Genadyne XLR8 Plus User manual

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XLR8+
Negative Pressure Wound Therapy
Distributed by:
Rehab Technologies, LLC
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TABLE OF CONTENTS
SAFETY STANDARDS................................................................................................................4
WARNINGS ..................................................................................................................................6
SYMBOLS.....................................................................................................................................7
INDICATION FOR USE...............................................................................................................8
USER..............................................................................................................................................8
CONTRAINDICATIONS..............................................................................................................8
PRECAUTIONS ............................................................................................................................9
STANDARD PRECAUTIONS......................................................................................................................................................................9
CONTINUOUS VERSUS VARIABLE THERAPY ...........................................................................................................................................9
PATIENT SIZE AND WEIGHT....................................................................................................................................................................9
SPINAL CORD INJURY.............................................................................................................................................................................9
BRADYCARDIA.......................................................................................................................................................................................9
ENTERIC FISTULAS.................................................................................................................................................................................9
PROTECT PERIWOUND SKIN .................................................................................................................................................................10
CIRCUMFERENTIAL DRESSING APPLICATION .......................................................................................................................................10
OPERATING PRECAUTIONS ...................................................................................................................................................................10
PHYSICIAN ORDERS................................................................................................................11
INTRODUCTION........................................................................................................................12
FEATURES..................................................................................................................................12
SYSTEM USAGE........................................................................................................................13
KEYPAD FEATURE...................................................................................................................14
OPERATING THE DEVICE.......................................................................................................15
THERAPY MODES.....................................................................................................................15
CONTINUOUS THERAPY MODE.............................................................................................................................................................15
VARIABLE THERAPY MODE .................................................................................................................................................................16
THERAPY SELECTION ...........................................................................................................................................................................17
ADJUSTING THE PRESSURE...................................................................................................................................................................18
INTENSITY MODE ....................................................................................................................18
ALERTS.......................................................................................................................................18
ENABLE /DISABLE ...............................................................................................................................................................................20
ALERT LOG ..........................................................................................................................................................................................22
ADVANCE MENU......................................................................................................................23
PREFERENCES.......................................................................................................................................................................................23
SYSTEM INFO .......................................................................................................................................................................................23
LANGUAGE SELECTION ........................................................................................................................................................................23
BATTERY POWER.....................................................................................................................24

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ADVANCE FEATURES.............................................................................................................25
LOCK /UNLOCK KEYPAD.....................................................................................................................................................................25
ALERT LOG CLEARING.........................................................................................................................................................................25
TREATMENT TIME RESET (BOTH CONTINUOUS AND VARIABLE THERAPY)..........................................................................................26
DRESSING APPLICATION.......................................................................................................27
MAINTENANCE.........................................................................................................................29
CLEANING ............................................................................................................................................................................................29
RETURNING THE DEVICE......................................................................................................................................................................30
DISPOSING OF THE DEVICE...................................................................................................................................................................30
LIMITED WARRANTY .............................................................................................................30
ELECTROMAGNETIC COMPATIBILITY...............................................................................31
ELECTROMAGNETIC COMPATIBILITY ...................................................................................................................................................31
ELECTROMAGNETIC COMPATIBILITY ...................................................................................................................................................32
TECHNICAL SPECIFICATIONS ..............................................................................................33
CONTACT INFORMATION......................................................................................................34

