Aircast VenaGo User manual

VenaGo™
AT-HOME CARE.
IN-HOSPITAL TECHNOLOGY
OPERATING MANUAL
EDITION V1.0
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PRACTITIONER
Only
READ THE MANUAL BEFORE OPERATING THIS PRODUCT
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TABLE OF CONTENTS
Introduction............................................................................................................................................................................. 3
Indications for Use ............................................................................................................................................................... 3
Safety Warning...................................................................................................................................................................... 3
Contraindications.................................................................................................................................................................. 3
Warnings and recautions.................................................................................................................................................. 3
Condition of Working, Storage and Transportation .............................................................................................. 3
Symbol Interpretation........................................................................................................................................................ 3
Electromagnetic Compatibility........................................................................................................................................4
Product Specifications....................................................................................................................................................... 6
Operating Instructions ...................................................................................................................................................... 6
Cleaning and Disinfecting .................................................................................................................................................7
Troubleshooting ....................................................................................................................................................................7
Maintenance and Disposal................................................................................................................................................7
Warranty ...................................................................................................................................................................................7
Contact Information............................................................................................................................................................. 8
INDICATIONS FOR USE
The VenaGo is intended to be an easy to use portable system, prescribed
by a physician, for use in the home or clinical setting to help prevent the
onset of DVT in patients by stimulating blood flow in the extremities
(simulating muscle contractions). This device can be used to:
• Aid in the prevention of DVT;
• Enhance blood circulation;
• Diminish post-operative pain and swelling;
• Aid in the treatment and healing of: stasis dermatitis, venous stasis
ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency
and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by
persons expecting to be stationary for long periods of time. This is
accomplished by an electronically controlled pump delivering a preset
amount of air to the leg cuffs that, in turn, compress the calf to aid blood
flow out of the lower extremities.
SAFETY WARNING
CONTRAINDICATIONS
The device MUST NOT be used to treat the following conditions:
• Persons with suspected, active or untreated: deep vein thrombosis,
ischemic vascular disease, severe arteriosclerosis, pulmonary
edema, severe congestive heart failure, thrombophlebitis, or an
active infection.
• On the legs where cuffs would interfere with the following
conditions: vein ligation, gangrene, dermatitis, open wounds, a
recent skin graft, massive edema or extreme deformity of the leg.
• On any neuropathy.
• On extremities that are insensitive to pain.
• Where increased venous or lymphatic return is undesirable.
CONDITION OF WORKING, STORAGE
AND TRANSPORTATION
• Normal working ambient temperature: 5~40°C
• Normal working ambient humidity: 15~90%
• Store and transport ambient temperature: -25~70°C
• Store and transport ambient humidity: 0~90%
• Atmospheric pressure: 70~106kPa
SYMBOL INTERPRETATION
Information essential for proper use shall be indicated by using the
corresponding symbols. The following symbols may be seen on the
device and labeling.
WARNINGS AND PRECAUTIONS
• The device wraps are designed for single patient use only.
• Medical Electrical Equipment needs special precautions regarding
EMC. Portable and mobile RF Communications Equipment can be
affected by other Medical Electrical Devices.
• Wraps used in combination with warming device may cause skin
irritation. Regular check for patent compliance, discomfort, and skin
irritation.
• To prevent extremity compartment syndrome, special attention
should be given to patients who are positioned in the supine
lithotomy position for extended lengths of time. This includes
patients with or without wraps.
• Do not open or remove covers. No user serviceable parts inside.
Direct all unit issues to the manufacturer or seller.
• If pulsations or throbbing occur, the wrap may be wrapped too
tightly. Loosen Immediately.
• Stop using device if swelling occurs; consult a Physician.
• Device is to be used only by the patient prescribed, and only for its
intended use.
• Ensure the device is turn off and unplugged from the wall outlet
prior to and while cleaning or disinfecting.
• Equipment should not be used in the presence of any flammable
anesthetic mixture with air, oxygen, or nitrous oxide.
• Do not immerse in any liquid for any reason.
• Do not operate device in a wet environment.
• Allow wraps to warm to room temperature if exposed to
temperatures below 5 oC (41oF).
• Do not subject the device to extreme shocks, such as dropping the
device.
• Do not place any items in an autoclave.
• Operation of this device can be done by the patient.
• No Service is to be attempted while the device is in use.
• This device is NOT to be altered or modified.
