DS Maref DVT-2600 User manual

ISO 13485
USER MANUAL
Intermittent Pneumatic Compression 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.
lndicaciones para un uso seguro
Lea detenidamente este manual para seguridad del usuario
y prevenir un mal uso. Antes de la utilizacin de nuestro
dispositivo, por favor lea sin falta este manual.
lndicazioni per un utilizzo sicuro
Leggere con attenzione ii presente manuale per tutelare la
sicurezza dell’utente ed evitare danni al dispositivo. Prima
di utilizzare il dispositivo è necessario leggere il manuale.
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1. Information
1-1. DVT-2600 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. Sleeve safekeeping and maintenance
2-4. Device safekeeping and maintenance
2-5. Cautions for battery safety
2-6. WEEE marking
2-7. Cleaning
2-8. Operating, storage and cleaning conditions
3. Product package
3-1. Device part
3-2. Accessories
4. Product description
4-1. Device specifications
4-2. Device views
4-3. Names and functions of parts
4-4. Sleeve specifications
4-5. Appearance and names and functions of buttons
5. Product use and procedure
5-1. Before using a device
5-2. Setup and use
5-3. Looking after the device after using
5-4. Regarding using time and pressure
6. Troubleshooting
6-1. General troubleshooting
6-2. Others related to defect
7. Maintenance and safety instructions
7-1. Test methods and calibration
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Contents
ENGLISH

8. Information on EMC
9. Label
9-1. Labels for main device
10. Symbols Information
10-1. Symbols Information (Device)
10-2. Symbols Information (EPS Packing Case)
10-3. Symbols Information (Inner Box)
10-4. Symbols Information (Carton Box)
10-5. Symbols Information (Sleeve Box)
10-6. Symbols Information (Sleeve Vinyl)
10-7. Symbols Information (Sleeve)
10-8. Symbols Information (User manual)
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1. Información
1-1. DVT-2600 Introducción
1-2. Indicaciones de uso
1-3. Grupo objetivo del tratamiento y enfermedades
1-4. Excepciones del tratamiento
1-5. Efectos secundarios
2. Información sobre Seguridad y Uso
2-1. Funcionamiento del dispositivo
2-2. Indicaciónes de uso
2-3. Seguridad de las fundas y mantenimiento
2-4. Seguridad del dispositivo y mantenimiento
2-5. Precauciones y seguridad de la batería
2-6. Marcaje WEEE
2-7. Limpieza
2-8. Condiciones del manejo, almacenaje y limpieza
3. Empaquetado del producto
3-1. Conjunto basico
3-2. Accesorios opcionales
4. Descripción del producto
4-1. Especificaciones del dispositivo
4-2. Vistas del dispositivo
4-3. Nombres y funciones de las partes
4-4. Especificaciones de las fundas
4-5. Apariencia, nombres y funciones de los botones
5. Procedimiento de uso del producto
5-1. Antes de utilizar el producto
5-2. Configuración y uso
5-3. Cuidando el dispositivo después de usar
5-4. Tiempo de uso y presión
6. Solución de problemas
6-1. Solución de problemas
6-2. Otros defectos relacionados
7. Tests de verificación y calibración
7-1. Métodos de ensayo y de calibración
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Contenidos
ESPANOL
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8. Información sobre EMC
9. Etiqueta
9-1. Etiqueta para el dispositivo principal
10. Simbolos de información
10-1. Símbolos de información (Dispositivo)
10-2. Símbolos de información (Caso Embalaje EPS)
10-3. Símbolos de información (Caja interior)
10-4. Símbolos de información (Caja de cartón)
10-5. Símbolos de información (Caja de la manga)
10-6. Símbolos de Información (Funda vinilo)
10-7. Símbolos de información (Funda)
10-8. Símbolos de información (Manual de usuario)
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1. Informazioni
1-1. Introduzione di DVT-2600
1-2. Destinazione d’uso
1-3. Gruppo e patologie oggetti del trattamento
1-4. Gruppo non oggetto del trattamento
1-5. Effetti collaterali
2. Informazioni su Sicurezza e trattamento
2-1. Funzionamento del dispositivo
2-2. Indicazioni per l’uso
2-3. Conservazione e manutenzione dei tutori
2-4. Conservazione e manutenzione del dispositivo
2-5. Precauzioni per la sicurezza della batteria
2-6. La marcatura WEEE
2-7. Pulizia
2-8. Condizioni di funzionamento, stoccaggio e per la pulizia
3. Confezionamento del prodotto
3-1. Set di base
3-2. Accessori opzionali
4. Descrizione del prodotto
4-1. Specifiche del dispositivo
4-2. Viste del dispositivo
4-3. Nomi e funzioni delle parti
4-4. Specifiche dei tutori
4-5. Aspetto, nomi e funzioni dei pulsanti
5. Procedura per l’utilizzo del prodotto
5-1. Prima di utilizzare il dispositivo
5-2. Impostazione e utilizzo
5-3. Cura del dispositivo dopo l'uso
5-4. Riferimento a tempo e pressione
6. Risoluzione dei problemi
6-1. Risoluzione dei problemi
6-2. Altri problemi
7. Istruzioni per la manutenzione e la sicurezza
7-1. Procedura di test e calibrazione
Indice dei Contenuti
ITALIANO

8. Informazioni sulla Compatibilità elettromagnetica
9. Etichette
9-1. Etichetta del dispositivo principale
10. Informazioni sui simboli
10-1. Informazioni sui simboli (Dispositivo)
10-2. Informazioni sui simboli (Imballaggio in EPS)
10-3. Informazioni sui simboli (Scatola interna)
10-4. Informazioni sui simboli (Scatola di cartone)
10-5. Informazioni sui simboli (Scatola dei tutori)
10-6. Informazioni sui simboli (Confezione in vinile dei tutori)
10-7. Informazioni sui simboli (Tutori)
10-8. Informazioni sui simboli (Manuale d’uso)
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Information
1-1. DVT-2600 Introduction
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 to a patient who has a
risk factor of DVT/PE.
