ACTIV.A.C Therapy Information Guide Rev M

IMPORTANT INFORMATION Please READ and KEEP this information posted in a handy place. YOUR CONTACT INFORMATION Your Nurse’s Name: Your Nurse’s Phone Number: Your Home Health Agency (HHA) or Wound Care Center: Your Doctor’s Name: Your Doctor’s Phone Number: 3M Medical Solutions Customer Support

Call 1-800-275-4524.

In case of emergency: • FIRST call 9-1-1 (or your local emergency number) • THEN call your doctor or nurse INFORMATION FOR YOU TO KNOW Your V.A.C.® Therapy Unit model: Where can you find Refer to the documents that came with your therapy unit for information about your specific instructions on how to use it. If you did not receive these V.A.C.® Therapy Unit? items, call 3M Medical Solutions Customer Support at 1-800-275-4524. Issues with the V.A.C.® Therapy Unit?

Do not attempt to fix the therapy unit. If you have any problems with the unit, call 3M Medical Solutions Customer Support right away at 1-800-275-4524.

Keep your V.A.C.® Therapy Unit ON.

If therapy is off/interrupted for more than two hours, your dressing will need to be changed!

Dressings:

Remember dressings are for single use only! The used dressing must be thrown away after each dressing change.

Who changes the dressings?

Your doctor will decide how and when your dressings will be changed. It could be in the doctor’s office, by a home health agency or at a wound care clinic. In some cases, a caregiver, family member or friend may be trained. ONLY THOSE WHO HAVE BEEN PROPERLY TRAINED SHOULD CHANGE THE DRESSINGS.

Ordering Supplies:

Call 3M Medical Solutions Customer Support at 1-800-275-4524. 3

WHEN TO CALL YOUR DOCTOR OR NURSE BLEEDING:

If you see a sudden increase or large amount of blood from your wound in the tubing or canister: 1. TURN OFF the therapy unit right away. 2. APPLY pressure over the area. 3. DO NOT remove your dressing. 4. CALL 9-1-1 (or your local emergency number) and THEN call your doctor or nurse.

DIFFICULTY BREATHING:

If you have DIFFICULTY BREATHING, CALL 9-1-1 (or your local emergency number).

Other Concerns:

Talk with your doctor or nurse if you have any concerns about: • Wound Infection • Other Serious Infections • Allergic Reactions See page 21 of this Therapy Information Guide for more safety information.

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How To Use This Book This Therapy Information Guide is designed to be an all in one resource for V.A.C.® Therapy. Please save this guide and all the documents that came with your therapy unit. You may be asked to refer to these items during a 3M service call. Read and follow all instructions in this guide. Your safety is our first concern. For important safety information, see page 21. Please read this information carefully. For a description of how V.A.C.® Therapy works and what to expect while you are using it, see page 13. For information about your benefits and the terms and conditions of use, see page 25. Please read this information carefully. Your signature on the Proof of Home Delivery/Assignment of Benefits (POD/AOB) form is your agreement to these important terms and conditions. This section also includes information about privacy practices and your rights and responsibilities as a patient. For information specific to the state where you live, see page 41. Check this section to see if your state is included.

Important Safety Information Comes With Your V.A.C.® Therapy Unit Your therapy unit comes with several documents that include important warnings for your safety. Before using your therapy unit: • Review the user manual included in this book with your doctor or nurse (see page 57). • Review the quick reference guide included in this book. Cut the guide out of the book and keep it with your therapy unit at all times (see page 45). • Review the safety information sheet with your doctor or nurse. Keep this SIS with your therapy unit at all times. • If there are questions or this information is missing, contact 3M Medical Solutions Customer Support right away at 1-800-2754524.

