DeRoyal Prospera PRO Series User manual
SAFETY US-CA
E355754
USER MANUAL
DeRoyal®Prospera®PRO Series
Negative Pressure Wound Therapy System
PRO-II®and PRO-III®
AS TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005),
CAN/CSA-C22.2 No. 60601-1
(2008)
3
Table of Contents
1.1 Using this Instruction Manual .................................................................... 5
1.2 Icons...................................................................................................... 5
1.2.1 General Symbols ................................................................................. 5
1.2.2 Device and Packaging........................................................................... 5
1.2.3 Display ............................................................................................... 6
1.3 Symbol Convention .................................................................................. 6
1.4 Glossary ................................................................................................. 7
1.5 Intended Use .......................................................................................... 8
1.5.1 Indications.......................................................................................... 8
1.5.2 Contraindications ................................................................................. 8
1.5.3 Precautions ......................................................................................... 8
1.5.4 Restrictions on use............................................................................... 9
1.6 Basic Safety Instructions .......................................................................... 9
1.7 User Requirements .................................................................................11
1.8 Information on Product Liability ................................................................11
1.9 Material Compatibility..............................................................................11
2.1 Whole View ............................................................................................12
2.1.1 PRO-II® Device ...................................................................................12
2.1.2 PRO-II® Device product contents ..........................................................12
2.1.3 Pro-III® Device ...................................................................................13
2.1.4 PRO-III® Device product contents .........................................................13
2.2 Product Properties ..................................................................................14
2.2.1 Disposable exudate canister for PRO-II® Device ......................................14
2.2.2 Information on the filter system for the PRO-II® Device ...........................15
2.2.3 Information on the carbon filter of the PRO-II® Device............................15
2.2.4 Disposable exudate canister system for PRO-III® Device ..........................15
2.2.5 Information on the double filter system for PRO-III®Device.....................16
2.2.6 Battery ..............................................................................................16
2.2.7 Pressure settings ................................................................................17
2.3 Warranty ...............................................................................................17
3.1 Set-Up and Startup.................................................................................19
3.1.1 Startup..............................................................................................19
3.1.2 Connecting the PRO-II®and PRO-III® Devices ........................................19
3.1.3 Positioning of the PRO-II®Devices ........................................................20
3.1.4 Connecting the disposable exudate canister of the PRO-II® Device ............20
3.1.5 Positioning of the PRO-III® Device.........................................................20
3.1.6 Connecting the DeRoyal®disposable exudate canister system of the PRO-III®
Device ...............................................................................................21
3.1.7 Connecting a wound drainage system....................................................21
3.2 Operation of the PRO-II®and PRO-III® Devices ..........................................22
3.2.1 Operation at initial startup ...................................................................22
3.2.2 Continuous operation ..........................................................................23
3.2.3 Intermittent operation .........................................................................24
3.2.4 Language selection .............................................................................26
3.2.5Alarm delay at startup.........................................................................26
3.3 Patient Mode ..........................................................................................27
3.4 Canister exchange ..................................................................................29
3.4.1 Replacement of the canister of the PRO-II® Device..................................29
3.4.2 Replacement of the canister of the PRO-III® Device ................................29
4.1 Cleaning and Care ..................................................................................30
4.1.1 General Information ............................................................................30
4.1.2 Cleaning and disinfection of the surface of the device ..............................30
4.1.3 Disposal of the exudate canister incl. the suction tube for PRO-II® Device ..31
3
Table of Contents
1.1 Using this Instruction Manual .................................................................... 5
1.2 Icons...................................................................................................... 5
1.2.1 General Symbols ................................................................................. 5
1.2.2 Device and Packaging........................................................................... 5
1.2.3 Display ............................................................................................... 6
1.3 Symbol Convention .................................................................................. 6
1.4 Glossary ................................................................................................. 7
1.5 Intended Use .......................................................................................... 8
1.5.1 Indications.......................................................................................... 8
1.5.2 Contraindications ................................................................................. 8
1.5.3 Precautions ......................................................................................... 8
1.5.4 Restrictions on use............................................................................... 9
1.6 Basic Safety Instructions .......................................................................... 9
1.7 User Requirements .................................................................................11
1.8 Information on Product Liability ................................................................11
1.9 Material Compatibility..............................................................................11
2.1 Whole View ............................................................................................12
2.1.1 PRO-II® Device ...................................................................................12
2.1.2 PRO-II® Device product contents ..........................................................12
2.1.3 Pro-III® Device ...................................................................................13
2.1.4 PRO-III® Device product contents .........................................................13
2.2 Product Properties ..................................................................................14
2.2.1 Disposable exudate canister for PRO-II® Device ......................................14
2.2.2 Information on the filter system for the PRO-II® Device ...........................15
2.2.3 Information on the carbon filter of the PRO-II® Device............................15
2.2.4 Disposable exudate canister system for PRO-III® Device ..........................15
2.2.5 Information on the double filter system for PRO-III®Device.....................16
2.2.6 Battery ..............................................................................................16
2.2.7 Pressure settings ................................................................................17
2.3 Warranty ...............................................................................................17
3.1 Set-Up and Startup.................................................................................19
3.1.1 Startup..............................................................................................19
3.1.2 Connecting the PRO-II®and PRO-III® Devices ........................................19
3.1.3 Positioning of the PRO-II®Devices ........................................................20
3.1.4 Connecting the disposable exudate canister of the PRO-II® Device ............20
3.1.5 Positioning of the PRO-III® Device.........................................................20
3.1.6 Connecting the DeRoyal®disposable exudate canister system of the PRO-III®
Device ...............................................................................................21
3.1.7 Connecting a wound drainage system....................................................21
3.2 Operation of the PRO-II®and PRO-III® Devices ..........................................22
3.2.1 Operation at initial startup ...................................................................22
3.2.2 Continuous operation ..........................................................................23
3.2.3 Intermittent operation .........................................................................24
3.2.4 Language selection .............................................................................26
3.2.5Alarm delay at startup.........................................................................26
3.3 Patient Mode ..........................................................................................27
3.4 Canister exchange ..................................................................................29
3.4.1 Replacement of the canister of the PRO-II® Device..................................29
3.4.2 Replacement of the canister of the PRO-III® Device ................................29
4.1 Cleaning and Care ..................................................................................30
4.1.1 General Information ............................................................................30
4.1.2 Cleaning and disinfection of the surface of the device ..............................30
4.1.3 Disposal of the exudate canister incl. the suction tube for PRO-II® Device ..31
4
4.1.4 Disposal of the canister and the suction tube for PRO-III® Device .............31
4.2 Maintenance and Service .........................................................................31
4.3 Testing the PRO-II®or PRO-III® Devices....................................................31
5.1 Function Test .........................................................................................32
5.2 Troubleshooting......................................................................................32
5.3 Error Messages.......................................................................................33
6.1 Decontamination prior to shipment ...........................................................35
6.2 Storage .................................................................................................35
6.3 Disposal ................................................................................................35
7.1 PRO-II® Device .......................................................................................36
7.2 PRO-III® Device......................................................................................37
7.3 EMC Information.....................................................................................38
8.1 PRO-II® Device .......................................................................................43
8.2 PRO-III® Device......................................................................................43
5
1User Information
1.1 Using this Instruction Manual
Read the entire User Manual before operating the DeRoyal® Prospera® PRO-II® (NP-2000)
or PRO-III® (NP-3000) negative pressure wound therapy devices (hereinafter the “PRO-II®”
and “PRO-III®” devices, respectively) for the first time.
•Read the safety instructions (chapter 1.6) to avoid hazards.
•The User Manual is a component of the PRO-II® and PRO-III® devices.
•Keep the User Manual in an easily accessible location.
•Include the User Manual when passing the PRO-II® or PRO-III® device onto third
parties.
•For additional copies of the User Manual, contact DeRoyal Customer Service within
the US, please call 1-800-251-9864; internationally please call +1-865-938-7828.
1.2 Icons
1.2.1 General Symbols
Symbol
Meaning
Symbol
Meaning
CAUTION
Warning of possible bodily
injury or health risk.
WARNING
Warning of severe bodily
injury or resulting death.
ATTENTION
Warning of possible property
damage.
NOTE
Note containing useful
information and tips.
Radiofrequency - RF
MRI - Unsafe
1.2.2 Device and Packaging
Symbol
Meaning
Symbol
Meaning
Protect from moisture.
This device must not be
disposed of in domestic waste.
