Cardinal Health PRO User manual

Cardinal Health™ Negative Pressure
Wound Therapy PRO/PRO TO GO
Patient User Manual

Patient User Manual
2
About Your Cardinal Health™ PRO/PRO to GO
Your doctor has chosen the Cardinal Health™ NPWT PRO/PRO to GO to remove uid from your wound by using
carefully controlled suction. It is important, however, for you to carefully watch the wound and the PRO/PRO to GO to
make sure that it is working properly. Below is some important information and questions that you should ask your
healthcare professional.
Things you need to know about your PRO/PRO to GO
• Do not allow the PRO/PRO to GO to get wet. Clamp the tubing and disconnect from the canister if you take a bath
or shower.
• Keep the PRO/PRO to GO plugged in whenever possible to keep the battery fully charged. Always take the
A.C. Power Adapter with you when you leave home.
• Keep the PRO/PRO to GO upright to avoid a false Canister Full Alert.
• Keep the PRO/PRO to GO turned on at all times unless there is bleeding from the wound or instructed by your
healthcare professional.
• Do not change the Pressure Settings on the PRO/PRO to GO unless you are told to do so by your
healthcare professional.
Things to ask your healthcare professional
• How to tell if there is a problem with your PRO/PRO to GO or dressing.
• What to do if you have a problem or a leak with your dressing.
• What to do if you notice bleeding from the wound.
• What to do if you must take your dressing o.
• What activities you can do while using the PRO/PRO to GO.
• Who to call if you need help.
• How to take care of your PRO/PRO to GO.

Patient User Manual
3
This Cardinal Health™ NPWT PRO/PRO to GO Patient User Manual is not a guarantee or warranty. It is intended only as
an operational guide.
For additional information and questions, please contact Cardinal Health Customer Service at 1.866.484.6798.
In order for the PRO/PRO to GO to provide safe, reliable, and proper performance, the following conditions must be met.
Failure to comply with these conditions will void all pertinent warranties.
• All assembly, operation, adjustment, modication, maintenance, and/or repair must be carried out only by
qualied personnel authorized by Cardinal Health. Unauthorized modication of the PRO/PRO to GO may result in
physical hazards, including delayed therapy, electrocution, and re that may lead to injury or death.
• The electrical outlets in the room in which the PRO/PRO to GO is used complies with the appropriate national
electrical standards.
• The PRO/PRO to GO must be used in accordance with this Patient User Manual and all associated labeling.
CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. As with any prescription medical
device, failure to follow product instructions or changing settings without the express direction and/or supervision of a
trained clinical caregiver may lead to improper product performance and the potential for serious or fatal injury.

Patient User Manual
4
Safety and Warnings
Note to healthcare personnel providing training to lay users or lay caregivers (lay responsible
organizations): Be sure to include all of the warnings below when providing training to lay operators, especially in a
home care environment. Lay users and caregivers should contact Customer Support if there is a change in the performance
of the PRO/PRO to GO. Additionally, lay users and caregivers should be instructed on proper cleaning procedures to avoid
hazards such as electric shock. Lay users and caregivers should also be trained on inappropriate environments for use
(e.g. bathtub). For guidance on training, please contact Customer Support.
WARNING: Strangulation hazard. Do not leave A.C. Power Adapter cord, tubing or other choking hazards where infants or
young children can become caught. If these objects get wrapped around the neck, strangulation and death can occur.
WARNING: The PRO/PRO to GO contains small parts, which could become detached and pose a choking hazard. Some of
these components could be inhaled or swallowed by a small child, toddler or infant, which could result in suocation or
death. Keep all parts of the PRO/PRO to GO out of reach of small children.
WARNING: Do not modify this equipment without authorization from the manufacturer. Modication of this system could
result in physical hazards, including delayed therapy, electrocution and re.These hazards could result in injury or death.
WARNING: Use only the Cardinal Health™ NPWT Dressing and accessories listed in this manual. Use of other dressings and
accessories can create hazardous situations, including improper therapy or delayed therapy.This could result in improper
healing, damage to the wound area, and infection.
CAUTION: Use the PRO/PRO to GO only as described in this user manual. Do not interconnect the PRO/PRO to GO with
other devices not included in this user manual. Failure to comply could result in improper therapy and could result in
damage to the PRO/PRO to GO.
CAUTION:This system is not intended to be used in MRI environments or in the presence of strong magnetic elds.
Do not use this device in any areas with strong magnetic elds.The system contains metal components which could cause
unintended movement.This unintended movement could cause clinician or patient harm due to falling objects or collisions.
CAUTION: If you are in an environment with pet hair, please use caution when adhering the wound dressing to the wound
site. Pet hair could contaminate the wound site and prevent adhesion of the wound dressing.This could result in possible
infection of the wound or reduced eectiveness of the system.
CAUTION:The PRO/PRO to GO system can be used outdoors for short periods of time (not more than 24 hours). Shelter
from the rain.