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Safety Standards
Read All Instructions Prior To Use
When using electrical devices, especially when children are present, basic safety precautions should always be followed, including the
following.
DANGER
To reduce the risk of electrocution:
1. ALWAYS unplug this product immediately after using or when charging is completed.
2. DO NOT use while bathing.
3. DO NOT place or store product where it can fall or be pulled into a tub or sink.
4. DO NOT Place or drop into water or other liquid.
5. DO NOT reach for a product that has fallen into water. Unplug immediately.
WARNING
The use of external accessories and cables other than those provided by Genadyne may result in increased Electromagnetic Emissions
or decrease in Immunity of the Wound Vacuum System.
When the Genadyne accessories (Type BF Applied Part) are used, patient leakage current will not exceed limits set for this Device
(Class II).
The USB port is blocked by tape. Removing the tape invalidates the Warranty. The use of the USB port is strictly limited to
Genadyne Personnel.
WARNING: The Cords and Tubing on this product present a potential strangulation hazard, particularly due to excessive
length. Keep cords and tubing out of reach of children.
WARNING: Disregarding the information on safety of this device is considered ABNORMAL USE
Do not wrap carrying case strap or dressing tubing around neck.
To reduce the risk of burns, electrocutions, fire or injury to persons:
1. This product should never be left unattended when plugged in.
2. Close supervision is necessary when this product is used near infants or children.
3. Use this product only for its intended use as described in this manual. DO NOT use attachments or kits not recommended by
Genadyne.
4. NEVER operate this product if it has a damaged cord or plug, any missing components, is not working properly, has been
dropped or damaged or has been dropped into water.
5. Keep the cord away from heated surfaces.
6. Do not use in presence of flammable anesthetics.
7. DO NOT operate where aerosol (spray) products are being used or where oxygen is being administered.
8. The AC ADAPTER should be unplugged from the outlet when not in use. When unit is not going to be used for an extended
period of time, store carefully in a cool, dry place.

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WARNING: The user SHOULD NOT attempt to service, repair or modify the Wound Vacuum System. Refer all servicing
to Genadyne. No user serviceable parts inside.
As with all prescription medical devices, failure to follow product instructions or adjusting settings and performing therapy
applications without the express direction and/or supervision of your trained clinical caregiver may lead to improper product
performance and the potential for serious fatal injury. For medical questions, please consult a physician. In case of medical
emergency, immediately contact your local emergency services provider.
CAUTION: Federal Law (USA) restricts this device to the sale by or on the order of a licensed physician.

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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.
Power Adapters
This system is internally powered with battery and externally powered with an approved Class II Power Adapter.
Note: Only this Power Adapter may be used with the device. Use of any other adapter automaticaly voids warranty and may be
hazardous to the patient and the operator.
IEC-320 C8 Power Cord
(Model# MPU30B-5)
19 VDC 1.57A 30W

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Symbols
Equipment Classification
Isolation Type BF Applied Part
Single Use Only
Date of Manufacture
Place of Manufacture
Storage Temperature
Biohazard
Keep Dry
EU:
Not for General Waste
Serial Number
Caution:
Read Instructions Before Use
Lot Number
Product Reference Number
Authorized European
Representative
XLR8+ Notified Body CE Mark
CSA International Classification
Double Insulated
Recognized Component Mark for
Canada and the United States
(Power adapter)
Certified Body (Power Adapter)
IP33
Protected against solid foreign
objects of 2.5 mm ∅and greater.
Protected against spraying water
Rx Only
Caution: Federal (US) law
restricts this device to sale/
rental by or on the order of
a physician
XLR8+ NPWT
System Label
Reproduction

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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.
User
The Genadyne XLR8+ NPWT System is designed for use by licensed healthcare professionals only.
Patients may be trained to perform some limited functions, but the keyboard is locked by the
professional to prevent the patient from changing the settings prescribed by the physician.
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.

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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 Variable Therapy
Continuous, rather than Variable, 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.
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.

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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.
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.
Operating Precautions:
When operating, transporting, repairing or disposing of XLR8+ devices and accessories, the risk of
infectious liquids being aspirated, or contamination of the device assembly through incorrect use,
cannot be eliminated. Universal precautions should be observed whenever working with potentially
contaminated parts or equipment.
As a condition of use, the XLR8+ Wound Care System should only be used by qualified and authorized
personnel. The user must have the necessary knowledge of the specific medical application for which
NPWT is being used.
The XLR8+ Wound Care System should remain on for the duration of the treatment. If the patient must
be disconnected, the ends of the tubing should be protected using the tethered cap. The length of time
a patient may be disconnected from the XLR8+ Wound Care System is a clinical decision based on
individual characteristics of the patient and the wound. Factors to consider include the location of the
wound, the volume of drainage, the integrity of the dressing seal, the assessment of bacterial burden
and the patient's risk of infection.