Protection class II
Order number
Air pressure limitation
Serial number
Humidity limitation
Lot number
Follow the instruction for
use. Date of manufacture
Protection class: Type BF
(Body Floating) Manufacturer
Temperature limitation
Do not use if packaging is
damaged!
Power supply unit
Do not reuse
Only available on
prescription
4
4.1.4 Disposal of the canister and the suction tube for PRO-III® Device .............31
4.2 Maintenance and Service .........................................................................31
4.3 Testing the PRO-II®or PRO-III® Devices....................................................31
5.1 Function Test .........................................................................................32
5.2 Troubleshooting......................................................................................32
5.3 Error Messages.......................................................................................33
6.1 Decontamination prior to shipment ...........................................................35
6.2 Storage .................................................................................................35
6.3 Disposal ................................................................................................35
7.1 PRO-II® Device .......................................................................................36
7.2 PRO-III® Device......................................................................................37
7.3 EMC Information.....................................................................................38
8.1 PRO-II® Device .......................................................................................43
8.2 PRO-III® Device......................................................................................43
5
1User Information
1.1 Using this Instruction Manual
Read the entire User Manual before operating the DeRoyal® Prospera® PRO-II® (NP-2000)
or PRO-III® (NP-3000) negative pressure wound therapy devices (hereinafter the “PRO-II®”
and “PRO-III®” devices, respectively) for the first time.
•Read the safety instructions (chapter 1.6) to avoid hazards.
•The User Manual is a component of the PRO-II® and PRO-III® devices.
•Keep the User Manual in an easily accessible location.
•Include the User Manual when passing the PRO-II® or PRO-III® device onto third
parties.
•For additional copies of the User Manual, contact DeRoyal Customer Service within
the US, please call 1-800-251-9864; internationally please call +1-865-938-7828.
1.2 Icons
1.2.1 General Symbols
Symbol
Meaning Symbol
Meaning
CAUTION
Warning of possible bodily
injury or health risk.
WARNING
Warning of severe bodily
injury or resulting death.
ATTENTION
Warning of possible property
damage.
NOTE
Note containing useful
information and tips.
Radiofrequency - RF
MRI - Unsafe
1.2.2 Device and Packaging
Symbol
Meaning
Symbol
Meaning
Protect from moisture.
This device must not be
disposed of in domestic waste.
Protection class II
Order number
Air pressure limitation
Serial number
Humidity limitation
Lot number
Follow the instruction for
use. Date of manufacture
Protection class: Type BF
(Body Floating) Manufacturer
Temperature limitation
Do not use if packaging is
damaged!
Power supply unit
Do not reuse
Only available on
prescription
6
1.2.3 Display
Symbol Meaning
Battery full
Battery low
Battery empty
Up
Down
OK (On, Enter)
Cancel (Off, Back)
Power supply unit is connected.
Max pressure / Max time
Min pressure / Min time
Keylock (symbol in display)
Activated automatically during operation and can be canceled by
simultaneously pressing the Up and Down buttons.
Filter run time elapsed; replacement of the internal filter by an
authorized DeRoyal service technician is required.
Alarm display settings
X = Represents Sensitivity of “System
closed” alarms
Y = Represents Sensitivity of “Check dressing
seal” alarms
1.3 Symbol Convention
Symbol Meaning
• Enumeration
1.
2.
3.
Perform the process in the specified order.
7
1.4 Glossary
A
approx.
Abbreviation for “approximately”
C
Contamination
Contamination means that liquids, exudate, bacteria and/or viruses
from the wound or environment have come into contact with the
interior of the device.
E
e.g.
For example, abbreviation for Latin “exempli gratia”
I
incl.
Abbreviation for “inclusive” or “including”
IP22
International Protection / Protection Class
The Protection Class defines the degree of protection of the device
against contact and ingress of liquids.
The PRO-II® and PRO-III® are protected against finger access and
falling water drops at an inclination of up to 15°.
O
Overflow
Overflow means that wound exudate is sucked into the interior of the
device.
W
Wound
exudate
The term wound exudate denotes all liquids and particles collected that
may be formed or present in a wound. The wound exudate is aspirated
from the wound using the PRO-II® and PRO-III® devices and collected in
a disposable exudate canister.
6
1.2.3 Display
Symbol Meaning
Battery full
Battery low
Battery empty
Up
Down
OK (On, Enter)
Cancel (Off, Back)
Power supply unit is connected.
Max pressure / Max time
Min pressure / Min time
Keylock (symbol in display)
Activated automatically during operation and can be canceled by
simultaneously pressing the Up and Down buttons.
Filter run time elapsed; replacement of the internal filter by an
authorized DeRoyal service technician is required.
Alarm display settings
X = Represents Sensitivity of “System
closed” alarms
Y = Represents Sensitivity of “Check dressing
seal” alarms
1.3 Symbol Convention
Symbol Meaning
• Enumeration
1.
2.
3.
Perform the process in the specified order.
7
1.4 Glossary
A
approx.
Abbreviation for “approximately”
C
Contamination
Contamination means that liquids, exudate, bacteria and/or viruses
from the wound or environment have come into contact with the
interior of the device.
E
e.g.
For example, abbreviation for Latin “exempli gratia”
I
incl.
Abbreviation for “inclusive” or “including”
IP22
International Protection / Protection Class
The Protection Class defines the degree of protection of the device
against contact and ingress of liquids.
The PRO-II® and PRO-III® are protected against finger access and
falling water drops at an inclination of up to 15°.
O
Overflow
Overflow means that wound exudate is sucked into the interior of the
device.
W
Wound
exudate
The term wound exudate denotes all liquids and particles collected that
may be formed or present in a wound. The wound exudate is aspirated
from the wound using the PRO-II® and PRO-III® devices and collected in
a disposable exudate canister.
8
1.5 Intended Use
These negative pressure wound therapy systems are indicated for patients that would
benefit from a suction device particularly as the device may promote wound healing by
removal of wound exudate, debris, and infectious material or for the aspiration and removal
of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the
patient's airway or respiratory support system. These devices may be used during surgery
or at the patient's bedside and are indicated for home use.
1.5.1 Indications
•Chronic Wounds
•Acute Wounds
•Subacute Wounds
•Traumatic Wounds
•Dehisced Wounds
•Partial Thickness Burns
•Ulcers (Such as diabetic or pressure)
•Flaps
•Grafts
1.5.2 Contraindications
The PRO-II® and PRO-III® devices are contraindicated for the following applications:
•Necrotic tissue with eschar present
•Unexplored or non-enteric fistulas
•Untreated osteomyelitis
•Wounds containing malignant tissue
•Exposed arteries, nerves (including vagus nerve), blood vessels, veins, or internal
organs
•Exposed anastomotic site
1.5.3 Precautions
Precautions must be taken in the following circumstances:
•Patients who receive anticoagulants and have active bleeding
•Patients with complicated wound hemostasis
•Use of the device in direct proximity to blood vessels, organs, muscles and fascias
•Irradiated vessels and tissues
•Bone fragments
•Non-compliant/non-responsive patients
•Untreated malnutrition
•Paralysis associated with the affected area or spinal cord injuries
•Circumferential dressing application
•Take extreme caution when the negative pressure wound therapy system is applied
in close proximity to friable vessels or potentially infected blood vessels.
•Infected wounds should be closely monitored and may require more frequent
dressing changes than non-infected wounds. View exudates for any sign of
infection, worsening infection, or other complications.
•Before using the negative pressure wound therapy system, all exposed or superficial
organs and vessels, nerves, tendon and ligaments in or around wound must be
completely covered and protected to avoid direct contact with wound dressing.
•When using the negative pressure wound therapy system, clinicians or caregivers
must keep written record of the type and number of wound dressing pieces that are
placed in the wound.
•Use of the negative pressure wound therapy system in a hyperbaric oxygen
chamber is prohibited. Negative pressure wound therapy is not suitable in this
environment and may be a fire hazard.
9
•In the event defibrillation is required, disconnect the DeRoyal negative pressure
wound therapy device from the wound dressing prior to defibrillation. Remove the
wound dressing if it will interfere with defibrillation.
•The patient height and weight should be considered before prescribing the DeRoyal
negative pressure wound therapy system. Infants, children, some small adults and
elderly patients should be closely monitored for excessive fluid loss and dehydration.
In addition, patients with heavily exudating wounds or large wounds should be
monitored carefully because they may have a risk of excessive fluid loss and
dehydration.
