Genadyne XLR8 User manual

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GenadyneBiotechnologies|EN(V5.0909.1)2
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
TABLEOFCONTENTS
WARNINGS...................................................................................................................................4
SAFETYSTANDARDS.....................................................................................................................4
SYMBOLS......................................................................................................................................5
INDICATIONFORUSE...................................................................................................................6
CONTRAINDICATIONS..................................................................................................................6
PRECAUTIONS..............................................................................................................................6
STANDARDPRECAUTIONS.........................................................................................................................................................................6
CONTINUOUSVERSUSINTERMITTENTTHERAPY..........................................................................................................................................6
PATIENTSIZEANDWEIGHT......................................................................................................................................................................7
SPINALCORDINJURY................................................................................................................................................................................7
BRADYCARDIA..........................................................................................................................................................................................7
ENTERICFISTULAS...................................................................................................................................................................................7
PROTECTPERIWOUNDSKIN......................................................................................................................................................................7
CIRCUMFERENTIALDRESSINGAPPLICATION...............................................................................................................................................8
PHYSICIANORDERS......................................................................................................................8
INTRODUCTION............................................................................................................................9
FEATURES.....................................................................................................................................9
SYSTEMUSAGE...........................................................................................................................10
POWERADAPTERS.....................................................................................................................11
CANISTERS..................................................................................................................................11
ACCESSORIES..............................................................................................................................12
KEYPADFEATURE.......................................................................................................................12
OPERATINGTHEDEVICE.............................................................................................................13
STARTINGUP...........................................................................................................................................................................................13
THERAPYMODE.........................................................................................................................13
THERAPYSELECTION..................................................................................................................................................................................15
ADJUSTINGTHEPRESSURE.........................................................................................................16
ALARMS......................................................................................................................................16
ENABLE/DISABLE....................................................................................................................................................................................17

GenadyneBiotechnologies|EN(V5.0909.1)3
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TARGETTIMEOUT.....................................................................................................................................................................................18
ALARMLOG............................................................................................................................................................................................18
ADVANCEMENU........................................................................................................................19
PREFERENCES...........................................................................................................................................................................................19
SYSTEMINFO...........................................................................................................................................................................................20
LANGUAGESELECTION...............................................................................................................................................................................20
BATTERYPOWER........................................................................................................................21
MAINTENANCE...........................................................................................................................22
CLEANING...............................................................................................................................................................................................22
RETURNINGTHEDEVICE.............................................................................................................................................................................22
ELECTROMAGNETICCOMPATIBILITY.........................................................................................23
LIMITEDWARRANTY..................................................................................................................26
TECHNICALSPECIFICATIONS......................................................................................................27
CONTACTINFORMATION...........................................................................................................28
ADVANCEFEATURE(REMOVABLE)............................................................................................29
LOCK/UNLOCKKEYPAD............................................................................................................................................................................29
ALARMLOGCLEARING..............................................................................................................................................................................29
TREATMENTTIMERESET(BOTHCONTINUOUSANDINTERMITTENT)...................................................................................................................30
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GenadyneBiotechnologies|EN(V5.0909.1)4
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Warnings
DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS
MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS AND
INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL
PERSONNEL IF APPLICABLE BEFORE ATTEMPTING TO USE THIS EQUIPMENT. OTHERWISE
INJURY OR DAMAGE MAY RESULT.
BEFORE PERFORMING ANY MAINTENANCE TO THE CONSOLE, DISCONNECT THE POWER
CORD FROM THE WALL OUTLET. REFER SERVICING TO QUALIFIED PERSONNEL ONLY.
GROUNDING RELIABILITY DEPENDS UPON A PROPERLY GROUNDED WALL OUTLET. DO
NOT USE THE POWER UNIT IN THE PRESENCE OF FLAMMABLE GASES SUCH AS
ANESTHETIC AGENTS.
WARNING/CAUTION NOTICES USED IN THIS MANUAL APPLY TO HAZARDS OR UNSAFE
PRACTICES WHICH COULD RESULT IN PERSONAL INJURY OR PROPERTY DAMAGE.
PLEASE MAKE SURE THAT THE POWER ADAPTER IS PLUGGED INTO THE WALL BEFORE
PLUGGING INTO THE UNIT. FAILURE TO FOLLOW THIS PRECAUTION MIGHT CAUSES
DAMAGE TO THE UNIT.
SafetyStandards
This system has been designed to comply with the regulatory safety standards including UL 60601-1,
CAN/CSA C22.2 No. 601.1-M90, CE 93/42/EEC Class IIa.
This system is internally powered with battery and externally powered with an approved Class II
power adapter.
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GenadyneBiotechnologies|EN(V5.0909.1)6
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Indicationforuse
The Genadyne XLR8 Wound Vacuum System is indicated for use in patients who would benefit from
negative pressure wound therapy particularly as the device may promote wound healing by the
removal of excess exudates, infectious material and tissue debris.
Contraindications
Genadyne XLR8 Therapy is contraindicated for patients with:-
oMalignancy in the wound
oUntreated osteomyelitis (NOTE: Refer to Clinical Guide for Osteomyelitis information.)
oNon-enteric and unexplored fistulas
oNecrotic tissue with eschar present (NOTE: After debridement of necrotic tissue and complete
removal of eschar, Genadyne XLR8 Therapy may be used.)
CAUTION:
Do not place dressing directly in contact with:-
oExposed blood vessels
oAnastomotic sites
oOrgans
oNerves
NOTE: Refer to Clinical Guide for additional information concerning Bleeding.
Precautions
Precautions should be taken for patients who are or may be: receiving anticoagulant therapy,
suffering from difficult hemostasis, untreated for malnutrition and non-compliant or combative.
StandardPrecautions

