Genadyne XLR8 Plus User manual

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XLR8+
Negative Pressure Wound Therapy
Distributed by:
Rehab Technologies, LLC
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Genadyne Biotechnologies | DMR-06-091- Rev F
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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.