Cardinal Health SVED NPWT User manual

Cardinal Health™
Negative Pressure Wound Therapy SVED®
Patient User Manual

2
Patient User Manual
About Your Cardinal Health™ SVED®
Your doctor has chosen the Cardinal Health™ SVED® to remove uid from your wound by using carefully controlled
suction. It is important, however, for you to carefully watch the wound and the SVED® to make sure that the SVED® is
working properly. Below is some important information and questions that you should ask your healthcare professional.
Things you need to know about your SVED®
• Do not allow the SVED® to get wet. Clamp the tubing and disconnect from the canister if you take a bath or shower.
• Keep the SVED® 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 SVED® upright to avoid a false Canister Full Alert.
• Keep the SVED® 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 SVED® 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 SVED® 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 SVED®.
• Who to call if you need help.
• How to take care of your SVED®.
This SVED® 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 SVED® 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 SVED device 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 SVED® is used complies with the appropriate national
electrical standards.
• The SVED® NPWT System must be used in accordance with this manual and all associated labeling and the
Instructions for Use.
• Any SVED® that does not function as expected must be returned to Cardinal Health.
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.

3
Patient User Manual
Safety and Warnings
Note to healthcare personnel providing training to lay users or 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. Layusers and caregivers should contact Customer Support if there is a change in the performance of the
SVED®. Additionally, lay users 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: Choking hazard.The SVED® 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 SVED® system 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 SVED® only as described in this user manual. Do not interconnect this SVED® with other devices not
included in this user manual. Failure to comply could result in improper therapy and could result in damage to
the SVED®.
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 SVED® can be used outdoors for short periods of time (not more than 24 hours). Shelter from rain.

Table of Contents
1. Introduction ...................................................................................................................................5
1.1 Indications .......................................................................................................................................................... 5
1.2 Contraindications ............................................................................................................................................... 5
1.3 Precautions ........................................................................................................................................................ 5
1.4 Safety Tips .......................................................................................................................................................... 6
2. Introduction to the SVED® ................................................................................................................7
2.1 Getting to Know the SVED® ................................................................................................................................ 7
2.2 Charging the Battery........................................................................................................................................... 8
2.3 Changing the Canister ........................................................................................................................................ 9
2.4 Disconnecting from the SVED® ......................................................................................................................... 11
3. Operating Instructions ................................................................................................................... 12
3.1 Power ON/OFF .................................................................................................................................................. 12
3.2 Troubleshooting Guide ...................................................................................................................................... 13
4. Care & Cleaning ............................................................................................................................. 14
4.1 Disposal of Used Components ........................................................................................................................... 14
4.2 Cleaning the SVED® .......................................................................................................................................... 14
4.3 A.C. Power Adapter Inspection ......................................................................................................................... 15
5. Symbols Glossary ........................................................................................................................... 16
6. Specications ................................................................................................................................26
6.1 Electromagnetic Compatibility..........................................................................................................................27
7. Questions & Information ................................................................................................................ 29

5
1. Introduction
1. Introduction
1.1 Indications
The SVED® 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 device
may promote wound healing by the removal of uids, including wound exudates, irrigation uids, body uids and
infectious materials.
The SVED® NPWT System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds,
surgical incisions following sutured or stapled closure, partial-thickness burns, ulcers (such as diabetic
or pressure), aps and grafts.The SVED® NPWT System is intended for use in acute, extended and home care settings.
1.2 Contraindications
The SVED® 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 dressings over exposed blood vessels or organs.
The 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.When placing the dressing in close proximity to blood vessels or organs, take care to ensure that
they are adequately protected with overlying fascia, tissue or other protective barriers. Exposed tendon, nerves or blood
vessels should be protected by moving available muscle or fascia over them or by a layer of synthetic material. Greater
care should be taken with respect to weakened, irradiated or sutured blood vessels or organs. Bone fragments or sharp
edges could puncture a dressing barrier, vessel or organ. Wounds with enteric stula require special precautions in order
to optimize therapy.
• Debrillation: The dressings 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 SVED® is not MRI-compatible and cannot be used in the presence
of strong magnetic elds. Do not take the SVED® into the MRI area or any area of high magnetic elds.The SVED®
contains metal components that could cause unintended movement resulting in harm due to falling objects
or collisions.
• Hyperbaric Oxygen Therapy (HBO): NEVER allow a SVED® inside a hyperbaric chamber.The SVED® must be
disconnected from the patient prior to HBO treatment.
• Changes in Performance: If you notice unusual changes in the performance of the system, contact customer
service at 1.866.484.6798.

