause
physical injury.
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Do not fold or bend the hose.
-
- For upper arm or thighs put the cuffs on the thickest areas. Turning the
inflated cuffs or changing the application areas with inflated cuffs may
damage the skin tissues on the application areas.
- Use the minimum pressure to stop bleeding to minimize the damage of
blood vessel, nerve, muscle or skin.
- If you can not deflation even pressing the Deflation button after surgery , remove
the hose from the device and forcibly deflated.
- The duration to stop bleeding shall not exceed generally 60 minutes for
upper body and 90 minutes for lower body. If more time is required due to
inevitable reasons, let blood flow for 15 minutes to minimize the inflammatory
reason of skin tissues.
- Keep the cuffs after washing and suitable sterilizing after application.
- Keep monitoring body temperature, blood pressure and pain 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 can interrupt LOP sensor to recognize.
- A cuff shall be the exclusive cuff for the model of DAESUNG MAREF. Do not use
any cuffs from other manufacturers or for other models of DAESUNG MAREF.
- Do not operate this device before putting on a cuff. Putting the inflated cuffs
may damage the cuffs and strain a body. Furthermore, putting the inflated
cuffs may decrease the efficiency of hemostasis because the cuffs may not
stick to the application area of a patient sufficiently.
- Do not press the deflate button during surgery.
(There is a risk of bleeding when the cuff is deflated.)
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- Select the proper cuffs depending on patients, application areas or types
of operations. Improper cuffs may drop the efficiency of hemostasis or
cause the failure in getting the intended effects from operations.
- Do not use the device in the area with strong magnetic field or
electromagnetic field. It may cause an error of motor or valve.
2-3. Cuff safekeeping and maintenance
- Do not inflate a cuff without putting it on a body except the tests. It may
damage a cuff or reduce its durability.
- Check the device and its parts on a regular basis.
- Do not keep out of 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 a cuff.
- Do not inflate a cuff without putting it on a body except the tests. It may
damage a cuff or reduce its durability.
- Do not inflate a cuff with any other objects except this device. It may break
down or damage a cuff.
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2-4. Device safekeeping and maintenance
- Be cautious not to bend or fold the hose. It may cause improper operation.
Immediately request maintenance to a vendor or customer service enter in
case of any damage of the compressor case.
(Doing so may lead to a risk of fire.)
- Prevent clips, staples, metals, food or liquid from getting into this device. It
may cause heat. If such objects get into this device, ask your vendor or the
store you purchase to check it.
- Keep in the safe place without influence by temperature, humidity or
atmospheric pressure.
- 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.
2-5. Cautions for Battery safety
- 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 0oC) may interrupt proper charge of the battery by
reducing the battery function. Excessively high temperature(below 40oC)
may interrupt proper charge of the battery by reducing the battery function
or the battery life by excessive heat.
- Do not leave the rechargeable lithium ion battery to be completely
discharged and kept as being discharged.
Unplug the AC cord immediately if you smell anything.
-
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- The performance of battery may be degraded when it is not used for a long
time. Keeping the discharged battery for a long time may increase the risk
of short circuit. Shorted battery may reduce the battery life and cause safety
accidents.
- Keep the battery charged by about 30 to 50% at room temperature. It is
recommended to charge the battery once a year during storage to prevent
excessive discharge of battery.
- A battery replacement is available only in the customer service center or
by your vendor. A battery shall be replaced or repaired only by the qualified
service engineer.
- In case of any damage of the battery in use, leakage of battery fluid or
foreign substances at the contact point of the battery, stop using the battery
and purchase the 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 with the rules and regulations on the disposal of battery in the
relevant region.
- Do not keep the battery or the main unit under the direct sunlight or in the
place of high temperature.
- Charge up the battery only at indoor spaces.
- Do not squash or make a hole on the body.
- Do not put the battery into fire or short out the contact point of battery.
- Do not expose the battery to water or other liquids.
- Strictly comply with the instructions on the user manual for charging up the
battery.
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2-6. Cleaning
2-6-1. How to clean the device
- If any foreign materials get on the device, first turn off the device and use a soft cloth
to wipe the device with a bit of water or a neutral detergent.
(It may cause discoloration, damage or malfunction.)
- If you sanitize product, first turn off the device and wipe off with soft cotton using
neutral detergent.
(It may cause discoloration, damage or malfunction.)