•NPWT must not be placed in proximity to the vagus nerve to minimize the risk of
bradycardia.
•If the patient appears to have autonomic dysreflexia (sudden changes in blood
pressure or heart rate stimulated by the sympathetic nervous system), immediately
stop negative pressure wound therapy to minimize the sensory stimulation and
immediately call for medical assistance.
•Protect fragile periwound skin with adhesive sealing films, hydrocolloid, or
transparent film dressing. Do not cover intact skin with gauze/foam dressing to
avoid risk of maceration or injury to tissue.
•Check the wound dressings at shift change or every 8 hours. Look for a wrinkled
appearance at the surface of the dressing, which indicates an occlusive
environment, thus maintaining proper suction.
1.5.4 Restrictions on use
•In medical rooms where potential equalization is necessary (e.g. heart surgery)
•In hazardous areas
•When patients use the device outside or outdoors, advise to not drop, overly shake
or permit the device to get wet or be exposed to other elements.
1.6 Basic Safety Instructions
CAUTION!
Health risks due to the handling of infectious liquids or pathogenic
germs.
Infectious and pathogenic germs in the wound exudate cause health risks.
•Perform wound treatment carefully.
•Follow the hygiene, cleaning and decontamination instructions.
WARNING!
Risk of damage due to improper power supply.
Improper operation causes overvoltage in the device, which may be
transmitted to the operator.
•Ensure prior to startup that the power supply is designed to operate at
supply voltages of 100-240 V alternating current.
•Ensure prior to startup in UL listed markets such as the USA and
Canada that the main supply is designed to operate at a supply
voltage of 120 V alternating current.
•Only operate the device with the provided power supply unit.
•Never connect the power supply unit to defective power sockets.
ATTENTION!
Risk of damage due to electromagnetic phenomena.
Medical electrical equipment is subject to special precautionary measures
regarding electromagnetic compatibility and must be installed and operated in
accordance with the EMC information provided in the accompanying
documentation (see chapter 7.3).
8
1.5 Intended Use
These negative pressure wound therapy systems are indicated for patients that would
benefit from a suction device particularly as the device may promote wound healing by
removal of wound exudate, debris, and infectious material or for the aspiration and removal
of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the
patient's airway or respiratory support system. These devices may be used during surgery
or at the patient's bedside and are indicated for home use.
1.5.1 Indications
•Chronic Wounds
•Acute Wounds
•Subacute Wounds
•Traumatic Wounds
•Dehisced Wounds
•Partial Thickness Burns
•Ulcers (Such as diabetic or pressure)
•Flaps
•Grafts
1.5.2 Contraindications
The PRO-II® and PRO-III® devices are contraindicated for the following applications:
•Necrotic tissue with eschar present
•Unexplored or non-enteric fistulas
•Untreated osteomyelitis
•Wounds containing malignant tissue
•Exposed arteries, nerves (including vagus nerve), blood vessels, veins, or internal
organs
•Exposed anastomotic site
1.5.3 Precautions
Precautions must be taken in the following circumstances:
•Patients who receive anticoagulants and have active bleeding
•Patients with complicated wound hemostasis
•Use of the device in direct proximity to blood vessels, organs, muscles and fascias
•Irradiated vessels and tissues
•Bone fragments
•Non-compliant/non-responsive patients
•Untreated malnutrition
•Paralysis associated with the affected area or spinal cord injuries
•Circumferential dressing application
•Take extreme caution when the negative pressure wound therapy system is applied
in close proximity to friable vessels or potentially infected blood vessels.
•Infected wounds should be closely monitored and may require more frequent
dressing changes than non-infected wounds. View exudates for any sign of
infection, worsening infection, or other complications.
•Before using the negative pressure wound therapy system, all exposed or superficial
organs and vessels, nerves, tendon and ligaments in or around wound must be
completely covered and protected to avoid direct contact with wound dressing.
•When using the negative pressure wound therapy system, clinicians or caregivers
must keep written record of the type and number of wound dressing pieces that are
placed in the wound.
•Use of the negative pressure wound therapy system in a hyperbaric oxygen
chamber is prohibited. Negative pressure wound therapy is not suitable in this
environment and may be a fire hazard.
9
•In the event defibrillation is required, disconnect the DeRoyal negative pressure
wound therapy device from the wound dressing prior to defibrillation. Remove the
wound dressing if it will interfere with defibrillation.
•The patient height and weight should be considered before prescribing the DeRoyal
negative pressure wound therapy system. Infants, children, some small adults and
elderly patients should be closely monitored for excessive fluid loss and dehydration.
In addition, patients with heavily exudating wounds or large wounds should be
monitored carefully because they may have a risk of excessive fluid loss and
dehydration.
•NPWT must not be placed in proximity to the vagus nerve to minimize the risk of
bradycardia.
•If the patient appears to have autonomic dysreflexia (sudden changes in blood
pressure or heart rate stimulated by the sympathetic nervous system), immediately
stop negative pressure wound therapy to minimize the sensory stimulation and
immediately call for medical assistance.
•Protect fragile periwound skin with adhesive sealing films, hydrocolloid, or
transparent film dressing. Do not cover intact skin with gauze/foam dressing to
avoid risk of maceration or injury to tissue.
•Check the wound dressings at shift change or every 8 hours. Look for a wrinkled
appearance at the surface of the dressing, which indicates an occlusive
environment, thus maintaining proper suction.
1.5.4 Restrictions on use
•In medical rooms where potential equalization is necessary (e.g. heart surgery)
•In hazardous areas
•When patients use the device outside or outdoors, advise to not drop, overly shake
or permit the device to get wet or be exposed to other elements.
1.6 Basic Safety Instructions
CAUTION!
Health risks due to the handling of infectious liquids or pathogenic
germs.
Infectious and pathogenic germs in the wound exudate cause health risks.
•Perform wound treatment carefully.
•Follow the hygiene, cleaning and decontamination instructions.
WARNING!
Risk of damage due to improper power supply.
Improper operation causes overvoltage in the device, which may be
transmitted to the operator.
•Ensure prior to startup that the power supply is designed to operate at
supply voltages of 100-240 V alternating current.
•Ensure prior to startup in UL listed markets such as the USA and
Canada that the main supply is designed to operate at a supply
voltage of 120 V alternating current.
•Only operate the device with the provided power supply unit.
•Never connect the power supply unit to defective power sockets.
ATTENTION!
Risk of damage due to electromagnetic phenomena.
Medical electrical equipment is subject to special precautionary measures
regarding electromagnetic compatibility and must be installed and operated in
accordance with the EMC information provided in the accompanying
documentation (see chapter 7.3).
10
CAUTION!
Hazards may be caused by improper handling.
•Use the device for its intended purpose only.
•When using the power supply unit, make sure the power supply unit is
connected to the main supply (100 V - 240 V AC) only after the power
cord plug of the power supply unit has first been connected to the
suction device.
•The separation of the power supply unit from the main supply must
occur in exactly the opposite sequence (first separate the power
supply unit from the mains supply (100 V - 240 V AC) and then the
power cord plug from the suction device).
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device if there is damage to the exterior housing.
CAUTION!
Safety defects due to improper accessories and spare parts.
The use of accessories, canisters and spare parts other than those
recommended by and sold from DeRoyal may compromise the safety and
function of the device. Warranty does not cover damage caused by using
non-recommended accessories and spare parts or by improper use in any
case.
•Only use DeRoyal approved accessories and spare parts.
ATTENTION!
Damage to the device by intake/exposure of liquids.
•Do not use the device near splashing water.
•Do not use the device in damp rooms or while bathing/showering.
•Do not allow the power supply unit, plug and display film to get wet.
•Never submerge the device in water or other liquids.
ATTENTION!
Damage to the device by heat.
•Do not cover the power supply unit.
•Keep the device as well as the power cord and power supply unit away
from other heat sources.
CAUTION!
Hazard of persons due to strangulation.
People may strangle themselves on the tubing or the power cord.
•Ensure that no unauthorized/uninvolved personnel is near the device
during use.
•Store the device and accessories in the shipping carton or other
approved DeRoyal provided hard-exterior carrying cases.
ATTENTION!
Known or identifiable conditions for medical care within a domestic
environment
•Children and pets must be kept away from the device to ensure that
the device is not knocked over or dropped.
•Prior to connecting the power supply unit, ensure that the voltage of
the device corresponds to the domestic power supply.
•Do not use the device in damp rooms, baths or showers.
•Do not allow the power supply unit or plug or device to get wet.
