Cardinal Health CATALYST NPWT User manual

1
Cardinal Health™ Negative Pressure
Wound Therapy CATALYST™
Patient User Manual

Patient User Manual
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About Your Cardinal Health™ CATALYST™
Your doctor has chosen the Cardinal Health CATALYST™ to remove uid from your wound by using carefully controlled
suction. It is important, however, for you to carefully watch the wound and the CATALYST™ 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 CATALYST™
• Do not allow the CATALYST™ to get wet. Clamp the tubing (if clamp is present) and disconnect from the canister if
you take a bath or shower.
• Keep the CATALYST™ 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 CATALYST™ upright to avoid a false Canister Full/Blockage alert.
• Keep the CATALYST™ 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 CATALYST™ 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 CATALYST™ 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 CATALYST™.
• Who to call if you need help.
• How to take care of your CATALYST™.
This CATALYST™ 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 CATALYST™ to provide safe, reliable and proper performance, the following conditions must be met.
Failure to comply with these conditions voids 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.
• The electrical outlets of the room in which the CATALYST™ is used complies with the appropriate national
electrical standards.
• The CATALYST™ must be used in accordance with this Patient User Manual and all associatedlabeling.
CAUTION: Federal law restricts the CATALYST™ for 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
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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 Catalyst™. 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 Catalyst™ 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 Catalyst™ 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 Occlusion Detection Dressing or Kendall™ NPWT Incision
Management 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 Catalyst™ only as described in this User Manual. Do not interconnect the Catalyst™ with other
devices not included in this user manual. Failure to comply could result in improper therapy and could result in damage
to the Catalyst™.
CAUTION: This system is not intended to be used in MRI environments or in the presence of strong magnetic elds. Do
not use the CATALYST™ 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 Catalyst™ system can be used outdoors for short periods of time (not more than 24 hours). Shelter from
the rain.

Patient User Manual
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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 CATALYST™............................................................7
2.1 Getting to Know the CATALYST™ ...............................................................7
2.2 Charging the Battery.........................................................................8
2.3 Changing the Canister.......................................................................10
2.4 Disconnecting from the CATALYST™ ...........................................................12
3. Operating Instructions .................................................................13
3.1 On/O ....................................................................................13
3.2Troubleshooting............................................................................14
4. Care & Cleaning........................................................................18
4.1 Disposal of Used Components ................................................................18
4.2 Cleaning the CATALYST™.....................................................................18
4.3 A.C. Power Adapter Inspection................................................................18
5. Symbols Glossary ......................................................................19
6. Specications .........................................................................28
6.1 Electromagnetic Compatibility ...............................................................29
7. Questions & Information................................................................31

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1. Introduction
1. Introduction
1.1 Indications
The CATALYST™ 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
CATALYST™ may promote wound healing by the removal of uids, including wound exudates, irrigation uids, body
uids and infectious materials.
When used with the Cardinal Health™ Occlusion Detection Dressing, the CATALYST™ 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 CATALYST™ NPWT system is
intended for use in acute, extended and home care settings.
The Kendall™ NPWT Incision Management Dressing Kit, when used with Cardinal Health™ NPWT CATALYST™, is
intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure
by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
The Cardinal Health™ NPWT CATALYST™ System is intended for use in acute, extended and home care settings.
1.2 Contraindications
The CATALYST™ 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 Occlusion
Detection Dressing or Kendall™ NPWT Incision Management Dressing over exposed blood vessels or organs.The
Cardinal Health™ NPWT Occlusion Detection Dressings and Kendall™ NPWT Incision Management 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 infected wounds, active bleeding, dicult wound hemostasis or if you are taking
anticoagulants.
• Debrillation: The NPWT Occlusion Detection Dressing or NPWT Incision Management 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 CATALYST™ is not MRI-compatible and cannot be used in the
presence of strong magnetic elds. Do not take the CATALYST™ into the MRI area or any area of high magnetic
elds.The CATALYST™ contains metal components that could cause unintended movement resulting in harm due
to falling objects or collisions.
• Hyperbaric Oxygen Therapy (HBO): Do not take CATALYST™ — whether on or o — into a hyperbaric
chamber. The CATALYST™ must be disconnected before HBO treatment.
• During negative pressure wound therapy, CATALYST™ and NPWT Occlusion Detection Dressing or NPWT Incision
Management Dressing are a closed system and are NOT vented to atmosphere.
• During negative pressure wound therapy, when the canister lls with uid, it should be replaced immediately.
Fluids are not removed from the dressing once the canister is full.