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Table of Contents IMPORTANT INFORMATION...3 How To Use This Book...5 What is V.A.C.® Therapy? ...13 Introduction...13 Wound healing is a process ... 13 How long will it take to heal my wound?... 13 Why V.A.C.® Therapy? ... 13 What is V.A.C.® Therapy? ... 13

The V.A.C.® Therapy System...14 The V.A.C.® Therapy System includes:... 14 V.A.C.® Dressing Placement... 14 V.A.C.® Dressing Changes... 15 V.A.C.® Therapy Units... 15 V.A.C.® Therapy Use... 16 V.A.C.® Therapy Settings... 16 Ordering Additional Supplies... 16 Hospital Admission... 17

Questions and Answers...18 Patient Safety Information...21 Warning – Some Patients May Have A Risk Of Bleeding... 21 Wound Infection... 22 Serious Infection... 22 Allergic Reactions... 22 Keep Therapy On (Off For No More Than Two Hours)... 23 Count Foam Dressing Pieces... 23 Cover Your Cough... 23 In Case of Evacuation or Immediate Departure ... 23 Electrical Requirements... 24 Fall Prevention Tips... 24

Patient Financial Responsibility...25 Assignment of Benefits (AOB)... 25 7

Patient Rights and Responsibilities... 28 Patient’s Bill of Rights and Responsibilities... 28

Notice of Privacy Practices... 30 3M Medical Solutions NOTICE OF PRIVACY PRACTICES (EFFECTIVE JULY 1, 2020)... 30

Medicare Supplier Standards... 38 Medicare DMEPOS Supplier Standards... 38

State Specific Information... 41 Tennessee Standards for Home Care Organizations providing HME... 41 Florida Home Medical Equipment Provider Standards and Guidelines... 41 Florida Special Needs Registry ... 42 Maryland – State Specific Addendum Sheet... 43

Customer Contact Information... 44 Quality of Care... 44

ACTIV.A.C.™ Therapy System Quick Reference Guide For Patient Use... 45 ACTIV.A.C.™ Therapy Unit... 45 Power Therapy Unit On or Off... 46 Confirmation Screen... 46 Therapy On or Off... 46 Patient Mode Home Screen... 46 Carrying Case ... 47 Alerts and Alarms... 47 Alerts... 48 Alarms... 48 Charge the Battery... 49 Battery Level... 50 Canister ... 50 Canister Changes... 51 SEAL CHECK™ Leak Detector... 53 Questions and Information... 54 Customer Contact Information... 54

ACTIV.A.C.™ Therapy System User Manual For Patients and Clinicians... 57 ACTIV.A.C.™ Therapy System For Patient Use... 61 Indications For Use ... 63 8

Important Safety Information Accompanies this Device...63 Warnings: Important Information for Users...64 Introduction...65 ACTIV.A.C.™ Therapy Unit...66 Patient Mode Home Screen...66 Common Screen Control Buttons...67 Battery Charging Instructions...67 Static Electricity...67 Charge the Battery...68 Battery Level...69 Canister...70 Canister Changes...70 Carrying Case...72 Power Supply Retainer Instructions...74 Therapy Unit Disconnect...75 Operating Instructions...76 Power Therapy Unit On or Off...76 Therapy On or Off...76 SEAL CHECK™ Leak Detector...77 Find and Fix the Leak...78 Alerts and Alarms...79 Battery Low Alert...80 Battery Critical Alarm...81 Canister Full Therapy Interrupted Alarm...82 Canister Not Engaged Alarm...83 Leak Alarm...84 Leak Alarm Therapy Interrupted...85 Blockage Alert...86 Blockage Alarm Therapy Interrupted...87 Low Pressure Alert...88 Low Pressure Alarm Therapy Interrupted...89 Therapy Inactive Alarm...90 Therapy Confirmation Screen...90 System Error Alarm...91 Service Timer Expired Alert...91 9

Help Menu... 92 Change Languages... 92 Onscreen Operating Instructions... 93 Clinician Mode... 93 Care and Cleaning... 94 Disposal... 94 Cleaning the Touch Screen... 94 Cleaning the Therapy Unit... 94 Frequently Asked Questions... 95