SYMBOL TITLE
ON/OFF button
Refer to instructions for use
IP code of the device
Unrecyclable
This way up
Date of manufacture
Batch code
Serial number
Manufacturer
Type BF applied part
Symbol for “AUTHORISED REPRESENTATIVE IN
THE EUROPEAN COMMUNITY”
Fragile, handle with care
Keep the product in the dry place
Away from water and rain.
Product packaging is able to be recycled
LOT
SN
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ELECTROMAGNETIC COMPATIBILITY
Warning: Don’t use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of
EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use
is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than
12 in (30 cm) to any part of the equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the
excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity.
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 should 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 Class B
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.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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 should 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. If floor is covered with
synthetic material, the relative humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
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)
± 2 kV line(s) to earth
±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)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality should be that of a typical commercial or hospital
environment. If 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
30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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 should assure that it is used
in such an environment.
IMMUNITY TEST IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
3 Vrms
10 V/m
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 = 1,2√p
d = 1,2√p 80 MHz to 800 MHz
d = 2,3√p 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,a 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.
A. 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. If 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 abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE DEVICE.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 KHZ TO 80 MHZ 80 MHZ TO 800 MHZ 800 MHZ TO 2.5 GHZ
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.
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PRODUCT SPECIFICATIONS
ACCESSORIES INCLUDED IN THE PACKAGE.
1. Device * 1 pair
2. Manual *1 piece
3. IEC 60601-1 compliant Charger *1 piece (Input: AC100-240V, output: DC5.0V--1A)
Model/type VenaGo Weight 378g±20g
Power supply Powered by internal 3.7V li-ion battery Degree of protection
against electric shock Type BF applied part
Leg Pressure 0--50mmHg Type of protection against
electric shock Class � and built-in battery
Warranty 1 year Grade of waterproof IP22
Recommend
Treatment time prescribed by a physician Software version A0
Modes 1 auto mode Mode of operation Continuous operation
The time required for me
equipment to warm from
the minimum storage
temperature between
uses until it is ready for
intended use
30 minutes
The time required for me
equipment to cool from
the maximum storage
temperature between
uses until it is ready for
intended use
15 minutes
Typical service
life of Battery 300 times of recharging Adapter for charging Please use the adapter of output DC5V and 1A for charging
Note: Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT
TECHNICAL INFORMATION
OPERATING INSTRUCTIONS
ON/OFF button
Light Indicator
Battery Indicator
Alarm Indicator
INSTRUCTION
WRAP APPLICATION
Wrap the device-operated wrap around your calf and secure the Velcro to
hold it in place. Make sure the wrap is snug, but not too tight. When both
wraps are secured on your legs, they should look like the picture blow. Note:
The wrap may be placed directly against the skin or over a light dressing.
POWER ON
Hold the On/Off button for approximately 1.5 seconds to turn on the device:
The buzzer will sound once when the device is powered on, the digital
display shows the accumulated working time for 2 seconds, and the green
indicator under the ON/OFF button power lights up (when the battery is low,
the light indicator is changed to orange).
ALARM
Low battery voltage: When the battery voltage is severely low (3.3V), the
device stops working, the red light under the ON/OFF button keeps flashing
quickly, the digital display shows “LO”, and the buzzer keeps beeping for 10
seconds. Afterward, the device turns off automatically.
Low pressure and air leakage: When the inflation time exceeds
approximately 21 seconds and the inflated air pressure has not reached
50mmHg, the device stops working, the red light under the ON/OFF button
keeps flashing quickly, the display shows “LP”, and the buzzer keeps
beeping for 10 seconds. Afterward, the device automatically shuts down.
USE DATA (By Prescribing Physician Only)
The device use time in hour(s) may be viewed directly on the digital display
of the device. In addition, the prescribing physician may track the device
use hours on the computer: Connect the data transfer cable provided
separately to the computer and the device, and then wait for the computer
to read the use data. When the data cable is connected between the device
and computer, the green light under the ON/OFF button of the device keeps
flashing slowly, and the digital display of device shows “CO” (CO represents
Connection, which means successful connection). The prescribing
physician can download the device use time unidirectionally into Microsoft
Excel via the data cable provided separately. There are no bidirectional
communications supported by this data cable.
POWER OFF
Hold the On/Off button for approximately 1.5 seconds to turn off the device:
The buzzer will sound twice when the device is shut down, the digital display
turns off, and the light indicator under the ON/OFF button turns off.
WORKING MODE
After turned on, the device first displays the accumulated working time for
2 seconds. Afterward, the device starts inflating, and meanwhile the display
shows the real-time inflation pressure in order of 00-10-20-30-40-50.