- Please be careful to prevent any liquid from going into the air socket or AC inlet.
If liquid does get in operation errors, electric shock, and fire could occur due to do an
affect of internal parts.
- Do not wipe the device with benzene, thinner, alcohol, etc or spray water directly on
the device.
(It may cause change of color, discoloration or damage.)
* Use neutral detergent or the alkalescence for cleaning.
Dilute in water if it is Alkali undiluted state.
Drug use: be careful not to enter into the skin or eyes.
2-6-2. How to clean the hose
- 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 on the hose or put the hose into the water.
- Do not wipe the hose with benzene, thinner, alcohol, etc.
2-6-3 How to clean the cuff
- deflate the bladder completely before cleaning the cuff.
- Cover the hose with a rubber cap to prevent liquid from entering the cuff.
- Do not wipe the cuff with benzene, thinner, alcohol, etc.
- Use a soft cloth to wipe the cuff with a bit of water and completely dry the cuff.
(It may cause durability reduction or any change on the cuff if it is not completely dry.)
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2-7. WEEE marking
2-7-1. Correct Disposal of this product
(Waste Electrical & Electronic Equipment)
As the market continues to expand and innovation cycles become
even shorter, the replacement of equipment accelerates, making
EEE a fast-growing source of waste. The content of hazardous
substances such as mercury, cadmium, lead, hexavalent chromium
in EEE is a major concern during the waste management phase.
The purpose of this Directive is to contribute to sustainable
production and consumption by, as a first priority, the prevention of
WEEE and, in addition, by the re-use, recyling and other forms of
recovery of such wastes so as to reduce the disposal of waste and
to contribute to the efficient use of resources and the retrieval of
valuable secondary raw materials.
The Definitions of this Directive is dependent on electric currents
or electromagnetic fields in order to work properly and equipment
for the generation, transfer and measurement of such currents and
fields and designed for 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.
The Producer have to provide the information of re-usable, recyclable and recoverable rate.
75% shall be recovered, and 55% shall be prepared for re-use and recycled within category
2 (Small household appliances) and 8 (Medical devices).
DTS-3000 is a recoverability rate of 76.9% and a recyclability
rate of 62.2%.
Information for treatment facilities shall be made available to centres which prepare for re-
use and treatment and recyling facilities by producers of EEE. DAESUNG MAREF, whenever,
is prepared to provide.
The symbol indicating separate collection for EEE consists of the cross-out wheeled bin, as
shown below.
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2-7-2. Correct disposal of batteries in this product
(1) Crossed-out wheeled bin applies to all batteries;
(2) Chemical symbols (Hg, Cd, Pb), indicating the heavy metal
content of batteries, 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 weight.
2-8. Operating, storage and cleaning conditions
2-8-1. Operating conditions
Temperature (oC) Relative humidity (%) Atmospheric Pressure (hPa)
2-8-2. Storage conditions
Temperature (oC) Relative humidity (%)
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3
Product package
3-1. Device part
Main device
User manual
Power code
Air Hose (Blue) 1EA Air Hose (Red) 1EA
Air Hose (Gray) 2EA
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3-2. Cuff part
Select and purchase the cuffs depending on user's status or application areas.
Single Cuff Double Cuff
Cone Single Cuff
Rubber Bladder Cuff
The cuff is a consumable product.
*
The cuff is defined as the mounting part in IEC 60601-1.
*
Cone Double Cuff
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3-3. LOP Sensor
The LOP sensor is defined as the
mounting part in IEC 60601-1.
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4
Product description
4-1. Device specifications
Items Specification
Model DTS-3000
Protection Type Class IIa, BF-type Device
Rated Voltage AC100-240V, 50/60Hz
Power Consumption 80VA
Rated Fuse T3.15A/250V
Setting Pressure
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
20~700mmHg ± 4mmHg
(Unit : 1, 5mmHg)
* Setting pressure
should be operated
under doctor's
instructions.