ACTIV.A.C.™ Therapy System For Clinician Use Only... 99 Important Safety Information Accompanies This Device...100 Indications For Use ...100 Warnings: Important Information For Users...101 Introduction...102 Clinician Mode Home Screen...103 Common Screen Control Buttons...104 Battery Level...104 Audio Pause...104 Operating Instructions...105 Power Therapy Unit On or Off...105 Therapy On or Off...105 Access Manual Therapy Settings...106 Settings...106 Pressure Settings...107 Intensity Control...107 Continuous and Intermittent Modes...108 Intermittent Settings...108 Settings Confirmation...108 Settings Guide...109 Settings Guide Confirmation...110 Starting Therapy...111 SEAL CHECK™ Leak Detector...112 How to Use the SEAL CHECK™ Leak Detector When Starting Therapy...112 Finding the Leak Using the SEAL CHECK™ Leak Detector...113 10

Log Tool... 113 How to Use the Log Tool When Starting Therapy... 113 View or Export Therapy History... 115 View Therapy History... 115 Export Therapy History Report... 116 USB Export Issues... 116 Help Menu... 117 Change Languages... 117 Onscreen Operating Instructions... 118 Change to Patient or Clinician Mode... 119 Utilities... 120 Change Time and Date... 120 Change Pressure Units and Date Format... 121 Change Screen Brightness... 121 Change AC Light... 121 Care and Cleaning... 122 Standard Precautions... 122 Waste Disposal... 122 Cleaning the ACTIV.A.C.™ Therapy Unit... 122 Cleaning the Touch Screen... 123 Electromagnetic Compatibility (EMC)... 124 Explanation of Symbols Used... 128 Specifications... 130 Customer Contact Information... 131

iON PROGRESS™ Remote Therapy Monitoring Electromagnetic Compatibility (EMC)... 133

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WHAT IS V.A.C.® THERAPY?

What is V.A.C.® Therapy? Introduction This Therapy Information Guide provides important information about your treatment with V.A.C.® Therapy Systems. If you have questions or need further information call your doctor or nurse, or call 3M Medical Solutions Customer Support at 1-800-275-4524.

Wound healing is a process Proper wound care management is needed to heal your wound. Your doctor has prescribed a V.A.C.® Therapy System for your care. A doctor or nurse is responsible for directing the use of the system, including therapy application and dressing changes.

How long will it take to heal my wound? The length of time to heal a wound is different for every patient. General conditions, size and location of the wound, and nutritional status can affect the time it takes for a wound to heal. Your doctor or nurse will discuss when and why V.A.C.® Therapy may end.

Why V.A.C.® Therapy? V.A.C.® Negative Pressure Wound Therapy has helped to promote wound healing for millions of patients worldwide. Doctors, nurses, and hospitals all rely on V.A.C.® Therapy as an advanced wound therapy to help their patients heal.

What is V.A.C.® Therapy? The V.A.C.® Therapy System is a medical device system that helps wounds heal by delivering negative pressure (a vacuum) to the wound through a special dressing and therapy unit. This creates an environment that promotes the wound healing process. This negative pressure helps: • Draw wound edges together • Remove wound fluids and infections materials • Promote granulation tissue formation (the connective tissue in healing wounds) Unlike gauze bandages that merely cover a wound, V.A.C.® Therapy actively works to help the wound healing process. The V.A.C.® Therapy System also helps: • Provide a moist wound healing environment • Reduce wound odor • Reduce the need for daily dressing changes 13

WHAT IS V.A.C.® THERAPY?

The V.A.C.® Therapy System The V.A.C.® Therapy System includes: • The V.A.C.® Therapy unit that delivers negative pressure • A specially designed disposable canister to manage wound fluid • Sterile tubing with a pressure sensing system that connects the therapy unit to the dressing • Special foam dressings that are placed in the wound • A clear drape with adhesive that covers the foam dressing V.A.C.® Therapy Unit and Canister

