DAESUNG MAREF DVT-2600 User manual

Indications for Safety Use
Read this manual carefully. This manual is for user's safety and preventing
any property-loss. Before using our device, please read this manual inevitably.
www.dsmaref.com
The Venous Assist System
User Manual
This product is medical device using under doctor's instructions.

1. Introduction
2. General contraindications and Cautions
1.1 Operation of the controller
Thank you for choosing the DVT-2600. This product is a specialized Intermittent
Pneumatic Compression (IPC) system designed to prevent DVT (Deep Vein Thrombosis)
and PE (Pulmonary Embolism) by improving venous blood flow in high risk patients.
This system consists of the controller, tubing sets and cuffs. The DVT-2600 offers
sequential inflation which promotes venous blood movement and metabolism. After
deflation, there is a time interval before reinflation to allow the veins to refill. The
operation of the inflation and deflation is repeated until the stop button is activated.
The DVT-2600 has an integrated self-checking system which includes checks for the
digital sensor, cuff connection, and power supply. If an error code shows during initial
operation of the DVT-2600, it can be checked against the error code key attached to the
side of the DVT-2600 unit for convenient reference.
2.1 Contraindications
The DVT-2600 system is not recommended for use with the following conditions:
- Pre-existing deep vein thrombosis, phlebothrombosis or pulmonary embolism
- Presumptive evidence of Congestive Heart Failure
- Inflammatory Phlebitis Process
- Severe arteriosclerosis or other ischemic vascular disease
- Decompensated cardiac insufficiency
- Carcinoma metastasis in the affected extremity
- Lymphatic return is undesirable
- Severe arteriosclerosis or active infection
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2.2 Precautions
- If any pain or oedema occurs during use of the device, cease therapy and seek medical
advice.
- Use caution with the device on patients with any prosthesis inserted.
- Assess skin integrity frequently during use in patients with diabetes or vascular
disease.
- If any electronic shock is detected, remove device from power source and disconnect
unit from patient.
- Manual settings should be adjusted under the advice of a medical practitioner.
2.3 Warnings
- Manual settings should be adjusted under the advice of a medical practitioner.
- Do not attempt to repair a faulty device or replace broken tubing connectors as
abnormal inflation of the cuff may occur. Contact your local representative.
- Use the device with a suitable AC power cord observing the electronic standards for
each local region. (Fire and electric shock are possible)
2.4 Clause 5
1) Type of protection against electric shock: Class I equipment.
2) Degree of protection against electric shock: Not classified - BF applied parts
3) Classify according to the degree of protection against ingress of water:
IPXO, ordinary equipment.
4) This equipment is not suitable for use in the presence of flammable anaesthetics or
oxygen.
5) Mode of operation - continuous operation
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2.5 Information regarding potential electromagneticor
other interference
This equipment has been tested and found to comply with the limits for medical devices
in IEC/EN 60601-1-2. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference
to other devices in the vicinity. However, there is no guarantee that interference will not
occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be
determined by tuning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures :
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a different circuit from that to which the
other device(s) are connected.
- Consult the manufacturer or field service technician for help.
2.6 WEEE marking
This marking shown on the product or its literature, indicates that it
should not be disposed of with other household waste at the end
of its working life. To prevent possible harm to the environment or
human health from uncontrolled waste disposal, please separate this
from other types of waste and recycle it responsibly to promote the
sustainable reuse of material resources.
Household users should contact either the place of purchase, or their local government
office, for details of where and how they can take this item for environmentally safe
recycling.
Business users should contact their supplier and check the items and conditions of the
purchase contract. This product should not be mixed with other commercial waste for
disposal.
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3. Product Description
3.1 Summary and Specifications
Composition
- The controller
- Air connectable hose
- AC power cord
Operating principle
The operating principle is that the air from the controller will be delivered to the cuff
with 3 air chambers and the air will sequentially pressurize the chambers from 1st to
3rd. After completion of pressurization to each chamber, the controller determines the
interval time for vein refilling and the controller will restart to pressurize the chambers
again. This operation will then be repeated.
Intended Use
This product is an ancillary medical device to help with the treatment of DVT by
accelerating blood circulation in the lower limbs. Please use this product in accordance
with medical direction.
