Ortho8 vera one 08-0042 User manual

Instructions for Use
Customer Support: [phone] • [e-mail] • www.Ortho8.com •
Ortho8 Inc., 2217 Plaza Drive, Rocklin, CA 95765
Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner
Model No. 08-0042, 08-0043, 08-0044, 07-0013-01 • ©2021 Ortho8 Inc.
Document #IFU - VenaOne 04-0019 Rev D June 2022
DVT Compression System
No Tubes
or Cords

2
Table of Contents
VENAONE OVERVIEW
CONTRAINDICATIONS
FEATURES AND BENEFITS
SYMBOLS
SYSTEM CONTENTS
BATTERY INDICATOR & CHARGING
APPLICATION INSTRUCTIONS
PUMP ALARM LEGEND
DEVICE HANDLING
CLEANING AND DISINFECTING
DISPOSAL
USER MAINTENANCE
STORAGE
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES
TECHNICAL DATA
WARNINGS
CAUTIONS
3
3
4
4
5
6
7
8
9
9
10
10
10
11
11
12
12

3
VENAONE OVERVIEW
Pneumatic compression is a clinically proven modality for reducing the risks associated with deep vein
thrombosis. 1 VenaOne is a tubeless, portable, lightweight and battery-operated DVT compression system
designed specically for the acute-care setting. VenaOne aids in the prevention of DVT by helping to
stimulate blood ow in the legs. The pump inates each leg cuff to a preset pressure of 55 mmHg and
deates once the pressure is reached. Then the cycle repeats. Internal rechargeable batteries allow the
VenaOne to be completely portable, thus preventing interruptions in treatment.
INDICATIONS FOR USE
VenaOne aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and
swelling, reduces wound healing time, and aids in the treatment and healing of: stasis dermatitis, venous
stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufciency, and reduction of edema edema in
the lower limbs.
.
CONTRAINDICATIONS
The VenaOne Vascular Therapy System 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.
1. Labropoulos N, OH D.S, Golts, E, et al: Improved Venous Return By Elliptical, Sequential and Seamless Air-cell
Compression. Loyola University Medical Center, January 2003.
INFLATION/DEFLATION CYCLE
When the device is powered on, the audible alarm beeps twice, the LED display
illuminates, and the battery icon stays on (refer to the battery indicator section for
battery life expectancy).
The devices apply compression to the legs in cycles. During each cycle, the device
inates the cuff to 55 mmHg in about 6 to 8 seconds, holds the pressure for about 4
seconds, then releases the pressure and rests for about 50 seconds. Then the cycle
repeats.

4
Portable
Fully ambulatory and simple design.
Easy One-Touch Operation
Controls all functions with just the power button.
Infection Control
Device is designed to help reduce bacterial
transfer and subsequent contamination.
No External Tubes or Cords
The tubeless, cordless design helps mitigate
tripping hazards and facilitates patient mobility.
Symbols
Features & Benets
Class II medical electricalequipment
Warning or Caution
Battery operated
The use of accessories, power supplies and cables
components sold bythe manufacturer of the Ortho 8 Inc.
as replacement parts, may result in increased
emissions or decreased immunity of the Ortho 8 Inc.
Refer to Instruction Manual/Booklet
Temperature range
Atmospheric pressure range
Not made with naturalrubber latex
single patient use. Use on more than one
patient may cause cross-contamination.
Waste ofelectrical and electronic equipment
must not be disposed as unsorted municipal
waste and must be collected separately.
Contact an authorized representative of the
manufacturer for information concerning the
decommissioning of your equipment.
This symboldesignates the degree of
protection against electrical shock from the
wrap as being a type BF applied part
Keep dry
No Scissors
Power Supply
Humidity range
Manufacturer with 4-digit year of
manufacture printed underneath
System failure
System failure reset
End of life indicator
Power button
Battery indicator
Idle pulse between
compression cycles
Low pressure indicator
High pressure indicator
Batteryevent
proper USB Connection.”
Battery low
Lightweight
Weighs less than a pound.
Battery Operated
~24 hour battery life allows for ease of use and
patient compliance.
Compression
Provides asymmetric compression at 55 mmHg.

5
Warning: ONLY USE WRAP(S) PROVIDED BY PRECISION MEDICAL PRODUCTS
VenaOne Wraps
Charging Port
LED Display
Power Button
Data Port
System Contents
08-0042
08-0043
Charging Station
08-0044
07-0013-01
VenaOne Single Device (No AC adapter/
charger included.
VenaOne, Bulk Pack, Case of 20
VenaOne, Replacement Device
Charging Station (2)
Systems are packaged in singles
or cases of 20. However, in most
cases, unless the provider instructs
otherwise, VenaOne is used on both
legs.