Patient User Manual
5
Table of Contents
1. Introduction ................................................................................................................................6
1.1 Indications ......................................................................................................................................................6
1.2 Contraindications............................................................................................................................................6
1.3 Precautions .....................................................................................................................................................6
1.4 Safety Tips.......................................................................................................................................................7
2. Getting to Know the PRO/PRO to GO .............................................................................................. 8
2.1 Getting to Know the PRO/PRO to GO ...............................................................................................................8
2.2 Charging the Battery.......................................................................................................................................9
2.3 Changing the Canister...................................................................................................................................10
2.4 Disconnecting from the PRO/PRO to GO ........................................................................................................11
3. Operating Instructions ............................................................................................................... 12
3.1 ON/OFF..........................................................................................................................................................12
3.2 Troubleshooting ............................................................................................................................................12
4. Care & Cleaning.......................................................................................................................... 14
4.1 Disposal of Used Components .......................................................................................................................14
4.2 Cleaning the PRO/PRO to GO.........................................................................................................................14
4.3 A.C. Power Adapter Inspection......................................................................................................................14
5. Symbols Glossary ....................................................................................................................... 15
6. Specications ............................................................................................................................ 25
6.1 Electromagnetic Compatibility......................................................................................................................26
7. Questions & Information............................................................................................................. 28

6
1. Introduction
1. Introduction
1.1 Indications
The PRO/PRO to GO Negative PressureWound Therapy (NPWT) system is an integrated wound management system,
indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the
PRO/PRO to GO may promote wound healing by the removal of uids, including wound exudates, irrigation uids,
body uids and infectious materials.
The PRO/PRO to GO NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced
wounds, partial-thickness burns, ulcers (such as diabetic or pressure), aps and grafts.The PRO/PRO to GO NPWT system
is intended for use in acute, extended and home care settings.
1.2 Contraindications
The NPWT PRO/PRO to GO is contraindicated for patients with malignancy in the wound, untreated osteomyelitis,
non-enteric and unexplored stulas, or necrotic tissue with eschar present. Do not place the Cardinal Health™
NPWT black foam dressing over exposed blood vessels or organs.The Cardinal Health™ NPWT Dressings are also
contraindicated for hydrogen peroxide and solutions which are alcohol based or contain alcohol. It is not recommended
to deliver uids to the thoracic cavity.
1.3 Precautions
Precautions should be taken for patients with infected wounds, active bleeding, dicult wound hemostasis, or who are
on anticoagulants.
• Debrillation: The NPWT Dressing must be removed if debrillation is required in the area of dressing placement.
Failure to remove the dressing may inhibit electrical current transmission and/or patient resuscitation.
• Magnetic Resonance Imaging (MRI): The PRO/PRO to GO is not MRI-compatible and cannot be used in the
presence of strong magnetic elds. Do not take the PRO/PRO to GO into the MRI area or any area of high magnetic
elds.The PRO/PRO to GO contains metal components that could cause unintended movement resulting in harm
due to falling objects or collisions.
• Hyperbaric Oxygen Therapy (HBO): Do not take the PRO/PRO to GO — whether on or o — into a hyperbaric
chamber.The PRO/PRO to GO must be disconnected before HBO treatment.
• During negative pressure wound therapy, the PRO/PRO to GO and Cardinal Health™ NPWT Dressing are a closed
system and are NOT vented to atmosphere.
• When the NPWT Canister is full, replace immediately 2.3 Changing the Canister). Fluids are not removed from
the dressing once the canister is full.

