Engenex Instructions for Use Rev D

Patents The Engenex™ system is manufactured under license from Boehringer Technologies, L.P. US and Foreign Patents Pending.

Trademark Bio-Dome™, Compliant Hours™, Engenex™, EasyRelease™, Opti-Flo™, and WoundFlo™ are trademarks owned by and used under license from Boehringer Technologies, L.P.

Copyright © 2007 Boehringer Technologies, L.P., all rights reserved. The software which runs your Engenex™ Pump 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 the 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.

Limited Warranty and Disclaimers Boehringer Wound Systems, LLC warrants that at the time of delivery and at all times during the lease period the Engenex™ pump 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 material and workmanship. However, any of the following conditions will void these warranties: (i) failure to perform normal and customary cleaning of the Engenex™ pump 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 pump, alteration of the consumable components or damage to the pump 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™ pump 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 pump 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 and patient as well as 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 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 Pump. There are no user serviceable fuses in the power supply or suction pump. Contact your Engenex representative for return/replacement of damaged units or contact Boehringer Wound Systems LLC at the number listed in this document.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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Table of Contents 1.

PRODUCT DESCRIPTION... 5

2.

INDICATIONS ... 5

3.

CONTRAINDICATIONS FOR USE ... 6

4.

WARNINGS ... 6

5.

CAUTIONS... 7

6.

ADVERSE REACTIONS... 7

7.

DEVICE LABELING... 8

8.

DIRECTIONS FOR USE ... 9

9.

PATIENT CARE BETWEEN DRESSING CHANGES... 13

10.

ADDITIONAL INFORMATION, CONSUMABLES ... 15

11.

ADDITIONAL INFORMATION, WOUND FLOTM PUMP ... 17

12.

SPECIAL CARE, TIPS AND RECOMMENDATIONS... 20

13.

TROUBLE SHOOTING GUIDE, WOUND CONDITION... 25

14.

TROUBLE SHOOTING GUIDE, CONSUMABLES... 26

15.

TROUBLE SHOOTING GUIDE, PUMP... 26

16.

SYMBOLS... 29

17.

PRODUCT SPECIFICATIONS ... 30

18.

SAMPLE PHYSICIANS ORDER ... 32

19.

NOTES PAGES ... 33

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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Engenex™ Advanced Negative Pressure Wound Therapy System Instructions for Use Congratulations on selecting the Engenex Advanced Negative Pressure Wound Therapy System. The Engenex 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. 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.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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1. PRODUCT DESCRIPTION The EngenexTM Advanced Negative Pressure Wound Therapy System consists of a battery powered suction pump for the application of negative pressure wound therapy. Accessories for use with the pump include: a canister for the collection of waste fluids; a Wound Contact Dressing, a Cover for wounds and a Tube Attachment Device (T.A.D.). The Engenex Wound FloTM Pump is intended for exclusive use with EngenexTM Consumables. SYSTEM COMPONENTS Bio-domeTM Wound Dressing The 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 BioDomeTM technology to promote healing. The Wound Dressing is comprised of non-woven polyester layers joined by a silicone elastomer. Dressings are provided sterile. Two types of wound contact dressings are available. Standard and EasyReleaseTM. Wound Cover The 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. 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 pump 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. Tube Attachment Devices are provided sterile. 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. 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. Engenex Wound FloTM Pump The pump device includes a case that encloses a diaphragm pump, a regulation control circuit and a rechargeable battery. The pump applies controlled suction adjustable by the user in the range of 30 mmHg to 75 mmHg. The pump 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 pump is designed for use in a non-acute care setting Model 6610 pump is designed for acute care use and includes a hospital grade cord set

2. INDICATIONS 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.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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3. 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.