6
1. Introduction
1.4 Safety Tips
Keep Therapy On
The CATALYST™ 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 CATALYST™ is o for more than
2 hours in a 24-hour period.Your dressing must be changed by your healthcare professional.
Troubleshooting
If the CATALYST™ alerts or does not seem to operate properly, see 3.2 Troubleshooting.
Monitoring the Wound
Inspect the dressing frequently to ensure that the foam is collapsed and that negative pressure wound therapy is being
delivered in a consistent manner. 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
CATALYST™, 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 CATALYST™ until the serious infection is diagnosed and properly treated by your healthcare professional.
NPWT Occlusion Detection Dressing or Kendall™ NPWT Incision Management 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 Dressing Kits are sterile. The decision to use clean versus sterile/aseptic technique
is dependent upon your healthcare professional’s preference. All components of the CATALYST™, the Dressing Kits,
the canisters and other accessories are made without natural rubber latex.
NOTE: Lint, dust and light (including sunlight) has no eect on the performance of the system. Keep away from
pets or children.
Be sure to comply with all 1.2 Contraindications and 1.3 Precautions for the CATALYST™.

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2. Introduction to the CATALYST™
2. Introduction to the CATALYST™
2.1 Getting to Know the CATALYST™
You may not need to use many of the buttons on the CATALYST™, but it is important that you are familiar with what they
are and their location (Figure 1).
NOTE: The CATALYST™ is quiet during normal operation with a well-sealed dressing.
Canister Release Button
ON Button
OFF Button
Canister Full/Blockage Alert
Canister
Pressure Settings
Battery Charging Port
Plugged In
Battery Charging
Therapy Timer/Display
Low Pressure/Leak Alert
Figure 1
NPWT Incision Management Dressing
The Kendall™ Negative PressureWoundTherapy Incision Management Dressing Kit is a wound dressing kit to be used
with Cardinal Health™ Negative PressureWoundTherapy (NPWT) CATALYST™, ALLY™ and ALLYTO GO™ systems
(K171499).The disposable single-use sterile Kendall™ NPWT Incision Management Dressing Kit consists of ve
dressing congurations, tubing and drape strips.The dressing covers the closed surgical site and forms a seal over
the sutured or stapled surgical site.The proximal end of the tubing is attached to the dressing while the distal end
of the tubing attaches to an exudate canister. The powered suction pump delivers negative pressure to the dressing
to aid in the removal of exudate from the wound into the exudate canister. The drape strips are used to patch any air
leaks if necessary.

8
2. Introduction to the CATALYST™
2.2 Charging the Battery
The CATALYST™ 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 sounds to let you know you must plug in the CATALYST™ to charge the battery.
See 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 left side of the CATALYST™ (Figure 2).
Figure 2
3. When the CATALYST™ is connected to an outlet, the green light next to the Plugged In symbol comes on (Figure 3).
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.
Plugged In
Battery Charging
Figure 3
NOTE: If the CATALYST™ is plugged in and green light does not turn on, check to make sure outlet is
working properly.
4. The CATALYST™ continues to work when charging.
CAUTION: The CATALYST™ must only be used with the supplied A.C. Power Adapter. Use of any other A.C. Power
Adapter or charger could create a shock hazard, cause re or severely damage the CATALYST™.

9
2. Introduction to the CATALYST™
Average Battery Life
The battery life of the CATALYST™ 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 CATALYST™ should be connected to an outlet via the A.C. Power
Adapter for approximately 3 hours. After approximately 2 hours of charging, the CATALYST™ reaches 80 percent of total
battery capacity.
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 CATALYST™ continues to operate
for approximately 1 hour after the Low Battery alert sounds.
If the battery charge gets too low, the CATALYST™ shuts o and the negative pressure wound therapy is stopped. At this
point, the CATALYST™ 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 CATALYST™.

