Engenex Instructions for Use and Clinical Guidelines Rev E

EngenexTM Quick Start Guide 1.

Prepare the wound bed by removing any foreign debris or contaminants and clean according to patient’s physician or institutional protocol.

2.

Visually inspect the wound and ensure that any underlying structures have been properly protected prior to applying an EngenexTM Dressing.

3.

Dress the wound with the appropriate EngenexTM Dressing (BioDomeTM side toward the wound). See sizes on pgs. v-vi.

4.

Apply the EngenexTM wound cover and place, at a minimum, a 2cm hole, in the cover, over the packing portion of the dressing.

5.

Apply the EngenexTM Tube Attachment Device (TAD) over the location of the hole. Do not cover the vent at the end of the TAD.

Vent

6.

i

Connect the TAD to the EngenexTM canister and connect the EngenexTM canister to the Wound-FloTM Therapy Unit.

7.

Set the therapy level and turn on the unit according to physician’s orders.

8.

Monitor the patient, wound and EngenexTM Advanced NPWT System between dressing changes.

9.

Change the dressing every 48-72 hours.

WARNING: These instructions are a supplement to and not a replacement for the complete EngenexTM instructions for use, normal wound care practices or local protocol. The EngenexTM instructions outline the indications, contraindications and safety information required for proper system utilization. Please read the complete instructions for use prior to initiating NPWT.

ii

EngenexTM Advanced NPWT System Wound Specific Quick Reference Guide Wound Type

Dressing

Abdominal (Complex)

Use a fenestrated nonadherent layer to cover exposed viscera. Apply EngenexTM dressing according to size, BioDomesTM facing away from the wound.

75mmHg Continuous

Acute/Traumatic/Burns Either the Standard or the Easy release (1st and 2nd degree) depending on need for debridement

75mmHg Continuous

Chronic Wounds

Either the Standard or the Easy release depending on need for debridement

75mmHg Continuous

Grafts/Flaps

Only use Easy Release dressing

Start therapy no higher than 55mmHg; set according to physician orders

Infected Wounds

Either the Standard or the Easy release depending on need for debridement

75mmHg Continuous

Orthopedic Appliances Either the Standard or the Easy release depending on need for debridement

75mmHg Continuous

Full Thickness Wounds Either the Standard or (Pressure Ulcers, Stage the Easy release depending on need for III and IV) debridement

75mmHg Continuous

Tunnel dressing or Tunnel dressing large

75mmHg Continuous

Tunneling

Therapy Settings

CAUTION Federal law restricts this System and its accessories to sale, lease or rent by or on the order of a physician. Please read these instructions carefully. Failure to follow these Instructions may result in the potential for death or serious injury.

iii

EngenexTM Advanced NPWT System Wound Specific Quick Reference Guide Additional Information

Page #

Special care is required for wounds in which exposed organs are present. Follow all standard precautions as well as the specific cautions outlined for complex abdominal wounds. 37-40

Follow all standard precautions associated with the EngenexTM NPWT System.

41-42

Do not place an EngenexTM dressing directly over any exposed structures; use a non-adherent intermediate layer. Low exudating wounds may benefit from intermittent therapy

43

It is suggested that an intermediate non-adherent layer be placed between the graft and the dressing.

For Infected wound consider the use a porous silver intermediate layer. Do not bridge any wounds with different etiologies. Change the dressing every 12-24 hours. Check for tunneling and also for the presence of osteomyelitis within the wound. Do not use EngenexTM on a wound with untreated osteomyelitis Follow all standard precautions associated with the EngenexTM NPWT System.

Never insert a tunnel dressing into unexplored tunnels or sinus tracts.

46

47-48

49-50

55-56

51

WARNING: These instructions are a supplement to and not a replacement for the complete EngenexTM instructions for use, normal wound care practices or local protocol. The EngenexTM instructions outline the indications, contraindications and safety information required for proper system utilization. Please read the complete instructions for use and clinical guidelines prior to initiating NPWT. iv