SENSAT.R.A.C.™ Pad Tubing

V.A.C.® Drape

V.A.C.® GRANUFOAM™ Dressing

V.A.C.® Dressing Placement The V.A.C.® Dressing goes inside the wound. The wound area is sealed with the clear V.A.C.® Drape that helps maintain negative pressure over the wound. One end of the tubing connects to the dressing, the other end connects to the canister that fits into the V.A.C.® Therapy Unit. SENSAT.R.A.C.™ Pad (pressure sensing pad) V.A.C.® Drape V.A.C.® GRANUFOAM™ Dressing* Wound *If used, V.A.C. WHITEFOAM™ is typically recommended for placement under V.A.C.® GRANUFOAM™ Dressing. 14

The V.A.C.® Therapy System uses special foam dressings with the therapy unit. Only V.A.C.® dressings are to be used with V.A.C.® Therapy units. Wounds treated with the V.A.C.® Therapy System should be checked on a regular basis by your doctor or nurse who is responsible for treatment. • For a non-infected wound: 3M recommends the dressings be changed every 48 to 72 hours, but no less than 3 times per week. • For infected wounds: These wounds must be checked often and very closely. Infected wounds dressings may need to be changed more often than 48 to 72 hours. Dressing change intervals should be based on continuing evaluation of your wound condition by your doctor or nurse.

V.A.C.® Therapy Units

B

V.A.C.® Therapy Units are lightweight portable devices designed for patients who enjoy the freedom of being mobile. Refer to the documents that came with your therapy unit for specific instructions on how to use it. Do not attempt to service or repair the V.A.C.® Therapy Unit. If you have any problems with the unit, call 3M Medical Solutions Customer Support right away at 1-800-275-4524.

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WHAT IS V.A.C.® THERAPY?

V.A.C.® Dressing Changes

WHAT IS V.A.C.® THERAPY?

V.A.C.® Therapy Use Keep V.A.C.® Therapy on (off for no more than two hours). • If therapy is turned off for more than two hours, the V.A.C.® Dressing must be removed and replaced. Call your doctor or nurse for more information. • If the unit is off for more than 15 minutes and the power to the unit is on, an alarm will sound. Refer to the documents that came with your therapy unit for instructions on how to manage this alarm. • The clear V.A.C.® Drape is waterproof. You can wash or shower with the dressings in place and with the tube clamped (closed off ). Turn off the unit and unplug it from the electrical outlet. Warning: do not take the therapy unit into the bathtub or shower.

V.A.C.® Therapy Settings Patient compliance with V.A.C.® Therapy is important for proper healing. Your doctor will determine the negative pressure settings for your unit. Please do not change any of the settings on the V.A.C.® Therapy System or remove the dressing unless told to do so by your doctor or nurse.

Ordering Additional Supplies • When you are down to one case of dressings OR five canisters, it is time to order new supplies. • To order new supplies, call 3M Medical Solutions Customer Support at 1-800-275-4524. Please allow at least 3-5 business days for delivery.

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WHAT IS V.A.C.® THERAPY?

IMPORTANT: DISPOSABLE ITEM RETURN INFORMATION 3M only accepts the return of unopened and/or unused V.A.C.® Therapy disposables if: • the product is identified as substandard (defective and less than full quality for the particular item) • the product is identified as unsuitable (inappropriate for the customer at the time it was sold) • the product was shipped in error by 3M Medical Solutions Customer Support, in accordance with the Centers for Medicare & Medicaid Services (CMS), Durable Medical Equipment (DME) Prosthetics, Orthotics and Supplies (POS) Supplier Standards

Hospital Admission Please notify 3M Medical Solutions Customer Support if you are admitted to a hospital or inpatient facility. Call 3M Medical Solutions Customer Support at 1-800-275-4524 to arrange for the return of your V.A.C.® Therapy System. This call stops the billing process and you will not be charged. Also call your doctor or nurse to arrange a visit to ensure the V.A.C.® Therapy Unit has been properly removed and all necessary precautions are in place to ensure your safe transfer.

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WHAT IS V.A.C.® THERAPY?