6
1. Introduction
• During negative pressure wound therapy, the SVED® and dressings are a closed system and are NOT vented
to atmosphere.
• During negative pressure wound therapy, when a canister lls with uid, it should be replaced immediately.
Fluid will not be removed from the dressing once the canister is full.
1.4 Safety Tips
Keep Therapy On
The SVED® should be operated at least 22 hours out of every 24-hour period. Contact your healthcare professional if
therapy stops or if the device is OFF for more than 2 hours in a 24-hour period.Your healthcare professional will need to
change your dressing.
Troubleshooting
If the SVED® alerts or does not seem to operate properly, see 3.2 Troubleshooting.
Monitoring the Wound
Inspect the dressing frequently to ensure that the dressing is collapsed and that therapy is being delivered in a
consistent manner. Monitor wound, canister and tubing for signs of active bleeding. Monitor around your wound
or incision 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 incerease in pain, purulent discharge
or a strong odor. Nausea, vomiting, diarrhea, heacache, dizziness, fainting, sore throat with swelling of the mucous
membrane, disorientation, high fever, refractory hypotension, orhtostatic 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
SVED®, 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
SVED® 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.
Monitoring the Tubing/A.C. Power Adapter Cord
Do not allow tubing or A.C. Power Adapter Cord around the neck area.
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. SVED®, the NPWT Dressing Kits, the
canisters and other accessories are made without natural rubber latex.
Be sure to comply with all other 1.2 Contraindications and 1.3 Precautions for the SVED®.

7
2. Introduction to the SVED®
2. Introduction to the SVED®
2.1 Getting to Know the SVED®
You may not need to use many of the buttons on the SVED®, but it is important that you are familiar with what they are
and their location (see Figure 1).
NOTE: The SVED® will be quiet during normal operation with a well-sealed dressing.
Canister Release Button
Low Pressure / Leak Alert
Battery Charging Port
ON Button
Canister Full Alert
Pressure Settings
OFF Button
Figure 1

8
2. Introduction to the SVED®
2.2 Charging the Battery
The SVED® has an internal battery that provides up to 18 hours of operation from a fully charged battery.
When the battery is running low, an alert will sound to let you know you must plug in the SVED® to charge the battery.
See 3.2 Troubleshooting.
1. Plug the A.C. Power Adapter into a suitable wall outlet (100-240VAC, 50-60Hz).
2. Insert the A.C. Power Adapter into the Battery Charging Port on the left side of the SVED® (Figure 2).
3. When the SVED® is connected to an outlet, the green light next to the Plugged In symbol comes on. 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 SVED® is plugged in and green light does not turn on, check to make sure outlet is working properly.
4.The SVED® continues to work when charging.
WARNING: The SVED® must only be used with the supplied A.C. Power Adapter. Use of any other A.C. Power Adapter
or charger 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 specied battery life of the SVED® with a fully-charged battery is up to 18 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 SVED® should be connected to an A.C. Power Adaptor for
approximately 3 hours. After approximately 2 hours of charging, the SVED® reaches 80 percent of total battery capacity.

9
2. Introduction to the SVED®
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 (See 3.2 Troubleshooting).Typically, the SVED® continues to operate for
approximately 1 hour after the Low Battery Alert sounds.
If the battery charge gets too low, the SVED® shuts o and the negative pressure wound therapy is stopped. At this
point, the SVED® 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 SVED®.
2.3 Changing the Canister
When the SVED® detects that the canister needs to be changed, a Canister Full Alert sounds.The SVED®
continues to work until the canister completely lls.When the canister is completely full, the SVED® turns o.
To change the canister:
1. Clamp the tubing closed (Figure 3).
2. Turn the SVED® OFF by pressing the OFF button.
3. Remove the blue SpeedConnect™ tubing connector from the top of the canister (Figure 3) by twisting o the
tapered connector.
Figure 3
SpeedConnect™ Tubing Connector
Clamp
Canister

10
2. Introduction to the SVED®
4. To remove the canister, press the Canister Release Button located above the canister, grasp the canister at the
bottom and gently pull downward (Figure 4).
Figure 4
Canister Release
Canister
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. Align the two short ports and press upwards until it“clicks”into place.
8. Reconnect the blue SpeedConnect™ tubing connector to the canister. Gently twist and push the connector on the
open port of the canister just enough to secure and seal it.
9. Turn the SVED® ON by pressing the ON button to resume therapy.
10. Reopen the tubing clamp.

