Alleva extricare 3000 User manual

www.allevamedical.com IFU1-MI391-002.001
Revision Date: 2023-02-15
ENGLISH VERSION - US
Negative Pressure Wound
Therapy System
For Clinicians Use
extriCARE
®
3000
Operating Manual
Online Reference for Clinicians

CLINICIAN 1
CONTENTS
FOR CLINICIAN USE
Introduction..............................................................................................................2
Indications for Use..................................................................................................3
Contraindications for Use......................................................................................3
Package Content.....................................................................................................4
Accessories.............................................................................................................4
Features....................................................................................................................5
User Interface..........................................................................................................6
Symbol.......................................................................................................................8
Device Specifications............................................................................................10
Warnings..................................................................................................................11
Precautions............................................................................................................ .12
Operating Instructions............................................................................................14
Error Messages / Troubleshooting.......................................................................20
Maintenance and Cleaning....................................................................................22
Warranty Information.............................................................................................23
Electromagnetic Compatibility Tables.................................................................24
Contact Infomation..................................................................................................27

CLINICIAN
Alleva Medical’s extriCARE® Negative Pressure Wound Therapy (NPWT) products consist
of a family of negative pressure pumps and dressings intended to promote wound
healing on patients in healthcare facilities. Patients with chronic, acute, traumatic,
subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic
ulcers, pressure ulcers, incisional wounds, flaps and grafts may benefit from using the
extriCARE® NPWT system.
The extriCARE® 3000 NPWT Pump is a portable, battery-powered pump with a touchscreen
user interface, capable of delivering continuous and/or intermittent negative pressure
intended to promote wound healing through the drainage and removal of wound
exudates, infectious material, and tissue debris from the wound bed. Each extriCARE®
3000 NPWT Pump comes with a sturdy 100cc collection canister provided with solidifying
agents to ease disposal and handling. For wounds with larger drainage needs, a 400cc
collection canister is also available.
Alleva Medical provides two main type of wound filler dressings to be used in
conjunction to an extriCARE® pump unit – the extriCARE® Negative Pressure Wound
Therapy Bandage Dressings and the extriCARE® Negative Pressure Wound Therapy Foam Kits.
Both types of wound dressing are designed to provide an air-tight environment to the
wound bed while allowing absorption and drainage of wound fluids into the collection
canister and are sold separately.
The extriCARE® 3000 NPWT Pump allows a user to select a treatment pressure ranging
from 20mmHg to 140mmHg. In continuous mode, the pressure is applied to the wound
as long as the pump is powered on. In intermittent mode, the pump will alternate
between applying the target pressure for 5 continuous minutes and a lower pressure
(20mmHg) for 2 minutes.
The extriCARE® 3000 NPWT Pump is meant for continuous use (at least 22 of 24 hours per
day). The extriCARE® 3000 NPWT Pump is to be used in healthcare facilities.
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
1. Introduction
2

2. Indications for Use
3. Contraindications for Use
The extriCARE® 3000 Negative Pressure Wound Therapy System is intended to generate
negative pressure or suction to remove wound exudates, infectious material, and
tissue debris from the wound bed.
It is indicated for the following wound types:
• chronic
• acute
• traumatic
• subacute and dehisced wounds
• partial-thickness burns
• ulcers (such as diabetic or pressure)
• flaps and grafts
The extriCARE 3000 Negative Pressure Wound Therapy System is suitable for use in
healthcare facilities.
The extriCARE® 3000 NPWT Pump should NOT be used in the following conditions:
• Exposed vessels, organs, or nerves
• Anastomotic sites
• Exposed arteries or veins in a wound
• Fistulas, unexplored or non-enteric
• Untreated osteomyelitis
• Malignancy in the wound
• Excess amount of necrotic tissue with eschar
• Wounds which are too large or too deep to be accommodated by the dressing
• Inability to be followed by a medical professional or to keep scheduled
appointments
• Allergy to urethane dressings and adhesives
• Use of topical products which must be applied more frequently than the dressing
change schedule allows
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4. Package Content
5. Accessories
Each box contains:
1. An extriCARE® 3000 Negative Pressure Wound Therapy Pump unit.
2. An extriCARE® 100cc collection canister with solidifying agents.
3. A 12V/2A AC/DC Adapter with US Plug.
The following accessories are available for purchase with the extriCARE® 3000
NPWT pump. Please contact your local distributor for purchase orders.
1. AC/DC Adapter: Please only use the AC/DC adapter provided in the package.
2. Collection Canister: Available in 100cc and 400cc.
3. Carrying Case: For use to carry the device with the two sizes of
collection canister.
4. Wound Dressings: Please contact your local distributor for a complete listing
of all currently available dressing options.
5. Foam Kits: additional Foam Kits are available.
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4
1 2 3
MODE:
INT

