Venen Engel 4 User manual

OPERATING INSTRUCTIONS
ENGLISH
VENEN ENGEL 4

PRELIMINARY REMARK
Congratulations on the purchase of this device! You will enjoy your Venen Engel very much! If you are satisfied with your Venen Engel, we
would be very pleased if you submitted a review.
This guide includes details that should be taken into account by the user, to avoid risks, and to enable the safe use of the device.
Should you have any questions about its application, its accessories, or if you have suggestions, please do not hesitate to contact us! We are
also happy to help you with any complications that develop during or after using the product.
Telephone:[phone]
Whatsapp:[phone]
Mail: [e-mail]
Web: www.venenengel.de
HelpDesk: help.venenengel.de
BEFORE YOU GET STARTED
●Please read the operating instructions carefully before using the device.
●Keep this user manual so you can consult it, if necessary.
●Venen Engel may not be used if you suffer from certain health conditions. Please read the list of contraindications carefully on last
page.
24 EN

KONTRAINDICATIONS
Absolute Contraindications:
●Acute inflammatory skin diseases
●Arrhythmias Erysipelas
●Deep vein thrombophlebitis
●Pulmonary edema
●Acute venous thrombosis Unstable hypertension
●Use of a cardiac pacemaker
●arterial insufficiencies
PRODUCT DESCRIPTION
25
The air pressure massager consists of a device with a pump, cuffs, air pressure sensor, etc., which work together as one unit. The device is
connected to the cuffs via a series of hoses. The compression massage is done by cyclically inflating and deflating the air chambers. The
pressure in the cuff is controlled by a sensor and microprocessor.
In medical use, the air pressure massager produces sequential compression from distal to proximal, helping to improve the circulation
of blood and lymph, prevent DVT and relieve lymphoedema.
In cosmetic use, the system provides drainage of loosened fat cells and debris through its massage from the feet towards the upper body.
INFORMATION
INDICATIONS
Prevention of:
●Deep vein thrombosis (DVT)
●Chronic venous insufficiency
Treatment of:
●Lymphedema
●Athletic regeneration
●Edema resulting from trauma and sports injuries
SIDE EFFECTS
●Feel discomfort when the output pressure is too large
●Redness, itching or discomfort
●Discomfort and pain sensations during treatment with a pressure of 120 mmHg or greater
INTENDED USE
The product is indicated for use by medical professionals and patient at home, who are under medical supervision, reducing swelling
and preventing thrombosis in the lower extremities or treatment of truncal or arm breast cancer-related lymphedema. such as: Primary
lymphedema, edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema. The system
can be used in the home or hospital, using the object (patient) must be over 18 years old of adults.
EN

26
IMPORTANT SAFETY INSTRUCTIONS AND WARNINGS
lt is important that you read all the warnings and precautions in this manual. They are for your safety, to prevent injury and to prevent
damage to the unit.
●Do not use this device if you have a pacemaker, implanted defibrillator or other implanted metallic or electronic device. Such use
may result in electric shock, bums, electrical malfunction or death.
●Please read the instructions carefully before using the product.
●Keep these instructions near the appliance so that you can read them during use.
●To avoid hazards, ensure safety or prevent non-standard operation, the following are some details that the user should be aware
of when using the appliance.
●The unit is not suitable for use in the presence of a flammable anaesthetic mixture with air, with oxygen or nitrous oxide.
●The device is not intended for unsupervised use by patients who are incapable of consenting, mentally disturbed or suffering from
dementia.
●Repairs, maintenance and replacement of components must not be carried out during use and only by specialists authorised by the
manufacturer. In addition, there is a risk of loss of warranty.
●In case of general discomfort or pain during use, please discontinue use immediately.
●Do not allow water or other materials (e.g. nails, needles and other meta[ objects) to get inside the unit.
●lf the unit does not operate correctly, do not open, disassemble or modify the unit in any way as this may result in fire, electric shock
or other injury.
●When using for the first time, the application time should not exceed 5 minutes. For subsequent applications, the application duration
should be gradually increased according to the user's physical condition. Prolonged applications could cause undesirable side effects.
●The product should not be used by infants or young children.
●Keep the device out of the reach of children.
●Make sure that the plug and your hand are dry when plugging in and unplugging the power plug.
●Use the appliance only with single-phase 220-230V power. After use, you should
●unplug the appliance from the mains socket. Make sure to position the appliance so that you can easily pull out the power plug at any
time.
●Make sure that the power cable is not twisted or kinked and do not place heavy objects (e.g. table and chair legs) on it.
EN