Questions and Answers 1. How does V.A.C.® Therapy feel? Most patients describe V.A.C.® Therapy as a non-painful, mild pulling sensation that, in most cases, is not noticeable after a few minutes. Wound comfort may vary by individual person. The wound may become tender or itch as it heals; this is usually a good sign. If itching or discomfort persists, please call your doctor. 2. Can you move around while on V.A.C.® Therapy? Yes. The V.A.C.® Therapy System is lightweight and was specifically designed to provide flexibility and freedom of mobility. Your ability to move around depends on your condition, the wound location and the treatment your doctor has prescribed. The V.A.C.® Therapy System may be disconnected so you can take a shower. Therapy may not be off any longer than two hours per day. If therapy is off/interrupted for more than two hours, your dressing will need to be changed. 3. What does the foam dressing look like when V.A.C.® Therapy is on? Your doctor may prescribe a V.A.C.® GRANUFOAM™ or V.A.C. WHITEFOAM™ Dressing for your wound type. The V.A.C.® GRANUFOAM™ Dressing will shrink down and wrinkle like a raisin when V.A.C.® Therapy is working. The V.A.C. WHITEFOAM™ Dressing may only have a few wrinkles. 4. Does changing the V.A.C.® Dressing hurt? Some people do experience discomfort during dressing changes depending on the wound type, location and patient condition. The discomfort is similar to other dressings and wound care treatments for the same wound type. Your doctor or nurse can give you advice about pain relief.

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Usually a nurse from your doctor’s office, home health agency or wound care clinic trained in V.A.C.® Therapy will change your dressing. If approved by your doctor or nurse, a caregiver, family member or friend may change the dressing if they have been properly trained. The following steps should be followed by you and your caregiver to reduce the risk of infection and the spread of germs: • Cover your mouth and nose with a tissue when you cough or sneeze or cough or sneeze into your upper sleeve, not your hands. Put your used tissue in a waste basket. • Caregiver should wash hands with soap and warm water for 20 seconds or clean hands with an alcohol-based hand cleaner, before and after each patient contact or procedure. • Caregiver should always wear gloves and protective clothing and eyewear when handling blood or body fluid, or when in contact with mucous membranes or open cuts. • Any caregiver with an open cut or skin condition should not care for the patient until the condition has been cleared. • Caregiver should dispose of soiled dressing according to hospital or institution protocols. Do not reuse dressing. • Caregiver should always count the total number of foam pieces put into the wound. They should record this number and the dressing change date on the drape or Foam Quantity Label (if supplied) and in your chart. • Refer to application instructions provided with the dressing for more information.

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WHAT IS V.A.C.® THERAPY?

5. Who should change my dressing, and how?

WHAT IS V.A.C.® THERAPY?

6. What if my V.A.C.® Therapy Unit alarms? Refer to the documents that came with your therapy unit for information on alerts and alarms. If needed, call your doctor, nurse or 3M for assistance. You can call 3M Medical Solutions Customer Support at 1-800-275-4524 to troubleshoot in real time over the phone, 24 hours a day. To help in troubleshooting your therapy unit, please keep handy the small white tubing cap that comes on the end of the canister tubing. 7. Who do I call in case of an emergency? • First, call your local emergency number (i.e., 911). • After you call local emergency, call your doctor or nurse. • For all other medical concerns, refer to the Patient Safety Information section of this guide. 8. How can my caregiver be helpful? A family caregiver or friend can help you by reminding you how important it is to keep your V.A.C.® Therapy Unit on. Also, when directed by your doctor or nurse and only after proper training, your caregiver can assist in: • changing dressings and canisters • responding to therapy unit alarms • monitoring the therapy 9. How do I order supplies? When you are down to one case of dressings OR five canisters, call 3M Medical Solutions Customer Support at 1-800- 275-4524 to order more. Please allow at least 3-5 business days for delivery. 10. What do I do when my V.A.C.® Therapy is completed? Call 3M Medical Solutions Customer Support at 1-800-275-4524 to arrange for the return of your V.A.C.® Therapy System. This call stops the billing process and you will not be charged.