6. Features
1. Power Button: to turn the device on or off.
2. Adapter Cover/Port: the soft adapter cover protects the adapter port from
dust and debris. The adapter port receives only the adapter model provided
in the package.
3. Canister Release Button: pressing the button will release the collection canister
from the device.
4. Play/Pause Button with backlight: to start or stop a therapy. The button
is also equipped with a red and blue backlight to indicate device status.
5. Collection canister: to store exudates removed from the wound.
6. Tubing Input: This is the connection port used for attaching the extriCARE®
dressings to the collection canister.
CLINICIAN 5
1. Power Button
2. Adapter
Cover/Port
3. Canister
Release Button
5. Collection canister
6. Tubing Input
4. Play/Pause Button
with backlight
MODE:
INT

7. User Interface
Therapy settings for extriCARE® 3000 NPWT Pump are adjusted using the device’s color
touchscreen. The resistive touchscreen can be used with surgical gloves and/or
through the clear panel of the carrying case.
The Main Page contains the following features:
1. Target Vacuum Pressure: displays the target therapy pressure in mmHg
2. +/- Pressure Adjustment buttons: the yellow buttons are used for adjusting the
target pressure. “+” increases the target pressure and “-“ decreases the target
pressure. Adjustment is done through increment of 5mmHg.
3. Actual Vacuum Pressure Indicators: indicates via arrows symbol the actual
vacuum pressure relative to target vacuum pressure. (see Section 10.4)
mmHg
000
IN OPERATION:
24h00m
OPTIONS
MODE:
INT 400cc
5. Options
6. Canister & Fluid Level Indicator
8. Battery Level
Indicator
9. Mute Symbol
10. Play/Pause Symbol
11. Lock /Unlock
Symbol
4. Mode button
3. Actual Vacuum
Pressure Indicator
7. Therapy
Time Display
1. Target Vacuum
Pressure
2. +/- Pressure
Adjustment buttons
CLINICIAN
6
12. Air pump status
indicator

4. Mode button: Pressing this area will change the mode from continuous
to intermittent or vice versa. The line below indicates the current mode –
a continuous line denotes continuous mode, whereas a dashed line denotes
intermittent mode. (see Section 10.3)
5. Options: A new window shall display where user could 1.) mute alarms and
sounds, and 2.) lock the device settings. (see Section 10.7)
6. Canister & Fluid Level Indicator: indicates the approximate level of the fluid
collected. Pressing this area will generate a log with collection time and level
(see Section 10.6)
7. Therapy Time Display: displays the duration of the current therapy since the
device was turned on.
8. Battery Level Indicator: displays the battery level (or whether the device is under
charging) (See Symbol List)
9. Mute Symbol: Indicates if the device alarm or sounds is muted. (See Symbol
List)
10. Play/Pause Symbol: Indicates whether the therapy is in session or on pause.
(See Symbol List)
11. Lock/Unlock Symbol: Indicates whether the device is under locked or unlocked
mode. (See Symbol List)
12. Air pump status indicator: Appears only when the internal air pump is operating.
7. User Interface (continued)
CLINICIAN 7

Alarm Indicator: Indicates if the device alarm is muted
or not.
8. Symbol List
Battery Level Indicator: In 5 states (1 to 4 bars, or empty)
This symbol appears when the device is under Lock
Mode (see Section 10.7 for further details).
See Section 11 for warnings and error handling.
Date of Manufacture
Type BF applied part
Single Use Only
Use-by Date
Exit Icon: Press to exist the current window.
Therapy Symbol: Indicates whether the device is in
therapy or in pause.
Indicates that the device is charging normally.
The battery levels would also alternate.
Therapy in session
Therapy in pause
Sound On
Sound Off
CLINICIAN
8

Class II Equipment
Keep Dry
CONFORMS TO AAMI STD ES 60601-1, IEC STD
60601-1-6, AAMI STD HA 60601-1-11.
Consult Instructions For Use
Operation temperature Limit (low left number
denotes the lower temperature limit and upper right
number denotes the upper temperature limit)
Protection against solid objects of >12.5mm and
modest vertical liquid ingress
Catalog / Model Number
Power Switch
Serial Number
8. Symbol List (continued)
SN
REF
IP22
MR
Unsafe
CLINICIAN 9