27
•Use the unit only for the specified purpose.
•Do not use the unit on multiple sockets. Do not plug the power plug of this appliance into a socket with other appliances.
•Avoid shaking or dropping the unit during use or transport. Protect the unit from falls and shocks.
•Keep the unit and cuffs away from heat sources (e.g. radiators, cigarettes or direct sunlight) and use only at the intended operating
temperature. Use outside the intended operating temperature could cause damage, discolouration and deformation to the cuffs.
•Remain seated during use. With the cuffs on, keep your legs and arms still. Do not run with the cuffs on
•Do not use running water, oil, petrol, alcohol or other chemicals to clean the cuffs and the unit to avoid shortening the product life.
Only use a damp cloth to clean the cuff and textile cleaner if it is very dirty. To clean the unit, please use a dry cloth.
•Do not use the device naked. Wear underwear or trousers during use.
•Do not open the cuffs during use to avoid damaging the cuffs.
•When disposing of the device, cuffs, remote control battery or packaging, please follow local disposal guidelines and avoid environ-
mental pollution.
•lf the pressure sensor is damaged, loose or fails, the unit may malfunction. Please
•contact the manufacturer for inspection and maintenance.
•Keep the unit out of reach of pets.
•The unit should be placed so that the plug can be easily connected and disconnected from the power supply.
•Take care not to place heavy objects on cuffs, hoses and other accessories and not to twist or bend them, as this may cause damage to
the pressure sensor.
•lf the unit is not used for a long time or is used at low temperatures, the unit may not be usable. Allow the unit to inflate any cuff 3 to 4
times to the highest pressure level before use
WORKING PRINCIPLE
Compression therapy using compressed air is a therapeutic technique used in medical equipment that includes an air pump and inflatable
cuffs (gloves, boots, jacket, sleeves). During application, an inflatable cuff envelops the limb to be treated. The cuff is connected to the
pump via several pressure pipes. When the pump is activated, it fills the cuff's air chambers, in order to exert pressure on the tissues in
the limb, thereby displacing liquids such as blood and lymph from the pressurized area. A short time later, the pressure is reduced,
allowing increased blood flow back to the limb.
EN

APPLICATION
STEP 1: BEFORE USE
CONNECT AIR HOSES
Connect the set of hoses to the cuffs, starting with the dark gray
connector, and then plugging the other gray connectors onto the
appropriate counterparts.
Note: We recommend that you do not detach the connectors
afterward.
Note: For users of combination sets with leg cuffs and belly cuff;
the two long ends of the tube set correspond to the legs and the
short end to the belly.
Device Set-Up
Ensure that the device is securely placed. Also make sure that the device is free standing and not covered by a blanket, or similar. Do not
use the device in damp rooms or those with high humidity, such as in saunas or bathrooms.
Tightening Leg cuffs
To prevent contamination, we recommend wearing leggings or sweatpants when using the device. Empty your pockets before
application!
The zippers on the cuffs must be completely closed to avoid the cuffs from suddenly splitting open and causing possible damage.
After plugging it into the power plug, putting on the cuffs, and tightening the zipper, the Venen Engel application controls on the control
unit can be adjusted.
Information: Always make sure that the hoses are not kinked, and that you are not sitting on the hoses.
Attaching the Multi-plug
Plug the multi-plug into the front of the device as far
as it will go. Be sure to insert the multi-plug into the
device the right way (the small nippte into the small
hole).
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1
STEP 2: CONTROL UNIT OPERATION
Follow the order as shown:
Turn the device on.
Select the pressure (30-240 mmHg). Start with a low
setting. During the massage application, you may change
the pressure.
Select duration of up to 30 minutes (a maximum of 5 minutes the first
time, and then increase incrementally)
2
3
Remote Control Batteries
Before the initial use: Remove the battery protection and insert the battery (Type: CR2032; Diameter: 20mm, Height:
2.5mm, Voltage: 3V)!
Due to shipping policies, we are not allowed to provide a battery. We kindly ask for your understanding.
Warning: Keep the remote control and battery out of reach of children as there is a risk of suffocation.
29
1
2
3
EN