v

Product Description and Ordering Information Resource Guide Maximum Part Wound Bio-DomeTM Wound Dressing Kits Number Dimensions Bio-DomeTM Standard Dressing Kit, Small 1 standard dressing (7 x 10cm), 1 wound 6530 7 x 10 cm cover, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Standard Dressing Kit, Medium 1 standard dressing (12 x 18cm), 2 6550 12 x 18 cm wound covers, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Standard Dressing Kit, Large 1 standard dressing (15 x 25cm), 2 6570 15 x 25 cm wound covers, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Easy Release Dressing Kit, Small 1 Easy Release dressing (7 x 10cm), 1 6531 7 x 10 cm wound cover, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Easy Release Dressing Kit, Medium 1 Easy Release dressing (12 x 18cm), 2 6551 12 x 18 cm wound covers, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Easy Release Dressing Kit, Large 1 Easy Release dressing (15 x 25cm), 2 6571 15 x 25 cm wound covers, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Easy Release Dressing Kit, XL 1 Easy Release dressing (25 x 27cm), 4 6553 25 x 27 cm wound covers, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Easy Release Dressing Kit, Thin 1 Easy Release dressing (12 x 18cm), 2 6552 12 x 18 cm wound covers, 1 Opti-FloTM T.A.D., Sterile and Latex Free Bio-DomeTM Easy Release Dressing Kit, Double Sided Thin (D.S.T.) 1 Easy Release dressing (12 x 18cm), 1 6554 12 x 18 cm wound cover, 1 Opti-FloTM T.A.D., Sterile and Latex Free

EngenexTM Individual Dressings EngenexTM Tunnel Dressing (1 x 15cm)

6450

15 cm long

EngenexTM Tunnel Dressing Large (2 x 15 cm)

6451

15 cm long

EngenexTM Wound-FloTM Therapy Units

Part Number

EngenexTM Wound-FloTM Non-Acute Therapy Unit

6600

EngenexTM Wound-FloTM Acute Therapy Unit

6610

Engenex

TM

Accessories

TM

Engenex Y-Connector Y- connector to allow the connection of two wounds to one EngenexTM Wound-FloTM therapy unit EngenexTM Collection Canister 500ml collection canister for either the 6600 or 6610 EngenexTM Wound-FloTM therapy unit, 6 ft. connection cord to dressing

6491

6520

EngenexTM Carrying Case – Increase the mobility of the patient with this discrete carrying case

6650

Carbon/desiccant odor control cartridge - Controls odors that may emanate from the unit

6655

Power supply - 100/240 input, 18 vole, 1.67 amps output Power cord - Hospital Grade, US Power Kit - Power supply & power cord wrapped together

6671

IV Mount - Allows for either the 6600 or 6610 therapy unit to be connected to an IV pole

6690

Bed Mount - Allows for either the 6600 or 6610 therapy unit to be connected to a patient’s bed

6691

Engenex Cover-This thin film seals off the wound and allows negative pressure to be delivered.

6470

Engenex T.A.D– The TAD provides a secure attachment for the suction source as well as a calibrated vent for monitoring the leak status of the wound.

6481

Engenex Cover Strips– The cover strips hold dressings in place on difficult to treat wounds.

6471

6670

6680

vi

Disclaimer and Warranty Boehringer Wound Systems, LLC warrants that at the time of delivery and at all times during the lease period the Engenex™ therapy unit will be free from manufacturer defects in material and workmanship. Boehringer Wound Systems, LLC warrants that at the time of delivery and for a period of one year after delivery, the consumable components (also sometimes referred to as disposable components) of the Engenex™ system will be free from manufacturer defects in materials and workmanship. However, any of the following conditions will void these warranties: (i) failure to perform normal and customary cleaning of the Engenex™ therapy unit or to change the consumable components in accordance with these instructions; (ii) neglect, misuse or abuse of any component of the Engenex™ system, including without limitation the opening of, alteration of or tampering with the unit, alteration of the consumable components or damage to the unit due to dropping or submersion in fluids; (iii) use of accessories, supplies, consumable components or power sources which have not been approved by Boehringer Wound Systems, LLC; or (iv) failure to timely return the Engenex™ therapy unit in accordance with the terms of the lease. The warranties set forth in the previous paragraph are in lieu of all other warranties, expressed or implied, and the sole remedy for breach of the warranties is repair or replacement of the unit or consumable at the option of Boehringer Wound Systems, LLC. Boehringer Wound Systems, LLC nor any of its affiliates has made no other warranties or representations, expressed or implied, which other warranties and representations are disclaimed and waived. Without limiting the generality of the foregoing, Boehringer Wound Systems, LLC makes no warranties or representations, expressed or implied, concerning the capacity or operation of the equipment, including, without limitation, implied warranties of merchantability or implied warranties of fitness for a particular purpose, all of which are disclaimed and waived. Boehringer Wound Systems, LLC shall have no liability for special, punitive or consequential damages, for lost profits or loss of business, for personal injury or property damage, or for any other loss, damage or expense arising, directly or indirectly, from the installation, use, misuse, maintenance, operation or removal of the Engenex™ system. The maximum amount of damages Boehringer Wound Systems, LLC may be liable for in connection with the use of the Engenex™ system is limited under the terms of the lease. There is no guarantee or warranty of successful outcomes made or implied. Use of the Engenex™ system has been shown to be effective in treating a wide array of wounds, but underlying medical conditions of the patient as well as patient and clinician compliance are complex and factor into a successful outcome. Boehringer Wound Systems, LLC shall have no liability for exposure to infectious, toxic or other harmful substances as a result of the use of the Engenex™ system. The specific legal rights conveyed by the warranties included in this document