7
1. Introduction
1.4 Safety Tips
Keep Therapy On
The PRO/PRO to GO should be operated at least 22 hours out of every 24-hour period. Contact your healthcare professional
if negative pressure wound therapy stops or if the PRO/PRO to GO is OFF for more than 2 hours in a 24-hour period.Your
dressing must be changed by your healthcare professional.
Monitoring the Wound
Inspect the dressing frequently to ensure that the dressing is collapsed and that negative pressure wound therapy is
being delivered in a consistent manner. Monitor wound exudates for signs of active bleeding. Monitor your wound
and the canister and tubing for signs of active bleeding. Monitor around your wound for signs of infection or other
complications. Signs of possible infection may include fever, tenderness, redness, swelling, itching and rash, increased
warmth in the wound area, sudden increase in pain, purulent discharge or a strong odor. Nausea, vomiting, diarrhea,
headache, dizziness, fainting, sore throat with swelling of the mucous membrane, disorientation, high fever, refractory
hypotension, orthostatic hypotension or periwound induration (a sunburn-like rash) may be added signs of more
serious complications of infection. Extra care and attention should be given if there are any signs of possible infection or
related complications. Infection can be serious.With or without the PRO/PRO to GO, infection can lead to many adverse
complications including pain, discomfort, fever, gangrene, toxic shock, septic shock and various other complications.
With signs of more serious complications of infection, discontinue the use of the PRO/PRO to GO until the serious
infection is diagnosed and properly treated by your healthcare professional.
NPWT Dressing Use
Your healthcare professional will apply and change your dressings for you.
NOTE: All dressing components of the NPWT Dressing Kit are packaged sterile.The decision to use clean versus sterile/
aseptic technique is dependent upon your healthcare professional’s preference. All components of the PRO/PRO to GO,
the NPWT Dressing Kits, the canisters and other accessories are made without natural rubber latex.
Be sure to comply with 1.2 Contraindications and 1.3 Precautions for the PRO/PRO to GO.
1. Introduction

8
2. Getting to Know the PRO/PRO to GO
2. Getting to Know the PRO/PRO to GO
2.1 Getting to Know the PRO/PRO to GO
You may not need to use many of the buttons on the PRO/PRO to GO, but it is important that you are familiar with what
they are and their location (Figure 1).
NOTE: The PRO/PRO to GO is quiet during normal operation with a well-sealed dressing.
OFF Button
Canister Release Button
Pressure Settings
Clamp
Battery Charging
Battery Charging Port
ON/Mute Button
Up Button
Down Button
Intermittent Mode
Plugged In
Canister
Alert Display
Figure 1