6
Battery Indicator & Charging
Battery icon: Remains illuminated at all times during operation
Solid Green all three Bars: 100% battery life remaining
Solid Green Two Bars: 31% to 60% battery life remaining, third bar pulses until fully charged.
Solid Green One Bar: 30% battery life remaining, second and third bar pulses alternately until
31% charged.
Solid Yellow One Bar: Battery will last 30 minutes or less. Alarm ONE (refer to page 9 for
alarm description) sounds three times every two minutes, and simultaneously “BL” quickly ashes
on the LED display three times every two minutes.
Flashing RED One Bar: Battery will last ve minutes or less. “BL” quickly ashes on the LED
display until the auto shut down or the device(s) are connected to the power supply. Alarm ONE
(refer to page 9 for alarm description) sounds three times every ten seconds.
USING THE AC ADAPTER/BATTERY
CHARGER
Insert the power supply plug into the port(s) at the bottom end
of each device and connect the power supply adapter to the
wall socket. The battery indicator icon on the LED Display will
illuminate three ashing green bars and provide the current
charge status. Once the device is fully charged, all three bars will
be solid green. The AC adapter can be connected while the device
is in use.

7
REMOVE THE DEVICES
Remove the devices from the plastic
packaging. Note: the devices will come in
separate packaging.
PLACE THE DEVICE IN THE WRAP
The device and bladder will slide to the
bottom of the wrap.
CALF WRAP APPLICATION
Apply the wrap around the calf and secure the
Velcro to hold it in place. Make sure the wrap
is snug, but not too tight. When one or both
wrap(s) are secured on the leg(s), the device(s)
are ready for operation.
SEALING THE WRAP(S)
Once the device is placed inside the cuff,
peel off the backing on the adhesive strip.
Then simply fold over and press to seal the
wrap.
USING THE DEVICE
The device will make a quiet “humming” sound when
inating to pressure. This is normal. The wraps inate
once each minute during use.
TURNING THE DEVICE ON OR OFF
To turn the device on or off, press the power button three
times.
1 2
4
5
Application Instructions
3

8
Pump Alarm Legend
High Pressure “HP” In the unlikely event the device applies higher pressures than normal, a
high pressure (HP) alarm will display. Power off and restart the system. If alarm persists, remove from
service and replace.
Low Pressure “LP” In the unlikely event the device applies lower pressures than normal, a low
pressure (LP) alarm will display. Power off and restart the system. If alarm persists, remove from
service and replace.
Battery Low “BL” When the battery is running low, a BL alarm will display. Replace battery as
needed per the battery indicator. See Battery Indicator section for more information.
System Failure “SF” If a system failure (SF) occurs, remove the device from service and replace.
TO SILENCE ALARM: Press and hold POWER BUTTON FOR ONE SECOND, without turning
OFF the device.
If the device is turned on after an alarm event, the LED displays the previous alarm.

9
DO NOT DISPOSE OF THE DEVICE
DISPOSE OF THE WRAP ONLY
All contaminated products or accessories should be disposed of appropriately according to
hospital policy and state law, taking environmental factors into consideration.
When use is completed, or the patient is discharged, remove the device, and discard only the
wraps.
DO NOT USE SCISSORS
DO NOT USE ANY SHARP OBJECTS NEAR THE BLADDER.
There is a perforated section at the top of the wrap designed to open the seal easily.
CLEANING AND DISINFECTING
NOTE: Inspect the VenaOne device and follow the cleaning and disinfecting procedures prior to
each use. The device is intended for multiple patient use.
WARNING: Device must be turned off and disconnected from the wall outlet prior to and during
cleaning or disinfecting and for storage between uses. See Storage section for instructions on
proper storage.
DEVICE CLEANING
DO NOT IMMERSE DEVICE IN ANY LIQUID FOR ANY REASON
Do not use abrasive or volatile cleaners.
NEVER remove the bladder from the device.
The device can be cleaned with a soft cloth dampened with soapy water or a mild detergent. To
sanitize the device, apply cleaning agents with a soft cloth, moistened with 70% isopropyl alcohol.
Avoid excessive spraying, especially in the areas of the connection ports on the top and bottom of
the device. If any liquid enters the ports, then internal component damage may occur.
The VenaOne DVT compression system cannot be effectively sterilized by liquid immersion,
autoclaving, or ETO sterilization, as irreparable damage to the system will occur.
To ensure the device is completely dry prior to use, leave the device powered off and disconnected
from the wall outlet for 30 minutes after cleaning or disinfecting.
USER MAINTENANCE
The device contains no serviceable parts. For more information, contact your local sales
representative.
Inspect the device and all components for any damage that may have occurred during shipping
or general handling prior to each use. For example: frayed or cut charging cord, cracked plastic
housing, torn cuff(s) or bladder(s), etc. Refer to the image of VenaOne for the description of all
components.
Do not attempt to connect to a battery charger if any damage is noticed. Avoid subjecting the
devices to shocks, such as dropping the pumps.
Device Handling

