Precision Medical venaone 08-0030 User manual

Instructions for Use
Caution: Federal Law restricts this device to sale by or on the order of alicensed practitioner
Model No. 08-0030
Precision Medical Products
DVT Compression System
Customer Support: [phone] • [email protected] • www.pmpmed.com
2217 Plaza Drive, Rocklin, CA 95765
No Tubes
or Cords Lightweight
Portable Infection
Control
One Touch
Operation
Battery
Operated

Table of Contents
VENAONE OVERVIEW 2
CONTRAINDICATIONS 2
FEATURESAND BENEFITS 3
SYMBOLS 3
SYSTEM CONTENTS 4
BATTERY INDICATORS & CHARGING 5
APPLICATION INSTRUCTIONS 6
PUMP ALARM INDICATORS 7
DEVICE HANDLING 8
CLEANING AND DISINFECTING 8
DISPOSAL 8
USER MAINTENANCE8-9
STORAGE 9
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES10-11
WARNINGS AND CAUTIONS 12
TECHNICAL DATA 13

2
VENAONE OVERVIEW
INDICATIONS FOR USE
.
CONTRAINDICATIONS
INFLATION/DEFLATION CYCLE
Pneumatic compression is a clinically proven modality for reducing the risks associated with deep vein
thrombosis (DVT).
1
VenaOne is a tubeless, portable, lightweight and battery-operated DVT compression
system designed specifically for the acute-care setting. VenaOne aids in the prevention of DVT by helping
to stimulate blood flow in the legs. The pump inflates each leg cuff to a preset pressure of 55 mmHg and
deflates once the pressure is reached. Then the cycle repeats. Internal rechargeable batteries allow the
VenaOne to be completely portable, thus preventing interruptions in treatment.
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 insufficiency, and reduction of edema in the
lower limbs.
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
inflates the cuff to 55 mmHg in about 6 to 8 seconds, holds the pressure for about
2 seconds, then releases the pressure and rests for about 50 seconds. Then the
cycle repeats.
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-cellCompression.
Loyola University Medical Center, January 2003.

3
Portable
VenaOne’s simple design is fully ambulatory.
Easy One-TouchOperation
Controls all functions with just the power button.
Infection Control
The 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
Lightweight
Weighs less than one pound.
Battery Operated
~24 hour battery life allows for ease of use and
patient compliance.
Compression
Features and Benefits
Atmospheric Pressure Range
Not made with Natural
Rubber Latex
Patient Wrap(s) intended for
single patient use. Use on more
than one patient may cause
cross-contamination.
Temperature Range
Waste of electrical 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.
The use of accessories, power supplies and
cables other than those specified, with the
exception of components sold by the
manufacturer as replacement parts, may
result in increased emissions or decreased
immunity.
This symbol designates the degree of
protection against electrical shock from the
wrap as being a type BF applied part.
Power Button
Battery Indicator
No Scissors
Power Supply
Manufacturer
Keep Dry
Serial Number
Class II Medical
Electrical Equipment
Warning or Caution
Battery Operated
Refer to Instruction Manual
Humidity Range
Idle Pulse Between
Compression Cycles
Low Pressure Indicator
High Pressure Indicator
Battery Low
System Failure
System Failure Reset
Provides asymmetric compression at 55 mmHg.

4
VenaOne Wraps (Sold Separately)
Part #07-0020
System Contents
Charging Station (Sold Separately)
Part #07-0013
Warning: Only Use Wrap(s) provided by Precision Medical Products
Charging Port
Power Button
LED Display

5
Battery Indicators & Charging
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 flashing 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.
All 3 Bars Solid Green:
The battery is 100% charged.
Remains illuminated at all times during operation.
Battery icon:
2 Bars Solid Green, 1 Bar Flashing:
The battery is between 31% and 60% charged. The third bar flashes until fully charged.
One Bar Solid Green, 2 Bars Flashing:
The battery has 30% charge remaining. The second and third bars flash alternately until the
battery reaches 31% charge.
One Bar Flashing RED:
The battery will last 5 minutes or less. Alarm ONE will sound 3 times every 10 seconds
and “BL” will flash on the LED display until auto shut down occurs or the device(s) is
connected to the power supply. See Page 7 for alarm descriptions.
One Bar Solid Yellow:
The battery will last 30 minutes or less. Alarm ONE will sound 3 times every 2 minutes
and “BL” will simultaneously flash on the LED display indicating the battery is nearly
depleted. See Page 7 for alarm descriptions.

6
Application Instructions
PLACE THE DEVICE INTHE WRAP
1
Device
Bladder
Wrap
The VenaOne Device and Bladder will slide to
the bottom of the Wrap (sold separately).
SEALING THE WRAP(S)
2Once the device is placed inside the wrap, peel
off the backing on the adhesive strip. Then
simply fold over and press to seal the wrap.
CALF WRAP APPLICATION
3Apply the wrap around the calf and secure the
fabric fasteners to hold it in place. Make sure
the wrap is snug, but not too tight. When one
or both wraps are secured on the leg(s), the
device(s) are ready for operation.
TURNING THE DEVICE ON OR OFF
4To turn the device on or off, press the power
button 3 times.
USING THE DEVICE
The device will make a quiet “humming” sound
when inflating to pressure. This is normal. The
wraps inflate once each minute during use.

