Related Manuals for Genadyne XLR8 Plus
Summary of Contents for Genadyne XLR8 Plus
- Page 1 XLR8+ Negative Pressure Wound Therapy Distributed by: Rehab Technologies, LLC 1 (800) 237-6708...
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Page 2: Table Of Contents
DJUSTING THE RESSURE INTENSITY MODE ........................18 ALERTS ............................18 ....................................20 NABLE ISABLE ......................................22 LERT ADVANCE MENU ........................23 ....................................... 23 REFERENCES ....................................... 23 YSTEM ..................................23 ANGUAGE ELECTION BATTERY POWER........................24 Genadyne Biotechnologies | DMR-06-091- Rev F... - Page 3 ..................................30 ETURNING THE EVICE ................................... 30 ISPOSING OF THE EVICE LIMITED WARRANTY ......................30 ELECTROMAGNETIC COMPATIBILITY................31 ..............................31 LECTROMAGNETIC OMPATIBILITY ..............................32 LECTROMAGNETIC OMPATIBILITY TECHNICAL SPECIFICATIONS ....................33 CONTACT INFORMATION ...................... 34 Genadyne Biotechnologies | DMR-06-091- Rev F...
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Page 4: Safety Standards
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). - Page 5 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.
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Page 6: Warnings
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 Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 7: Symbols
Protected against solid foreign Rx Only Caution: Federal (US) law objects of 2.5 mm ∅ and greater. restricts this device to sale/ rental by or on the order of Protected against spraying water a physician Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 8: Indication For Use
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. -
Page 9: Precautions
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. -
Page 10: Protect Periwound Skin
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. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 11: Physician Orders
Pressure Wound Therapy Treatment is being used. 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. -
Page 12: Introduction
Information provided in this user manual contains important information regarding the safe and effective operation of the Genadyne XLR8+ Negative Pressure Wound Therapy (NPWT) System. Use this manual as a personal reference and also in the training of personnel. Preventive maintenance, cleaning and disposal information are also included. -
Page 13: System Usage
System Usage The XLR8+ must be used ONLY at these suggested orientations. YES (KEEP UPRIGHT) Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 14: Keypad Feature
Lock and unlock keypad. Menu / Select Brings up the system menu. Enables user to select the desired function. Exit / Cancel Exit from the system menu. Enables user to cancel from current and selected function. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 15: Operating The Device
The pump will always remember the previous settings before it was powered off. Therapy Modes The Genadyne XLR8+ provides the user with 2 therapy modes: 1. Continuous Therapy 2. Variable Therapy... -
Page 16: Variable Therapy Mode
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 Variable Therapy. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 17: Therapy Selection
6. To exit the variable 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. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 18: Adjusting The Pressure
Alerts There are 6 Alert Notifications in the XLR8+. Whenever there is a leak in the dressing or the canister, the Leak Alert will Leak Alert occur. The message on the screen will show: Genadyne Biotechnologies | DMR-06-091- Rev F... - Page 19 Battery the machine. NOTE: MACHINE WILL NOT WORK UNTIL A POWER ADAPTER IS PLUG IN. The message on the screen will show: Genadyne Biotechnologies | DMR-06-091- Rev F...
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Page 20: Enable / Disable
The XLR8+ provides the option for the caregiver to enable or disable which Alert Notifications they want to have turned on. To Enable / Disable the Alert, the caregiver would have to request the special key combination from Genadyne. Genadyne Biotechnologies | DMR-06-091- Rev F... - Page 21 Critical Battery side. Disabled (No arrows). Leak Alert Low Battery To disable the Alerts, navigate to the desired Blockage Alert and press Menu / Select once to have Canister Full Critical Battery the arrow disappear. Genadyne Biotechnologies | DMR-06-091- Rev F...
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Page 22: Alert Log
3. Navigate to the Alert Log by using the Up / Down button and press the Menu / Select button to enter into the Alert Log screen. 4. Scroll to the desired Alert Notification and press the Menu / Select button to acknowledge them. 5. The Alert Notification Icon will clear once acknowledged. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 23: Advance Menu
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. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 24: Battery Power
(Alert Notification will occur. User needs to plug in the power adapter to recharge the battery) Battery is charging Battery is fully charged and system is running on while the power adapter is plugged in Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 25: Advance Features
2. Press the (Lock / Unlock) and release while holding onto number 1. 3. Press the (Exit / Cancel) and release while holding onto number 1. 4. Release the (Menu / Select) button. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 26: Treatment Time Reset (Both Continuous And Variable Therapy)
(Menu / Select) button. 2. Press and release in sequence, the (On / Off) button, and the (Lock / Unlock) button. 3. Release the (Menu / Select) button. 4. The Treatment Time will be reset to 00:00:00. Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 27: Dressing Application
1” in diameter. Remove paper backing (number 1) from the port pad*. Place over the hole. Peel number 2. Remove handlers. *Actual port pad may be different from the picture. The picture is for illustrative purposes only. Genadyne Biotechnologies | DMR-06-091- Rev F... - Page 28 Connect the port pad tubing to the canister tubing. Ensure all clamps are unclamped at this time. Step 8 Initiate therapy at the prescribed pressure by turning the machine on. Step 9 Foam will collapse down and target pressure will be achieved. Genadyne Biotechnologies | DMR-06-091- Rev F...
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Page 29: Maintenance
Product is also recommended to be opened and inspected between patient use by trained personnel to detect any possible issues before returning the device to the field. Please contact Genadyne for a free training on how to perform both the recommended and mandatory preventative maintenance on the device. -
Page 30: Returning The Device
Limited Warranty Genadyne Biotechnologies warrants its products, as listed below for one year on the machine. This warranty does not cover damage or breakdown to Genadyne units due to misuse or improper handling. The company will repair the system outside of the warranty coverage and shall bill the customer for parts and labor. -
Page 31: Electromagnetic Compatibility
Complies IEC 61000-3-3 Electromagnetic Compatibility The Genadyne XLR8+ is intended for use in the electromagnetic environment specified below. The customer or the user of the Genadyne XLR8+ should assure that it is used in such an environment. Electromagnetic environment –... -
Page 32: Electromagnetic Compatibility
Electromagnetic Compatibility The Genadyne XLR8+ is intended for use in the electromagnetic environment specified below. The customer or the user of the Genadyne XLR8+ should assure that it is used in such an environment. Immunity Test IEC 60601 test level... -
Page 33: Technical Specifications
Ambient Temperature : -18°C to 43°C, 0°F to 110°F : ≤ 93% Non-Condensing Relative Humidity PATIENT PROTECTION Class II per EN60601-1 Applied Part Type BF per EN60601-1 COMPLIANCE IEC 60601-1, 3 Edition IEC 60601-1-2 Genadyne Biotechnologies | DMR-06-091- Rev F... -
Page 34: Contact Information
Toll Free +1.800.208.2025 Tel. +1.516.487.8787 Fax +1.516.487.7878 www.genadyne.com Obelis S.A. EU Representative Bd. General Wahis 53 1030 Brussels BELGIUM +32 (0) 2.732.59.54 (Tel) +32 (0) 2.732.60.03 (Fax) www.obelis.net Distributed by Rehab Technologies, LLC 800-237-6708 Genadyne Biotechnologies | DMR-06-091- Rev F...
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