To reduce the risk of transmission of blood borne pathogens, apply standard precautions for infection
control with all patients, per institutional protocol, regardless of their diagnosis or presumed infection
status. In addition to gloves, use gown and goggles if exposure to body fluid is likely.

ContinuousversusIntermittentTherapy

Continuous, rather than intermittent, Genadyne XLR8 Therapy is recommended over unstable
structures, such as an unstable chest wall or non-intact fascia, in order to help minimize movement
and stabilize the wound bed. Continuous therapy is also generally recommended for patients at
increased risk of bleeding, highly exudating wounds, fresh flaps and grafts, and wounds with acute
enteric fistulae.
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GenadyneBiotechnologies|EN(V5.0909.1)7
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PatientSizeandWeight

The size and weight of the patient should be considered when prescribing Genadyne XLR8 Therapy.
Infants, children, certain small adults and elderly patients should be closely monitored for fluid loss
and dehydration. Also, patients with highly exudating wounds or large wounds in relation to the
patient size and weight should be closely monitored, as they may have a risk of excessive fluid loss
and dehydration. When monitoring fluid output, consider the volume of fluid in both the tubing and
canister.

SpinalCordInjury

In the event a patient experiences autonomic hyperreflexia (sudden elevation in blood pressure or
heart rate in response to stimulation of the sympathetic nervous system), discontinue Genadyne
XLR8 Therapy to help minimize sensory stimulation and seek immediate medical assistance.
Bradycardia

To minimize the risk of bradycardia, the Genadyne XLR8 Therapy dressing must not be placed in
proximity to the vagus nerve.

EntericFistulas

Wounds with enteric fistulas require special precautions to optimize Genadyne XLR8 Therapy. In
certain circumstances, the Genadyne XLR8 Therapy may help to promote healing in wounds with an
enteric fistula. When the physician orders the Genadyne XLR8 Therapy, it is recommended that
support from an expert clinician is sought. Genadyne XLR8 Therapy is not recommended or
designed for fistula effluent management or containment, but as an aid to wound healing. Genadyne
XLR8 Therapy is not recommended if enteric fistula effluent management or containment is the sole
goal of this therapy.