4. WARNINGS • The use of any other wound/skin contact dressing or adjunctive therapies, except as described in this manual, may compromise the performance characteristics of the Engenex system and detrimentally affect patient care. • The Wound FloTM Pump and Engenex consumables have been designed to operate as a system and are to be used in conjunction with one another. Use of the EngenexTM Pump and Consumables in a manner other than described in this document may compromise patient safety. Use the Wound Flo™ pump only with Engenex consumables. • 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. See Section 6. • 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 nonadherent dressings. Where appropriate, multiple layers of fine mesh non-adherent dressings should be used to protect delicate tissues. Do not apply the Bio-dome wound dressing directly to exposed bowel surfaces. • 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 used to verify their complete removal. • The Wound Flo™ Pump is not compatible for use in an MRI environment. Disconnect the Pump from the Patient prior to entering the MRI environment. The canister may remain attached to serve as a gravity drain during imaging procedures. • The Wound Flo™ Pump is not compatible for use in a hyperbaric oxygen environment. The Wound Flo™ Pump is an electrical device and represents an ignition risk. The Engenex 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. If 22 hours of wound therapy can not be maintained for the day of hyperbaric oxygen therapy, then apply a gauze dressing to the Patient and resume use of the Engenex as soon as possible.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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5. CAUTIONS • Tube Attachment Devices, Covers and 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. 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 device, BWS P/N 6670, to ensure proper operation. Use of nonapproved 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. • Safe Performance: Even in fault conditions, the Engenex will not exceed 250 mmHg of suction. If the unit becomes inoperable, the user will be alerted through audible and/or visual signals. • Do not use the Wound Flo™ Pump in the presence of flammable anesthetics.

6. ADVERSE REACTIONS • Bleeding Excessive bleeding is a serious risk associated with the application of suction to wounds which 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. 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 Engenex System on Patients that are at risk for bleeding should be performed under the supervision of a Physician in a Hospital setting.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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7. DEVICE LABELING FIGURE 1. LABELING ON THE TOP OF THE WOUND FLOTM PUMP - STATUS INDICATORS SUCTION SELECTOR

POWER LED HOUR METER

ALARM SNOOZE BUTTON

POWER/MODE SELECTOR

CANISTER RELEASE BUTTON

STATUS INDICATORS:

COLOR CODED INFORMATION PANEL THAT INDICATES THE CONDITION OF THE DRESSING SYSTEM WITH RESPECT TO AIR LEAKS AND NEGATIVE PRESSURE

HOUR METER:

INDICATES THE ELAPSED TIME THAT EFFECTIVE THERAPY IS APPLIED TO THE WOUND, THE HOURS REMAINING ON THE PUMP AND ANY ERROR CODES

POWER LED:

INDICATES THE POWER STATUS OF THE DEVICE WITH RESPECT TO WALL OR BATTERY POWER.

CANISTER RELEASE BUTTON: ALARM SNOOZE BUTTON:

RELEASES THE CANISTER FROM THE PUMP

TEMPORARILY SILENCES THE AUDIBLE ALARM AND FORCES THE DISPLAY OF COMPLIANT HOURS REMAINING ON THE PUMP

POWER MODE SELECTOR:

TURNS THE UNIT ON OR PERMITS INTERMITTING OPERATION

SUCTION SELECTOR:

SETS THE DESIRED SUCTION LEVEL

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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8. DIRECTIONS FOR USE The EngenexTM Advanced Negative Pressure Wound Therapy System has been designed for reliable trouble free operation with minimal maintenance requirements. Please follow physician’s orders and these instructions to ensure optimal performance.

PROPER WOUND MANAGEMENT Use of this system is not intended to replace proper wound care techniques. Proper wound management includes: debridement of slough, eschar and devitalized tissue, monitoring bacteria load, wound measurement, use of appropriate support surfaces, monitoring the patient’s nutrition and other techniques specified by the Patient’s Physician and used by the Wound Care Professional. It is important that the Patient is determined to be an appropriate candidate for negative pressure wound therapy.

SELECTION OF WOUND DRESSING MATERIALS EngenexTM dressings incorporate an innovative new material and construction for the application of negative pressure wound therapy. The contact surface of the dressing incorporates the patent pending Bio-domeTM technology for enhanced tissue growth. It is important to be sure that the Bio-domeTM surface is placed in contact with the wound. Bio-domeTM dressings were developed to provide a wound contact surface that will maintain a void directly above the wound surface for unobstructed tissue growth. The void is specifically engineered to maintain its size and shape when under the influence of negative pressure and in the presence of bodily fluids. This dressing may be used in all wound types and can be employed to remove some mild slough. There are two types of Bio-domeTM dressings for use: ¾

Bio-domeTM Standard dressing features a fibrous wound contact surface.

¾

Bio-domeTM EasyRelease, in addition to all of the features of the Bio-domeTM Standard, provides a smooth contact surface. This dressing may be used in all wound types and should result in less patient discomfort during dressing changes.