7
TO SILENCE ALARM:
Pump Alarm Indicators
If the device is turned on after an alarm event, the LED will display the previous alarm.
High Pressure “HP”
In the unlikely event that the device applies higher pressures than normal, a high pressure (HP)
alarm will display. If this occurs, power off and restart the system. If the alarm persists, remove the
device from service and replace.
Low Pressure “LP”
In the unlikely event that the device applies lower pressures than normal, a low pressure (LP)
alarm will display. If this occurs, power off and restart the system. If the alarm persists, remove the
device from service and replace.
Battery Low “BL”
When the battery is running low, a BL alarm will display. Replace the battery as needed per the
battery indicator. See the Battery Indicator section on page 5 for more information.
System Failure “SF”
If a system failure (SF) occurs, remove the device from service and replace.
Press and hold POWER BUTTON FOR ONE SECOND, without turning OFF the device.

8
.
DO NOT DISPOSE OF THE DEVICE DISPOSE OF THE WRAPONLY
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 wrap(s).
Device Handling
DEVICE DISPOSAL
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.
DO NOT USE SCISSORS
NOTE: Inspect the VenaOne device and follow the cleaning and disinfecting procedures prior to each use.
The device is intended for multiple patient use.
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.
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 AND DISINFECTING
DO NOT IMMERSE DEVICE IN ANY LIQUID FOR ANY REASON
DO NOT USE ABRASIVE OR VOLATILE CLEANERS.
NEVER REMOVE THE BLADDER FROM THE DEVICE.
TO CLEAN:
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.
USER MAINTENANCE:

9
Avoid folding or creasing the bladder during the use and transportation of the devices.
This device is not protected against water.
STORAGE AND TRANSPORTATION
Do not store items indirect sunlight.
DEVICE DISPOSAL
LATEX INFORMATION
LITHIUM-ION BATTERY MAINTENANCE GUIDELINES
OVERVIEW
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 5.
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.
This device is an electromechanical device that includes printed circuit boards and rechargeable batteries
Do not discard in landfills. Consult local country requirements for proper disposal instructions.
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 first. 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.
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.
Replacement devices will be made available to you by your local sales representative.
Store in a dry location between -25C (-13F) and+60C (140F).
Relative Humidity: 15% to 93%
Atmospheric Pressure: 525mmHg to 795mmHg

10
EMC GUIDANCE
Warning:
Warning:
operating normally.
Warning:
result inimproper operation.
Warning:
TECHNICAL DESCRIPTION
1.
disturbances for the excepted service life.
2.
GUIDANCEANDMANUFACTURER’SDECLARATION - ELECTROMAGNETIC EMISSIONS
EMISSIONS TEST Compliance ELECTROMAGNETIC ENVIRONMENT GUIDANCE
61000-3-2Class A
VoltageFluctuations Complies
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
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
(50/60Hz) Magnetic
Fields
I EC 61000-4-8
+6kV contact
+8kV air
3 A/m 3 A/m
+1kV differential mode
+2kV air common mode
+
+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
VenaOne is intended for use in the electromagnetic environment specified below. The customer or the user of VenaOne should
assure that it is used in such an environment.
VenaOne is intended for use in the electromagnetic environment specified below. The customer or the user of VenaOne should
assure that it is used in such an environment.
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.
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.
Mains power quality should be that of a typical commercial or
hospital environment. If the user of VenaOne requires continued
operation during power mains interruptions, it is recommended
that the device be powered from an uninterrupted power supply
or a battery.

11
Conducted RF
IEC 61000-4-6
Recommended separation distance
a
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
transmitter
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
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
VenaOne is intended for use in the electromagnetic environment specified below. The customer or the user of VenaOne should assure that it is used in such
an environment.
VenaOne is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of VenaOne can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and VenaOne
as recommended below, according to the maximum output power of the communications equipment.
aField 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 VenaOne is used exceeds the applicable RF compliance level above, VenaOne should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating VenaOne.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V /m.

12
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
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
• 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
•
by other medical electrical devices. If you
believe interference is occurring, please consult
• 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 operate device in a wet environment.
•
dust-free environment.
in accordance with instructions, may cause harmful
there is no guarantee that interference will not occur
other devices can be determined by turning this
using one or more of the following:
• Reorient or relocate the receiving device
•
• Consult your local customer service representative
for help
•
interference. Potential electromagnetic or other
interference could occur to this or to the other
device.
•
unplugged from the wall outlet prior to and while
cleaning or disinfecting.
• Do not place any items in an autoclave.
•
use.
•
• Contains no user serviceable parts. Contact your
• 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 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.
•
• Properly dispose of a leaking battery pack.
•
least 15 minutes, lifting upper and lower lids, until no

TECHNICAL DATA
MAIN DEVICE:
CAUTION:
Charge batteries using only the power source provided
with the device.
POWER SUPPLY:
OUTPUT:
Mode of Operation: Continuous
Precision Medical Products
Customer Support: [phone] • [email protected] • www.pmpmed.com
2217 Plaza Drive, Rocklin, CA 95765
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
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.
SYSTEM OPERATING ENVIRONMENT:
Temperature: +5C (41F) and +40C (104F)
Relative Humidity: 15%-93%
Atmospheric Pressure: 525mmHg to 795mmHg
DEFAULT SETTINGS:
TOLERANCES:
Pressure 10%
BATTERY:
BATTERY CHARGE:
Leg Pressure (not adjustable) 55 mmHg
Cycle time: 60 Seconds
This device is powered by internal
Li-ion batteries
Takes approximately 4 hours (from
depleted state).
©2023 Precision Medical Products, 2217 Plaza Drive, Rocklin, CA 95765
Document # - VenaOne 04-0019 Rev E, June 2023