DAESUNG MAREF DTS-3000 User manual

USER MANUAL
ISO 9001
EN ISO 13485
Digital Pneumatic Tourniquet system
Indications
for 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.
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CONTENTS
1. Information
1-1. DTS-3000 Introduction
1-2. Intended use
1-3. Target treatment group and diseases
1-4. Expected except group of treatment
1-5. Side effect
2. Information on Safety and Handling
2-1. Operation of the device
2-2. Indications for use
2-3. Cuff safekeeping and maintenance
2-4. Device Safekeeping and Maintenance
2-5. Cautions for Battery safety
2-6. Cleaning
2-7. WEEE marking
2-8. Operating, storage and cleaning 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. Troubleshooting
6-1. Alarm messages
6-2. General troubleshooting
6-3. Troubleshooting
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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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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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2-1. 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.
Information on Safety and Handling
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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 40oC or under
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.
- 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.
- 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.
2-3. Cuff safekeeping and maintenance
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- 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.
- 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.
2-4. Device safekeeping and maintenance
2-5. Cautions for Battery safety
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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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- 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.
- 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.
2-6-1. How to clean the device
2-6-2. How to clean the hose
2-6. Cleaning
- 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.)
2-6-3 How to clean the cuff
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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.
2-7-1. Correct Disposal of this product
(Waste Electrical & Electronic Equipment)
2-7. WEEE marking
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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Temperature (oC) Relative humidity (%) Atmospheric Pressure (hPa)
2-8. Operating, storage and cleaning conditions
2-8-1. Operating conditions
2-8-2. Storage conditions
Temperature (oC) Relative humidity (%)
(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.
2-7-2. Correct disposal of batteries in this product
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3-1. Device part
Product package
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Air Hose (Blue) 1EA Air Hose (Red) 1EA Air Hose (Gray) 2EA
Main device
Power code
User manual
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3-2. Cuff part
Single Cuff Double Cuff
Rubber Bladder Cuff
Cone 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.
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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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Product description
4-2. Device views
TopBack
Front Right sideLeft side
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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 20~700mmHg ± 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
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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 CONE DOUBLE 70 X 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 SINGLE 76 X 11cm CUFF
DTC-SA07 AC SINGLE 86 X 11cm CUFF
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1
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4-4. Names and Functions of Parts
No Name Function
1 LCD Screen Display the operating status of the device.
2 1CH Air Socket
- Socket for inserting red hose into 1ch when using single cuff.
- Socket for inserting red hose and gray hose into 1ch when
using double cuff.
3 2CH Air Socket
- Socket for inserting red hose into 2ch when using single cuff.
- Socket for inserting red hose and gray hose into 2ch when
using double 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.
8Holder fixing pin/
Handle
- Pin to fix the device on the holder.
- Use the handle when moving the device.
9 Battery Cover - 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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