This system consists of the device, tubing sets and sleeves. 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, sleeve 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.
1-2. Intended use
A device intended to prevent DVT/PE by increasing venous blood flow to a patient who
has a risk factor of DVT/PE.
1-3. Target treatment group of disease
- Pulmonary embolism
- Deep vein thrombosis
1-4. Expected except group of treatment
Do not use this product if you have any of 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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- Acute pulmonary edema
- Acute thrombophlebitis
- Acute congenitive cardia failure
- Acute infections
- Episodes of Pulmonary embolism
- Wounds lesions or tumors at or in the vicinity of application
- Where increased venous and lymphatic return is undesirable
- Bone fractures or dislocations at or in the vicinity of application
- Diabetes or vascular disease is required to assess the skin frequently.
1-5. Side effect
- A slight pain during using the device.
- Temporary itchy or skin trouble.
- Skin trace or bruising after treatment.
- Heart attack or disease.
- Rupture of Capillary vessels. (Overpressure use.)
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2-1. Operation of the device
- The device is for indoor use only. Do not also use the device in
high humidity places such as sauna, bathroom.
(This 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 insert many plugs in an outlet.
(Use an outlet that has a circuit breaker to prevent the risk of fire.)
- Do not plug in or plug out with wet hands, which may cause electric
shock.
- Do not turn on the power switch before applying sleeve to a patient.
Connect the tubings after the sleeve are applied to the patient. Turn the
power on to the device after connecting the tubings to the air socket at
rear of device to ensure self check.
- Do not operate with patient standing or sitting down. There could be a
risk of malfunction of the device and sleeve.
- The manufacturer recommends using basic pressure settings for initial
use. Caution is recommended for manual pressure settings (Leg : over
60mmHg, Foot : over 140mmHg)
- To avoid the risk of electric shock, use the power supply with protective
grounding.
(There is a risk of fire and electric shock.)
- Insert the plug completely in an outlet to prevent the risk of fire.
- Install the power plug in a place where it can be easily removed.
- Do not pull the wire to move the device.
(If the wire is damaged, it may cause a fire or electric shock during use.)
Information on Safety and Handling
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- Grip the plug, not a wire, when plugging or unplugging the device.
(It may result in physical damage caused by an electric shock or scald.)
- Do not fold or bend the wire by force or put any heavy objects on the
wire.
(Doing so may lead to a risk of fire.)
- Do not use oil, benzene, alcohol, or any other chemicals to clean the
device or sleeve. The device may be gently wiped with a dry towel
or cloth.
- Be careful to not let dust, water or other fluids come in contact with or
seep inside the main unit of this device. Do not place the main unit where
it could fall into water or be pulled into water. Do not use this device while
bathing or near water.
- Do not put or pull out a power line from a socket with wet hands.
(Fire or electric shock may occur.)
- 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 the area with strong magnetic field or electromagnetic
field. It may cause an error of motor or valve.
- 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.
- Do not use the device to direct pressurized air towards your eyes,
nose, mouth, or ears. Doing so may lead to a serious injury.
- Do not fold or bend the tubing.
- Clothing, body hair, and skin may get caught in the velcro.
2-2. Indications for use
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- Use the sleeves with wearing thin cloths.
(It can cause an allergy to a person with sensitive skin.)
- A sleeve may cause rash or allergy reaction when it is used for the first
time. In that case, remove a sleeve immediately and consult your doctor.
- Do not use the device in the area with dense oxygen or exposed to
inflammable gas.