After reaching the maximum pressure of 50mmHg, the device remains at
50mmHg for 0-4 seconds and then starts deflating. During deflation, the
display of pressure is changed from “50” to “00”, and keeps flashing until
the next cycle starts (Note: A complete circle of inflation, deflation, and rest
takes approximately 60 seconds).
CHARGE/DISCHARGE
The green light under the On/Off button will keep flashing when the device
is being charged, and become solid when the device is fully charged.
Note:
1. The device can work normally during the period of charging. Use only
the charger provided by DJO, LLC. The use of the wrong charger can
cause damage and even danger to the device and patient.
2. The light color under the ON/OFF button of the turned-on device is
used to represent the battery level of the device: The green light means
the device is fully charged or has sufficient power; the light will turn to
orange when the battery is consumed to the medium level; when the
battery level is low, the red light will appear.
3. When the battery power drops below a critical level, the red light under
the ON/OFF button keeps flashing quickly. Meanwhile, the device stops
working, the digital display shows “LO”, and the buzzer keeps beeping
for 10 seconds. Unless the device is connected to the charger within 10
seconds, the device turns off automatically.
CLEANING AND DISINFECTING
NOTE: Inspect the device and follow the cleaning and disinfecting
procedures prior to each use.
WARNING: Device must be turned off and disconnected from the wall
outlet prior to and during cleaning or disinfecting.
DO NOT IMMERSE DEVICE IN ANY LIQUID FOR ANY REASON.
Clean the outer surface of the device using a soft cloth, moistened with
soapy water or 70% isopropyl alcohol.
Do not use abrasive or volatile cleaners.
Do not place the device and wraps in dryer or microwave.
NEVER remove the device from the wrap.
Hand wash the exterior of the wraps using a soft cloth, moistened with
soapy water or 70% isopropyl alcohol and let air dry.
To ensure the device is completely dry prior to use, leave the device in
the OFF condition and disconnected from the wall outlet for at least 30
minutes after cleaning or disinfecting.
MAINTENANCE AND DISPOSAL
The device contains no serviceable parts. Direct all device issues to the
manufacturer or seller at [phone].
Inspect the device and all components for any damage that may have
occurred prior to each use (for example, frayed or cut charging cord,
cracked plastic housings, torn wraps, etc). Refer to this manual for
description of all components.
Do not attempt to connect the wall supply if any damage is noticed.
Avoid subjecting the device to shocks, such as dropping the device.
Do not handle the wrap that contains air bladders with any sharp
objects. If the air bladder is punctured or you notice a leak, do not
attempt to repair the device or wrap. Replacement devices are available
through customer service.
Avoid folding or creasing the air bladder during use and transportation
of the device. Battery is not replaceable; replacement devices are
available through customer service. Contact the manufacturer or seller
to receive replacement instructions for any damaged item.
This device is an electromechanical device that includes printed circuit
boards and rechargeable batteries. Dispose of the battery-containing
device according to the local, state, or federal laws. Do not discard in
landfill. Do not discard the device in regular waste.
TROUBLESHOOTING
If your device is not operating properly, please check below for the
common problems and suggested solutions. If the recommended action
does not solve the problem, please contact the seller.
PROBLEM POSSIBLE CAUSE SOLUTION
The skin turns red or
the skin feels irritated
The use time may be
too long Reduce the use time
No display shown
on the device
The battery capacity
is depleted Charge the battery
Power cuts off
during use The battery runs out Charge the battery
WARRANTY
This device carries a limited warranty of one year from the date of
delivery. The warranty applies to the device only, and the accessories
are not covered by this warranty.
During the warranty period, defective items will be repaired or replaced
at no charge. Any evidence of misuse, abuse, alternations, or externally
caused damage may have this warranty invalid.
For more information, please contact the manufacturer or seller.
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CONTACT INFORMATION
Manufactured by DJO, LLC
1430 Decision Street
Vista CA, 92081
United States
Customer Care: 1-800-336-6569
Product Support: 1-888-405-3251
T 800.336.6569 F 800.936.6569
2900 Lake Vista Drive I Lewisville, TX 75067 I U.S.A.
djolobal.com/aircast
Copyright © 2021 by DJO, LLC
MKT00-10811 Rev A
Individual results may vary. Neither DJO, LLC nor any of its subsidiaries dispense medical advice. The contents of
this document do not constitute medical, legal, or any other type of professional advice. Rather, please consult your
healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.
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