10
Do not handle the leg cuffs with any sharp objects. If a bladder is punctured or you notice a leak,
do not attempt to repair the device or cuffs.
Replacement devices will be made available to you by your local sales representative.
Avoid folding or creasing the bladder during the use and transportation of the devices.
This device is not protected against water.
STORAGE AND TRANSPORTATION
Store in a dry location between -25C (-13F) and+70C (158F).
Relative Humidity: 15% to 93%
Atmospheric Pressure: 525mmHg to 795mmHg
Do not store items in direct sunlight.
DEVICE DISPOSAL
This device is an electromechanical device that includes printed circuit boards and rechargeable
batteries.
Do not discard in landlls. Consult local country requirements for proper disposal instructions.
LATEX INFORMATION
All components of the VenaOne Vascular Therapy System are latex-free. All VenaOne wraps are
latex-free and may be placed directly against the skin or over a light compression dressing.
LITHIUM-ION BATTERY MAINTENANCE GUIDELINES
OVERVIEW
Do not leave batteries unused for extended periods of time because Lithium-Ion batteries continue
to slowly discharge (self-discharge) when not in use or while in storage. The typical estimated life
of a Lithium-Ion battery is about two to three years or 300 to 500 charge cycles, whichever occurs
rst. One charge cycle is a period of use from fully charged to fully discharged and fully recharged
again. For batteries that do not run through complete charge cycles, there is a two to three-year
life expectancy. Rechargeable Lithium-Ion batteries have a limited life and will gradually lose their
capacity to hold a charge. This loss of capacity (aging) is irreversible. As the battery loses capacity,
the length of time it will power the product (run time) decreases.
BATTERY MAINTENANCE
Always follow the charging instructions provided in your Operator’s manual.
CHARGING
Always follow the charging instructions provided in your Operator’s manual.
See battery charging accessories and instructions on page 7.

11
EMC GUIDANCE
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 specied 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 specied by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
TECHNICAL DESCRIPTION
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 EMISSIONS
The VenaOne is intended for use in the electromagnetic environment specied below. The customer or the user of the VenaOne
should assure that it is used in such an environment.
EMISSIONS TEST Compliance ELECTROMAGNETIC ENVIRONMENT GUIDANCE
RF Emissions CISPR 11 Group 1
The VenaOne 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 Emissions CISPR 11 Class B
The VenaOne 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 VenaOne is intended for use in the electromagnetic environment specied below. The customer or the user of the VenaOne should assure
that it is used in such an environment.
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
)
for 0,5 cycle
40% U
T
(60% dip in U
T
) for
5 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95% dip in U
T
)
for 0,5 cycle
40% U
T
(60% dip in U
T
) for
5 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
Electrical Fast
Transient/Burst
I EC 61000-4-4
Power Frequency
(50/60Hz) Magnetic
Fields
I EC 61000-4-8
Floors should be wood, concrete or ceramic tile. If oors are covered
with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or
hospital environment.
Mains power quality should be that of a typical commercial or
hospital environment.
Power frequency magnetic elds should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the Circl8 One requires
continued operation during power mains interruptions, it is
recommended that the Circl8 One be powered from an uninterrupted
power supply or a battery.
+6kV contact
+8kV air
3 A/m 3 A/m
+1kV differential mode
+2kV air common mode
+2kV for power supply lines
+1kV for input output /lines
+6kV contact
+8kV air
+1kV differential mode
+2kV common mode
+1kV differential mode
+2kV common mode
IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE

12
Conducted RF
IEC 61000-4-6
Portable and mobile RF communications equipment should be used no closer to any part of the VenaOne
including cables, than the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
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 xed RF transmitters as determined by an electromagnetic site survey,a should be less
than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following symbol:
d = 150 KHz to 80 MHz
d = 80 MHz to 800 MHz
d = 80 MHz to 800 MHz
3Vrms
150 kHz to 80
MHz
3V
Immunity Test IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE
Separation distance according to frequency of transmitter m
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE VENAONE
Radiated RF
IEC 61000-4-6
Rated maximum
output power of
transmitter
w
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
150 KHz to 80 MHz
d = d = d =
80 MHz to 800 MHz 800 MHz to 2,5 GHz
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 reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-
cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic
site survey should be considered. If the measured eld strength in the location in which the VenaOne e is used exceeds the applicable RF compliance level above,
the VenaOne should be observed tc verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the VenaOne .
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [V1] V /m.
The VenaOne is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VenaOne can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VenaOne as
recommended below, according to the maximum output power of the communications equipment.
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 reection from structures, objects and people.
The VenaOne is intended for use in the electromagnetic environment specied below. The customer or the user of the VenaOne should assure that it is
used in such an environment.
3V/m
80 MHz to
2,5 GHz
3V/m 3,5
V1
P
3,5
V1
P
3,5
E1
P
3,5
E1
P
7
E1
P
7
E1
P