PRESSURE SETTINGS FOR USE OF THE ENGENEX SYSTEM The Engenex System with Bio-dome technology has been engineered to provide effective application of negative pressure while minimizing the level of suction that is applied to wounds. The unique Bio-dome construction enables the use of low, safe levels of suction of 75 mm Hg. This low setting works well in many cases. Lower levels of negative pressure may be used to minimize pain during treatment as well dressing removal. Lower levels of negative pressure may also be useful in treating conditions where there is obvious bruising in the bed of the wound.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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PREPARING THE WOUND-FLOTM PUMP FOR USE - Follow these steps to fully charge the battery in the Wound-Flo Pump prior to use. a. Plug the power connector from the approved power supply P/N 6670 into the power receptacle on the rear of the unit. b. Plug the pentagon shaped end from the power cord P/N 6671 into the receptacle of the power supply. If this connection has already been made, ensure both parts are firmly attached. c. Plug the opposite end of the power cord into a working outlet suitable for patient care. d. Once the unit has been plugged in the Power LED of the unit must be solid green (battery fully charged) or blinking green (battery charging). e. To move the pump, ensure the unit has been unplugged from wall power before attempting to disconnect any other components.

a

b

c

If the unit has shipped with an IV Mount P/N 6690, or Bed Mount P/N 6691, please refer to the attachment instructions on page 21.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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APPLICATION OF THE WOUND CONTACT DRESSING Carefully inspect the wound and treat per the order of the patient’s physician and according to the institution’s protocol and standards of practice for wound care. This should include proper hand washing and gloving practices. Appropriate skin prep should be used to preserve the wound margins and prevent epithelial stripping. Remove the EngenexTM consumables from sterile package. 1. Cut the wound contact dressing just smaller than the size of the wound. 2. The Bio-DomeTM Surface must face the wound. 3. Carefully place the dressing in the wound. Do not force the wound dressing into cavity wounds. *

1

2

4.

5. 6. 7.

3

Bio-Dome surface towards wound

Prior to application of the cover, ensure that the skin around the wound is clean and dry. This will ensure proper adherence of the thin film dressing. Use of a skin preparation layer may protect peri-wound skin and promote and prolong cover adhesion. Remove the center cutout on the unlabelled side of the cover. Carefully remove the labeled release liner from the other side of the cover leaving the release tab and frame portion intact. Position the dressing over the wound and carefully apply, taking care to minimize folds and wrinkles. 6

7

5

*For wounds smaller than 7 x 10 cm, you may skip to step 10.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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8. Remove the release tab from the cover that is now secured to the wound 9. Remove the frame from the cover that is now secured to the wound. 10. Cut a hole approximately 3 cm in size in the film cover at the location of the wound where the Opti-FloTM Tube Attachment will be secured. It is permissible to cut into the wound packing when creating the hole.*

10

8

9

11. Remove backing from the Opti-Flo™ Tube Attachment Device (T.A.D.). Place the screened portion of the T.A.D. over the 3 cm hole that was cut in the cover. Make sure that the T.A.D. is adequately secured to cover. 12. Connect the T.A.D. to the suction tubing of the EngenexTM canister. Do not cover the vent on the T.A.D. 13. Connect the EngenexTM Canister to the Wound FloTM Pump by aligning the fitting on the canister with the receiver of the pump. The pump should only be used with the Boehringer disposable accessories.

11

12

13

14. Set the vacuum level per Physician’s orders, typically 75 mm Hg. 15. Turn the pump to ON for continuous operation or INTER for intermitting suction per Physician’s orders. 16. Place the Pump at a convenient location where it can be periodically monitored. 17. Ensure patient comfort by carefully observing the patient. Check on the patient regularly.

*See page 12 for alternate cover application methods

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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9. Patient Care between Dressing Changes The EngenexTM Advanced Negative Pressure Wound Therapy System is not intended to replace routine Patient care. It is important to regularly monitor the patient, wound and system between dressing changes. Patient 1. 2. 3.

Wound 1. 2. 3. System 1. 2. 3.

Monitor the patient’s vital signs, including temperature. Assess patient’s nutritional status. Check albumin levels. Use appropriate pressure relieving support surfaces. Turn and reposition the Patient as directed by Hospital Policy and/or Physician’s orders.

Monitor the Wound for signs of potential infection as evidenced by odor, consistency of drainage fluids, localized temperature and coloration. Assess wound bed and surrounding tissue for edema and/or erythema. Check that the dressing is sealed and appears to be drawn down by the negative pressure. Periodically check the status monitor on the Wound FloTM Pump for presence of leaks in the dressing and correct as indicated. Monitor Patient compliance by checking the Hour Meter and comparing to chart records. Record compliant and total hours at each dressing change. Check that the Unit is plugged into wall power and that the battery is charging.