9. Device Specifications
Temperature: -20°C to 50°C;
Humidity: <93% non-condensing
STORAGE/TRANSPORTATION
CONDITIONS:
IP22
INGRESS PROTECTION:
<2000m
ALTITUDE RANGE:
80kPa-106kPa
BAROMETRIC PRESSURE:
<4.5 hours
Continuous or Intermittent
CHARGING TIME:
1.21 lbs (0.55 kg)
WEIGHT:
Model Number: SAW30B-120-2000U
AC Input: 100-240Vac, 50/60Hz, 0.8A
DC output: 12V 2A
VACUUM MODES:
AC/DC ADAPTER:
Length: 4.0” (10.2cm)
Depth: 3.1” (7.9cm)
Height: 5.0” (12.7cm)
DIMENSIONS:
20mmHg - 140mmHg
in increments of 5mmHg
PRESSURE OPTIONS:
Temperature: +5°C to 40°C (41°F to 104°F)
Humidity: 15-93%
OPERATING CONDITIONS:
Lithium Battery, 7.4V, 2600mAh
(rechargeable)
BATTERY TYPE:
Type BFPATIENT PROTECTION:
3 Years
SHELF LIFE:
3000 hours
PUMP SERVICE LIFE:
Class II
PROTECTION AGAINST
ELECTRICAL SHOCK:
CLINICIAN
10

10. Warnings
• Review this manual prior to using the extriCARE® 3000 NPWT Pump. If clarification is
needed, contact technical personnel or Alleva Medical Devices at 1-877-312-NPWT
prior to use. Additional questions can be immediately addressed as well.
• Do not use the extriCARE® 3000 NPWT Pump around explosive or flammable material.
Do not use the pump in an MRI environment or hyperbaric chamber. Disconnect
pump from dressing prior to MRI, hyperbaric chamber, or defibrillation according
to dressing instructions found with each dressing kit.
• This device should be used only under the direction of a trained professional,
such as a doctor or nurse.
• 400cc should only be used in a facility where drainage can be closely monitored
due to the increased risk of injury to the patient due to bleeding when using the
400cc canister. Precautionary measures should be taken for patients who have an
increased risk of bleeding (Please see Section 14.1) when using the 400cc canisters.
• Negative Pressure Wound Therapy has not been cleared for use on children.
• Use a properly rated charger to charge the lithium battery. Incorrect voltage and/or
current can cause fire.
• Do not place this device at temperatures greater than 170°F for more than 2 hours
which may cause a battery fire.
• If battery swells, gets hot, or smokes while charging, disconnect the charger
immediately. This may cause the battery to leak, and the reaction with air may
cause the chemicals to ignite, resulting in fire.
• Battery may need to be replaced after 500 discharge cycles.
• Avoid heat from a fireplace or radiant heater.
• Use the device in a clean environment; one that is free from dirt, dust, pets, hair,
etc.
• Do not position the device that makes it difficult to unplug the power cord.
* There is a risk of strangulation if one gets tangled in the cables or tubing.
Keep away from babies and children.
CLINICIAN 11

11. Precautions
11.1 Be aware for any of the following conditions:
There are additional conditions to take into account before using Negative Pressure
Wound Therapy, such as:
1. BLEEDING: There is a risk of bleeding/hemorrhaging with negative pressure
wound therapy. If hemostasis cannot be achieved, if the patient is on
anticoagulants or platelet aggregation factors, or if the patient has friable blood
vessels or infected vascular anastomosis, he or she may have an increased risk
of bleeding; accordingly, complete evaluations shall be conducted per the
facility’s guideline before beginning treatment and special care and monitoring
of collected exudate level shall be exercised during treatment; If active bleeding
develops suddenly or in large amounts during therapy, immediately disconnect
the pump, leave the extriCARE® wound dressings in place, and take measures to
stop bleeding. Seek medical attention immediately.
2. VESSEL AND BONE PROTECTION: Precautionary measures should be taken if
any bones, vessels, ligaments or tendons are exposed. Additionally, sharp edges
(due to bone fragments) require special attention; these areas should be covered
and smoothed wherever possible. These conditions should be factored into the
therapy prescription as the attending clinician sees fit.
3. ENVIRONMENT: The extriCARE® system should not be used in an magnetic
resonance im-aging (MRI) environment, in hyperbaric chamber environment
(HBO), nor with defibrillation. Please disconnect device and/or remove dressings
as instructed by your physician if these situations arise.
4. INFECTION: Infected wounds and osteomyelitis pose significant risks for Negative
Pressure Wound Therapy. If untreated osteomyelitis is present, therapy should
not be initiated. Negative Pressure Wound Therapy should not be used to treat
infections, and all infections should be treated and addressed prior to using the
extriCARE® Negative Pressure Wound Therapy System.
5. PERIWOUND SKIN: Protect periwound skin with additional hydrocolloid, other
transparent film, or other skin prep methods. Monitor skin for any signs of
irritation or irregularity. If this occurs, stop treatment and consult physician.
CLINICIAN
12