9
2. Getting to Know the PRO/PRO to GO
2.2 Charging the Battery
The PRO/PRO to GO has an internal battery that provides up to 24 hours of operation from a fully-charged battery.
When the battery is running low, an alert sounds to let you know you must plug in the PRO/PRO to GO to charge
the battery. See section 3.2 Troubleshooting.
1. Plug the A.C. Power Adapter into a wall outlet.
2. Insert the A.C. Power Adapter into the Battery Charging Port on the side of the PRO/PRO to GO (Figure 2).
3. When the PRO/PRO to GO is connected to an outlet, the green light next to the Plugged In symbol comes on
(Figure 2). If the battery is charging, the yellow light next to the Battery Charging symbol comes on. Once
the battery is fully charged, the light goes o.
NOTE: If the PRO/PRO to GO is plugged in and the green light does not turn on, check to make sure the outlet is
working properly.
4. The PRO/PRO to GO continues to work when charging.
CAUTION: The PRO/PRO to GO must be used with the supplied A.C. Power Adapter. Use of another adapter/power cord
could result in physical hazard, including delayed therapy, electrocution, and re.These hazards could result in injury
or death.
Figure 2
Battery Charging Port
Plugged In
Battery Charging
Average Battery Life
The battery life of the PRO/PRO to GO with a fully-charged battery is up to 24 hours.The actual life is dependent on the
integrity of the dressing. A leak in the dressing can signicantly reduce overall battery longevity.
Average Time for Recharging
To ensure the battery has been fully charged, the PRO/PRO to GO should be connected to an outlet via the A.C. Power
Adapter for approximately 3 hours. After approximately 2 hours of charging, the PRO/PRO to GO reaches 80 percent of
total battery capacity.
2. Getting to Know the PRO/PRO to GO

10
Low Battery Alert
While running on battery, a Low Battery alert“chirps”every 10 seconds and the OFF Button ashes when remaining
capacity of the battery is less than 20 percent (3.2 Troubleshooting). Typically, the PRO/PRO to GO continues to
operate for approximately 1 hour after the Low Battery Alert sounds.
If the battery charge gets too low, the PRO/PRO to GO shuts o and the negative pressure wound therapy is stopped.
At this point, the PRO/PRO to GO must be plugged into an outlet using the A.C. Power Adapter for negative pressure
wound therapy to resume. Once the A.C. Power Adapter is plugged in, press the ON Button to restart the PRO/PRO to GO.
2.3 Changing the Canister
When the PRO/PRO to GO detects that the canister needs to be changed, a Canister Full alert sounds.The PRO/PRO to GO
continues to work until the canister completely lls.When the canister is completely full, the PRO/PRO to GO turns o.
To change the canister:
1. Clamp the tubing closed (Figure 1).
2. Turn the PRO/PRO to GO o by pressing the OFF Button.
3. Disconnect SpeedConnect™ tubing connector from top of canister by twisting o the tapered connector.
4. To remove the canister, press the Canister Release Button located above the canister and gently pull the bottom of
canister down to remove from the PRO/PRO to GO.
5. Cap the canister and ask your healthcare professional how to properly dispose of a used canister.
6. To install a new canister, hold the new unused canister at the bottom and slide upwards into the holder.
7. Line up the two ports on the canister with the two ports on the PRO/PRO to GO. Press the canister up and into the
PRO/PRO to GO until it clicks and locks into place.
8. Connect the distal end of the SpeedConnect™ tubing with the blue tapered connector to the patient port of the
canister. Gently twist and push the connector on just enough to secure and seal it.
9. Reopen the tubing clamp by pushing down on the top of the clamp until it releases.
10. Turn the PRO/PRO to GO on by pressing the ON Button to resume negative pressure wound therapy.
2. Getting to Know the PRO/PRO to GO

11
2. Getting to Know the PRO/PRO to GO
2.4 Disconnecting from the PRO/PRO to GO
You may disconnect the PRO/PRO to GO from your dressing for short amounts of time for activities such as bathing
or showering. Ask your healthcare professional about care of your dressing during bathing or showering.
NOTE:The PRO/PRO to GO should be operated at least 22 hours out of every 24-hour period. Contact your healthcare
professional immediately if negative pressure wound therapy has stopped or is o for more than 2 hours in a 24-hour
period.Your dressing may need to be changed.
To disconnect from the PRO/PRO to GO:
1. Clamp the tubing closed.
2. Turn the PRO/PRO to GO o by pressing the OFF Button.
3. Disconnect SpeedConnect™ tubing connector from top of canister by twisting the tapered connector o the canister.
4. If canister is full, change the canister (2.3 Changing the Canister).
To reconnect to the PRO/PRO to GO:
1. Connect the distal end of the SpeedConnect™ tubing with the blue tapered connector to the patient port
of the canister. Gently twist and push the connector on just enough to secure and seal it.
2. Reopen the tubing clamp by pushing down on the top of the clamp until it releases.
3. Turn the PRO/PRO to GO on by pressing the ON Button to resume negative pressure wound therapy.
2. Getting to Know the PRO/PRO to GO