10
2. Introduction to the CATALYST™
2.3 Changing the Canister
When the CATALYST™ detects that the canister needs to be changed, a Canister Full/Blockage alert sounds.The CATALYST™
continues to work until the canister completely lls.When the canister is completely full, the CATALYST™ turns o.
To change the canister:
1. Clamp the tubing closed (Figure 4).
NOTE: Only applicable if clamp is present. If clamp is not present, skip to the next step.
Figure 4
2. Turn the CATALYST™ o by pressing the OFF Button.
3. Grasp the blueTwist N’Connect™ end of the tubing attached to the canister. Gently twist counterclockwise and
pull up to remove tubing from canister (Figure 5).
Figure 5

11
2. Introduction to the CATALYST™
4. To remove the canister, press the Canister Release Button located above the canister (Figure 6), grasp the canister
at the bottom and gently pull downward.
Figure 6
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 ports and press upwards until it“clicks”into place (Figure 7).
Figure 7
8. Gently line up the blueTwist N’Connect™ end of the tubing to the blueTwist N’Connect™ port on the canister,
push down and twist clockwise to lock into place (Figure 8).
Figure 8

12
2. Introduction to the CATALYST™
9. Reopen the tubing clamp by pushing down on the top of the clamp until it releases (Figure 9).
NOTE: Only applicable if clamp is present. If clamp is not present, skip to the next step.
Figure 9
10. Turn the CATALYST™ on by pressing the ON Button to resume negative pressure wound therapy.
2.4 Disconnecting from the CATALYST™
You may disconnect the CATALYST™ 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 CATALYST™ 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 CATALYST™:
1. Clamp the tubing closed (Figure 4).
NOTE: Only applicable if clamp is present. If clamp is not present, skip to the next step.
2. Turn the CATALYST™ o by pressing the OFF Button.
3. Grasp the blueTwist N’Connect™ end of the tubing attached to the canister. Gently twist counterclockwise
and pull up to remove tubing from canister (Figure 7).
4. If canister is full, change the canister (2.3 Changing the Canister).
To reconnect to the CATALYST™:
1. Gently line up the blueTwist N’Connect™ end of the tubing to the blueTwist N’Connect™ port on the canister,
push down and twist clockwise to lock into place (Figure 8).
2. Reopen the tubing clamp by pushing down on the top of the clamp until it releases.
NOTE: Only applicable if clamp is present. If clamp is not present, skip to the next step.
3. Turn the CATALYST™ on by pressing the ON Button to resume negative pressure wound therapy.

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3. Operating Instructions
3. Operating Instructions
Carefully read 1.3 Precautions and 1.4 Safety Tips in 1. Introduction section before attempting to operate
the CATALYST™.
CAUTION: The CATALYST™ should only be used with the supplied A.C. Power Adapter or Global Power Adapter.The
Global Power Adapter must be purchased separately. Use of another adapter/power cord could create a shock hazard for
you or your caregiver, cause re and/or severely damage the CATALYST™. 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 CATALYST™ (Figure 10).
OFF Button
ON Button
Figure 10
1. Press the ON Button. All lights show for 1 second during the power-on self-test. When nished, the ON Button
stays green (Figure 11).
Figure 11
2. The dressing should collapse, indicating the presence of negative pressure. If there is a Low Pressure/Leak alert,
there may be a problem (3.2 Troubleshooting).
3. The CATALYST™ should be operated at least 22 hours out of every 24-hour period. Contact your healthcare
professional if the CATALYST™ 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.
CAUTION: In the event of an emergency, please contact your treating physician, caregiver or your local
emergency responders.