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may vary from state to state. If any portion of these provisions concerning the limited warranty and disclaimer are held to be illegal or unenforceable, then these provisions shall be amended to the extent necessary to comply with applicable law and the remaining provisions shall not be affected. Service There are no user serviceable components inside the Engenex Advanced Negative Pressure Wound Therapy System Therapy Unit. There are no user serviceable fuses in the power supply or therapy unit. Contact your EngenexTM representative for return/replacement of damaged units or contact Boehringer Wound Systems LLC at the number listed in this document. Copyright © 2008 Boehringer Technologies, L.P., all rights reserved. The software which runs your Engenex™ Therapy Unit is copyrighted by Boehringer Technologies, L.P. and protected by Title 17 U.S.C. 1201. Anyone convicted of coping or modifying this software may be fined not more than $500,000 or imprisoned for not more than 5 years, or both, for the first offense Permitted Copies Use of this Product Instruction Manual is strictly limited to the internal use of authorized lessees of the Engenex™ system and may not be copied or reproduced except as expressly permitted in this paragraph or with the prior written consent of Boehringer Technologies, L.P. Authorized lessees of the Engenex™ system may download or copy complete electronic or printed versions of this Product Instruction Manual for their internal use only. Use of copies, electronic or printed, of this Product Instruction Manual in less than its entirety shall result in the voiding of all warranties in the Product Instruction Manual. No other rights, commercial or otherwise, are granted hereunder to the Engenex™ system or this Product Instruction Manual. Updates Boehringer Technologies, L.P. and Boehringer Wound Systems, LLC reserve the right to make revisions and changes to this Product Instruction Manual without notification to lessees or other users of the Engenex™ system. Lessees and other users of the Engenex™ system must obtain the most current version of this Product Instruction Manual from our website located at www.boehringerwound.com.

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TABLE OF CONTENTS EngenexTM Quick Start Guide ... i-ii Wound Care Quick Reference Guide ... iii-iv Product Description and Ordering Information Resource Guide ... v-vi Disclaimer and Warranty ... 1-2 Introduction ... 5-6 Product Overview ... 7-8 EngenexTM Safety Information ... 9-16 Prescribing EngenexTM...9 Indications for Use ...9 Contraindications for Use ...9 Warnings, Cautions and Potential Adverse Reactions ... 9-13 Transitioning Into a Home Healthcare Environment with EngenexTM ...13 Suggested Nutritional Monitoring ...14 Additional Considerations ... 15-16 General Dressing Guidelines ... 17-24 Device Labeling...17 Preparing the Wound Bed ...18 Preparing the Wound-FloTM Therapy Unit for Use ...19 Pressure Settings with the EngenexTM System ...19 Applying the Dressing ... 20-21 Replacing Disposable Components ... 22-23 Changing the Wound Dressing ...22 Removing the Canister ...23 Monitoring Between Dressing Changes ...24 Additional Information ... 25-31 Consumables ... 25-26 Wound-FloTM Therapy Unit ... 27-31 Wound Specific Dressing Techniques ... 32-35 Tunneling or Sinus Tracts ... 32-33 Bridging Wounds ... 33-34 Small Wounds ...35 Multiple Wounds...35 Clinical Guidelines... 36-58 Overview ...36 Abdominal Compartment Syndrome/Complex Open Abdominal Wounds ... 37-40 Acute/Traumatic Wounds/Burns (1st, 2nd) ... 41-42 Chronic Wounds...43 Dehisced Surgical Incisions ... 44-45 Flaps and Grafts...46 Infected Wounds ... 47-48 Orthopedic Appliances... 49-50 Tunnel Wounds and Sinus Tracts ...51 Ulcers ... 52-58