•Never submerge the device in water or other liquids.
•Incandescent light may affect the readability of the display negatively.
11
1.7 User Requirements
The PRO-II®or PRO-III® device must only be operated and used by instructed and trained
personnel.
Familiarize yourself with the functions of the PRO-II® or PRO-III® device prior to startup.
Training on the operation of PRO-II® and PRO-III® devices is provided by DeRoyal or an
authorized distribution partner of DeRoyal. Product training takes approximately one to two
hours and includes an explanation of the design and function of the device, the handling of
the device, the alarm system, and the cleaning and disinfection of the device.
Training should be repeated on a regular basis or at least every 24 months.
1.8 Information on Product Liability
The liability for the operation of the device is channeled to the operator in the following
cases:
•the device is used outside its intended use,
•the device is not used in accordance with the instruction for use,
•the device is opened by unauthorized personnel,
•installation, settings, enhancements, routine maintenance or repairs are performed
by unauthorized personnel,
•unauthorized accessories and spare parts have been used, or
•the device is used beyond its lifetime of 3 years.
1.9 Material Compatibility
ATTENTION!
Aggressive substances may damage the device and the
accessories.
•Please follow the cleaning and care instructions (chapter 4.1)
10
CAUTION!
Hazards may be caused by improper handling.
•Use the device for its intended purpose only.
•When using the power supply unit, make sure the power supply unit is
connected to the main supply (100 V - 240 V AC) only after the power
cord plug of the power supply unit has first been connected to the
suction device.
•The separation of the power supply unit from the main supply must
occur in exactly the opposite sequence (first separate the power
supply unit from the mains supply (100 V - 240 V AC) and then the
power cord plug from the suction device).
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device if there is damage to the exterior housing.
CAUTION!
Safety defects due to improper accessories and spare parts.
The use of accessories, canisters and spare parts other than those
recommended by and sold from DeRoyal may compromise the safety and
function of the device. Warranty does not cover damage caused by using
non-recommended accessories and spare parts or by improper use in any
case.
•Only use DeRoyal approved accessories and spare parts.
ATTENTION!
Damage to the device by intake/exposure of liquids.
•Do not use the device near splashing water.
•Do not use the device in damp rooms or while bathing/showering.
•Do not allow the power supply unit, plug and display film to get wet.
•Never submerge the device in water or other liquids.
ATTENTION!
Damage to the device by heat.
•Do not cover the power supply unit.
•Keep the device as well as the power cord and power supply unit away
from other heat sources.
CAUTION!
Hazard of persons due to strangulation.
People may strangle themselves on the tubing or the power cord.
•Ensure that no unauthorized/uninvolved personnel is near the device
during use.
•Store the device and accessories in the shipping carton or other
approved DeRoyal provided hard-exterior carrying cases.
ATTENTION!
Known or identifiable conditions for medical care within a domestic
environment
•Children and pets must be kept away from the device to ensure that
the device is not knocked over or dropped.
•Prior to connecting the power supply unit, ensure that the voltage of
the device corresponds to the domestic power supply.
•Do not use the device in damp rooms, baths or showers.
•Do not allow the power supply unit or plug or device to get wet.
•Never submerge the device in water or other liquids.
•Incandescent light may affect the readability of the display negatively.
11
1.7 User Requirements
The PRO-II®or PRO-III® device must only be operated and used by instructed and trained
personnel.
Familiarize yourself with the functions of the PRO-II® or PRO-III® device prior to startup.
Training on the operation of PRO-II® and PRO-III® devices is provided by DeRoyal or an
authorized distribution partner of DeRoyal. Product training takes approximately one to two
hours and includes an explanation of the design and function of the device, the handling of
the device, the alarm system, and the cleaning and disinfection of the device.
Training should be repeated on a regular basis or at least every 24 months.
1.8 Information on Product Liability
The liability for the operation of the device is channeled to the operator in the following
cases:
•the device is used outside its intended use,
•the device is not used in accordance with the instruction for use,
•the device is opened by unauthorized personnel,
•installation, settings, enhancements, routine maintenance or repairs are performed
by unauthorized personnel,
•unauthorized accessories and spare parts have been used, or
•the device is used beyond its lifetime of 3 years.
1.9 Material Compatibility
ATTENTION!
Aggressive substances may damage the device and the
accessories.
•Please follow the cleaning and care instructions (chapter 4.1)
12
2Product Description
2.1 Whole View
2.1.1 PRO-II® Device
Fig. 1 PRO-II® Device
A Disposable exudate canister (250 cc canister shown) with integrated suction tube
B Canister locking mechanism
C (On) and (Off) buttons
D Display
E and arrow buttons
F PRO-II® device
2.1.2 PRO-II® Device product contents
•PRO-II® device
•2 x disposable exudate canister (250 cc) with integrated bacterial filter, carbon
filter, solidifier and suction tube
•power supply unit
•instruction for use
•multilingual charging instructions
•instructions for safe handling of battery packs
•DeRoyal warranty statement
•optional accessories (depending on the order)
A separate Quick Reference Guide for use of the PRO-II®device for in-home care is
available for download via the internet (www.deroyal.com) under Negative Pressure
Wound Therapy.
A
B
F
C
D
E
13
2.1.3 Pro-III® Device
Fig. 2 PRO-III®
A Disposable exudate canister system (800 cc)
B Holder for external canister
C Display
D Control panel ( (On) and (Off) buttons and and arrow buttons)
E PRO-III® device
2.1.4 PRO-III® Device product contents
•PRO-III® device
•disposable exudate canister system
(comprising the external canister, holder for external canister, connecting tube)
•power supply unit
•instruction for use
•multilingual charging instructions
•instructions for safe handling of battery packs
•DeRoyal warranty statement
•optional accessories (depending on the order)
A separate Quick Reference Guide for use of the PRO-III®device for in-home care is
available for download via the internet (www.deroyal.com) under Negative Pressure
Wound Therapy.
A
B
C
D
E
12
2Product Description
2.1 Whole View
2.1.1 PRO-II® Device
Fig. 1 PRO-II® Device
A Disposable exudate canister (250 cc canister shown) with integrated suction tube
B Canister locking mechanism
C (On) and (Off) buttons
D Display
E and arrow buttons
F PRO-II® device
2.1.2 PRO-II® Device product contents
•PRO-II® device
•2 x disposable exudate canister (250 cc) with integrated bacterial filter, carbon
filter, solidifier and suction tube
•power supply unit
•instruction for use
•multilingual charging instructions
•instructions for safe handling of battery packs
•DeRoyal warranty statement
•optional accessories (depending on the order)
A separate Quick Reference Guide for use of the PRO-II®device for in-home care is
available for download via the internet (www.deroyal.com) under Negative Pressure
Wound Therapy.
A
B
F
C
D
E
13
2.1.3 Pro-III® Device
Fig. 2 PRO-III®
A Disposable exudate canister system (800 cc)
B Holder for external canister
C Display
D Control panel ( (On) and (Off) buttons and and arrow buttons)
E PRO-III® device
2.1.4 PRO-III® Device product contents
•PRO-III® device
•disposable exudate canister system
(comprising the external canister, holder for external canister, connecting tube)
•power supply unit
•instruction for use
•multilingual charging instructions
•instructions for safe handling of battery packs
•DeRoyal warranty statement
•optional accessories (depending on the order)
A separate Quick Reference Guide for use of the PRO-III®device for in-home care is
available for download via the internet (www.deroyal.com) under Negative Pressure
Wound Therapy.
A
B
C
D
E
14
2.2 Product Properties
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended use only.
•Never use the device for tracheal aspiration.
•Never use the device for thorax drainage.
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device in case of apparent housing damage.
The PRO-II® and PRO-III® devices are lightweight, portable, battery-powered negative
pressure devices for mobile and stationary use for the application of negative pressure wound
therapy resulting in the removal of wound exudate. They are intended for exudate removal
in the low vacuum range and can be used in the hospital and doctor’s office, during patient
transport as well as during in-home care.
The PRO-II® and PRO-III® devices are operated via the internal battery or via the supplied
power supply unit that also is used to recharge the battery.
The vacuum is generated by a maintenance-free electric motor driven membrane pump. After
it is switched on, the vacuum pump creates a vacuum in the tubing system and disposable
exudate canister, which is used to extract wound exudate. The wound exudate is directed
away from the patient and collected in the disposable exudate canister. If the disposable
exudate canister is full, the device triggers the “System closed” alarm via an integrated
overflow protection system and stops the pump.