- All the manual settings should be adjusted with a doctor’s indications or
prescriptions.
- Keep out of children’s reach.
- Consult with your doctor before using the device if you have any
treatment from doctor.
- If any pain, abnormal condition or edema occurs during use of the
device, stop using it and let a physician or a doctor to see the symptom.
- Even though a device and sleeve are connected correctly, if there is any
trouble during operations, turn it off.
- Please consult a physician before using this device :
: If you are pregnant or feel weak.
: If you have an implant at the site of application.
: If you have a cardiac pacemaker.
- Stop the device immediately when any of the following symptoms is
observed and consult your doctor :
* any abnormal symptom in a body including feet, calves or legs during
the application.
* hyperventilating or dizziness during the application.
* excessive pressure by air pressure on a specific area or a body itching
or paralysis while putting on a sleeve.
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- Use in ambient room temperature ranging from 0oC to 40oC. The use
deviating the scope may cause defect to the device and fire.
- A sleeve shall be the exclusive sleeve for the model of DAESUNG MAREF.
Do not use any sleeve from other manufacturers or for other models of
DAESUNG MAREF.
- If the device malfunctions in any way stop the device immediately with
the Start/Stop button.
- Make sure to unplug the device after use, and store sleeve in a safe
place.
- Do not use this device in the environment with the possibility of water
penetration including when it rains or humid places.
- make sure that don't put the sleeve plug under the patient's legs.
- Do not keep sleeve near to stove, cigarettes, needles, or scissors to prevent
damage to sleeve or fire accident.
- Check the device and its parts on a regular basis.
- Check cleanness and safe operation before using the device when the
device is not used for a long time.
- A sleeve may have mold if it is kept in the area with excessively high
humidity for a long time.
- Keep unused sleeve in a clean place. Do not keep the sleeve at low
temperature in the winter time. Sleeve may get stiff.
- Keep in the safe place without influence by temperature, humidity or
atmospheric pressure.
- Keep out of the children’s reach.
2-3. Sleeve safekeeping and maintenance
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- Immediately request maintenance to a vendor or customer service enter in
case of any damage of the device case. device.
- Store the device in low moisture environment.
- Store the device in an area without where harmful condition are not
present. Such as steam pressure, temperature, humidity, ventilation,
sunlight, dust, and salinity.
- When you install or carry the device be sure not to shake or drop the
device.
- Do not store the device near children’s touch.
- Inspect the device and accessories on a regular basis.
- Prior to using the device, check to see that the device is clean and
functions properly.
- Once a year, please check the maintenance by a service center agent
or distributor.
2-4. Device safekeeping and maintenance
- Be cautious of impacts or vibrations.
- Except testing the device, do not blow air into sleeve without wearing.
Do not also use other products, except our device, to blow air into
sleeve. It may cause damage to sleeve.
- Do not fold or bend by force and put any heavy object on the sleeve.
- Sleeve is not washable.
(The durability of sleeve may be weaker if it is wet.)
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- 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 should the battery not be within normal
operating parameters consult your vendor or service agent.
(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.
- 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 6 months 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.
2-5. Cautions for battery safety
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- 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 contact 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. WEEE marking
2-6-1. Correct Disposal of this product
(Waste Electrical & Electronic Equipment)
This symbol indicating separate collection for EEE is based on
DIRECTIVE 2012/19/EU.
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, recycling 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.
This Directive cover all EEE used by consumers and EEE
internded for professional use.
Consumers 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
5 (Small equipment) in DIRECTIVE 2012/19/EU ANNEX III .
DVT-2600 is a recoverability rate of 77.57% and a recyclability rate of 71.27%.
Information for treatment facilities shall be made available to centres which prepare for
re-use and treatment and recycling facilities by producers of EEE.
DAESUNG MAREF, whenever, is prepared to provide.
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2-7. Cleaning
2-7-1. 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 on the
back of device. 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 discoloration, damage, electric shock or fire.)
* 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. 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.
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2-7-2. How to clean the tubing
- If any foreign material gets on the tubing, use a soft cloth to wipe the tubing with a bit
of water or a neutral detergent.
- Be careful of any liquid doesn’t go into the tubing.
(It may cause the durability of the tubing if water is inside of the tubing, it could also
break and cause a fire if and when water goes into the device from the tubing.)
- Do not spray water directly on the tubing or put the tubing into the water.
- Do not wipe the device with benzene, thinner, alcohol, etc.
2-7-3. How to clean the sleeve
- If any foreign material on the sleeve, use dried cloth or tissue to wipe the sleeve.
- Use little bit of neutral detergent or water on a soft cloth and completely dry the sleeve.
(It may cause decline the durability or modify when the sleeve is wet.)
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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 (%)
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