How to connect the hose to the cuff
The controller has a self test function to automatically recognise the kind of cuff(s)
connected to it during initial operation. Press the "START/STOP" button after turning
on the power switch to initiate this self test feature.
System features
Self-test function of the controller
On device start up, the controller initiates an automatic check of the cuff connection
and the type of cuff applied. The controller also detects any abnormal pressures
encountered during regular operation.
Manual setting program
The controller is designed to allow custom pressure values to be delivered to the
patient.
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3.2 The functions
(1) Name of each part
1. Leg Pressure Button
Sets the pressure to be delivered.
When the user presses the START/STOP button, the pressure is set according to the
type of cuff connected. (LEG/CALF/BOOT CUFF: 40mmHg). This value is not able to be
changed during operation.
Basic pressure is set at 40mmHg. This pressure setting can be changed at 10mmHg
increments (ex. 40→50→60→20→30→40mmHg).
The LCD screen will remain turned off if the user does not apply the cuff, as the
controller automatically selects the cuff when the START/STOP button is selected.
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2. Foot Pressure Button
This button sets the pressure at which the device will be operated. When the user
presses the START/STOP button, the pressure will be selected according to the type of
cuff. (Foot Cuff: 120mmHg). The pressure setting cannot be changed during operating.
Basic pressure is set as 120mmHg. The pressure setting can be changed by 10mmHg
increments by pressing the button (ex. 120→130→140→120mmHg). The LCD screen
will remain be off if the user does not apply the cuff , as the controller automatically
selects the cuff when the START/STOP button is selected.
The controller has an automatic gradient pressure application which applies gradient
pressure into each chamber of a cuff sequentially (+/- 5mmHg).
For cuffs with 3 chambers such as the leg/calf/boot cuff; if 40mmHg is set, pressure
will be delivered as 35/40/45mmHg to the three chambers.
3. Interval Button
This button sets the interval time. The time value which the user sets will be
saved. Default time is set at 48 sec, and it can be changed to 48→60→24→48 sec
each time the interval button is selected. After initial inflation of pressure to each
chamber the controller will then restart therapy with the interval time selected.
This operation will be repeated and the setting cannot be changed during operation.
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4. Mode Button
Sets the mode to be operated. The default setting is set to DVT Mode during initial
power on.
5. START/STOP Button
Starts or stops the operation. It goes back to STOP mode when the user presses
START/STOP button during the error mark on the screen.
6. LCD display screen
1) Batteries status indicator
DVT-2600 is equipped with a battery pack as standard. There are four battery status
indicator LED's used to represent the charge level of the battery.
2) AC power indicator
AC power indicator (LED) represents one of power input or the fail of power input.
3) Battery charging indicator
Indicates whether batteries are charging. Indication of the battery charge level will not
be displayed when the unit is off. The indicator for battery charging will be displayed
only when the batteries are not fully charged.
※ The batteries require the device to be powered on for charging. Warranty period for the
batteries will be 6 months after the date of purchasing. Do remove the batteries from the
device.
Battery fully charged
Battery is 50%charged
Battery needs to be recharged
Out of battery
Power plugged in
Battery is charging
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4) Battery charging
To charge the batteries, please ensure the device is plugged in and the device power
switch is on. The amount of power the batteries can deliver will vary according to a
battery’s condition and the settings of the device. Regular battery charging time is
approximately 4 hours. Maximum running time is up to 8 hours.
5) Operation indicator
Shows normal operating condition and the type of applied cuffs.
Initial self-test will detect the type of cuff.
When the device is turned on, the controller will check the type of cuff. During the
controller check; the symbols below will be gradually encircled demonstrating progress
of the check.
The operation indicator below displays the variety of cuff types which may be used.
Please note if there is no cuff applied to the controller, an error code will be displayed.
Two feet Two legs Left foot
& right leg
Left leg
& Right foot
Right leg Left leg Left foot Right foot
<Picture 1>
<Picture 2>
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(2) Operating Mode
The operating mode is divided into DVT and LYMPH mode.
During normal operation, the operation indicator activates repeatedly.
1) DVT Operation Mode
In DVT mode, the controller first pressurizes the cuffs. (Refer to picture 1). The interval
time will start after pressurisation of both legs.