STEP 3: ENJOY THE MASSAGE
The leg cuff air chambers inflate one by one.This creates an optimal gliding pressure wave massage for a relaxed feeling in both legs.
Duration and pressure can be adjusted, even during the massage.
Massage programs:
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STEP 4: COMPLETION & DISMANTLING THE DEVICE
After the set time has elapsed, or after pressing the off switch, you can unplug the multi-plug from the device. lf you are not comfortable
during the massage, you can also end the massage at any time, as you wish. After that you may open the cuff. To vent the air from the air
cushions faster, after application, we recommend pushing the remaining air out of the cuffs with both hands, ensuring that the multi-plug is
removed.
After application, we recommend leaving the grey cufflink plugs attached to the cuff and simply removing the multi-plug from the device. For
storage, place the cuffs on top of each other and loosely roll them together with the attached hose set.
SCHRITT 5: CLEANING AND STORAGE
Cleaning
To clean the cuffs and the rest of the accessories, we recommend using a damp cloth. In case of heavy soiling, you can also use a gentle
textile cleaner. Before cleaning the cuffs, remove the hose plugs and always allow the cuffs to dry thoroughly. When used by different
people, we recommend disinfection of the cuffs, using a textile disinfectant spray. Use detergents and disinfectants free of oil, benzene,
alcohol, gasoline, and/or chemical agents. Do not wash the cuffs in a washing machine or under running water. Switch off the unit before
cleaning. Disinfectants such as Descosept pur or comparable products with a similar composition are suitable for disinfecting the cuffs.
Storage
Store the product at room temperature (minimum 10°c, maximum 40°() and in well-ventilated, dry, and dust-free spaces (minimum 30%,
maximum 85% relative humidity). Store the product in places free of frost, or it may damage the product.
Also be careful not to damage the cuffs during storage, especially if stored together with sharp objects such as scissors, or objects with
sharp edges.
For long-term storage, we recommend that you store the product in the packaging you bought it in.
31
EN

TROUBLESHOOTING
THE DEVICE DOES NOT TURN ON
lf the device does not turn on, please check (A) whether the power plug has been correctly plugged into the socket and/or whether the
device is turned on. lf the unit is still not turning on, unplug the power plug (B) and unscrew the fuse holder with the inscription "FUSE" on
the bottom of the unit (see picture on the left) completely (with a screwdriver or small coin) and check that the fuse inside is intact. (see
picture on the right)..
The fuse is located on the
bottom of the device Intact fuse: the wire in the fuse is undamaged.
(C) lf the fuse is intact, screw the fuse holder with the fuse back into the device completely. lf the fuse is damaged, replace the fuse with a
commercially-available fine fuse (TR); 3.15 A; 5 x 20 mm). You are also welcome to contact our customer service. (D) Note that the device
may only be powered by 220V power.
THE DEVICEIS PUMPING, BUT IT ONLY BLOWS ONE OR NONE OF THE TWO CUFFS
lf only one or neither of the two cuffs should inflate after starting the application, please check (A) whether the multi-plug is fully and
correctly inserted into the device. Also, make sure (B) that the air hoses are not kinked, for example, because you are sitting on the
hoses. Check (C) that the gray cuff plugs are all correctly attached to the cuff.
32 EN

MY VENEN ENGEL IS VERY LOUD
One should be able to talk or relax and chat with another person, without any issues, during the application. lf this is not the case, due to the
Venen Engel being too noisy, it is an indication that the transport screw on the bottom of the device has not yet been removed. Open the cover on
the bottom and remove the safety screw with the enclosed screwdriver. The screw is only used for securing the de vice during transport, and it can
subsequently be disposed of.
THE CUFFS ARE INFLATING IN THE WRONG ORDER
Make sure that the multi-plug is correctly inserted into the device. There is a small additional nipple, the multi-plug, which
must be inserted into the hole provided for this purpose. lf the multi-plug is inserted into the device the wrong way, the
multi-plug will be placed crooked.
YOU CAN HEAR AIR ESCAPING FROM THE DEVICE, HOSES ,OR CUFFS
(A) Check the hoses and plugs for damage.
(B) Check that the multi-plug is correctly plugged into the unit.
(C) Check if the hose is bent or has been pulled off.
33
EN