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Ulcer Staging ... 52-53 Diabetic Foot Ulcers ...54 Full Thickness Pressure Ulcers/ Large Deficit Wounds ... 55-56 Sacral Decubitus Ulcers ...57 Venous Ulcers ...58 Appendix 1: Trouble Shooting ... 59-64 Wound Condition... 59-60 Consumables ...60 Wound-FloTM Therapy Unit ... 61-64 Appendix 2: Accessory Installation Procedures ...65 Appendix 3: Symbols ... 66-67 Appendix 4: Product Specification ... 68-70 Appendix 5: Sample Physicians Orders...71 Index... 72-75 EngenexTM References ...76 Notes ... 77-80

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Engenex™ Advanced Negative Pressure Wound Therapy System

Congratulations on selecting the EngenexTM Advanced Negative Pressure Wound Therapy System. The EngenexTM System is the culmination of many years of engineering research and development to provide an optimum system for negative pressure wound therapy. We are proud to bring you the enhancements and innovations that define virtually every aspect of the System. Please read these instructions carefully to ensure that you fully understand the System and are able to take full advantage of the many benefits the System has to offer. Thank you for your support. We welcome your feedback and inputs and will carefully consider your comments and suggestions in our continual effort to improve our Product.

Introduction into Foundation Based Healing

The EngenexTM Advanced wound therapy system is a refinement of negative pressure wound therapy (NPWT) that encourages healing of wounds in a manner that mimics normal acute wound healing. The EngenexTM system promotes rapid tissue growth by imposing controlled strain, removing deleterious materials while maintaining a moist healing environment. At the heart of the EngenexTM dressing material is a novel technology, the Bio -DomesTM that promote granular tissue growth at lower and therefore safer negative pressures than previously thought possible. The Bio-DomesTM in the EngenexTM dressing are specially engineered structures that form a defined space above the surface of the wound. This space will maintain its size and integrity in the presence of negative pressure and wound fluids and thus effectively impose strain on the underlying tissue, thereby promoting unobstructed growth with less dressing integration into the wound. Further, the structure will allow the passage of wound fluids, essential for effective NPWT. The material properties of the dressing permits moist wound healing while encouraging efficient removal of exudates. The contact material will not absorb fluid. It has been clinically shown that the Bio-Domestm are effective at growing granular tissue in the base of a wound at a safe low negative pressure of 75 mmHg. The collapsible packing portion of the Bio-DomeTM dressing is intended to effectively fill the wound while permitting efficient fluid transport of exudates. The packing is specifically designed to resist collapse in a given direction to allow for preferred anatomic closure. The anisotropic collapse characteristic of the EngenexTM dressing is tailored to perform in a manner that encourages wound healing that is supportive of the natural healing process.

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Combining the benefits of the defined, noncollapsible Bio-DomesTM with a safer, subatmospheric pressure and a dressing that encourages anatomic closure, the EngenexTM NPWT system provides complete therapy support for promotion of the body’s natural healing ability. Patents The Engenex™ system is manufactured under license from Boehringer Technologies, L.P. US and Foreign Patents Pending. Trademark BoehringerTM, Bio-Dome™, Compliant Hours™, Engenex™, EasyRelease™, Opti-Flo™, and Wound-Flo™ are trademarks owned by and used under license from Boehringer Technologies, L.P.