4-2. Device views
TopBack
Front Right sideLeft side
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4-3. Cuff specifications
Part no. Cuff names and size Part no. Cuff names and size
DTC-S02 SINGLE 40 X 7cm CUFF DTC-D05 DOUBLE 80 X 15cm CUFF
DTC-S04 SINGLE 52 X 7.5cm CUFF DTC-D06 DOUBLE 107 X 15cm CUFF
DTC-S05 SINGLE 61 X 9cmCUFF DTC-D07 DOUBLE 57 X 15cm CUFF
DTC-S06 SINGLE 80 X 9cm CUFF DTC-CD25
DTC-S07 SINGLE 86 X 10cm CUFF DTC-CD26
DTC-S08 SINGLE 107 X 10cm CUFF DTC-CD27
DTC-C25
DTC-C26
DTC-C27
DTC-D04 DOUBLE 57 X 10cm CUFF
CONE SINGLE 70 X 10cm
CUFF
CONE SINGLE 90 X 12cm
CUFF
CONE SINGLE 107 X 14cm
CUFF
DTC-SA01 AC SINGLE 30 X 11cm CUFF
DTC-SA02 AC SINGLE 46 X 11cm CUFF
DTC-SA05 AC SINGLE 61 X 11cm CUFF
DTC-SA06 AC SINGLE 76 X 11cm CUFF
DTC-SA07 AC SINGLE 86 X 11cm CUFF
CONE DOUBLE 70 X 10cm
CUFF
CONE DOUBLE 90 X 12cm
CUFF
CONE DOUBLE 107 X 14cm
CUFF
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1
2
3
4
6
7
5
11
8
10
9
4-4. Names and Functions of Parts
No Name Function
1 LCD Screen Display the operating status of the device.
- Socket for inserting red hose into 1ch when using single cuff.
2 1CH Air Socket
- Socket for inserting red hose and gray hose into 1ch when
using double cuff.
- Socket for inserting red hose into 2ch when using single cuff.
3 2CH Air Socket
- Socket for inserting red hose and gray hose into 2ch when
using double cuff.
4 LOP Socket Socket to connect LOP Sensor.
LED indicating the operating status and errors.
5 Alarm LED
- 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.
Holder fixing pin/
8
Handle
9 Battery Cover
- Pin to fix the device on the holder.
- Use the handle when moving the device.
- Battery mounted on the device.
- Do not open the battery cover and do not change the battery.
10 Power Inlet Inlet to connect power cord.
11 Power ON/OFF Switch Switch to turn power on or off.
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4-5. Names and Functions of Control Panel
14
No Name Function
13
71
82
93
104
115
126
Control of Pressure of 1CH
The previous setting is saved and displayed. The pressure
can be adjusted from 20 to 700mmHg depending on patient’s
status and application areas.
1CH
1
Pressure
Control
Button
Set the pressure using 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.
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Inflation of the cuff of 1CH
1CH
2
Inflation
Button
1CH Time
3
Setting
Button
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.
Time setting of 1CH
The previous value is saved and displayed. It can be adjusted
to 1 to 240 minutes depending on patient’s status or operation
types. Press the Time Setting button ( , ) to set the time.
User can change the set pressure during operation. (Unit :
5min (Long push), 1min (Short push)). The time displayed
during operation indicates the elapse time. Time can be
adjusted during operation using the button ( , ).
22
1CH
4
Deflate
Button
1CH Cuff
5
Change
Button
6
1CH LOP
Button
Deflate the cuff of 1CH
For deflating a cuff, press the Deflate button long (3seconds).
LCD displays during deflating.
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) while using the
Cuff A. Pressure is applied to the Cuff B and then the Cuff A is
deflated. In this case, LCD shows the change from the Cuff A
to the Cuff B at the bottom of the screen.
Set LOP of 1CH
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.
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Then, LOP automatically estimates and notifies the proper
pressure for a patient. To start, press the Inflate button to
6
1CH LOP
Button
2CH
7
Pressure
Control
Button
2CH
8
Inflation
Button
activate. The icon below is activated on the LCD
during LOP measurement. LOP icon color is changed as
shown below.
Control of Pressure of 2CH
The previous setting is saved and displayed. The pressure
can be adjusted from 20 to 700mmHg depending on patient’s
status and application areas.
Set the pressure using 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.
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.
Time setting of 2CH
The previous value is saved and displayed. It can be adjusted
to 1 to 240 minutes depending on patient’s status or operation
2CH Time
9
Setting
Button
types. Press the Time Setting button ( , ) to set the time.
User can change the set pressure during operation. (Unit :
5min (Long push), 1min (Short push)). The time displayed
during operation indicates the elapse time. Time can be
adjusted during operation using the button ( , ).