11
2. Introduction to the SVED®
2.4 Disconnecting from the SVED®
You may disconnect the SVED® from your dressing for short amounts of time for activities such as bathing.
Ask your healthcare professional about care of your dressing during bathing or showering.
NOTE: The SVED® should be operated at least 22 hours out of every 24-hour period. Contactyourhealthcare
professional immediately if therapy is terminated or is o for more than 2 hours in a 24-hour period.Your dressing may
need to be changed.
To disconnect from the SVED®:
1. Clamp the tubing closed (Figure 5).
2. Turn the SVED® o by pressing the OFF button.
3. Remove the blue SpeedConnect™ tubing connector from the top of the canister (Figure 5) by twisting the tapered
connector o the canister.
Figure 5
SpeedConnect™ Tubing Connector
Clamp
Canister

12
3. Operating Instructions
3. Operating Instructions
Carefully read the 1.3 Precautions and 1.4 Safety Tips in the 1. Introduction section before attempting to operate
the SVED®.
CAUTION: The SVED® should only be used with the supplied A.C. Power Adapter or Global Power Adapter.The Global
Power Adapter must be purchased separately. Another A.C. Power Adapter or power cord could create a shock hazard for
you or your caregiver, cause re and/or severely damage the SVED®. If you need a replacement A.C. Power Adapter, call
Cardinal Health Customer Service at 1.866.484.6798.
3.1 POWER ON/OFF
The ON and OFF buttons are located on the front of the SVED®.
1. Press the ON button. All lights show for 1 second during the power-on self-test.When nished, the ON button
stays green.
2. Dressing should collapse indicating the presence of negative pressure. If there is a Low Pressure/Leak Alert,
see 3.2 Troubleshooting.
3. The SVED® should be operated at least 22 hours out of every 24-hour period. Contact your healthcare
professional if the SVED® is o 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.

13
3. Operating Instructions
3.2 Troubleshooting Guide
To clear an alert, use the Troubleshooting table below. To manually reset an alert, turn the SVED® OFF then ON.
The alert will clear when the power is cycled.
What you see
or hear
Problem What to do More information
OFF Button is ashing.
Single beep.
The battery is low and has
approximately 30 minutes
before the battery will be
too low to support continued
operation of the SVED®.
Plug in the SVED. A green light shows next to Plugged
In indicator and a yellow light next to Battery Charging
indicates that power is going to the SVED®.The yellow light
turns o after the battery is fully charged.
Use only the A.C. Power Adapter
that came with the SVED. If the alert
continues or a replacement A.C. Power
Adapter is needed, call Cardinal Health at
1.866.484.6798 for more assistance.
LOW PRESSURE/LEAK
indicator is lit.
Single beep.
Pressure Setting Button
is ashing.
SVED® is making noise.
There is an air leak in either
the dressing or the tubing
connections.
Leaks often occur over areas
of moist skin, creases or
folds in skin and wrinkles in
the dressing.They can occur
if the dressing snags on
clothing or bed sheets.
• Clamp the tubing.
• If the Low Pressure/Leak light stops, there is a leak between
the clamp and the dressing — 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 or drape strips.
• If Low Pressure/Leak Alert continues, there is a leak
between the clamp and the SVED®. Check the tubing
connection at the canister. Check to ensure that the canister
is fully seated and locked. Check for cracks in the canister or
lid separation. If found, replace the canister.
• Open the clamp.
Once the leak is found and sealed,
the alert resets, the Pressure Setting
Button quits ashing and the SVED®
becomes quiet.
If alert continues, call Cardinal Health at
1.866.484.6798 for more assistance.
CANISTER FULL indicator
is lit.
Single beep.
The canister is full. •Visually assess the canister to see if full.
If the canister is full, change the canister.
• If the canister is not full, turn the SVED® o by pressing
the OFF Button and then turn the SVED® back on to
resume therapy.
The Canister Full alert begins when the
canister is 90 percent full, but the SVED®
continues to work until the canister
completely lls. If the SVED® device is
placed on its front, uid entering the
canister will cause a false Canister Full
Alert and the canister must be changed.
If alert continues, call Cardinal Health at
1.866.484.6798 for more assistance.
Pressure will not
change.
Pressure Setting has been
locked by the clinician.
No action needed. Pressure Setting can only be changed per
a healthcare professional’s orders.
SVED® is quiet and uid
is not moving in the
tubing.
This is NOT a problem.
The dressing has a good seal
and the SVED® is maintaining
target pressure.
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 SVED® is
quiet.
Your healthcare professional will change
the SVED® if required.
ON Button is ashing.
The SVED® is making
more noise every ve
minutes.
This is NOT a problem.
The SVED® is in Intermittent
Mode.
No action needed. Intermittent Mode maintains target
pressure for 5 minutes and decreases to
-25mmHg for 2 minutes.
CAUTION: In the event of an emergency, please contact your treating physician, caregiver, or your local emergency responders.
NOTE: If an alert persists and cannot be resolved, please contact Cardinal Health Customer Service at 1.866.484.6798 for
further assistance.