Instruction for Accessories
ATTACHING THE EXTENSIONFLOP PUTTING ON THE ARM CUFF
Step 1 Step 2
Step 4
Step 3
Velcrothe strap to the back of the cuff.
Pull the cuff onto your arm and makesure the end is sittingon your shoulder. Runthe strap
under yourother arm and attach it to the front of the cuff.
34 EN

COMBINING ACCESSORIES
lf you want to use other accessory cuffs, pay attention to the correct number of chambers in the cuff when buying. lf you
want to use several accessory cuffs at the same time, you can combine them as you like using the Quick Connectors. You
can find more information about this at help.venenengel.de.
DISPOSAL
Note that the product contains small amounts of lead. For this reason, please ensure that the disposal carried out by an official
electronic waste disposal service. important: Please do not dispose of the product via your general household waste disposal.
Alternatively: we are happy to take care of the disposal of your old Venen Engel free of charge. Just send it to:
Wellcosan GmbH
Bellinger Tor 16a
36396 Steinau a. d. Str.
Germany
Please enclose a note with a request for disposal.
PLACEMENT OF THE ABDOMEN CUFF
Apply so that it sits in a direct transition to the leg cuffs (top leg cuff bumps to the bottom chamber of the abdominal cuff;
"side by side"). Tip: First put on the leg cuffs. Then lay the belly cuff flat behind you on the floor, lounger, or sofa (inside
part facing up). Slowly lie down onto the stomach cuff, on your back. After pulling the abdominal cuff to the right height,
close it over your stomach.
35
EN

TECHNICAL DETAILS
Pump output 40l / Min.
Fuse T 0,315 A H
Controller Dimensions 28x28x15 cm
Protection Class II /
Temperature range
(use and storage) 10-40 °C
Humidity
(relative, use and storage) 30-85%
Programmes 1
Number of chambers 4
Weight ca. 3 kg
Power output 30 W
Mains Frequency 50-60 Hz
Voltage 220-240 V
Programme Length up to 30 Min.
Pressure 30-240 mmHg
36 EN

PACKAGE CONTENTS
Control unit Multi-Plug air hose set
Compression boots
The scope of delivery of the
boots depends on the set
purchased
Power plug
37
EN

Directive 2002/96/EG on
electrical and electronic waste:
separate collection of electrical
and electronic equipment
EXPLANATION OF SYMBOLS USED
Press the button with this
symbol to start and pause the
application.
Press the button with this
symbol to switch on the unit.
Only use in enclosed rooms
Protection class II: This icon
indicates that the device has an
electrical earthing connection
(dimension) not needed.
Compliant with the directives of
the European Union
Collaboration of a nominated
agency; Directive 93/42/EEC
Serial number
Lot number
Attention: Please pay
attention to this important
information regarding
health risks
European
plenipotentiary
Operate only in
temperature
range+10°C to 40°C
Non-sterile
IP21 Protect from medium-sized
solid foreign bodies
(diameter >12 mm) and
against perpendicular-
dripping water
Manufacturer’s
symbol
Date of manufacture
Certified medical
device
Follow the
instructions for use
Caution additional
information Note - take
note of information
Reference number on the
packaging: Protect against
liquids and moisture
Operate only in barometric
pressure range from
500hPa to 1060hPa
Operate only in a humidity
range 30% to 85%.
Keep away from
sunlight.
38 EN

IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY
(EMC)
1) This product needs special precautions regarding EMC and needs to be installed and put into service according to the
EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
1) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect
operation of the unit.
1) Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
1) Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked
use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be
used Guidance and manufacturer's declaration -electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device sho
uld
assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment
-guidance
RF emissions CISPR 11
Group 1
The device 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.
RF emission CISPR 11
Harmonie emissions
IEC 61000
-3-2
Voltage fluctuations / flicker
emissions IEC 61000
-3-3
Class B
Class A
Complies
The device is suitable for use in all establishments, including domestic
establishments and those directly connected to
the public low
-voltage power supply network that supplies buildings
used for domestic purposes.
39
EN

