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Digital Pneumatic Tourniquet system
EN ISO 13485 : 2016
ISO 13485 : 2016
Tourniquet Cuff User Manual
RND-R-EM-210-01 2022-05 (REV.3)
1. Intended use
• Tourniquet cuffs intended to occlude the blood flow to obtain hemostasis field during limb surgery.
2. Cuff description
- Cuff appearance
※The shape could be different
depending on products.
Velcro
Air hose
Bladder
- Features of the cuff
• As the elastic bladder guarantees the transmission of pressure to deeper tissue, the bladder can inflated
easily by lower pressure.
(Please refer to general pressure used normally in hospitals normal max pressure value is 300mmHg for adult’s arm,
400mmHg for adult’s leg, 200mmHg for child’s arm and 300mmHg for a child’s leg but the pressure setting value
can be adjusted according to a patient’s age, sex, weight, size… etc..)
• All the cuffs have been tested under 800mmHg under high quality control.
3. How to use cuff
※ In accordance with national or regional surgical procedures, sterile drapes are applied to DTS cuff and all parts
(except the surgical site).
- Cautions before wearing the cuff
• Check if the Velcro part
is inserted properly into
the fixing belt.
• Check if the Velcro is
attached to the bladder
part.
- How to wear cuff
• The selection of the cuff should be considered each patient’s conditions and various assessment like contraindications,
complications, infection and any damage with limitation.
• Double cuff can be recommended if operation time is more than 1 hour, it should be considered using the double cuff to
minimize any damage like blood vessel, skin and nerve.
• Cone cuff should be selected if difference between the distal and proximal cuff edges of the patient's wear area is big.
7cm(Min)
7cm(Min)
• The cuff should be overlapped at least 7cm (3inches) when a cuff is wrapped on the part requiring homeostasis.
• The width of the cuff should be individualized and wider than half of the limb's diameter.
• The cuff should be wrapped on the most muscular and wide body part proximally(near the heart) as possible
to minimize the damage of blood vessels, nerves and skin.
• Position the cuff hose(tube) upwards when a cuff is wrapped on a limb.
Attach the cuff part with a ribbon on the center of the extremity as the starting point
as the starting point, and then wind it tightly as far as just two fingers can be input
inside of the cuff.
* If there is the gap between the skin and the cuff, pinch or leakage of blood
may occur.
- Cautions after wearing calf - How to connect the device and cuff
Cuff should be aligned
with ribbon ties not to be
twisted or bounced out
during inflation.
After putting the cuff,
make sure that you can
insert two fingers
between the skin and
the bladder.
4. DISPOSAL
• Used or damaged devices must be disposed of in accordance with the relevant national and international legal
regulations.
www.dsmaref.com
Ribbon ties
• Check a Velcro to be
attached to inner part of
a cuff when a cuff is
spread out.
Connect the hose jacks
to the socket of device
and the jack of cuff hose
until click is sounded.
Check whether the
indicated colors are equal
for the air socket of the
device, the cuff hose and
the air hose.
5. How to reprocess cuff
※ Please refer to the user manual for more information on reprocessing.
5-1. Cuff
Preparation
Cleaning
Inspection
Package
Storage
Transfer
Remove all accessories (hose/cuff/IOP sensor).
Use a cloth/sponge or brush to wipe off foreign substances on the cuff hose and gently shake off dust
from the Velcro part. Wipe until contaminants are no longer visible to the naked eye.
ll up the cuff and tie the ribbon, then connect it to the DTS-3000 and the hose.
1. Ro
2. Enter the maintenance mode of DTS-3000.
3. Enter the Cuff test mode and run the test 3 times.
4. During the test, there should be no flaring of the velcro, and check if the Pass is output on the display.
* Connect the cleaned Hose and proceed with the inspection. The test is conducted 3 times, and
PASS must be issued at least 2 times. For detailed test method, refer to the description of the Cuff test
in the user's manual.