14
4. Care & Cleaning
4. Care & Cleaning
Your healthcare professional will handle much of the care and cleaning needed for your SVED®. Pleaseperiodicallycheck
to make sure the SVED® is working properly.
If the SVED® does not seem to work properly or is showing an alert, refer to 3.2 Troubleshooting or 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: TheSVED® is rated IP22, but is not waterproof. Avoid spilling liquid on any part of theSVED®. Liquids can
cause corrosion when left on electronic controls which can lead to failure. Component failure may cause theSVED® to
operate erratically, possibly causing a potential hazard to the patient or caregiver. Avoid using theSVED® in or near the
shower or bathtub, as electric shock could occur.
WARNING: The SVED® should only be used with the supplied A.C. Power Adapter. Use of an incorrectly rated adapter or
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, tubings, clamps, used canisters and any other disposables.
Ask your healthcare professional what to do with a used canister you have changed yourself.
Dispose of all disposable components in accordance with local, state and federal regulations.
4.2 Cleaning the SVED®
The SVED® should need only light cleaning. Make sure to unplug the SVED® before cleaning.The battery provides power
so negative pressure wound therapy is not interrupted. Clean the SVED® with a damp soft cloth and a mild detergent
and water solution.
Do not saturate the SVED® with liquid or allow liquid to pool on the SVED®.This can present a potential hazard for you
and/or your healthcare professional.
WARNING: The SVED® and associated A.C. Power Adapter are not designed to be immersed underwater. Do not
immerse the SVED®, A.C. Power Adapter, or accessories in water or other cleaning solutions. Failure to follow the
cleaning procedures described herein could result in hazards to users, patients and clinicians. As with any powered
electrical device, care must be taken to prevent liquid from entering the device or A.C. Power Adapter to avoid electrical
shock, re or damage to electrical components.

15
4. Care & Cleaning
Directions for cleaning the A.C. Power Adapter
• Unless soiling is observed, the A.C. Power Adapter should not be cleaned.
• If cleaning the A.C. Power Adapter is necessary, unplug and wipe the exterior surfaces with a cloth dampened with
isopropyl alcohol.
• Allow excess moisture to evaporate prior to use.
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 SVED® should only be used with the supplied A.C. Power Adapter. Use of an incorrectly rated adapter or
power cord could result in physical hazards, including delayed therapy, electrocution and re.These hazards could result
in injury or death.
WARNING: Avoid spilling liquid on any part of the SVED®. Liquids can cause corrosion when left on electronic controls
which can lead to failure. Component failure may cause the SVED® to operate erratically, possibly causing a potential hazard
to the patient or caregiver.

16
5. Symbols
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

17
5. Symbols
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

18
5. Symbols
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
that 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
that 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

19
5. Symbols
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, Sym-
bol 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
ElectroMagnetic
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
equipment 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.

20
5. Symbols
Symbol Standard/Law
Reference Standard/Law Title Symbol Title/ Text Reference Explanatory Text
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.
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 or
recycling instructions for
this product. Residents
outside the European Union
must dispose of or recycle
this product in accordance
with local laws or
regulations that apply.