Guidance and manufacturer's declaration -electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device sho
uld
assure that it is
used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment
-guidance
Electrostatic
discharge (ESD)
IEC
61000-4-2
±
8 kV contact
±
15 kV air
±
8 kV
contact
±15 kV air
Floors should be wood, concrete or ceramic tile. lf
floor are covered with synthetic materi
- al, the
relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000
-4-4
±
2 kV for power supply lines
±
2kV for power
supply lines
Mains
power quality should be that of a typical
commercial
or hospital environment.
Surge IEC 61000
-4-5
±
1 kV line(s) to line(s)
±
1 kV
differential mode
Mains
power quality should be that of a typical
commercial
or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines IEC 61000
-4-
11
<5% UT (>95% dip
in UT) for 0.5 cycle 40% UT (60%
dip
in UT) for 5 cycles 70%UT(30%
dip in UT) for 25 cycles <5% UT
(>95% dip in UT) for 5 sec
<5% UT (>95%
dip in UT) for
0.5 cycle 40% UT
(60% dip in UT) for 5
cycles 70% UT (30%
dip in UT) for25
cycles <5% UT
(>950/odip in UT) for 5
sec
Mains power quality should be that of a typical
commercial
or hospital environment. lf the user of the DEVICE
requires continued operation during power mains
interruptions,
it is recommended that the DEVICE be powered
from an uninterruptible power supply or a
battery.
Power frequency (50Hz/60Hz)
magnetic field IEC 61000
-4-8
l0V/m
l0V/m
Power frequency magnetic field should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Note: Ur is the AC mains voltage prior to application of the test level.
40 EN

Guidance and manufacturer's declaration -electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device sho
uld assure that it
is used in such an environment.
Immunity test IEC 60601
test tevel
Compliance level Electromagnetic environment -guidance
Radiated RF IEC 61000
-4-3
lOV/m & table 9
l0V/m & table 9
Portable and mobile RF communications
equipment should be used no closer to any part
of the Device
, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter
.
Recommended separation distance
d = 1.167
80 MHz to 800 MHz
d = 2
.333 800 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey
,should
be less than the compliance level
in each frequency range. 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.
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. lf the measured field strength in the location in which the Device is
used exceeds the applicable RF compliance level above, the Device should be observed to verify normal operation. If normal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Device. b Over the frequency range 150 kHz to 80 MHz,
field strengths should be less than [Vii V/m].
41
EN

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment (Table 9)
Test frequency
(MHz)
Band
•1 (MHz)
Service
•1
Modulation
bl
Maximum
power (W)
Distance (m)
immunity Test Level
(V
/m)
385
380
-390
TETRA400
Pulse modulation
bl
18Hz
1.8
0.3
27
450
430
-470
GMRS460
, FRS 460
FM
'1±
SkHz deviation !kHz sine
2
0.3
28
710
745
780
704
-787
LTE Band 13, 17
Pulse mod
- ulationbl
217Hz
0.2
0.3
9
810
870
930
800
-960
GSM800
/900, TETRA 800,
iDEN 820, CDMA850,
LTE Band 5
Pulse modulation
bl
18Hz
2
0.3
28
1720
1845
1700
-1990
GSM1800
; CDMA 1900;
Pulse modulation
bl
2
0.3
28
1970
GSM 1900;
DECT
; LTE
Band 1,3,
4,25; UMTS
217Hz
2450
2400
-2570
Bluetooth
, WLAN,
802
.11 b/g/n, RFID 2450,
LTE Band 7
Pulse
modulation bl
217
Hz
2
0
.3
28
5240
5500
5785
5100
-5800
WLAN 802.11
a
/n
Pulse
modulation bl
217
Hz
0.2
0
.3
9
NOTE: lf necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or
ME SYSTEM
may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000
-4-3.
a)For some services, only the uplink frequencies are included.
b)The carrier shall be modulated using a SO% duty cycle square wave signal.
c)
As an alternative to FM modulation, SO% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it
would be the worst case
.
42 EN