The PRO-II® and PRO-III® devices must only be operated with DeRoyal supplied disposable
exudate canisters.
The expected lifetime of a PRO-II® and/or PRO-III® device is 36 months.
The provided disposable exudate canister for the PRO-II® device as well as the disposable
canister and tubing for the PRO-III® device are intended for single use.
2.2.1 Disposable exudate canister for PRO-II® Device
The disposable exudate canister consists of a canister with a connected suction tube. The
disposable exudate canister has an integrated bacterial filter, carbon filter and may be
available with and without solidifier. This integrated filter helps to prevent an overflow in the
event of an operational error. If the liquid reaches this filter, suction is no longer possible
and the error message “System closed” appears on the display. The therapy will be
discontinued. The disposable exudate canister must be replaced. The carbon filter in the
disposable exudate canister also may help reduce the spread of odor.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The disposable exudate canister including the suction tube is intended for
single use. Replace the disposable exudate canister in accordance to the
respectively applicable hygiene instructions, if it is full, prior to each new patient
or every 3-5 days.
15
2.2.2 Information on the filter system for the PRO-II® Device
The filter system of the PRO-II® device consists of the external bacterial filter integrated in
the disposable exudate canister and the internal filter installed in the device (for devices
manufactured prior to Jan 1, 2016 – internal filters were not included).
The filter system effectively protects the interior of the device from contamination and
overflow.
Service life and reuse
The internal filter is not intended for reuse. To ensure consistent performance, the
internal filter must be replaced after contact with the exudate (blocked),
after the filter service life has expired ( symbol in the display) or during
maintenance/repair.
The internal filter must be replaced by DeRoyal or an authorized service partner of
DeRoyal.
2.2.3 Information on the carbon filter of the PRO-II® Device
An additional filter in the exhaust air vent of the PRO-II® device removes undesirable odor
out of the exhaust air of the device. This filter consists of a thin activated carbon-coated
nonwoven. The activated carbon in the nonwoven absorbs the odor particles of the exhaust
air and neutralizes them. Spreading of odor will be effectively reduced.
Service life and reuse
The carbon filter is not intended for reuse. To ensure consistent performance, the
carbon filter must be replaced during maintenance or after 2 years of use
(approximately 8,000 hours).
The carbon filter must be replaced by DeRoyal or an authorized service partner of
DeRoyal.
2.2.4 Disposable exudate canister system for PRO-III® Device
The disposable exudate canister system consists of the external canister, silicone tubing,
external filter, and is available with and without solidifier. The external filter prevents an
overflow in the event of an operational error. If the liquid reaches this filter, suction will no
longer be possible and the error message “System closed” appears on the display. The
negative pressure therapy will be discontinued. The canister and all tubing must be replaced.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The canisters and suction tubing are intended for single use. Replace the
disposable exudate canister and tubing in accordance to the respectively applicable
hygiene instructions, if it is full, prior to each new patient or every 3-5 days.
14
2.2 Product Properties
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended use only.
•Never use the device for tracheal aspiration.
•Never use the device for thorax drainage.
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device in case of apparent housing damage.
The PRO-II® and PRO-III® devices are lightweight, portable, battery-powered negative
pressure devices for mobile and stationary use for the application of negative pressure wound
therapy resulting in the removal of wound exudate. They are intended for exudate removal
in the low vacuum range and can be used in the hospital and doctor’s office, during patient
transport as well as during in-home care.
The PRO-II® and PRO-III® devices are operated via the internal battery or via the supplied
power supply unit that also is used to recharge the battery.
The vacuum is generated by a maintenance-free electric motor driven membrane pump. After
it is switched on, the vacuum pump creates a vacuum in the tubing system and disposable
exudate canister, which is used to extract wound exudate. The wound exudate is directed
away from the patient and collected in the disposable exudate canister. If the disposable
exudate canister is full, the device triggers the “System closed” alarm via an integrated
overflow protection system and stops the pump.
The PRO-II® and PRO-III® devices must only be operated with DeRoyal supplied disposable
exudate canisters.
The expected lifetime of a PRO-II® and/or PRO-III® device is 36 months.
The provided disposable exudate canister for the PRO-II® device as well as the disposable
canister and tubing for the PRO-III® device are intended for single use.
2.2.1 Disposable exudate canister for PRO-II® Device
The disposable exudate canister consists of a canister with a connected suction tube. The
disposable exudate canister has an integrated bacterial filter, carbon filter and may be
available with and without solidifier. This integrated filter helps to prevent an overflow in the
event of an operational error. If the liquid reaches this filter, suction is no longer possible
and the error message “System closed” appears on the display. The therapy will be
discontinued. The disposable exudate canister must be replaced. The carbon filter in the
disposable exudate canister also may help reduce the spread of odor.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The disposable exudate canister including the suction tube is intended for
single use. Replace the disposable exudate canister in accordance to the
respectively applicable hygiene instructions, if it is full, prior to each new patient
or every 3-5 days.
14
2.2 Product Properties
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended use only.
•Never use the device for tracheal aspiration.
•Never use the device for thorax drainage.
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device in case of apparent housing damage.
The PRO-II® and PRO-III® devices are lightweight, portable, battery-powered negative
pressure devices for mobile and stationary use for the application of negative pressure wound
therapy resulting in the removal of wound exudate. They are intended for exudate removal
in the low vacuum range and can be used in the hospital and doctor’s office, during patient
transport as well as during in-home care.
The PRO-II® and PRO-III® devices are operated via the internal battery or via the supplied
power supply unit that also is used to recharge the battery.
The vacuum is generated by a maintenance-free electric motor driven membrane pump. After
it is switched on, the vacuum pump creates a vacuum in the tubing system and disposable
exudate canister, which is used to extract wound exudate. The wound exudate is directed
away from the patient and collected in the disposable exudate canister. If the disposable
exudate canister is full, the device triggers the “System closed” alarm via an integrated
overflow protection system and stops the pump.
The PRO-II® and PRO-III® devices must only be operated with DeRoyal supplied disposable
exudate canisters.
The expected lifetime of a PRO-II® and/or PRO-III® device is 36 months.
The provided disposable exudate canister for the PRO-II® device as well as the disposable
canister and tubing for the PRO-III® device are intended for single use.
2.2.1 Disposable exudate canister for PRO-II® Device
The disposable exudate canister consists of a canister with a connected suction tube. The
disposable exudate canister has an integrated bacterial filter, carbon filter and may be
available with and without solidifier. This integrated filter helps to prevent an overflow in the
event of an operational error. If the liquid reaches this filter, suction is no longer possible
and the error message “System closed” appears on the display. The therapy will be
discontinued. The disposable exudate canister must be replaced. The carbon filter in the
disposable exudate canister also may help reduce the spread of odor.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The disposable exudate canister including the suction tube is intended for
single use. Replace the disposable exudate canister in accordance to the
respectively applicable hygiene instructions, if it is full, prior to each new patient
or every 3-5 days.
14
2.2 Product Properties
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended use only.
•Never use the device for tracheal aspiration.
•Never use the device for thorax drainage.
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device in case of apparent housing damage.
The PRO-II® and PRO-III® devices are lightweight, portable, battery-powered negative
pressure devices for mobile and stationary use for the application of negative pressure wound
therapy resulting in the removal of wound exudate. They are intended for exudate removal
in the low vacuum range and can be used in the hospital and doctor’s office, during patient
transport as well as during in-home care.
The PRO-II® and PRO-III® devices are operated via the internal battery or via the supplied
power supply unit that also is used to recharge the battery.
The vacuum is generated by a maintenance-free electric motor driven membrane pump. After
it is switched on, the vacuum pump creates a vacuum in the tubing system and disposable
exudate canister, which is used to extract wound exudate. The wound exudate is directed
away from the patient and collected in the disposable exudate canister. If the disposable
exudate canister is full, the device triggers the “System closed” alarm via an integrated
overflow protection system and stops the pump.
The PRO-II® and PRO-III® devices must only be operated with DeRoyal supplied disposable
exudate canisters.
The expected lifetime of a PRO-II® and/or PRO-III® device is 36 months.
The provided disposable exudate canister for the PRO-II® device as well as the disposable
canister and tubing for the PRO-III® device are intended for single use.