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10
11
12
2CH
Deflate
Button
2CH Cuff
Change
Button
2CH LOP
Button
Deflate the cuff of 2CH
For deflating a cuff, press the Deflate button long (3seconds).
LCD displays during deflating.
Change the hemostasis area while using
double cuff of 2CH
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) while using the
Cuff A. Pressure is applied to the Cuff B and then the Cuff A is
deflated. In this case, LCD shows the change from the Cuff A
to the Cuff B at the bottom of the screen.
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
below is activated on the LCD during LOP
measurement. LOP icon color is changed as shown below.
13
14
Record
Button
Power
Button
Record the history of application
Setting values or errors are saved during the application.
Power Button
Turn power on or off with this button.
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4-6. LCD Screen
AC CordIndication
Screen
Battery
Remaining Icon
Error Indication Icon
Channel 1
Pressure Indication
Time Indication Screen
Operation Status Screen
Channel 1
Channel 1
Channel 1
LOP Sensor Icon
Channel 1
CUFF Channel Icon
1) LCD Information
AC Cord Indication
Screen
Battery Remaining
Icon
Error Indication
Icon
Pressure Indication
Screen
Time Indication
Screen
Operation Status
Screen
Channel 2
Pressure Indication Screen
Channel 2
Time Indication Screen
Channel 2
Operation Status Screen
Channel 2
LOP Sensor Icon
Channel 2
CUFF Channel Icon
Current Time Indication
The icon of indicating the connection of AC cord to the product
* Inactivate if there is no AC cord connection
The icon of indicating battery remaining by 4 steps of marking
Activated if there is an error in the product
* Alarm LED at Errors: Red color
-The screen of indicating pressure values by pressing PRESSURE
▲, ▼
button.
- The screen of indicating pressure values of INFLATE
- The screen of indicating time values by pressing TIME ▲, ▼ button.
-Indicate the elapsed time while operating
- When INFLATE button is pressed, the READY icon is changed
to the OK icon after compression.
LOP Sensor Icon
CUFF Channel Icon
Current Time
Indication
The LOP sensor icon is activated based on LOP sensor connection 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
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2) Power Status
- Display the power status on the top of LCD.
3) Battery Status
- Display the battery status in four steps depending on the charging amount. The battery
is automatically charged when AC power is supplied.
Full Charge
External power connection
Medium Charge
Charge Required
(Supply Power)
No Power
(Supply Power)
* Disassembly and Replacement of Battery
- Open 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.
External power
Cutt-off
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5
Product use and procedure
5-1. Before using a device
Use this device in accordance with the instruction from a doctor.
Select proper application area, types of cuffs and pressure level in consideration of a patient’s
status and operation area. Improper application may have adverse impact to patients during
operation.
5-2. Use and install
1) Connect the cuff and the air hose.
2) Put a bandange 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 screen, the pressure is completely
applied to the cuff. At this point, check the blood flow at the end of limbs and start
operation.
8) For changing the hemostasis area while using the double cuff, touch the Cuff Change
button long (3 seconds) to change the pressure area.
9) For deflating the cuff after the completion of operation, touch the Deflate button long
(3 seconds) to deflate the cuff.
10) After the air is completely deflated from the cuff, disconnect the power cable and touch
the power button to shut off the power completely.
* Even when power is forcibly off, the cuff is not deflated.
(When power cord is pulled off, the device works with the battery so that power is
not turned off).
* Do not press the deflate button during surgery.
(There is a risk of bleeding when the cuff is deflated.)
5-3. LOP Application
1) Connect the parts as described from Step No. 1 to 5 above in Application and
Installation section.
2) Put the LOP sensors to the index finger or the second toe of the limb where the cuff is
applied.
3) Touch the LOP button long (3 seconds), and LOP starts measuring and displays the
proper pressure value for a patient.
4) For using the recommended pressure value by LOP sensor, touch the Inflate button to
apply the pressure to the cuff. Or set the pressure value as desired using the Pressure
Control button without using the recommended pressure value.
5) After the pressurization is complete , remove the LOP sensor worn by the patient.
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5-4. Cuff connection
5-4-1. Single cuff
- Connect the air hose to the channel until you
hear the ‘click’ sound.
(When the Lock Pin is not pressed in the air
socket in the device, press 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.
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5-4-2. Double cuff connection
- Connect the air hose to the channel until you
hear the ‘click’ sound.