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PRODUCT OVERVIEW Bio-DomeTM Wound Dressings The Bio-DomeTM Wound Contact Dressing is a permeable dressing that is placed over or in the wound to facilitate the application of suction to wounds. The Wound Dressing incorporates the unique Bio-DomeTM technology to promote healing. The Wound Dressing is comprised of nonwoven polyester layers joined by a silicone elastomer. This material is arranged in three layers and comprises the packing portion of the dressing, which effectively fills the wound while permitting efficient fluid transport of exudates. Dressings are provided sterile and latex free. Two types of wound contact dressings are available-Standard and EasyReleaseTM. Bio-DomeTM Standard These dressings feature a fibrous wound contact surface. This type of dressing is optimal for wounds that require light debridement as well as for cases where mild slough is present. Standard dressings are available in small, medium and large varieties. Bio-DomeTM EasyReleaseTM These dressings provide a smooth contact surface that may be used in all wound types and should result in less patient discomfort during dressing changes. The Bio-DomeTM TM EasyRelease dressing is available in small, medium, large and extra large varieties. Bio-DomeTM Thin This dressing possesses the same properties as the EasyReleaseTM version; however, with only one fluted packing layer, this dressing is optimized for shallow, superficial wounds. This dressing is available in medium size only. Bio-DomeTM Double Sided Thin (D.S.T.) This dressing is a thin version of the EasyReleaseTM variety that incorporates Bio-DomeTM Technology on both sides of the dressing. The D.S.T. is intended for use with surgical dehiscence, superficial stage III and IV and well as shallow undermined wounds. The D.S.T. is available in medium size only. Tunnel Dressing

7

The EngenexTM Tunnel Dressing is recommended for use in wounds with tunnels or sinus tracts. The tunnel dressing is comprised of non-woven polyester layers, and are provided sterile and latex free. Tunnel dressings are

PRODUCT OVERVIEW tapered for ease of insertion. Tunnel dressings are used to maintain a flow passage for therapy administration until the distal portion of the tunnel has closed. Wound Cover The Wound Cover is a thin film dressing that serves to cover and seal wounds. It consists of polyurethane film coated on one side with a hypoallergenic, pressure sensitive acrylate adhesive. The user cuts a hole in the Cover prior to securing the Tube Attachment Device to the Cover. This allows negative pressure wound therapy to be applied from the Tube Attachment Device to beneath the Cover. Covers are provided sterile and latex free. Opti-FloTM Tube Attachment Device (T.A.D) The Tube Attachment Device consists of tubing joined to a moisture vapor permeable adhesive film. The Tube Attachment Device includes a controlled filter vent. The vent works in combination with the flow detection system of the therapy unit to provide information on system performance. The Tube Attachment Device is applied over the wound cover to provide the suction source for negative pressure wound therapy. On small wounds, the T.A.D. may be used in place of the wound cover to cover and seal the wound. The T.A.D. is provided sterile and latex free EngenexTM Canister The canister is a rigid 500 ml capacity collection canister with flexible tubing (6 ft long) and a proprietary connector. The canister includes an integral filter to prevent overflow and a gelling agent to absorb and solidify the contents of the canister. Canisters are provided sterile and latex free. EngenexTM Wound-FloTM Therapy Units The therapy unit includes a case that encloses a positive displacement pump, a regulation control circuit, independent flow monitoring circuitry, and a rechargeable battery. The therapy unit applies controlled suction adjustable by the user in the range of 30 mmHg to 75 mmHg. The unit operates in continuous and intermittent modes. It incorporates a proprietary detection system to monitor and display the condition of the wound dressing and the collection system. Model 6600 therapy unit is designed for use in a non-acute care setting Model 6610 therapy unit is designed for acute care use and includes a hospital grade cord set

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ENGENEXTM SAFETY INFORMATION PRESCRIBING ENGENEXTM Only treating physicians and nurse practitioners can prescribe EngenexTM Advanced Negative Pressure Wound Therapy. In addition, failure to consult a physician and follow all product information, including Clinical Guidelines, may result in inappropriate product performance, which may cause a serious or fatal injury to the patient.

INDICATIONS FOR USE The EngenexTM Advanced Negative Pressure Wound Therapy System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids, and infectious materials.

CONTRAINDICATIONS FOR USE

Do not use the EngenexTM Advanced Negative Pressure Wound Therapy System for – • Application to wounds where there is evidence of a) Exposed arteries or veins in wound b) Fistula – unexplored c) Fistula - non enteric d) Osteomyelitis, untreated e) Malignancy in the wound f) Necrotic tissue with eschar • Emergency Airway Aspiration • Pleural, mediastinal or chest tube drainage. These applications require a device that provides specific low suction levels and an underwater seal. • Surgical Suction • Do not apply the EngenexTM Wound Dressings directly to exposed blood vessels, organs, or nerves.