13
WARNINGS
CAUTIONS
• The VenaOne wraps are designed for single
patient use only.
• The device is to be used only by the patient
prescribed, and only for its intended use.
• To avoid tripping or falling, do not walk with
cuffs on your legs while the device is charging.
• Keep this device out of the reach of children and
away from household pets and pests.
• The VenaOne is a standalone device that uses a
VenaOne AC Adapter and Battery Charger only
(see Using the AC Adapter and Battery Charger
section). It is not to be used or interconnected to
any other device.
• Do not open or remove covers. No user-
serviceable parts inside. Direct all device issues
to your local Customer Service representative.
• If you experience pain, swelling, sensation
changes, or any unusual reactions (including
allergic reactions to the materials used in this
device) while using this device, stop using this
device and consult your medical professional
immediately.
• If pulsations or throbbing occur, the cuff may be
wrapped too tightly. Loosen Immediately.
• The device is designed to comply with
electromagnetic safety standards. This
equipment generates, uses, and can radiate
• Medical Electrical Equipment needs special
precautions regarding EMC. Portable and mobile
RF communication equipment can be affected
by other medical electrical devices. If you
believe interference is occurring, please consult
Electromagnetic Compatibility (EMC) section.
• 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 cuffs.
• Cuffs used in combination with warming devices
may cause skin irritation. Regularly check
for patient discomfort, compliance, and skin
irritation.
• Allow cuffs to warm to room temperature if
exposed to temperatures below 5C (41F).
• Do not immerse in any liquid for any reason.
• Do not operate device in a wet environment.
• Equipment should be used in a lint-free and
dust-free environment.
radio frequency energy and, if not installed and used
in accordance with 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. Harmful interference to
other devices can be determined by turning this
equipment on and off. Try to correct the interference
using one or more of the following:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Consult your local Customer Service
representative for help
• Care must be taken when operating this equipment
around other equipment to avoid reciprocal
interference. Potential electromagnetic or other
interference could occur to this or to the other
equipment. Try to minimize this interference by
not using other equipment in conjunction with this
device.
• Ensure the pump control device is turned off and
unplugged from the wall outlet prior to and while
cleaning or disinfecting.
• Do not place any items in an autoclave.
• No Service is to be attempted while the device is in
use.
• This device is NOT to be altered or modied.
• Contains no user serviceable parts. Contact your
local Customer Service representative.
• Do not subject the device to extreme shocks, such as
dropping the pump.
• Do not disassemble, crush, or puncture a battery.
• Do not short the external contacts on a battery.
• Do not dispose of a battery in re or water.
• Do not expose a battery to temperatures above 60
°C (140 °F).
• Keep the battery away from children.
• Avoid exposing the battery to excessive shock or
vibration.
• Do not use a damaged battery.
• If a battery pack has leaking uids, do not touch any
uids.
• Properly dispose of a leaking battery pack.
• In case of eye contact with uid, do not rub eyes.
Immediately ush eyes thoroughly with water for at
least 15 minutes, lifting upper and lower lids, until no
evidence of the uid remains. Seek medical attention

TECHNICAL DATA
MAIN DEVICE:
Dimensions: 190 mm X 44 mm X 36.3mm (7.5” X
1.7”X2.5”)
Weight: Approx. 0.276.7 kg (0.61 lb)
Mode of Operation: Cyclic
Source of Power: 3.7V 3600mA Lithium-Ion Battery
CAUTION:
Charge batteries using only the power source provided
with the device.
POWER SUPPLY:
Class II, input: 100 - 240 Vac, 50 - 60 Hz, output: 12
Vdc @ 2 Amp
Use only UL/60601-1 approved power supplies from
VenaOne for use in hospital settings.
OUTPUT:
Mode of Operation: Continuous
SYSTEM OPERATING ENVIRONMENT:
Temperature: +5C (41F) and +40C (104F)
Relative Humidity: 15%-93%
Atmospheric Pressure: 525mmHg to
795mmHg
DEFAULT SETTINGS:
Leg Pressure (not adjustable) 55 mmHg
Cycle time: 60 Seconds
TOLERANCES:
Pressure 10%
BATTERY:
This device is powered by internal
Li-ion batteries
BATTERY CHARGE:
Takes approximately 4 hours (from
depleted state).
Customer Support: [phone] • [e-mail] • www.Ortho8.com •
Ortho8 Inc., 2217 Plaza Drive, Rocklin, CA 95765
Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner
Model No. 08-0042, 08-0043, 08-0044, 07-0013-01 • ©2021 Ortho8 Inc.
Document #IFU - VenaOne 04-0019 Rev D June 2022
DVT Compression System