(When the Lock Pin is not pressed in the air
socket in the device, press 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 double cuff to the other end of
the air hose until you hear the ‘click’ sound
- Use the device after checking the proper
connection.
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5-5. LOP connection
- Connect the port of LOP Sensor to the
device.
- 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.
* Remove all foreign substances including nail polish on fingers or toenails where the
LOP Sensor is applied.
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6
Troubleshooting
6-1. Alarm messages
No Alarm Code Description Actions
- Take the follow-up actions in accordance
with the instructions from a doctor.
1
2
3
4
Indicate the set
time is over.
A certain pressure
is detected, but
pressure doesn’t
reach to the set
value or a cuff
is continuously
deflated.
A cuff is not
connected to the
device.
Voltage error while
using the battery.
- Finish alarm rings after the set time.
(However, the device is not turned off
and cuffs are not deflated.)
- Press the Deflate button to deflate the
cuffs.
- Check the connection of a cuff and a
hose.
- Check air leakage of a cuff and a hose.
- If the error persists even checking a cuff
and a hose, contact your vendor.
- Check the connection of a cuff and a
hose.
- If the error persists even checking the
connection of a cuff and a hose, contact
your vendor.
- 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.
5
* When an alarm occurs, Alarm LED turns red.
Press the Alarm button, and alarm stops. However, Low Battery Alarm keeps ringing and Time
Over Alarm is activated 30 seconds after the first alarm. Alarms occurred are displayed in the
numbers as shown in the table above on the top of LCD. When the errors occur in both 1CH
and 2CH at the same time, more urgent error is displayed.
Errors during LOP
operation.
- Check the connection of LOP Sensor.
- If the error persists even checking LOP
connection, contact your vendor.
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6-2. General Troubleshooting
No Problem Cause Solution
1 No electric power
Power on but not
2
operating
Noisy during
3
operating
4 No air in the hose
6-3. Troubleshooting
Power connection
alarm
Rated power
FUSE shortcut
Power supply alarm Turn power to the controller off and on
Setting condition
Hose connection
alarm
Bent hose Check that the hose is not bent.
Check that the plug is correctly inserted into
the power outlet
Check if your power supply is in the range of
AC100-240V, 50/60Hz
Check if FUSE is in the state of shortcut.
(FUSE is located inside AC INLET.)
Check that the device is installed horizontally
or fixed the screw hard-locking.
Check that there is nothing laying on top of
the device or underneath.
Check that the hose is inserted correctly into
the device.
No Problem Cause Solution
Air hose damage
1 Weak air injection
Power on but not
2
operating
Air hose socket
damage
Defect of Inner parts
of cuff
Defect of Inner parts
Contact the seller if there is a defect in the
inner hose or cuff connection.
Check that the plug is correctly inserted into
the outlet.
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7
Maintenance and safety instructions
Once a year, please check the maintenance by a service center agent or
distributor.
7-1. Test Methods and Calibration
1) Connect AC cord while CH1, CH2 air sockets are fully connected with 4 cuffs.
2) Turn on power switch ON/OFF located at the back of the device.
3) Press Alarm Button + Power Button together and go to Maintenance mode.
4) Press Power button with long key to quit Maintenance mode.
7-2. Explanation of each test
7-2-1. Version verification
- 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 and Sub board, Sub board
version won’t be shown. In this reason user can notices if the data communicates
w or not.
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7-2-2. Power display
Display Status Test method
AC is not
connected.
Reboot the device in Maintenance mode
while battery is in it then check if AC
connection status shows in the right way
as AC connection goes and disconnection
goes.
AC is connected
7-2-3. Battery indicator
Display Status Test method
- Reboot in Maintenance mode while
Battery is not
recognized
AC cord is connected then check if
battery connection condition works
on display correctly.
- Verify if battery is in the acceptable
- Battery is recognized
- Battery capacity
indication and
Acceptance coverage
indication
* Check the service manual for battery specifications and replacement instructions.
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.
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7-2-4. Button check
Display Status Test method
Condition that
button is not
pressed firmly.
Condition that
button is pressed
firmly.
* Power goes out after power button is pressed for 3 seconds.
- Verify if selected button indicates
on Display or not and make sure
if it is matched with images on
the left.
- PRESSURE, INFLATE, TIME,
DEFLATE, CHANGE, LOP,
RECORD, POWER, ALARM
button can be verified.