REPLACING DISPOSABLE COMPONENTS The Bio-domeTM Wound Dressing, Wound Cover and Opti-FloTM Tube Attachment Device should be replaced every 48 hours. For infected wounds, dressings should be replaced every 12-24 hours. 1. 2. 3.

4. 5. 6.

Turn Off the Wound FloTM Pump and disconnect the EngenexTM Canister from the Opti-FloTM Tube Attachment Device. Carefully remove the wound cover and all dressing materials from the wound. Exercise care to ensure that all dressings are removed from the wound at every dressing change. Cleanse the wound and perform any necessary procedures as directed by the Physician. Inspect the wound for the presence of infection, osteomyelitis or other potentially abnormal conditions and report to the Physician. Dress the wound with fresh, sterile materials as previously described and initiate the Wound FloTM Pump. If evidence suggests that there is an infection in the wound, pay strict adherence to Physician orders and hospital policy. Discontinue use if appropriate. If the wound dressing is sticking to the wound or the patient is experiencing serious pain upon removal, try moistening the wound bed with saline to reduce adhesion or use saline moistened sterile cotton tip applicators to remove dressings that are sticking to the wound bed. Contact the Physician to consider changing the orders to include more frequent dressing changes or titrating down the level of suction.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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REMOVING THE CANISTER The canister should be checked periodically and should be replaced whenever it is full or nearly full. Replace canister after 5 days of use- even if it is not full. An indelible marker may be used to record the due date for changing the canister on the top cap of the canister. When the canister is full or it is necessary to remove the canister - -

1. 2. 3. 4. 5. 6.

Turn the unit OFF. Disconnect the Canister from the Opti-FloTM Tube Attachment Device. Depress the Canister Release Button. Remove the canister. Install new canister and connect to the Opti-FloTM Tube Attachment Device. Turn the unit back ON.

Dispose of used dressing materials and canisters as medical waste.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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10. Additional Information, Consumables Maintaining Negative Pressure: Negative pressure should be applied for at least 22 of 24 hours per day. If suction will not be maintained for a period greater than 2 hours the Wound Cover and Bio-domeTM Wound Dressing should be removed and a traditional dressing applied in its place. The Wound FloTM Pump enables effective monitoring of compliant time with the Compliant HoursTM Monitoring Technology. If compliant therapy can not be maintained, for whatever reason, the Patient should be changed to a more traditional dressing system until the cause of non-compliance can be determined. Adhesive promoters Skin preparations or barriers are used to improve the quality of seal and to protect the peri-wound skin from repeated application and removal of the adhesive cover. If the Cover has a tendency to loosen such that a seal is not maintained a skin prep may be applied to the skin surrounding the wound. Skin preps must be completely dry prior to applying the cover. Oily, greasy or petroleum based skin conditioners should not be used in the vicinity of the wound. It is preferable to use a skin prep that is not water soluble such as:

Product Name

Manufacturer

Skin-Prep Pads

Smith and Nephew

Uroprep Pads

Urocare, Inc

Allkare

Convatec

Dressing small wounds: The Opti-FloTM Tube Attachment Device (TAD) is sized to accommodate a variety of wound sizes without the need for additional covers. The peri-wound skin should be protected by transparent film or a hydrocolloid dressing if the wound is the same size or smaller that the mesh in the OptiFlo™ TAD. Irregularly contoured skin surfaces: In the event that it is necessary to seal a wound with very irregular skin surface or if there is less than 2.5 cm of intact peri-wound skin, it is acceptable to use ostomy paste under the wound cover to improve sealing. Detailed directions on application of the Cover to the Patient To effectively apply the entire Cover to a wound, follow these steps: 1. 2. 3. 4.

Remove the center cutout on the unlabelled side of the cover. Carefully remove the labeled release liner from the other side of the cover leaving the release tab and frame portion intact. Position the dressing over the wound and carefully apply, taking care to minimize folds and wrinkles. Remove the release tab and frame from the cover that is now secured to the wound.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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Alternate Method 1. Remove the center cutout on the unlabelled side of the cover. 2. Remove the small release tab and carefully peel back the labeled release liner, exposing approximately one third of the adhesive surface. 3. Place adhesive side of the cover on the skin at the edge of the wound. 4. Completely remove large release liner while simultaneously allowing the cover to drape over the wound. Take care to minimize folds and wrinkles. 5. Remove the frame from the cover that is now secured to the wound.