12
3. Operating Instructions
3. Operating Instructions
Carefully read 1.3 Precautions and 1.4 Safety Tips in the 1. Introduction section before attempting to operate and
adjust the PRO/PRO to GO.
CAUTION: The PRO/PRO to GO must only be used with the supplied A.C. Power Adapter. Use of another adapter/power
cord could create a shock hazard for you or your caregiver, cause re, and/or severely damage the PRO/PRO to GO. If you
need a replacement A.C. Power Adapter, call Cardinal Health Customer Service at 1.866.484.6798.
3.1 ON / OFF
The ON and OFF Buttons are located on the front of the PRO/PRO to GO.
1. Press the ON Button. All lights on the PRO/PRO to GO will sequentially light up during the power-on self-test.
2. Each time the PRO/PRO to GO is turned on, it goes through self-test and the Alert Display shows a series of numbers
and/or letters.
3. The dressing should slowly collapse, indicating the presence of negative pressure. If there is a Low Pressure/Leak
alert, there may be a problem (3.2 Troubleshooting).
4. The PRO/PRO to GO should be operated at least 22 hours out of every 24-hour period. Contact your healthcare
professional if the PRO/PRO to GO is OFF for more than 2 hours in a 24-hour period.Your dressing must be changed
by your healthcare professional.
NOTE: If an alert persists and cannot be resolved, please call Cardinal Health Customer Service at 1.866.484.6798.
CAUTION: In the event of an emergency, please contact your treating physician, caregiver or your local emergency
responders.
3.2 Troubleshooting
Alert Volume
The Alert Display indicates the volume level, which ranges from 1 to 5.The volume of the alert can be adjusted.
To increase the alert volume, press and hold the ON Button while pressing the Up Button.To decrease the alert volume,
press and hold the ON Button while pressing the Down Button. Pressing the ON (MUTE) Button after an alert silences
the alert for 5 minutes.The alert continues to sound every 5 minutes until the problem is corrected.The alert showing
number 4 in the Alert Display cannot be muted and you must call your healthcare professional.
To clear an alert, use the Troubleshooting table on the next page.
NOTE: If an alert persists and cannot be resolved, please call Cardinal Health Customer Service at 1.866.484.6798.
CAUTION: In the event of an emergency, please contact your treating physician, caregiver or your local
emergency responders.