WARNINGS & PRECAUTIONS •

The uses of any other wound/skin contact dressing or adjunctive therapies, except as described herein, may compromise the performance characteristics of the EngenexTM system and detrimentally affect patient care.

•

The Wound-FloTM Therapy Unit and EngenexTM consumables have been designed to operate as a system and are to be used in conjunction with one another. Use of the EngenexTM Therapy Unit and Consumables in a manner other than described in this document may compromise patient safety. Use the Wound-Flo™ Therapy Unit only with EngenexTM consumables.

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ENGENEXTM SAFETY INFORMATION Bleeding •

Excessive bleeding is a serious risk associated with the application of suction to wounds and may result in death or serious injury. Careful patient selection, in view of the above stated contraindications, warnings and precautions, is essential. Carefully monitor the wound and collection circuit for any evidence of a change in the blood loss status of the patient. Notify the Physician of any sudden or abrupt changes in the volume or the color of exudate.

Defibrillation •

If defibrillation is required in a region where an EngenexTM dressing is placed, remove the dressing first before performing any emergent action. Inability to comply could impede patient resuscitation.

Dressing Placement •

Inadvertently leaving wound dressings in a wound cavity is a risk associated with wound therapy. Exercise care to ensure the complete removal of dressings at each dressing change, including recording the number of dressings. Verify the complete removal of all dressings and materials.

Hyper Baric Oxygen Therapy (HBO) •

The Wound-Flo™ Therapy Unit is not compatible for use in a hyperbaric oxygen environment. The Wound Flo™ Therapy Unit is an electrical device and represents an ignition risk. The EngenexTM consumables may be left in place on the wound provided that 22 hours of wound therapy can be maintained for the day of hyperbaric oxygen therapy. Cover the dressing with a moist towel while in the hyperbaric chamber. Resume use of the EngenexTM System as soon as possible after hyperbaric treatment. EngenexTM NPWT is not intended for concomitant use with Topical Hyperbaric Treatment.

Infection Bacterial Infections •

Wounds with bacterial infections should be monitored closely. More frequent dressing changes may be required as well as a secondary method of treatment, such as I.V. antibiotics or an antimicrobial intermediate layer. Wound monitoring for symptoms such as increased exudate, fever, tenderness, swelling, redness, odor and rash is required for at risk patients. If any of these symptoms are present, please contact the treating physician immediately.

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ENGENEXTM SAFETY INFORMATION Yeast Infections •

On Patients that are prone to topical, peri-wound yeast infections, take care to ensure the wound area is properly ventilated to minimize excess moisture in contact with the intact skin. A Miconozil powder as prescribed by a physician may be useful in controlling the yeast infection. Prepare the infected area with a topical skin prep. Before the skin prep has dried, apply the powder to the area, taking care to avoid the open wound area. Allow the skin prep to dry completely. Remove excess powder away from the wound area.

Magnetic Resonance Imaging (MRI) •

The Wound-Flo™ Therapy Unit is not compatible for use in an MRI environment. Disconnect the unit from the Patient prior to entering the MRI environment. The dressing and canister may remain attached to serve as a gravity drain during imaging procedures. If 22 hours of wound therapy cannot be maintained for a given 24 hour period, revert to a traditional dressing modality and resume use of the EngenexTM NPWT System as soon as possible.

Osteomyelitis •

Never apply EngenexTM on a wound that presents with untreated osteomyelitis. A thorough debridement of any necrotic tissue, prior to therapy, is necessary for optimizing the healing potential of any wound. If a patient with osteomyelitis has received thorough debridement to remove necrotic tissue as well as antibiotic therapy for at least 5 days, EngenexTM NPWT can be prescribed.

Periwound Skin •

Protection of the periwound skin is vital for proper wound healing. A liquid skin protectant should be used to treat the surrounding skin in order to prevent damage. Applying multiple layers of the wound cover will decrease the vapor permeability of the cover and could lead to skin maceration.

Protect Vessels and Organs •

All exposed vessels and organs, within a wound site, should be protected with a non-adherent intermediate layer. Choose an intermediate layer that has the ability to remain in place for the duration of treatment. Before initiating NPWT therapy, verify that no EngenexTM dressing material is in direct contact with an organ or vessel.