7-2-5. Sensor, Solenoid, Leak check
- 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 to check next chamber that
is being tested. Standard check order starts from 1CH to 4CH accordingly.
Display Status
Check completion with good condition
Check failure Error condition
Condition that Check is not proceeded
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Display Test method
The test starts from CH1 after inflating for
10 seconds whether there pressure stays or
not. If pressure sensor does not recognize
pressure, then the machine decides there is
problem with Solenoid and shows solenoid
error.
The machine does not perform following test.
Sensor check / Leak check test.
Display 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 completing test until 4CH then it
automatically stop all.
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Code
2017-02-22
Date
손동영
AN-70-DTS-W41-01
Designer Reviewe Approve Revision
Rev.01하정훈 김국한
8
Labels
8-1. Label for main device
Label location
and description
Device : Digital Pneumatic Tourniquet system
Model : DTS-3000
Weight : 3Kg (Only Body)
Dimension : 180(W) x 200(D) x 260(H) mm
1
Power consumption : 80VA
Power source : AC100 - 240V, 50/60Hz
Battery : DC 14.4V, 2600mAh
Setting Time : 1~240min (Unit : 1, 5min)
Setting Pressure : 20~700mmHg ±4mmHg (Unit : 1, 5mmHg)
Ambient operating conditions : 0~40 C
Label designsNo
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
DONGBANG AcuPrime Ltd
1 The Forrest Units, Hennock Road East Exeter, EX2 8RU, UK
Tel: +44-1392-829500 Fax: +44-1392-823232
DSM-UM-008
, 0~60%, 700~1060hPa
Left side of Device
(Main Label)
2
Front of Device
(Window Sheet)
3
Front of Device
(Deco Window)
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4
Side of Device
KEEP POWER CORD PLUGGED IN. BATTERY ONLY FOR USE DURING
POWER EMERGENCY OR TEMPORARY PATIENT TRANSPORT.
5
ATTENTION : UNIT SHOULD BE PLUGGED IN 24 HOURS BEFORE USE
TO PROPERLY CHARGE BATTERIES.
Back of Device
6
Back of Device
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9
Information on EMC
9-1. Guidance and manufacturer’s declaration
- electromagnetic emissions
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.
Emissions test Compliance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Group 1
Class A
Class A
Complies
Electromagnetic environment - guidance
The DTS-3000 uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The DTS-3000 is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply net work that supplies buildings
used for domestic purposes.
9-2. 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 DTS-3000 should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
IEC 60601
test level
±6kV contact
±8kV air
±2kV for power
supply lines
±1kV for input/
output lines
Compliance
level
±6kV contact
±8kV air
±2kV for power
supply lines
Electromagneticenvironment -
guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
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Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency (50/
60Hz) magnetic field
IEC 61000-4-8
±1kV
±1kV differential
mode
±2kV common mode
differential
mode
±2kV common
mode
<5% U
T
(>95% dip in UT)
for 0.5cycle
40% U
T
(60% dip in UT)
for 5cycles
70% U
T
(30 % dip in UT)
for 25cycles
<5% U
T
(>95% dip in UT)
for 5sec
<5% U
(>95% dip in
UT)
for 0.5cycle
40% U
(60% dip in UT)
for 5cycles
70% U
(30 % dip in UT)
for 25cycles
<5% U
(>95% dip in
UT)
for 5sec
3A/m 3A/m
Mains power quality should be
that of a typical commercial or
hospital environment.
T
Mains power quality should
be that of a typical commercial
T
or hospital environment. If the
user of the DTS-3000 requires
continued operation during
T
power mains interruptions, it
is recommended that the
DTS-3000 be powered from an
T
uninterruptible power supply or
a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
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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.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
test level
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2.5GHz
Compliance
level
3Vrms
3V/m
Electromagnetic environment -
guidance
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
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
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Interference may occur in 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 propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM 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 abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the DTS-3000.
b
Over the frequency range 150kHz to 80 MHz, field strengths should be less than [V1] V/m.