Store in a clean cloth or plastic bag.
1. Store in the hospital storage room according to our instructions.
2. Store the cuff according to hospital storage procedures, referring to the environmental conditions for
storage in the user's manual.
Avoid contact with contaminants when the product is moved other than where it was cleaned.
5-2. Silicone bladder cuff
Preparation
Cleaning
Inspection
Package
Sterilization
Storage
Transfer
Remove all accessories (hose/cuff/IOP sensor).
After plugging the hose plug of the silicone bladder cuff, Use a brush or cloth/sponge to shake off
foreign substances on the tube and cuff.
Wipe until no foreign matter can be seen with the naked eye.
1. Roll the cuff and tie the ribbon, then connect it to the hose and main device.
2. Enter the maintenance mode of DTS-3000.
3. Enter the Cuff test mode and run the test 3 times.
4. During the test, there should be no flaring of the velcro, and check if the Pass is output on the display.
* Connect the cleaned Hose and proceed with the inspection. The test is conducted 3 times, and PAS
must appear at least 2 times. For detailed test method, refer to the description of the Cuff test in the
main body user's manual.
Pack the Silicone bladder cuff by sterilization-wraps approved as a medical device with the two layers.
Put the packaged CUFF into the Auto Clave and sterilize it under the following conditions.
Temperature: 134 degrees
Atmospheric pressure: 2 atm
Sterilization time: 5 minutes
Drying time: 15 minutes
After sterilization according to hospital policy, check whether sterilization is done properly with MI / CI, BI, etc.
1. Store in the hospital storage room according to our instructions.
2. Store the cuff according to hospital storage procedures, referring to the environmental conditions for
storage in the user’s manual.
Avoid contact with contaminants when the product is moved other than where it was cleaned.
6. Cuff specifications
Bladder size
Bladder size
e
z
i
s
x
a
M
/
n
i
M
- Cuff
Ref.No Bladder size Shape
DTC-S02
DTC-S04
DTC-S05
DTC-S06
DTC-S07
DTC-S08
DTC-D04
DTC-D05
DTC-D06
DTC-D07
DTC-C25 48cm <
DTC-C26
DTC-C27
DTC-CD25
DTC-CD26
DTC-CD27
Minimum
recommended size
25cm <
30cm <
39cm <
53cm <
59cm <
80cm <
35cm <
53cm <
80cm <
35cm <
63cm <
80cm <
48cm <
63cm <
80cm <
Maximum
recommended size
< 33cm
< 45cm
< 54cm
< 73cm
< 79cm
< 100cm
< 50cm
< 73cm
< 100cm
< 50cm
< 63cm
< 83cm
< 100cm
< 63cm
< 83cm
< 100cm
Cleaning
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
Sterilization
possible
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
- Silicone bladder cuff
Ref.No Bladder size Shape
DTC-SA01
DTC-SA02
DTC-SA05
DTC-SA06
DTC-SA07
DTC-SA15
※The dimensions of above table can be occurred deviation of 4~5cm according to production condition.
Number of reuses : Cuff : 100 times, Silicone bladder cuff : 40 times
Any serious incident that has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user and/or patient is established.
Minimum
recommended size
10cm <
23cm <
39cm <
54cm <
64cm <
30cm <
298-24, Gongdan-ro, Gunpo-si, Gyeonggi-do, Korea
Tel : +82-31-459-7211 Fax : +82-31-459-7215 E-mail : info@dsmaref.com
KTR Europe GmbH
Mergenthalerallee 77, Eschborn, Hessen, 65760, Germany
Tel : +49(0) 6196-887170 Fax : +49(0) 6196-887-1728
Maximum
recommended size
< 23cm
< 39cm
< 54cm
< 69cm
< 79cm
< 45cm
Cleaning
O
O
O
O
O
O
Sterilization
possible
O
O
O
O
O
O
SINGLE
DOUBLE
CONE
SINGLE
CONE
DOUBLE
SINGLE
S
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