11. Precautions (continued)
11.1 Be aware for any of the following conditions (continued):
NOTE: If any of this information is not understood, contact the manufacturer before
using the device.
6. SPINAL CORD INJURY: If a patient experiences autonomic dysreflexia (sudden
changes in blood pressure or heart rate because of sympathetic nervous system
stimulation), discontinue the therapy to minimize sensory stimulation and give
immediate medical assistance.
7. MODE: In unstable anatomical structures, continuous rather than intermittent
therapy is recommended to help minimize movement and instability.
Continuous therapy is also recommended in patients with an increased
bleeding risk, profusely exudating wounds, fresh grafts and/or flaps, and
wounds with acute enteric fistulae.
8. ENTERIC FISTULAS: Wounds with enteric fistulas require special consideration
to be effective in negative pressure wound therapy. If enteric fistula effluent
management or containment is the only goal of such therapy, extriCARE® is
not recommended.
9. CIRCUMFERENTIAL DRESSING: Do not use circumferential dressings.
10. BRADYCARDIA: Avoid placement of the extriCARE® Negative Pressure Wound
Therapy Dressings next to the vagus nerve to minimize the risk of bradycardia.
11.2 Prior to Therapy
• Patient should be assessed, and measures should be taken to optimize and
stabilize their medical condition. Nutrition, medication, blood glucose, blood
pressure, and circulation as well as other medical issues should be addressed.
• The wound should be recently debrided by whatever measure is appropriate
and the amount of necrotic tissue should be minimized.
• Issues of infection should be addressed.
CLINICIAN 13

Please consult Section 10 Warnings and Section 11
Precautions before reading this section.
12.1 Canister Installation
The extriCARE® 3000 pump comes with a pre-installed 100cc canister. To install a
fresh canister, engage the canister to the pump at the bottom. Then push the
canister against the pump, so a snap can be felt and heard.
12. Operating Instructions
12.2 Turning on the Device
To turn on the device, locate the Power Button on the side of the device
(See Section 6. Features).
Press down the Power Button for 2 seconds. The color touchscreen shall turn on
and display the device model (extriCARE® 3000) and current software version.
The Main Page shall appear on the screen as the device makes a single chirp sound.
12.3 Adjusting Treatment Settings
On extriCARE® 3000, target vacuum pressure and pattern of vacuum delivered to the
wound site can be adjusted for different clinical situations. Before adjusting either
of these treatment settings, please ensure that the device is NOT in Lock Mode
(See Section 10.7). Settings can be adjusted during a treatment or at pause.
To adjust the target pressure, simply press the yellow “+” or “-“ symbol on the
Main Page. The target pressure displayed in the middle of the screen will be
adjusted according. Each press changes the target pressure by 5mmHg.
CLINICIAN
14
extriCARE® 3000 Wound Dressings (sold separately) include bandages and foam kits.
Follow detailed instructions that come with your extriCARE® 3000 Wound Dressing
to apply the dressing.

12. Operating Instructions (continued)
The extriCARE® 3000 pump can either deliver a continuous or an intermittent vacuum
pattern. In the intermittent vacuum mode, each cycle consists of a continuous
vacuum at the target pressure for 5 minutes, and then followed by a vacuum at
20mmHg for 2 minutes.
To switch between the vacuum patterns, press down on the blue MODE button for
one second. If the switch is successful, a chrip will sound and the white line
underneath the word "MODE" will switch from a continuous line to a dashed lined,
and the word belwo will also change from "CONT" (continuous) to "INT"
(intermittent), or vice versa, to indicate the current vaccum pattern per below:
mmHg
000
IN OPERATION:
24h00m
OPTIONS
MODE:
400cc
MODE:
INT
INT
MODE:
CONT
Intermittent Vacuum Mode Continuous Vacuum Mode
Increases the target pressure
in 5mmHg increment.
Decreases the target pressure
in 5mmHg increment.
CLINICIAN 15