3) Interval Mode
After initial pressurisation, the interval time setting on the LCD (counter) will decrease
gradually and will restart the pressurisation cycle at the end of the interval time.
2) Lymph Operating Mode
In Lymph Mode, the controller first pressurizes the cuffs. (Refer to picture 2). The
Interval time will start after pressurisation of both legs.
Foot cuff Leg cuff
Foot cuff Leg cuff
<Picture 2>
<Picture 1>
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※Error codes and instructions to follow
1) Code 10 (Cuff connection error)
- During power on the controller performs an automatic one cycle calibration to
detect the cuff type and proper garment fit. If the controller fails to detect the cuff,
it shows Error code 10 with an alarm sound.
*Checking point
①Check the connection of the controller to the
hoses (tubing).
②Check that each cuff is wrapped properly on the
patient’s leg.
(3) Error Description
If there is an error with the controller; the error mode will start with an alarm. The
controller will revert back to Waiting Mode when the user presses START/STOP.
> Error Mode
Segment
Error 10
(Cuff
connection
error)
This error mark will be
on the screen if there
is no cuff connection
to the controller.
Lower pressure error
Under the 30%pressure
has consecutively
checked five times.
Vent error
Pressure in cuff doesn't
ventilate.
Pump error
When the device pump
has an error.
Device error
When the device has an
error.
The voltage of the
controller has an error
after AC power is on.
Warning of low battery
Connect the AC power.
High pressure error
Over the 30%pressure
has consecutively
checked five times.
Error 30
(system
error)
Error 20
(Pressure
error)
Error 40
(Power
error)
Error information Error information
Segment
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2) Code 21 (Low pressure error)
- If pressures lower than 30%of the set value are detected more than 3 times during
operation, it will indicate Error code 21.
*Checking point
①Check the connection of the controller to the hoses
(tubing).
②Check that each cuff is wrapped properly on the
patient’s leg.
③Check whether there is any leakage from a connected
cuff.
④Separate the cuff and hose, check air is leaving from the air socket of the controller.
3) Code 22 (higher pressure error)
- If pressures higher than 30%of the set value are detected more than 3 times during
operation, it will indicate Error code 22.
*Checking points
①Check whether the hose is bent.
②Check if there is something blocking the hose.
③Check whether air socket is blocked.
4) Code 31 (Ventilation error)
If air is not ventilated (deflated) under 20mmHg during INTERVAL TIME, Error code 31
will be indicated.
*Checking points
① Check the inner solenoid valve (Exchange the valve)
5) Code 32 (Pump error)
- During the initial self detection test, if the pump is not operating normally, Error code
32 will be displayed.
*Checking points
①Check pump operation after opening the cover of the controller
②Check the wire connection in the controller.
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6) Code 33 (System error)
- This error indicates the inner controller is damaged seriously.
- Please call your local representative.
7) Code 41 (Power supply error)
- Code 41 is displayed if the power supply from the outer AC power generates any
problem.
- Please call your local representative.
8) Code 42
- Code 42 is displayed when there is a problem with the power supply generated by the
inner batteries. Please call your local representative.
3.3 System description
(1) Main compositions
1) DVT-2600 controller
●Voltage and AC power
: 100-200V~, 50/60Hz
●Power consumption : 25W(35VA)
●Output : 2
●Pressure range
: LEG - 20~60mmHg
Foot - 120~140mmHg
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2) DVT-2600 Accessories
>Single use cuff
>Multi-use cuff
Cuff
Non woven
Cuff
Soft fabric Size
Size
Width
Width
Code
Code
Tubings
Small
Medium
Large
X-Large
Small
Medium
Large
X-Large
One size
One size
One size
One size
One size
One size
80cm
66cm
42cm
63cm
DS111
DS121
DS131
DS141
60cm
75cm
93cm
113cm
50cm
62cm
77cm
97cm
42cm
63cm
DS011 / DS211
DS012 / DS212
DS013 / DS213
DS014 / DS214
DS021 / DS221
DS022 / DS222
DS023 / DS223
DS024 / DS224
DS031 / DS231
DS041 / DS241
Thigh
cuff
Thigh
cuff
Calf
cuff
Calf
cuff
Foot
cuff
Foot
cuff
Boot
cuff
Boot
cuff
※The dimensions given in the above table may deviate by 2~3cm depending on production conditions.