13
What you
see or hear
Problem What to do More Information
FLASHING “1”
Low Pressure/Leak
Single beep.
Device is making
more noise.
There is an air
leak in either the
dressing or the
tubing connections.
• Clamp the tubing.
• If Low Pressure/Leak ashing“1”and audible
alert resets, there is a leak below the clamp —
often in the dressing. Reopen the clamp before
addressing the leak. Gently press around drape
to check for leaks. If leak is found, patch with
extra drape material.
• If Low Pressure/Leak ashing“1”and audible
alert continues, there is a leak above the clamp.
Check tubing connection at the canister.
Check to ensure the canister is fully seated and
locked. Check for cracks in the canister or lid
separation. If found, replace the canister.
• Open the clamp.
The alert will reset, the pressure light will stop
ashing, and the pump will become quiet after you
nd and seal the leak.
Leaks often occur over areas of moist skin, creases
or folds in skin, and wrinkles in the drape. They can
occur if the drape snags on clothes or bed sheets.
FLASHING “2”
Canister Full
Two-tone beep.
The canister is full. • Clamp the tubing.
• Turn device o by pressing the OFF button.
• Press the canister release button above the
canister and slide the full canister out. Cap and
dispose of properly. Slide new canister in, align
the short ports and click into place.
• Open the clamp and press the ON button to
resume therapy.
The canister full alert begins when the
canister is 90 percent full, but the device will
continue to work until the canister completely lls.
If the PRO/PRO to GO are placed on their fronts, uid
entering the canisters will cause a false canister full
alert and require the canisters to be changed.
FLASHING “3”
Low Battery
Three-tone beep.
The battery is low
and will run out in
about 30 minutes.
Plug in the device. Use only the power cord that came with the
PRO/PRO to GO.
When the device is getting power, a green light will
illuminate on the front of the device.
A yellow light below the green light will show that
the battery is charging. It will turn o once the
battery is fully charged.
FLASHING “4”
Therapy Time
Four beeps every
10 seconds.
Device therapy time
has expired.
Contact your healthcare professional. This alert cannot be muted or manually reset by
cycling power.
Pressure Setting will
not change.
Pressure lock-out
is engaged.
Contact your healthcare professional. Pressure Setting can only be changed per a
healthcare professional’s orders.
Device is quiet and
uid is not moving in
the tubing.
This is NOT
a problem.
No action needed. When the dressing has a good seal, uid may be
removed from the wound and stay in the tubing.
The foam will be compressed normally and the
PRO/PRO to GO is quiet.
Your healthcare professional will change the
PRO/PRO to GO if required.
An amber light is
showing on the
front of the device
below the pressure
numbers.
This is NOT a
problem.The device
is operating in
Intermittent Mode.
No action needed. Intermittent mode maintains target pressure
for 5 minutes and decreases to -25mmHg
for 2 minutes.
3. Operating Instructions

14
4. Care & Cleaning
4. Care & Cleaning
Your healthcare professional will handle much of the care and cleaning needed for your PRO/PRO to GO.
Periodically check to make sure the PRO/PRO to GO is working properly.
If the PRO/PRO to GO does not seem to work properly or is showing an alert, see 3.2 Troubleshooting. Contact your
healthcare professional for help. If the A.C. Power Adapter is damaged, it must be replaced immediately. Contact your
healthcare professional for help.
WARNING: The PRO/PRO to GO must only be used with the supplied A.C. Power Adapter. Use of another adapter/power
cord could result in physical hazards, including delayed therapy, electrocution and re.These hazards could result in injury
or death.
4.1 Disposal of Used Components
Your healthcare professional should remove your dressings, tubing and used canisters.
4.2 Cleaning the PRO/PRO to GO
The PRO/PRO to GO should need only light cleaning. Make sure to unplug the PRO/PRO to GO before cleaning. The
battery provides power when the PRO/PRO to GO is unplugged so negative pressure wound therapy is not interrupted.
Clean the PRO/PRO to GO with a damp soft cloth and a mild soap and water solution.
Do not saturate the PRO/PRO to GO with liquid or allow liquid to pool on the PRO/PRO to GO. This can present a potential
hazard for you and/or your healthcare professional.
WARNING: Avoid spilling or spraying liquid on any part of the PRO/PRO to GO. Liquids can cause corrosion when left
on electronic controls which can lead to failure. Component failure may cause the PRO/PRO to GO to operate erratically,
possibly causing a potential hazard to you or your caregiver.
Carrying Case and IV Pole Adapter:Follow the same procedure as above.
4.3 A.C. Power Adapter Inspection
The A.C. Power Adapter should be inspected regularly for damage. If you notice any damage to the A.C. Power Adapter,
call your healthcare professional for a replacement to avoid interruption of therapy.
WARNING: The PRO/PRO to GO must only be used with the supplied A.C. Power Adapter. Use of another adapter/power
cord could result in physical hazards, including delayed therapy, electrocution and re.These hazards could result in
injury or death.