2.2.1 Disposable exudate canister for PRO-II® Device
The disposable exudate canister consists of a canister with a connected suction tube. The
disposable exudate canister has an integrated bacterial filter, carbon filter and may be
available with and without solidifier. This integrated filter helps to prevent an overflow in the
event of an operational error. If the liquid reaches this filter, suction is no longer possible
and the error message “System closed” appears on the display. The therapy will be
discontinued. The disposable exudate canister must be replaced. The carbon filter in the
disposable exudate canister also may help reduce the spread of odor.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The disposable exudate canister including the suction tube is intended for
single use. Replace the disposable exudate canister in accordance to the
respectively applicable hygiene instructions, if it is full, prior to each new patient
or every 3-5 days.
15
2.2.2 Information on the filter system for the PRO-II® Device
The filter system of the PRO-II® device consists of the external bacterial filter integrated in
the disposable exudate canister and the internal filter installed in the device (for devices
manufactured prior to Jan 1, 2016 – internal filters were not included).
The filter system effectively protects the interior of the device from contamination and
overflow.
Service life and reuse
The internal filter is not intended for reuse. To ensure consistent performance, the
internal filter must be replaced after contact with the exudate (blocked),
after the filter service life has expired ( symbol in the display) or during
maintenance/repair.
The internal filter must be replaced by DeRoyal or an authorized service partner of
DeRoyal.
2.2.3 Information on the carbon filter of the PRO-II® Device
An additional filter in the exhaust air vent of the PRO-II® device removes undesirable odor
out of the exhaust air of the device. This filter consists of a thin activated carbon-coated
nonwoven. The activated carbon in the nonwoven absorbs the odor particles of the exhaust
air and neutralizes them. Spreading of odor will be effectively reduced.
Service life and reuse
The carbon filter is not intended for reuse. To ensure consistent performance, the
carbon filter must be replaced during maintenance or after 2 years of use
(approximately 8,000 hours).
The carbon filter must be replaced by DeRoyal or an authorized service partner of
DeRoyal.
2.2.4 Disposable exudate canister system for PRO-III® Device
The disposable exudate canister system consists of the external canister, silicone tubing,
external filter, and is available with and without solidifier. The external filter prevents an
overflow in the event of an operational error. If the liquid reaches this filter, suction will no
longer be possible and the error message “System closed” appears on the display. The
negative pressure therapy will be discontinued. The canister and all tubing must be replaced.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The canisters and suction tubing are intended for single use. Replace the
disposable exudate canister and tubing in accordance to the respectively applicable
hygiene instructions, if it is full, prior to each new patient or every 3-5 days.
14
2.2 Product Properties
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended use only.
•Never use the device for tracheal aspiration.
•Never use the device for thorax drainage.
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device in case of apparent housing damage.
The PRO-II® and PRO-III® devices are lightweight, portable, battery-powered negative
pressure devices for mobile and stationary use for the application of negative pressure wound
therapy resulting in the removal of wound exudate. They are intended for exudate removal
in the low vacuum range and can be used in the hospital and doctor’s office, during patient
transport as well as during in-home care.
The PRO-II® and PRO-III® devices are operated via the internal battery or via the supplied
power supply unit that also is used to recharge the battery.
The vacuum is generated by a maintenance-free electric motor driven membrane pump. After
it is switched on, the vacuum pump creates a vacuum in the tubing system and disposable
exudate canister, which is used to extract wound exudate. The wound exudate is directed
away from the patient and collected in the disposable exudate canister. If the disposable
exudate canister is full, the device triggers the “System closed” alarm via an integrated
overflow protection system and stops the pump.
The PRO-II® and PRO-III® devices must only be operated with DeRoyal supplied disposable
exudate canisters.
The expected lifetime of a PRO-II® and/or PRO-III® device is 36 months.
The provided disposable exudate canister for the PRO-II® device as well as the disposable
canister and tubing for the PRO-III® device are intended for single use.
2.2.1 Disposable exudate canister for PRO-II® Device
The disposable exudate canister consists of a canister with a connected suction tube. The
disposable exudate canister has an integrated bacterial filter, carbon filter and may be
available with and without solidifier. This integrated filter helps to prevent an overflow in the
event of an operational error. If the liquid reaches this filter, suction is no longer possible
and the error message “System closed” appears on the display. The therapy will be
discontinued. The disposable exudate canister must be replaced. The carbon filter in the
disposable exudate canister also may help reduce the spread of odor.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The disposable exudate canister including the suction tube is intended for
single use. Replace the disposable exudate canister in accordance to the
respectively applicable hygiene instructions, if it is full, prior to each new patient
or every 3-5 days.
14
2.2 Product Properties
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended use only.
•Never use the device for tracheal aspiration.
•Never use the device for thorax drainage.
ATTENTION!
Damage to the device due to improper handling.
•Never aspirate flammable, corrosive or explosive liquids or gases.
•Do not drop the device.
•Do not use the device in case of apparent housing damage.
The PRO-II® and PRO-III® devices are lightweight, portable, battery-powered negative
pressure devices for mobile and stationary use for the application of negative pressure wound
therapy resulting in the removal of wound exudate. They are intended for exudate removal
in the low vacuum range and can be used in the hospital and doctor’s office, during patient
transport as well as during in-home care.
The PRO-II® and PRO-III® devices are operated via the internal battery or via the supplied
power supply unit that also is used to recharge the battery.
The vacuum is generated by a maintenance-free electric motor driven membrane pump. After
it is switched on, the vacuum pump creates a vacuum in the tubing system and disposable
exudate canister, which is used to extract wound exudate. The wound exudate is directed
away from the patient and collected in the disposable exudate canister. If the disposable
exudate canister is full, the device triggers the “System closed” alarm via an integrated
overflow protection system and stops the pump.
The PRO-II® and PRO-III® devices must only be operated with DeRoyal supplied disposable
exudate canisters.
The expected lifetime of a PRO-II® and/or PRO-III® device is 36 months.
The provided disposable exudate canister for the PRO-II® device as well as the disposable
canister and tubing for the PRO-III® device are intended for single use.
2.2.1 Disposable exudate canister for PRO-II® Device
The disposable exudate canister consists of a canister with a connected suction tube. The
disposable exudate canister has an integrated bacterial filter, carbon filter and may be
available with and without solidifier. This integrated filter helps to prevent an overflow in the
event of an operational error. If the liquid reaches this filter, suction is no longer possible
and the error message “System closed” appears on the display. The therapy will be
discontinued. The disposable exudate canister must be replaced. The carbon filter in the
disposable exudate canister also may help reduce the spread of odor.
Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed in
a leak-proof manner by using the solidifier. The wound exudate solidifies after an average
gelling time of 2 to 5 minutes (depending on the consistency of the wound exudate),
irrespective of the pressure settings.
The disposable exudate canister including the suction tube is intended for
single use. Replace the disposable exudate canister in accordance to the
respectively applicable hygiene instructions, if it is full, prior to each new patient
or every 3-5 days.
16
2.2.5 Information on the double filter system for PRO-III®Device
The double filter system consists of the external bacterial filter integrated in the canister
tubing and the internal filter installed in the device.
The external bacterial filter is incorporated in the available connection tubing provided by
DeRoyal.
The double filter system effectively protects against overflow and contamination of
the interior of the device.
Service life and reuse
To ensure consistent performance, the internal filter must be replaced after
contact with the exudate (blocked), after the filter service life has expired
(8,000 hours) ( symbol in the display) or during maintenance/repair.
The internal filter must be replaced by DeRoyal or an authorized service partner of
DeRoyal.
2.2.6 Battery
The charge level of the battery is shown in the display.
It is strongly recommended to fully charge the battery prior to first startup of the PRO-II®
and PRO-III® devices and to repeat this after the each use.
The PRO-II® and PRO-III® devices are equipped with a lithium-ion battery, which, unlike
traditional types of rechargeable batteries, have a low self-discharge rate.
The PRO-II® and PRO-III® devices should ideally be stored and charged at room
temperature in accordance with the ambient conditions specified in the technical data.
Never store the device incl. battery in a discharged state.
Fully recharge the battery if the device is not operated for a longer period of time (approx.
10 months).
Lithium-ion rechargeable batteries do not have a memory effect. They can, therefore, be
recharged at any time after initial charging. Only frequent short-time charging should be
avoided.
The batteries of the PRO-II® and PRO-III® devices are protected against deep discharge,
but the charging information listed above must nevertheless be followed. The batteries also
are protected against overheating during charging. If the battery temperature is exceeded
during charging due to improper ambient conditions, charging is temporarily discontinued
to allow for cooling. The purpose of this measure is to ensure safe operation and to protect
the battery.