ProtectPeriwoundSkin

Consider use of a skin preparation product to protect periwound skin. Do not allow wound filler to
overlap onto intact skin. Protect fragile/friable periwound skin with additional hydrocolloid or other
transparent film.
Multiple layers of the transparent film dressing may decrease the moisture vapor transmission
rate, which may increase the risk of maceration.
If any signs of irritation or sensitivity to the film dressing, wound filler or tubing assembly
appear, discontinue use and consult a physician.
To avoid trauma to the periwound skin, do not pull or stretch the transparent film over the
wound filler dressing during film application.
Extra caution should be used for patients with neuropathic etiologies or circulatory compromise.
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GenadyneBiotechnologies|EN(V5.0909.1)8
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CircumferentialDressingApplication

Avoid use of circumferential dressings except in the presence of anasarca or excessively weeping
extremities, where a circumferential film technique may be necessary to establish and maintain a seal.
Consider using multiple small pieces of transparent film rather than one continuous piece to minimize
the risk of decreased distal circulation. Extreme care should be taken not to stretch or pull the film
when securing it, but let it attach loosely and stabilize edges with an elastic wrap if necessary. When
using circumferential film techniques, it is crucial to systematically and recurrently palpate distal
pulses and assess distal circulatory status. If circulatory compromise is suspected, discontinue
therapy, remove dressing and contact a physician.

PhysicianOrders
Prior to placement of the Genadyne XLR8, the medical professional treating the wound must assess
how to best use the system for an individual wound. It is important to carefully assess the wound and
patient to ensure clinical indications for Negative Pressure Wound Therapy (NPWT) are met.
All orders should include:
- Wound location, size and type
- Dressing kit type
- Vacuum settings
- Frequency of dressing changes
- Adjunctive dressings

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GenadyneBiotechnologies|EN(V5.0909.1)11
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PowerAdapters
IEC-320 C8 Power Cord
(Model# MPU30B-5)
19 VDC 1.57A 30W
Canisters
200CCCanister400CCCanister

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GenadyneBiotechnologies|EN(V5.0909.1)13
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Operatingthedevice
StartingUp
Press the Power Button once. The LCD will be lighted up. The pump will start running. Suction
is immediately available.
TherapyMode
The Genadyne XLR8 provides the user with 2 therapy mode.
1. Continuous
2. Intermittent
If a symbol Cis observed on the top left corner of the screen, this means continuous therapy is active.
The system sets it at continuous therapy mode by default. If the symbol Iis observed, this means
intermittent therapy is in active.
Continuous Mode Intermittent Mode

GenadyneBiotechnologies|EN(V5.0909.1)14

In intermittent mode, the high pressure time (Up Time) and low pressure time (Down Time) will also
be displayed on the main screen. The user will be asked to set 5 parameters when selecting
intermittent:-
1. Treatment time. Treatment time allows the user to set how long they want the patient to be on
intermittent therapy mode. Once the treatment time ended, the system will automatically switch
back to continuous therapy mode.
2. Up Time. Up time allows the user to determine how long they want the system to hold at a set
high pressure vacuum. When the time is up, it will go down to the set down pressure and will
remain at that level until the down time ends. The whole process will then cycle up and down
until the treatment time finishes.
3. Up Pressure. Up pressure allows the user to determine the high vacuum threshold while the
patient is on intermittent therapy.
4. Down Time. Down time allows the user to determine how long they want the system to hold at
a set low pressure vacuum. When the time is up, it will go up to the set up pressure and will
remain at that level until the up time ends. The whole process will then cycle down and up until
the treatment time finishes.
5. Down Pressure. Down pressure allows the user to determine the low vacuum threshold while
the patient is on intermittent therapy.
UpPressure
Down
Pressure
DownTime
UpTime
Treatment
Time