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3. Operating Instructions
3.2 Troubleshooting
Clearing an Alert
To clear an alert, use the Troubleshooting table below.
To manually reset an alert, turn the CATALYST™ OFF then back ON.The alert will clear when the power is cycled.
WHAT YOU
SEE/HEAR
1. Low Pressure/Leak
BLINK
Push up
on bottom
of canister.
Wait 30 seconds
BEEP BLINK
++
WHAT TO DO
1
If you see: If you see/hear:
SOLID LIGHT
2
Call Cardinal Health
at 1.866.484.6798
Low Pressure/Leak
is xed.
+ +
Low
Pressure/
Leak
BLINK BLINKBEEP

15
3. Operating Instructions
2. Canister Full/Blockage - With Clamp on Tubing
If alert
continues,
go to step 3.
2
If alert
stays on, go
to step 5.
4
Make sure
clamp is
OPEN.
1Wait
30 seconds
Wait
30 seconds
Look for kinks in
tubing. Unkink
if found.
3
Turn ON.
8
Clamp tubing and remove
canister (see “Changing the
Canister” on front page).
6
Replace with new canister,
reattach tubing and open clamp
(see “Changing the Canister” on front page).
7
Turn OFF.
5
If you see: If you see/hear:
Canister Full/Blockage
is xed.
BLINK BLINK
9
Wait
1 minute
BEEP
Call Cardinal Health
at 1.866.484.6798
SOLID LIGHT
+ +
WHAT YOU
SEE/HEAR BLINK BEEP BLINK
++
Canister
Full/
Blockage
First, look at the canister to see if it is full. If the canister is full, change
the canister (see “Changing the Canister” on front page). If the canister
is not full, proceed with the steps below.
WHAT TO DO
NOTE: A false Canister Full/Blockage alert can occur if drainage moves into the canister while the CATALYST™ is lying on
its front (the button side) or if it is turned upside down. If this occurs, you must change the canister to resume device
operation. Always keep the CATALYST™ upright.

16
3. Operating Instructions
3. Canister Full/Blockage - Without Clamp
WHAT YOU
SEE/HEAR BLINK BEEP BLINK
++
Canister
Full/
Blockage
First, look at the canister to see if it is full. If the canister is full, change
the canister (see “Changing the Canister” on front page). If the canister
is not full, proceed with the steps below.
WHAT TO DO
Turn ON.
21 Wait
30 seconds
If you see: If you see/hear:
Canister Full/Blockage
is xed. Call Cardinal Health at 1.866.484.6798
SOLID LIGHT
+ +
BLINK BLINKBEEP
Turn OFF.
NOTE: A false Canister Full/Blockage alert can occur if drainage moves into the canister while the CATALYST™ is lying
on its front (the button side) or if it is turned upside down. If this occurs, you must change the canister to resume
device operation. Always keep the CATALYST™ upright.

17
3. Operating Instructions
WHAT YOU
SEE/HEAR
4. Battery Low
BLINK
Plug A.C. Power Adapter into outlet. Wait 30 seconds
CHIRP
+
WHAT TO DO
1
If you see: If you see/hear:
SOLID LIGHT
2
BLINK CHIRP
Call Cardinal Health
at 1.866.484.6798
Low battery xed.
+
WHAT YOU
SEE/HEAR
5. Intermittent Mode
WHAT TO DO
CATALYST™ makes more noise every 5 minutes when in Intermittent Mode. No
troubleshooting needed. For more information, contact your healthcare professional.
BLINK
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.

18
4. Care & Cleaning
4. Care & Cleaning
Your healthcare professional will handle much of the care and cleaning needed for your CATALYST™. Periodically check
to make sure the CATALYST™ is working properly and look for signs that uid has entered into the CATALYST™.
If the CATALYST™ 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: The CATALYST™ 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 CATALYST™
The CATALYST™ should only need light cleaning. Make sure to unplug the CATALYST™ before cleaning.The battery
provides power when the CATALYST™ is unplugged so negative pressure wound therapy is not interrupted. Clean the
CATALYST™ with a damp soft cloth and a mild soap and water solution.
Do not saturate the CATALYST™ with liquid or allow liquid to pool on the device.This can present a potential hazard for
you and/or your healthcare professional.
WARNING: Avoid spilling or spraying liquid on any part of the CATALYST™. Liquids can cause corrosion when left
on electronic controls which can lead to failure. Component failure may cause the CATALYST™ 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.
CAUTION: The CATALYST™ 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.

19
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

20
5. Symbols Glossary
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
Limitation
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