To effectively apply a portion of the Cover to a wound, follow these steps: 1. 2. 3. 4. 5. 6. 7.

When cutting the Cover, all cut pieces should have a release tab on an edge. Cut the Cover to size. Remove the labeled release liner. Apply the Cover portion over the wound as needed. Remove the release tab. Remove Center cutout. Remove frame portion.

Alternate Method 1. Remove the center cutout on the unlabelled side of the Cover. 2. Cut a complete strip in the long direction of the Cover. 3. Partially peel back the labeled release liner. 4. Place the exposed Cover over the skin at the edge of the wound, 5. Simultaneously remove the rest of the labeled release liner while allowing the Cover to drape over the wound. 6. Remove the release tab and the rest of the frame.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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11. Additional Information, Wound Flo Pump TM

Status Indicators: (see figure 1) The Wound FloTM Pump is equipped with status monitors that provide important information on the leak status of the wound dressing. The presence of leaks or occlusions in the collection circuit can have a significant impact on the quality of negative pressure that is applied to the wound. The Wound FloTM Pump provides the clinician with the essential information to ensure that the system is providing effective negative pressure The four color coded status monitors provide the following important information:

Indication

Significance

RED

High leak rate. An audible alarm will sound after 90 seconds. The alarm can be silenced by depressing the alarm switch. The alarm will self silence if the leak is corrected.

(Stop the leak)

YELLOW (Caution)

Low level of leak in the system. Adequate suction is being applied to the wound site, but therapy could be improved by addressing the quality of the seal. Extended operation in this range will reduce the available battery life.

GREEN (Go)

Normal operation. A nominal flow of air through the system is occurring. Adequate negative pressure within 10% of setting is being applied to the wound site.

BLUE (Blocked)

Possible occlusion. Indicates a possible blockage in the line or a full canister. In this case, an audible alarm will sound after 90 seconds. The alarm may be temporarily silenced by the pressing the Alarm Silence switch. The alarm will self silence if acceptable flow resumes.

ALL INDICATORS ON AND BLINKING

Suction is not being applied to the wound. Possible causes are a full canister, a discharged battery, use of an improper power cord or no remaining hours on the Pump. The Alarm Snooze button will not silence the alarm. The condition must be corrected before resuming operation.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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Hour Meter: (see figure 1) Tracking Patient Compliance The hour meter is located on the top panel of the Wound FloTM Pump and provides patient compliance tracking (Compliant Hours™). Consistent application of negative pressure is key to effective therapy. The Boehringer Wound FloTM Pump accumulates Compliant Hours™ when the status monitors are indicating GREEN or YELLOW. When the Engenex Advanced Negative Pressure Wound Therapy System Pump is attached to wall power - 1.

The Hour Meter displays the total number of hours the Pump has operated in the GREEN and YELLOW (compliant negative pressure therapy) range during its lifetime.

2.

This display cannot be reset by the Patient or Caregiver.

When the pump is running on battery power - 1. The Hour Meter will continue to accumulate Compliant Hours™, however, to conserve battery power, however, the Hour Meter display is not lit. 2. When the Snooze button is depressed and held for 3 seconds the Hour Meter displays the total Compliant Time™. Continuum of Care Assurance To insure consistent performance, each Wound FloTM Pump is pre-programmed to alert the user when the unit should be returned for routine maintenance. The Wound FloTM Pump tracks elapsed Compliant Hours™. To ensure a continuum of care: 1. When approximately 168 hours are remaining, the pump beeps once every hour. At that time, arrangements should be made to replace the pump. “hr” and a number is alternately displayed for 1 minute, and the power LED flashes RED/GREEN continually.. 2. To display hours remaining at any time, press and hold the snooze button for 3 seconds. (This feature will not display while the pump is on battery power.) 3. To arrange for a replacement pump, contact your Engenex representative or call 1-888-390-HEAL Power LED: (see figure 1) The Power LED is located on the top panel of the Wound FloTM Pump and provides important information on the status of the system battery and wall power. The following indications may appear on the Power LED.

Solid Green

When the pump is plugged in to wall power the Power LED will be GREEN even if the Power switch is in the OFF position. This indicates that the unit has a fully charged battery and is ready for use.

Blinking Green

The unit is charging its internal battery. This light will blink during the entire charge period which may be as long as 16 hours.

OFF

The unit is running on its internal battery supply and has an adequate charge.