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(2) Cuff usage and caution
1) Two cuffs + Controller
Controller Two connectable hoses Two same cuffs Two different cuffs
Controller One connectable hose One cuff
(3) Cuff usage and caution
1) Do not turn on the power switch before applying cuff(s) to a patient. Connect the
hoses after the cuffs are applied to the patient. Turn the power on to the device after
connecting the hoses to the air socket at rear of device to ensure self check.
2) Do not operate with patient standing or sitting down. There could be a risk of
malfunction of the device and cuffs.
3) The manufacturer recommends using basic pressure settings for initial use. Caution
is recommended for manual pressure settings (Leg : over 50mmHg, Foot : over
140mmHg)
2) One cuff + Controller
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3.4 Controller views
3.5 Technique data
(1) Specifications and Dimensions
3.6 Products Label
(1) Copyright
Top view Front view Rear view Right side view Left side view
Test descriptions Standard Remarks
AC voltage
Power consumption
Air power consumption
Noise level
Operation nose level
Max. pressure level
Controller weight
Controller size
100-240V~, 50/60Hz
25W(35VA)
below 5W
Above 2 KV
below 60dB
140mmHg
2kg
200(W) x 165(D) x 190(H) mm
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(2) Label
Caution
Europe certificate mark
Service supplier mark
LOT NO
BF type medical equipment
Manufacturer mark
Production date
Serial No.
<Products information sticker>
※ This label is attached on the rear of a controller.
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4. Product composition
4.1 Package
DVT-2600 consists of a controller box and a cuff box.
The contents of each box are described below.
(1) Controller
A. DVT-2600 main body
B. The form for shock prevention of the controller
C. Connectable hose
D. AC cord
E. Operation manual
(2) Cuff box (Optional items)
A. Thigh cuff (large, Medium, Small)
B. Calf cuff (Large, Medium, small)
C. Foot cuff (One size)
D. Boot cuff (One size)
E. Multi-use cuff (Thigh, calf, foot and boot / One size)
4.2 Product checking
※Caution : Do not open the box with a sharp knife or scissors. The product may be
damaged.
(1) Composition inspection in a box
Check the accessories included are correct as ordered and that a user manual is
included in the box.
1) Basic set
A. DVT-2600 main body
B. Connectable hose
C. AC cord
D. Operation manual
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2) Optional items
A. Thigh cuff (large, Medium, Small)
B. Calf cuff (Large, Medium, small)
C. Foot cuff (One size)
D. Boot cuff (One size)
E. Multi-use cuff (Thigh, calf, foot and boot / One size)
F. User manual for cuffs
G. Cuff package pack
Check point of normal products
A. Products model name (DVT-2600)
B. Cuff size and material
C. The right connection of a hose socket and outlet of a controller
D. The right connection of a hose socket and outlet of a cuff hose
E. AC cord for local voltage
(2) Products or package defect
A. Please contact your local representative if products are found to be damaged or
quantities/items are incorrect.
(3) Other Points to Note
A. Damage during opening of the package by a user cannot be warranted.
B. Store device in a safe place protected from dust or humidity. Unplug the unit when
the device is not in use.
(4) Environmental conditions for transport and storage
Temperature (℃)
Relative humidity(%)
Atmospheric pressure (hPa)
Temperature (℃)
Relative humidity(%)
Atmospheric pressure (hPa)
0-40
10-90
700-1060
-20-60
0-90
500-1060
Operating
condition
Transport and
storage condition
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5. Product use procedure
5.1 Before using a device
Use this device only under medical supervision.
5.2 Setup and use
1) Place the device on a hard and flat table, or hang on the bed and connect to a power
outlet.
2) Ensure the cuff is the correct size and securely fitted to the patient.
3) Connect the cuff to the controller with the connectable hose(s).
4) Turn on the power switch at the rear of the controller.
5) Operate the controller by pressing the START/STOP button for the automatic setting
DVT or enter pressure and interval time manually after initial inflation.
6) The controller will operate automatically utilizing the entered settings after the cuff
self-test operation.
7) Press and hold the START/STOP button for 3 sec to stop therapy.
Check therapy parameters are in accordance with medical supervision.
8) Start the operation.
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