12. Operating Instructions (continued)
12.4 Running a Treatment
Once the treatment settings are set, treatment can begin by pressing the
Play/Pause Button. When treatment begins, the blue backlight will light for the
duration of the treatment.
Pressure sensing technology in the pump will ramp up pumping power depending
on the amount of air leaks in the dressing and vacuum level. At the beginning and
during the therapy, blue arrow(s) might appear next to the Target Vacuum Pressure.
These arrows indicate the actual vacuum pressure as compared to the target
vacuum pressure:
The total duration of the current treatment sessions
is displayed above the Target Vacuum Pressure,
to a maximum of 99 hours and 59 minutes.
If the treatment is paused, the duration will resume
only when the session is resumed.
Tilting : If the device is tilted for more than 10 seconds, an alarm will sound
(See 11.1). Please place the device upright to resume therapy.
When actual pressure is more than 10mmHg
above the target vacuum pressure.
Two upward arrows
When actual pressure is 5-10mmHg below
the target vacuum pressure.
One downward arrow
When actual pressure is 5-10mmHg above
the target vacuum pressure.
One upward arrow
When actual pressure is more than 10mmHg
below the target vacuum pressure.
Two upward arrows
ConditionsDescriptionSymbols
mmHg
000
IN OPERATION:
24h00m
OPTIONS
MODE
400cc
CLINICIAN
16

12. Operating Instructions (continued)
12.5 Automatic Screen Shut-Off
To maximize battery life, extriCARE® 3000 has an automatic screen shut-off feature.
If the screen is not touched for 5 minutes, it will automatically shut off. One of the
following scenarios would re-activate the screen:
• Pressing the Power Button.
• Pressing the Play/Pause button
• Pressing anywhere on the touchscreen
• Plugging the device to the external charger
• An alarm is generated
Note: When the screen is shut-off, a blue light will be on if treatment is in process,
or a greenlight light will be flashing if the device is charging normally.
12.6 Tracking Exudate Level in Collection Canister
extriCARE® 3000 has a proprietary technology to not only monitor exudate level in the
collection canister, but also the time to reach these levels. Furthermore, extriCARE®
3000 has the ability to detect the volume of the canister (100cc or 400cc) connected
to the pump.
On the main page, the Canister & Fluid Level Indicator would display the
approximate level of fluid collected as per below (with a canister).
Exudate level is < 25% of the canister capacity.
Exudate level between 25-50% of the canister capacity.
100cc
0cc
Exudate level between 50-75% of the canister capacity.
Exudate level between 75-100% of the canister capacity.
200cc
Canister is full, replacement is needed.
400cc
300cc
CLINICIAN 17

mmHg
000
IN OPERATION:
24h00m
OPTIONS
MODE
400cc
DRAIN TIME (CUMULATIVE):
00h00m
100cc
00h00m
200cc
00h00m
300cc
000h00m
400cc
12. Operating Instructions (continued)
12.6 Tracking Exudate Level in Collection Canister (continued)
Pressing the Canister & Fluid Level Indicator would display a new window that list
out the cumulative collection time to reach each level. The cumulative drain time
allow user to determine whether exudate level collection is accelerating (possible
bleeding) or decelerating (increased wound healing).
The extriCARE® 3000 has an internal algorithm to determine whether a canister has
been changed. If a canister is changed, the cumulative collection time would be
reset.
Press the red Exit icon would close
this window and bring the user
back to the Main Page.
Cumulative drain time
12.7 Alarm Sound and Lock Mode Toggles
extriCARE® 3000 has two settings options where user can turn on or off:
• Alarm sound: the user has the option of muting the alarm sound (but error
message will still display on the screen with the red light on the Play/Pause
button flashing)
• Lock mode: in order to avoid accidental adjustment of the treatment
parameters, the user has the option of turning the device into Lock Mode,
where neither target vacuum pressure, vacuum pattern, nor sound alarm
can be changed.
Pressing the Options Button, a new window will appear:`
CLINICIAN
18

Alarm sound toggle: the display window shows the current state (mute, in the above
example). Pressing the sound symbol will toggle the alarm sound on or off:
Lock Mode toggle: the display window shows the current state (unlocked, in the
above example). Pressing the lock symbol will turn on/off the Lock Mode.
12. Operating Instructions (continued)
mmHg
000
IN OPERATION:
24h00m
OPTIONS
MODE
400cc
Alarm sound toggle Lock Mode toggle
12.7 Alarm Sound and Lock Mode Toggles (continued)
Alarm sound is turned on.
Alarm sound is muted (only error message and
red flashing warning light will be displayed to alert user).
Lock Mode is turned on
Lock Mode is turned Off.
CLINICIAN 19