Blinking Red

Solid Red

If the battery is low, the Power LED will blink red every second. The pump will also chirp every 10 minutes. Under normal circumstances the pump should be plugged in within 30 minutes of the first battery alarm. If the battery is too low to run the pump, the Power LED will be red and the audible alarm will sound continuously. The pump should be plugged in to wall power to continue operation. bAt will be displayed on the Hour Meter.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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Error Codes: (see figure 1) Error Codes are indicated on the Pump Hour Meter. If the Pump’s internal circuitry detects a fault with the pressure control, it will shut down the pump, sound an audible alarm, and the hour meter will display an error code. You can attempt to clear the error by turning the unit off, waiting 5 seconds and turning the unit back on. If the error condition persists please contact your Engenex representative or call 1-888-390-4325 for the prompt delivery of a replacement Pump. ERROR CODE

CONDITION

bAt

The battery needs to be recharged. Plug the pump into the appropriate power supply to continue therapy and charge the internal battery supply. The unit will deliver therapy while recharging.

ERR1

The pump is attempting to deliver too high of a pressure. Turn the unit off and back on again. If the error persists please contact your Engenex representative.

ERR2

Canister detached. Re-install canister and reapply therapy. If error persists please contact your Engenex representative.

ERR3

Improper Power Cord attached. Locate the appropriate power supply or contact the factory to order a replacement.

Battery Charging 1. The pump requires 16 hours to fully charge the internal battery during its first use. If the unit has been in storage longer than 1 month, a full charge is needed as well. Plug the unit in and allow it to fully charge. The pump can be operated while the battery is charging. 2. The pump may be plugged into the wall charger and charged during use. It is recommended to run the pump on the wall charger as much as possible. This will ensure that the pump is fully charged for periods of transport. 3. The pump will provide up to 16 hours of normal operation with a fully charged, new battery and operating in the green. Battery life is dependent on leak rate in the wound dressing. Maximum battery life can be expected when operation is consistently in the Green. 4. Recharge the pump as needed.

Cleaning and Disinfection The exterior of the Pump may be cleaned by wiping the exterior surfaces with a mild surface disinfectant such as Cavicide® or 3M Quat®. Follow the manufacturer's guidelines for proper use of cleaning agents. Do not use solvents or strong oxidizing solutions as this may cause crazing or cracking of Pump components. Do not sterilize or aspirate liquids into the Pump. Do not immerse the Pump or use a pressurized source of water to clean. Service 1. There are no user serviceable components inside the Engenex Advanced Negative Pressure Wound Therapy System Pump. There are no user serviceable fuses in the power supply or suction pump. 2. Contact your Engenex representative for return/replacement of damaged Pumps. 3. Do not open the Wound Flo™ pump or attempt to service it yourself.

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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12. Special Care, Tips and Recommendations Leak Detection and Correction The Wound FloTM Pump provides for a convenient method to monitor the leak condition of the dressing. The color-coded status indicators provide a simple and intuitive approach to system operation. In situations where difficult anatomy is encountered, it is acceptable to employ an ostomy paste under the wound cover to assist in establishing and maintaining a seal. A stethoscope may be useful in detecting leaks under the cover.

Showering with the EngenexTM System It is permissible to shower while using the EngenexTM System. Disconnect canister from the Wound-Flo Pump. Do not take the Pump into the shower. Protect the filter element in the Opti-FloTM Tube Attachment Device from getting wet. Upon resumption of Therapy, the Pump may indicate a blue light if the filter gets wet. Allow 5 minutes for moisture to clear through the filter and return the system to normal operation.

Yellow Indication If a Yellow indication appears after the initial application of the dressing, often allowing a few moments for suction to draw down the dressing results in an improvement in the seal and a Green status indication will appear.

Treatment of Multiple Wounds A collection “Y” Adapter (P/N 6491) is available for managing two wounds on a single Patient. The “Y” adapter is placed in the collection line between the Canister and the two Opti-FloTM Tube Attachment Devices. The “Y” Adapter provides sufficient length to allow for the application to wounds that are up to 30 inches apart. Extra care will be required to ensure that each wound is effectively sealed, since the leak from each wound will contribute to the flow used to illuminate the status monitors. NOTE: No more than one y-connector should be used per pump (e.g. for a patient with three distinct wound sites, one pump should be connected directly to the largest wound another pump may be connected with a y-connector to the two smaller wounds).

Engenex™ Instructions for Use P/N 60119 Rev. D © August 2007, Boehringer Wound Systems, LLC

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