15
5. Symbols Glossary
5. Symbols Glossary
5. Symbols Glossary
Symbols Recognized by Standard/Law
Symbol Standard/Law
Reference Standard/Law Title Symbol Title/ Text Reference Explanatory Text
ISO 13225-1,
Clause 5.1.1
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Manufacturer Indicates the medical
device manufacturer.
ISO 7000-3082 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.1.3
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Date of Manufacture Indicates the date when
the medical device was
manufactured.
ISO 7000-2497 Graphical symbols for use on equipment
EN 60417-6049 Graphical symbols for use on equipment Country of Origin To identify the country of
manufacture of products.
To identify country
abbreviation, see https://
www.iso.org/obp/ui/#-
search.
ISO 3166-1 Codes for the representation of names of
countries and their subdivisions - Part 1:
Country Codes
ISO 15223-1,
Clause 5.1.2
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Authorized
European
Representative
Indicates the Authorized
Representative in the
European Union.
ISO 15223-1,
Clause 5.1.6
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Catalogue or
Model Number
Indicates the
manufacturer’s catalogue
number so the device can
be identied.
ISO 7000-2493 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.1.7
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Serial Number Indicates the
manufacturer’s serial
number so that a
specic device can be
identied.
ISO 7000-2498 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.1.5
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Batch/Lot Code Indicates the
manufacturer’s batch/lot
code so that the batch or
lot can be identied.
ISO 7000-2492 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.1.4
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Use by Date Indicates the date after
which the medical device is
not to be used.
ISO 7000-2607 Graphical symbols for use on equipment

16
Symbol Standard/Law
Reference Standard/Law Title Symbol Title/ Text Reference Explanatory Text
ISO 15223-1,
Clause 5.5.1
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
In Vitro Diagnostic
Medical Device
Indicates that a medical
device is intended to be
used as an in vitro
diagnostic medical device.
IEC 60601-1,Table
D.1, Symbol 10
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance
Caution Indicates the need for
the user to consult the
instructions for use for
important cautionary
information such as
warnings and precautions
that cannot, for a variety of
reasons, be presented on
the medical device itself.
ISO 7000-0434 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.7
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Temperature Limit Indicates the temperature
limits to which the medical
device can be safely
exposed.
ISO 7000-0632 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.8
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Humidity Limitation Indicates the range of
humidity to which the
medical device can be
safely exposed.
ISO 7000-2620 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.4
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Keep Dry Indicates a medical device
that needs to be protected
from moisture.
ISO 7000-0626 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.1
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Fragile,
Handle with Care
Indicates a medical device
that can be broken or
damaged if not handled
carefully.
ISO 7000-0621 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.4.2
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Do Not Reuse Indicates a medical device
that is intended for one
use or for use on a single
patient during a single
procedure.
ISO 7000-1051 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.6
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Do Not Resterilize Indicates that a medical
device should not be
resterilized.
ISO 7000-2608 Graphical symbols for use on equipment
5. Symbols Glossary

17
5. Symbols Glossary
Symbol Standard/Law
Reference Standard/Law Title Symbol Title/ Text Reference Explanatory Text
ISO 15223-1,
Clause 5.2.1
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Sterile Indicates a medical device
that has been subjected to
a sterilization process.
ISO 7000-2499 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.2
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Sterile Using Aseptic
Techniques
Indicates medical device
that has been sterilized
by using accepted aseptic
technique.
ISO 7000-2500 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.3
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Sterilized by
Ethylene Oxide
Sterilized by ethylene oxide
ISO 7000-2501 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.4
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Sterilized Using
Irradiation
Indicates a medical device
has been sterilized using
irradiation.
ISO 7000-2502 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.5
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Sterilized Using Steam
or Dry Heat
Indicates a medical device
has been sterilized using
steam or dry heat.
ISO 7000-2503 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.9
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Sterile Fluid Path To identify the presence of
a sterile uid path within
the medical device when
other parts of the medical
device are not necessarily
supplied sterile.
ISO 7000-3084 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.2
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Keep Away From
Sunlight
Indicates a medical device
that needs protection from
light sources.
ISO 7000-0624 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.7
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Non-sterile Indicates a medical device
that has not been subjected
to a sterilization process.
ISO 7000-2609 Graphical symbols for use on equipment
5. Symbols Glossary