Tunneling Wounds •

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Never use EngenexTM on unexplored tunneling wounds. If a tunnel connects two wounds, EngenexTM NPWT must be applied to both wounds. Please consult the treating physician prior to implementing EngenexTM therapy.

ENGENEXTM SAFETY INFORMATION

CAUTIONS •

Opti-FloTM Tube Attachment Devices, Wound Covers and Bio-DomeTM Wound Dressings are single patient use only and should be disposed of in accordance with local rules and practices regarding infectious waste.

•

Canisters are single patient use only and cannot be reused or emptied. Dispose of in accordance with local rules and practices regarding infectious waste.

•

When performing dressing changes, sterile technique is recommended to reduce the risk of spread of blood borne pathogens and infection. Use of clean technique is the responsibility of the health care professional directly responsible for patient care.

•

Only use the power supply provided with the Wound-FloTM Therapy Unit, BWS P/N 6670, to ensure proper operation. Use of non-approved power supplies will void the product’s warranty and may adversely affect patient safety. Please see Section 16 of this manual for the complete listing of all compatible power supplies (IEC 60601-1:1988 + A1:1991 + A2:1995) that may be used with your unit.

•

Do not use the Wound-Flo™ Therapy Unit in the presence of flammable anesthetics.

ADVERSE REACTIONS Allergic Reaction •

A hypoallergenic acrylate adhesive is used in the wound cover. Any patient who is allergic to acrylate adhesives should not be permitted to use the EngenexTM NPWT system. If any signs of allergic reaction present themselves during treatment, EngenexTM therapy should be discontinued immediately. Symptoms such as swelling, rash and blistering of the skin should be reported to the treating physician immediately. Seek emergent medical attention if signs of anaphylaxis are present. Bleeding • Excessive bleeding is a serious risk associated with the application of suction to wounds and may result in death or serious injury. Careful patient selection, in view of the above stated contraindications, warnings and precautions, is essential. Carefully monitor the wound and collection circuit for any evidence of a change in the blood loss status of the patient. Notify the Physician of any sudden or abrupt changes in the volume or the color of exudate.

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ENGENEXTM SAFETY INFORMATION Exercise care when: Treating Patients that are undergoing anticoagulant therapy. Treating Patients that are actively bleeding. Treating Patients that have had operations due to cardiovascular conditions. Treating Patients who are being treated for or who are at risk of systemic infection. Treating wounds where there is the potential of a sharp edge such as a broken bone that could compromise blood vessels. •

Use of the EngenexTM System on Patients that are at risk for bleeding should be performed under the strict supervision of a Physician in a Hospital setting.

•

Excess blood loss leading to death or serious injury (hypovolemic shock) is a risk associated with the application of suction to wounds. Careful adherence to device contraindications is required. Patients at risk for bleeding or who are on anticoagulant therapy should be carefully monitored. Pay extra attention to infants, small children and elderly patients to note any signs of excess fluid loss.

•

Care must be taken when applying suction in the vicinity of weakened blood vessels or organs, for example, sutured blood vessels, infected blood vessels or blood vessels that have been exposed to radiation.

•

Cover exposed blood vessels, organs, tendons, ligaments and nerves with multiple layers of fine mesh non-adherent dressings. Where appropriate, multiple layers of fine mesh non-adherent dressings should be used to protect delicate tissues. Do not apply the Bio-DomeTM wound dressing directly to exposed bowel surfaces.

TRANSITIONING INTO A HOME HEALTHTM CARE ENVIRONMENT WITH ENGENEX TM

The versatility of the Engenex Advanced NPWT system allows a simple transition to be made from the acute setting to a home healthcare environment. All standard hospital protocols, as well as the precautions prescribed in this document should be followed. Before the transition into a home healthcare environment can take place, the following items at a minimum should be considered:

• • •

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EngenexTM non-acute Therapy Unit (P/N 6600) and all consumables are ordered prior to leaving the acute setting. Ensure that the patient, patient’s family and treating facility are capable of continuing with EngenexTM NPWT, understanding the safety information and able to respond to adverse events as prescribed herein. All continuing healthcare personnel should be made aware of any potential patient conditions, such as risk of bleeding or exposed structures, which may arise before transitioning into a home healthcare facility.