GenadyneBiotechnologies|EN(V5.0909.1)15

TherapySelection
To select which therapy to use at anytime
1. Press the Menu / Select button.
2. Scroll using the Up button or Down button and choose the Treatment Mode function by
pressing the Menu / Select button once.
3. Choose either Continuous or Intermittent by pressing the Menu / Select button once.
4. For Continuous selection, after Step 3, exit to the main screen by holding on to the Exit /
Cancel button for 5 seconds. The user can also press the Exit / Cancel button 2 times or more
to exit to the main screen.
5. For Intermittent selection, after Step 3, press Menu / Select button one more time to enter into
the intermittent setting screen.
a. Treatment Time. Press the Menu / Select button to enter the desired treatment time.
Use the Up button or Down button to increase or decrease the desired time. All settings
are in minutes. Once the treatment time is set, press the Menu / Select button again to
confirm selection. It will then bring you back to the Intermittent setting screen.
b. Up Time. Press the Menu / Select button to enter the desired up time. Use the Up
button or Down button to increase or decrease the desired time. All settings are in
minutes. Once the up time is set, press the Menu / Select button again to confirm
selection. It will then bring you back to the Intermittent setting screen.
c. Up Pressure. Press the Menu / Select button to enter the desired high pressure
threshold. Use the Up button or Down button to increase or decrease the desired
vacuum pressure. All settings are in mmHg. Once the vacuum pressure is set, press the
Menu / Select button to confirm selection. It will then bring you back to the Intermittent
setting screen.
d. Down Time. Press the Menu / Select button to enter the desired down time. Use the Up
button or Down button to increase or decrease the desired time. All settings are in
minutes. Once the down time is set, press the Menu / Select button to confirm selection.
It will then bring you back to the Intermittent setting screen.
e. Down Pressure. Press the Menu / Select button to enter the desired low pressure
threshold. Use the Up button or Down button to increase or decrease the desired
vacuum pressure. All settings are in mmHg. Once the vacuum pressure is set, press the
Menu / Select button to confirm selection. It will then bring you back to the Intermittent
setting screen.
6. To exit the intermittent setting screen and return to the main screen, hold on to the Exit /
Cancel button for 5 seconds. The user can also press the Exit / Cancel button 3 times or more
to exit to the main screen.


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GenadyneBiotechnologies|EN(V5.0909.1)17

Enable/Disable
The XLR8 provides the option for the user to enable or disable which alarm notifications they want to
have turned on.
To Enable / Disable the Alarm
1. Press Menu/Select button, use the Up/Down button to navigate to Alarm Setup, press the
Menu/Select button again to enter into the Alarm Setup function.
2. Press Menu/Select button to select the Enable/Disable function.
3.
Arrows on the side means enabled.
To select the desired alarm, navigate to the
desired alarm and press the Menu/Select
button once. The arrow will appear on the
side.
Disabled (No arrows).
To disable the alarms, navigate to the desired
alarm and press Menu/Select once to have the
arrow disappear.
4. To exit to the main screen, press and hold the Exit/Cancel button for 5 seconds.

GenadyneBiotechnologies|EN(V5.0909.1)18

TargetTimeout
The target timeout function is to enable the user to determine how soon after should the device start
alarming to notify the user of a leakage event occurring.
For example, if the target timeout is set at 30 seconds, this means that in the event of a target timeout,
it will have to last for at least 30 seconds continuously before the system starts alarming.
Use the Up/Down button to increase or decrease the desired time limit and press the Menu/Select
button to confirm setting.
AlarmLog
All alarms are logged and saved in the XLR8 memory.
To enter into the alarm log
1. Press Menu/Select button
2. Navigate to Alarm Setup by using the Up/Down button and press the Menu/Select button to
enter into the Alarm Setup function
3. Navigate to the Alarm Log by using the Up/Down button and press the Menu/Select button to
enter into the Alarm Log screen
4. All the past alarms will be shown on the screen
5. To acknowledged them scroll to the desired alarm notification and press the Menu/Select
button
6. The alarm bell will stop once acknowledged.
7. The asterisk (*) on the left side of the notification WILL NOT disappear until the problem is
fixed.
To exit to the main screen, press and hold on to the Exit/Cancel button for 5 seconds.

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GenadyneBiotechnologies|EN(V5.0909.1)20

SystemInfo
System info provides information about the system.
Software version, serial number and the usage meter is included in this function.
LanguageSelection
This function allows the user to choose which language to use.
To select the desired language, navigate using the Up/Down button in the Language and press the
Menu/Select button.
The words in system will then automatically change to the selected language.