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9-4. Recommended separation distances between portable and mobile
RF communications equipment and the DTS-3000
The DTS-3000 is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the DTS-3000 can help prevent
electromagnetic interference by maintaining a minimum distance bet ween portable and
mobile RF communications equipment (transmitters) and the DTS-3000 as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
(W)
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 maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnet ic propagation is
affected by absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2, 5 GHz
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10
Symbols Information
10-1. Symbols Information (Device)
Symbols Explanation Reference
Manufacturer
European Representative
Data of Manufacture
Serial Number
Symbol that indicates electrical and
electronic components which must be
collected separately.
The official mark of Europe
Certificate
Type of applied part
Refer to instruction manual
Alternating current
EN 980
5.12
EN 980
5.13
EN 980
5.6
EN 980
5.5
EN 50419
CE logo
IEC 60878
5333
ISO 7010
M002
IEC 60878
5032
Alarm off Button Custom Symbol
Increase Button Custom Symbol
Decrese Button Custom Symbol
Inflation Button Custom Symbol
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Deflate Button Custom Symbol
Cuff Change Button Custom Symbol
LOP Button Custom Symbol
Record Button Custom Symbol
"ON" (power)
"OFF" (power)
Power Button
General warning, Caution
10-2. Symbols Information (Set Box)
Symbols Explanation Reference
The official mark of Europe Certificate CE logo
Humidity limitation
This way up
IEC 60878
5007
IEC 60878
5008
IEC 60878
5009
ISO 7010
W001
ISO 7000
2620
ISO 7000
0623
Do not hang on hooks in the box
ISO 7000
0622
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Temperature limitation
EN 980
5.17.3
Load Limitation
Fragile, handle with care
Keep dry
Easy settings symbols Custom Symbol
Self Check system symbols Custom Symbol
Data Recording symbols Custom Symbol
10-3. Symbols Information (EPS)
ISO 7000
2403
ISO 7000
0621
EN 980
5.21
Symbols Explanation Reference
Symbol recommending the recycling
of polluting components
IEC60878
1135
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10-4. Symbols Information (Cuff Box)
Symbols Explanation Reference
General warning, Caution
Load Limitation
Do not hang on hooks in the box
Fragile, handle with care
Keep dry
Temperature limitation
Humidity limitation
ISO 7010
W001
ISO 7000
2403
ISO 7000
0622
ISO 7000
0621
EN 980
5.21
EN 980
5.17.3
ISO 7000
2620
The official mark of Europe Certificate CE logo
47
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10-5. Symbols Information (Cuff)
Symbols Explanation Reference
The official mark of Europe Certificate CE logo
10-6. Symbols Information (Out Box)
Symbols Explanation Reference
The official mark of Europe Certificate CE logo
48
Humidity limitation
This way up
Do not hang on hooks in the box
Load Limitation
Fragile, handle with care
ISO 7000
2620
ISO 7000
0623
ISO 7000
0622
ISO 7000
2403
ISO 7000
0621
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Keep dry
EN 980
5.21
Temperature limitation
Easy settings symbols Custom Symbol
Self Check system symbols Custom Symbol
Data Recording symbols Custom Symbol
10-7. Symbols Information (User Manual)
Symbols Explanation Reference
General warning, Caution
General prohibition sign
EN 980
5.17.3
ISO 7010
W001
ISO 7010
P001
Do not take to pieces CustomSymbol
Symbol that indicates electrical and
electronic components which must be
collected separately.
EN 50419
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Symbol that indicates electrical and
electronic components which must be
collected separately.
The official mark of Europe Certificate CE logo
IEC 62133
Manufacturer
European Representative
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
EN 980
5.12
EN 980
5.13
EN 980
5.17.3
ISO 7000
2620
ISO 7000
2621
50
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Warranty
Much appreciated on using our device. We, DAESUNG MAREF are
doing our best to improve the quality of our products.
※
We can not be responsible for any defect occured from user's
careless use or in case of followings, 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.
DESCRIPTION
MODEL NAME
WARRANTY
Digital Pneumatic Tournique
system
DTS-3000
Device : 1 year
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DSM-UM-008 (REV.0) 2017-02
History & Certificates
2015 The 8th medical devices day president award to industrial
company
2014 Commissioned member of INNO-BIZ
Korean world-class product award 2014
in recognition of DVT prevention system
2013 Commissioned member of the Ministry of
Trade Industry Energy planning committee
2013 Consultant of National Unification Advisory Council
2013 Member of Trade Industry Forum
2011 President Award
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, DL1200, DVT-2600)
1986 DS MAREF established
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 Web : www.dsmaref.com
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