18
Symbol Standard/Law
Reference Standard/Law Title Symbol Title/ Text Reference Explanatory Text
ISO 15223-1,
Clause 5.4.3
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Consult Instructions
for Use
Indicates user needs to
consult instructions for use.
ISO 7000-1641 Graphical symbols for use on equipment
IEC 60601-1,
Table D.2, Symbol
10
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance
Refer to Instruction
Manual/Booklet
Indicates user needs to
consult instructions for use.
IEC 60601-1-
2:2007, Clause
5.1.1
Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
standard: Electromagnetic compatibility
- Requirements and tests
Non-ionizing Electro-
magnetic Radiation
To indicate generally
elevated, potentially
hazardous, levels of
nonionizing radiation, or
to indicate equipment or
systems e.g. in the medical
electrical area that include
RF transmitters or that
intentionally apply RF
electromagnetic energy for
diagnosis or treatment.
IEC 60417-5140 Graphical symbols for use on equipment
IEC 60878-5140 Graphical symbols for electrical equip-
ment in medical practice
ISO 15223-1,
Clause 5.3.9
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Atmospheric
Pressure Limits
Indicates the range of
atmospheric pressure to
which the medical device
can be safely exposed.
ISO 7000-2621 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.6.3
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Non-pyrogenic Indicates that the medical
device is non-pyrogenic.
ISO 7000-2724 Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.8
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Do Not Use if
Package is Damaged
Indicates that the medical
device should not be used
if the package holding
device has been damaged
or opened.
ISO 7000-2606 Graphical symbols for use on equipment
ISO 7000-3079 Graphical symbols for use on equipment Open Here Indicates where the package
can be opened and to
indicate method of opening
it.
ASTM F2503 Standard practice for marking medical
devices and other items for safety in the
magnetic resonance environment
Magnetic Resonance
(MR) Unsafe
Keep device away from
magnetic resonance
imaging (MRI) equipment.
5. Symbols Glossary

19
5. Symbols Glossary
Symbol Standard/Law
Reference Standard/Law Title Symbol Title/ Text Reference Explanatory Text
IS EN-
15986:2011
Symbol for use in the labeling of medical
devices. Requirements for labeling of
medical devices containing phthalates.
Contains Presence of
Phthalates
Indicates presence of Bis
(2-ethylexyl) phthalate
(DEHP).
ISO 15223-1,
Clause 5.4.5,
Annex B.2
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Does Not Contain
Natural Rubber Latex
The medical device or the
packaging of the medical
device does not contain
natural rubber latex.
ISO 15223-1,
Clause 5.4.5,
Annex B.2
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Does Not Contain
Natural Rubber Latex
The medical device or the
packaging of the medical
device does not contain
natural rubber latex.
ISO 15223-1,
Clause 5.4.5
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Contains or Presence
of Natural Rubber
Latex
Indicates the presence of
natural rubber or dry natural
rubber latex as a material of
construction within the
medical device or the
packaging of a medical
device.
EN 50419 Marking of Electrical and Electronic
Equipment in accordance with Article
11(2) of Directive 2002/96/EC (WEEE).
WEEEWheeled Bin This product contains
electrical and electronic
components that may
contain materials which, if
disposed with general waste,
could be damaging to the
environment. Residents of
the European Union must
follow specic disposal of
or recycling instructions
for this product. Residents
outside the European Union
must dispose or recycle this
product in accordance with
local laws or regulations that
apply.
IEC 60601-1,
Table D.1, Symbol
20
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance
Type BF Applied Part Identies a type BF applied
part complying with IEC
60601-1-11.
ISO 7000-5333 Graphical symbols for use on equipment
5. Symbols Glossary