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Patient Safety Information

• Most issues can be resolved over the phone. • If the issue cannot be resolved over the phone, 3M can provide additional assistance. For operating instructions and additional safety information, please see the documents included with your therapy unit. Your doctor or nurse has more information about your wound. Ask your doctor or nurse for any additional information you may need before using this product. Important

Do not change the settings on the therapy unit without your doctor or nurse giving you specific direction.

If approved by your nurse or doctor, a caregiver, family member or friend may change the dressing if they have been trained by a doctor or nurse. Warning – Some Patients May Have A Risk Of Bleeding If you have recently had heart surgery, or surgery on blood vessels, or are on blood thinners, you may have a higher risk of bleeding, whether you are using V.A.C.® Therapy or not. If you see a sudden increase or a large amount of blood from your wound in the tubing or canister: • Turn OFF the therapy unit right away. Bleeding

• Apply pressure over the area.

• Do not remove your dressing. • Call 9-1-1 (or local emergency number) FIRST. • Then call your doctor or nurse.

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PATIENT SAFETY INFORMATION

At 3M, your safety is our first concern. If you have questions or concerns about product delivery, set up or any related issues, call 3M Medical Solutions Customer Support at 1-800-275-4524.

PATIENT SAFETY INFORMATION

Wound Infection If you have an infected wound, your doctor or nurse will decide the right treatment for you. Your dressing should be changed more frequently. Wound Infections

Call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: • You have a fever • Your wound is sore, red or swollen • Your skin itches or you have a rash or redness around the wound • The area in or around the wound feels very warm • You have pus or a bad smell coming from the wound Serious Infection Sometimes a wound infection can spread throughout the rest of the body. Call your doctor or nurse right away if you have any of the following symptoms: • You are sick to your stomach or throwing up • You are dizzy or feel faint when you stand up

Serious Infections

V.A.C.® Disposables

• You have diarrhea

•

You have a headache

• Your throat is sore

•

You have a rash

• You feel confused

•

You have a fever over 102°F

Allergic Reactions V.A.C.® Dressings, V.A.C.® Drape and V.A.C.® Canisters are delivered sterile and do not contain latex. Use items only from unopened packages, use them only once and then throw them away. The V.A.C.® Drape (dressing cover) has a coating that may cause an allergic reaction if you are allergic or sensitive to some glues. Call your doctor or nurse right away if you have any of the following symptoms: • Redness

•

Rash or hives

• Swelling

•

Severe itching

If you have difficulty breathing, seek immediate emergency medical assistance or call 9-1-1 (or local emergency number).

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A new V.A.C.® Dressing from an unopened sterile package should be applied and V.A.C.® Therapy restarted. Or, an alternate dressing should be applied at the direction of the treating nurse or doctor. Call your nurse or doctor to have this done.

V.A.C.® SIMPLACE™ Dressing

Count Foam Dressing Pieces Your doctor, nurse, or trained caregiver should always count the total number of foam pieces put into your wound. They should record this number and the dressing change date on the drape or Foam Quantity Label (if supplied) and in your chart. Make sure that the same number of foam pieces is removed during your dressing change.

Cover Your Cough Cover your mouth and nose with a tissue when you cough or sneeze, or cough or sneeze into your upper sleeve, not into your hands. Put your used tissue in the waste basket. Clean your hands after coughing or sneezing. Wash hands with soap and warm water for 20 seconds, or clean with alcohol-based cleaner. In Case of Evacuation or Immediate Departure Please call 3M Medical Solutions Customer Support at 1-800- 275-4524 if you are evacuated due to natural disaster or choose to evacuate or immediately depart from your current address. We will need your new or temporary address so we can best support your needs.

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PATIENT SAFETY INFORMATION

V.A.C.® Therapy Unit

Keep Therapy On (Off For No More Than Two Hours) If therapy is interrupted or turned off for more than two hours, call your nurse or doctor right away. The old dressing will need to be removed and the wound irrigated. Never leave a V.A.C.® Dressing in place without active V.A.C.® Therapy for more than two hours.