The operational service life of the battery is 2 years. According to the manufacturer of the
battery, the battery has a remaining capacity of more than 80% after 300 charge cycles.
17
2.2.7 Pressure settings
Once the PRO-II® or PRO-III® device has been switched on, the pressure settings can be
individually adjusted by a healthcare professional.
The pressure settings can be adjusted in a range from -20 mmHg to -200 mmHg (in steps
of 5 mmHg). The setting of the pressure and time values is described in chapter 3.2.
Adjustments to device settings must only be made if instructed to do so and only
by healthcare professionals. Prior to switching on the PRO-II® or PRO-III® device it
must be ensured that the device is equipped with a disposable exudate canister.
2.3 Warranty
These devices are warranted to be free of defects in material and workmanship for one
year from date of shipment. All operational aspects (mechanical and electrical) are
covered by this warranty. The warranty does not cover accessories, spare parts and
consumables. Batteries are covered by a warranty of 6 months from purchase date.
DeRoyal warranty is neither extended nor renewed by warranty/service work.
TO THE EXTENT ALLOWED BY LAW, DEROYAL’S WRITTEN WARRANTIES ARE GIVEN IN
LIEU OF ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
CAUTION: Warranty claims will not be accepted if (1) the unit has been opened or repaired
by unauthorized individuals, (2) the unit has not been used in accordance with proper
guidelines; this includes using any non-DeRoyal provided accessories (kits, canisters, etc.)
(3) the special tamper proof seal is missing or broken, or (4) the unit has been rendered
inoperable due to physical damage (inclusive of drops or falls of the device). Any
maintenance or service repair that is not covered by the warranty may be performed by
DeRoyal at a cost of $75 per hour. A minimum of $75 may be charged and billed
appropriately. Any repair charges less than $500.00 will be automatically billed, unless
otherwise instructed by customer at time service is requested.
DeRoyal is responsible for impacts on safety, reliability and specified performance only if:
•original DeRoyal accessories and spare parts are used,
•maintenance and repair are performed by professionals authorized by DeRoyal. or
by DeRoyal itself,
•the affected product is used and operated in accordance with the instruction for use
and within its intended use.
DeRoyal does not warrant accurate function of the devices PRO-II® and PRO-III® devices
and is not liable for a loss of property or personal injury in the following circumstances:
•non-original DeRoyal accessories or spare parts are used,
•use information of this instruction for use are ignored,
•installation, settings, changes, upgrades or repairs are not carried out by DeRoyal or
by professionals authorized by DeRoyal,
•the safety seal is broken or removed.
All warranty claims are voided if the device is opened by unauthorized individuals, the
safety seal is removed / damaged or repairs have been performed by unauthorized
individuals.
16
2.2.5 Information on the double filter system for PRO-III®Device
The double filter system consists of the external bacterial filter integrated in the canister
tubing and the internal filter installed in the device.
The external bacterial filter is incorporated in the available connection tubing provided by
DeRoyal.
The double filter system effectively protects against overflow and contamination of
the interior of the device.
Service life and reuse
To ensure consistent performance, the internal filter must be replaced after
contact with the exudate (blocked), after the filter service life has expired
(8,000 hours) ( symbol in the display) or during maintenance/repair.
The internal filter must be replaced by DeRoyal or an authorized service partner of
DeRoyal.
2.2.6 Battery
The charge level of the battery is shown in the display.
It is strongly recommended to fully charge the battery prior to first startup of the PRO-II®
and PRO-III® devices and to repeat this after the each use.
The PRO-II® and PRO-III® devices are equipped with a lithium-ion battery, which, unlike
traditional types of rechargeable batteries, have a low self-discharge rate.
The PRO-II® and PRO-III® devices should ideally be stored and charged at room
temperature in accordance with the ambient conditions specified in the technical data.
Never store the device incl. battery in a discharged state.
Fully recharge the battery if the device is not operated for a longer period of time (approx.
10 months).
Lithium-ion rechargeable batteries do not have a memory effect. They can, therefore, be
recharged at any time after initial charging. Only frequent short-time charging should be
avoided.
The batteries of the PRO-II® and PRO-III® devices are protected against deep discharge,
but the charging information listed above must nevertheless be followed. The batteries also
are protected against overheating during charging. If the battery temperature is exceeded
during charging due to improper ambient conditions, charging is temporarily discontinued
to allow for cooling. The purpose of this measure is to ensure safe operation and to protect
the battery.
The operational service life of the battery is 2 years. According to the manufacturer of the
battery, the battery has a remaining capacity of more than 80% after 300 charge cycles.
17
2.2.7 Pressure settings
Once the PRO-II® or PRO-III® device has been switched on, the pressure settings can be
individually adjusted by a healthcare professional.
The pressure settings can be adjusted in a range from -20 mmHg to -200 mmHg (in steps
of 5 mmHg). The setting of the pressure and time values is described in chapter 3.2.
Adjustments to device settings must only be made if instructed to do so and only
by healthcare professionals. Prior to switching on the PRO-II® or PRO-III® device it
must be ensured that the device is equipped with a disposable exudate canister.
2.3 Warranty
These devices are warranted to be free of defects in material and workmanship for one
year from date of shipment. All operational aspects (mechanical and electrical) are
covered by this warranty. The warranty does not cover accessories, spare parts and
consumables. Batteries are covered by a warranty of 6 months from purchase date.
DeRoyal warranty is neither extended nor renewed by warranty/service work.
TO THE EXTENT ALLOWED BY LAW, DEROYAL’S WRITTEN WARRANTIES ARE GIVEN IN
LIEU OF ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
CAUTION: Warranty claims will not be accepted if (1) the unit has been opened or repaired
by unauthorized individuals, (2) the unit has not been used in accordance with proper
guidelines; this includes using any non-DeRoyal provided accessories (kits, canisters, etc.)
(3) the special tamper proof seal is missing or broken, or (4) the unit has been rendered
inoperable due to physical damage (inclusive of drops or falls of the device). Any
maintenance or service repair that is not covered by the warranty may be performed by
DeRoyal at a cost of $75 per hour. A minimum of $75 may be charged and billed
appropriately. Any repair charges less than $500.00 will be automatically billed, unless
otherwise instructed by customer at time service is requested.
DeRoyal is responsible for impacts on safety, reliability and specified performance only if:
•original DeRoyal accessories and spare parts are used,
•maintenance and repair are performed by professionals authorized by DeRoyal. or
by DeRoyal itself,
•the affected product is used and operated in accordance with the instruction for use
and within its intended use.
DeRoyal does not warrant accurate function of the devices PRO-II® and PRO-III® devices
and is not liable for a loss of property or personal injury in the following circumstances:
•non-original DeRoyal accessories or spare parts are used,
•use information of this instruction for use are ignored,
•installation, settings, changes, upgrades or repairs are not carried out by DeRoyal or
by professionals authorized by DeRoyal,
•the safety seal is broken or removed.
All warranty claims are voided if the device is opened by unauthorized individuals, the
safety seal is removed / damaged or repairs have been performed by unauthorized
individuals.
18
3Operation
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended purpose only.
•Read chapter 3.1 and 3.2.
ATTENTION!
Malfunction due to wound exudate overflow.
•Ensure that the disposable exudate canister of the PRO-II® and
PRO-III® device is replaced on a regular basis. If the disposable
exudate canister is full, the integrated overflow protection system
will be triggered. This disrupts the aspiration process.
•Switch the device off when replacing the disposable exudate
canister.
•If the internal filter of the PRO-II® or the PRO-III® device is
blocked, the device must be serviced by DeRoyal. or by an
authorized service partner of DeRoyal.
WARNING!
Hazard of persons due to inadequate monitoring of patient.
Adequate monitoring of patients is mandatory in cases of highly exuding
wounds, wounds with viscous or strongly deposited exudate and strong
bleeding. Particular attention must be paid to exudate retention in the
wound dressing and the proper sealing of the dressing.
The establishment of monitoring intervals must be dependent on the
wound situation, the health of the patient and the settings of the alarm
sensitivities.
WARNING!
Hazard of persons due to decreasing the alarm sensitivities.
When greatly decreasing alarm sensitivities, it is possible that a blockage
or leakage in the wound and tube system may not be detected and thus
no alarm will be triggered.
The PRO-II® and PRO-III® devices are designed to build up a vacuum in
the wound drainage system and to extract the exudate. The devices are
not designed to detect strong bleeding of the wound. For this reason,
you must not rely solely on the alarm system of the PRO-II® and PRO-
III®devices.
The regular monitoring of the patient and the wound dressing can reduce
a severe deterioration of health of the patient dramatically.
WARNING!
Hazard of persons during operation in a domestic environment.
Due to the increasing mobility of patients in a domestic environment,
there is an increasing risk of forming leaks or blockages in the wound
dressing or tube system.
For this reason, detailed training and instruction for patients as well as
performing regular monitoring of the wound dressing and negative
pressure wound therapy system by trained personnel is mandatory.
19
3.1 Setup and Startup
3.1.1 Startup
It is important to follow the safety instruction in chapter 1.6 prior to initial startup.
Always have one backup disposable exudate canister for the PRO-II® and one backup
disposable canister and tubing for the PRO-III® device ready since it is absolutely necessary
for safe operation.
•Please read the entire instruction for use before operating the PRO-II® or PRO-III®
device for the first time.
•Remove the device and the accessories from the packaging.
•Always place the device on a sturdy and flat surface. Take care to correctly position
the device.
•Inspect all tubing as well as the power supply unit for damage prior to each startup
of the PRO-II® and PRO-III® device. It is important to avoid kinking when connecting
the tubing. Ensure prior to switching on the unit that the disposable exudate
canister and all tubing are properly connected.
•Fully charge the battery prior to initial startup.
•Perform a function test (Please refer to chapter 5.1).
3.1.2 Connecting the PRO-II®and PRO-III® Devices
Use the socket for power supply unit of the PRO-II® device (chapter 2.1.1, fig.1 (G)) or the
socket for power supply unit of the PRO-III®device (chapter 2.1.3, fig.2 (G)) to connect the
device to the main power supply via the supplied power supply unit for charging or operation
as required.
Use the supplied power supply unit only. First connect the power supply unit to the socket
for power supply unit of the PRO-II® or PRO-III®device and then to the main power supply.
Fig. 3 Connecting the PRO-II® and PRO-III® devices to the patient and accessories
18
3Operation
CAUTION!
Hazard of persons due to improper handling.
•Use the device for its intended purpose only.
•Read chapter 3.1 and 3.2.
ATTENTION!
Malfunction due to wound exudate overflow.
•Ensure that the disposable exudate canister of the PRO-II® and
PRO-III® device is replaced on a regular basis. If the disposable
exudate canister is full, the integrated overflow protection system
will be triggered. This disrupts the aspiration process.
•Switch the device off when replacing the disposable exudate
canister.
•If the internal filter of the PRO-II® or the PRO-III® device is
blocked, the device must be serviced by DeRoyal. or by an
authorized service partner of DeRoyal.
WARNING!
Hazard of persons due to inadequate monitoring of patient.
Adequate monitoring of patients is mandatory in cases of highly exuding
wounds, wounds with viscous or strongly deposited exudate and strong
bleeding. Particular attention must be paid to exudate retention in the
wound dressing and the proper sealing of the dressing.
The establishment of monitoring intervals must be dependent on the
wound situation, the health of the patient and the settings of the alarm
sensitivities.
WARNING!
Hazard of persons due to decreasing the alarm sensitivities.
When greatly decreasing alarm sensitivities, it is possible that a blockage
or leakage in the wound and tube system may not be detected and thus
no alarm will be triggered.
The PRO-II® and PRO-III® devices are designed to build up a vacuum in
the wound drainage system and to extract the exudate. The devices are
not designed to detect strong bleeding of the wound. For this reason,
you must not rely solely on the alarm system of the PRO-II® and PRO-
III®devices.
The regular monitoring of the patient and the wound dressing can reduce
a severe deterioration of health of the patient dramatically.
WARNING!
Hazard of persons during operation in a domestic environment.
Due to the increasing mobility of patients in a domestic environment,
there is an increasing risk of forming leaks or blockages in the wound
dressing or tube system.
For this reason, detailed training and instruction for patients as well as
performing regular monitoring of the wound dressing and negative
pressure wound therapy system by trained personnel is mandatory.
19
3.1 Setup and Startup
3.1.1 Startup
It is important to follow the safety instruction in chapter 1.6 prior to initial startup.
Always have one backup disposable exudate canister for the PRO-II® and one backup
disposable canister and tubing for the PRO-III® device ready since it is absolutely necessary
for safe operation.
•Please read the entire instruction for use before operating the PRO-II® or PRO-III®
device for the first time.
•Remove the device and the accessories from the packaging.
•Always place the device on a sturdy and flat surface. Take care to correctly position
the device.
•Inspect all tubing as well as the power supply unit for damage prior to each startup
of the PRO-II® and PRO-III® device. It is important to avoid kinking when connecting
the tubing. Ensure prior to switching on the unit that the disposable exudate
canister and all tubing are properly connected.
•Fully charge the battery prior to initial startup.
•Perform a function test (Please refer to chapter 5.1).
3.1.2 Connecting the PRO-II®and PRO-III® Devices
Use the socket for power supply unit of the PRO-II® device (chapter 2.1.1, fig.1 (G)) or the
socket for power supply unit of the PRO-III®device (chapter 2.1.3, fig.2 (G)) to connect the
device to the main power supply via the supplied power supply unit for charging or operation
as required.
Use the supplied power supply unit only. First connect the power supply unit to the socket
for power supply unit of the PRO-II® or PRO-III®device and then to the main power supply.
Fig. 3 Connecting the PRO-II® and PRO-III® devices to the patient and accessories
20
3.1.3 Positioning of the PRO-II®Devices
The PRO-II® device can be placed next to the patient bed or attached via the DeRoyal® PRO-
II® device Holder (NP-170). An optional carrying bag (NP-2001) is available for portable use.
Note: The PRO-II® device carrying bag is single patient use.
It is up to the physician/healthcare provider to decide whether the condition of the patient
permits portable use.
To ensure optimum extraction of the wound exudate, place the PRO-II® device
below the wound to be treated. It should be noted that the suction tube does not
form a dip and is situated at least on patient level.
3.1.4 Connecting the disposable exudate canister of the PRO-II® Device
Fig.5 Connecting the disposable exudate canister
A Disposable exudate canister incl. suction tube
B Locking mechanism for canister
C Aspiration port
D PRO-II® device
E Guiding rail
1. Remove the disposable exudate canister (fig. 5 (A)) from the packaging.
2. Slide the canister on the guiding rails (fig. 5 (E)) of the PRO-II® device until the
disposable exudate canister clicks into place in the locking mechanism (fig. 5 (B)).
3. To remove from the device after use, press the “Press Here” button on the top of the
canister prior to sliding back along the guiding rails.
3.1.5 Positioning of the PRO-III® Device
The PRO-III® device can be placed next to the patient bed or attached via the DeRoyal PRO-
III®device bed holder (NP-140). An optional carrying bag (NP-3001) is available for portable
use, as well as IV Pole holder. Note: The PRO-III®carrying bag is single patient use.
To ensure optimum extraction of the wound exudate, place the PRO-III® device
below the wound to be treated. It should be noted that the suction tube does not
form a dip and is situated at least on patient level.
21
3.1.6 Connecting the DeRoyal®disposable exudate canister system of the PRO-
III® Device
The original DeRoyal® disposable exudate canister system consists of the external canister,
the holder for the external canister, and the connecting tube with external filter.
3.1.7 Connecting a wound drainage system
Connect the suction tube to the wound drainage system, such as the DeRoyal®TopDraw®
Medium Black foam Kit with Triple Release Transeal®(NP-0501).For a complete listing of
approved DeRoyal wound draining kits, please visit www.deroyal.com/npwt.
The suction tube must never come into direct contact with the aspiration area.
This manual suits for next models
2
Table of contents
Other DeRoyal Medical Equipment manuals
DeRoyal
DeRoyal SurgiMate User manual
DeRoyal
DeRoyal Hypercontrol User manual
DeRoyal
DeRoyal Inline Air Walker User manual
DeRoyal
DeRoyal SOFT OA KNEE BRACE User manual
DeRoyal
DeRoyal Element Sport User manual
DeRoyal
DeRoyal Solace 13400005 User manual
DeRoyal
DeRoyal BODY BELT W/ HOOK & LOOP CLOSURE User manual
DeRoyal
DeRoyal Pucci 405 User manual
DeRoyal
DeRoyal FALL MAT M10 User manual
DeRoyal
DeRoyal PRUVENTOR User manual
