Quicker Healing, Better Outcomes

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Contained Wound Irrigation System

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What is the ComfortHeal Contained Wound Irrigation System

The Comfort Heal contained wound irrigation system is a patented design fluid contained system that allows for pulse lavage wound cleansing treatment at any bedside location in rehabilitative facilities. The system consists of an abdominal (AB) and an extremity bag (EB) models used with any pulse lavage irrigator.

Disrupting Biofilm and Improving Wound Healing

General knowledge of wound irrigation requires high volumes of irrigation at a constant rate flow of 5-15psi.

Studies show that 8-12 psi is required to effectively flush wounds of debris and biofilm that are responsible for infections and prolonged healing. Syringe and bottle flushing methods cannot produce enough steady pressure for proper wound management in addition where typical wounds need in excess of over 3 liter of saline solution for wash treatment.

Benefits of Contained Pulse Lavage Wound Irrigation System
  • Right Pressure

  • Right Time

  • Right Volume

  • Portable - Wound Cleansing Can Occur at Any Bedside Location (Hospitals, Clinics, Nursing Homes, Homecare Without Risk of Contamination)

  • Proven to Reduce Biofilm by 86.9%

  • Can be used to eliminate Biofilm in conjunction with - Negative Pressure Dressings, Hyperbaric Oxygen Treatments

  • Never Exceeds 15 psi

  • Patient pain and suffering is reduced significantly

  • Reduces hospital and rehabilitation facility admissions and readmissions

  • 3-speed or Variable Irrigation Control

  • Realized Cost Savings Over In-Hospital Care Cost effective - Eliminates cost and time of operating room debridement because Comfort Heal™ can be safely administered at the bedside

  • Frees Up Valuable Operating Rooms and ICU Ward Space

  • Increases Patient and Caregiver Safety

  • Battery Operated

  • Splash Back Protection

  • Safe Non-Biohazard Disposal (No Free Flowing Liquid After Procedure)

AB Model (Abdominal)

The AB model is designed to adhere a water tight seal to the body for effective safe treatment of hip, back, sacral, and chest wounds.

A perforated sealed entrance tube allows easy access for a pulse lavage irrigator with various tips

Medical grade adhesive with size adjustable opening.

EB Model (Extremity)

The EB model is designed to contain and create a water tight seal around an arm, leg, hand, foot, and head wounds.

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Collection bag with a one way valve collects all fluid away from the wound where a solidifier turns all contaminated fluid into a gel for safe easy disposal. The collection bag and solidifier can contain up to 6000ml of 0.9% saline fluid

Multiple access entrance tube

Medical grade adhesive

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Pulse Lavage Irrigator

The pulse lavage irrigator all in one package (with tips) is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Saline solution fluid is used in pulsatile action of the pump and helps to remove blood, tissue debris, biofilm and foreign matter from the operative or wound site.

Ease of Use

  • Battery powered no external power needed

  • Complete kit contains all accessories

  • Pulse lavage irrigator (1pc)

  • Cone tip (1pc)

  • Coaxial tip (1pc)

  • Can be operated with one hand

Simple Disposal

  • Limited single-use design

  • Battery pack can be easily removed and disposed

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Performance

  • Consistent variable power control supporting multiple surgical and clinical situations

  • Ergonomic trigger design with power control and a high pressure trigger lock prevents hand fatigue

  • Trigger with safety lock cover to ensure no tampering

  • Tip options provide different configurations for optimum cleaning and maximum flexibility

  • Internal batter design eliminating need for external battery pack.

  • Sterile packaging

Specifications

 

  • 20 minute flow rate of constant pressure

  • Pressure rate range of 6 psi to maximum 15 psi

  • Flow Rate (Cone Tip ST 01 Z):

  • 1 minute volume rate > 1,000ml

  • 20 minute volume rate > 18,000ml

  • Flow Rate (Coaxial Canal Tip CT 02 Z):

  • 1 minute volume rate > 1,000ml

  • 20 minute volume rate > 15,000ml

Tips may vary and are optional in certain markets.

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Usage Examples

Comfort Heal contained wound irrigation bags can be adjusted with a water tight seal on any part of the body. The system is designed to provide maximum adjustability with multiple access points, allowing for fluid to flow down into collection chamber and solidify once the procedure is completed.

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Pulsed Lavage System Precautions

1.Single use. Do not reuse.

2.If package is damaged or open, do not use product.

3. Read all instructions prior to use.

4. Do not submerge handle in liquid as this may compromise efficiency of the pump or alter the pH of the liquid.

5.Install medical equipment according to the EMC information provided.

6.Mobile RF communications equipment can effect medical equipment

Pulsed Lavage System Warnings

1.This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user.

2.Do not resterilize.

3.Do not use in an oxygen-enriched atmosphere due to explosion hazard.

4.Do not incinerate the batteries as this can cause a risk to the environment.

5.Do not recharge batteries, put in backwards, or mix with used or other battery types as these actions may cause explosion or leakage leading to personal injury or can cause a risk to the environment.

6.After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws.

7.Follow Occupational Safety and Health Administration (OSHA) standards or Universal Precautions for bloodborne pathogens (29 CFR-1910.1030). These may be found by searching the OSHA website at www.osha.gov.

8.Use continuous suction at 60-100 mmHg to keep operative or wound site clean.

Contained Wound Irrigation Bag Warnings

1. Single use only. Do not reuse, re-process, re-package.

2. Do not eat the solidifier in the collection bag or let it be in direct contact with open wounds.

3. Use sterilized medical scissors when cutting the adhesive area for use.

4. After use, roll the bag carefully to prevent leakage of the content and dispose of it.

5. The adhesive is medical grade yet it may cause allergic reactions depending on users.

6. Leave the bag in contact with the skin during the procedure only. Do not leave the bag on skin for an extended period time.

7. Do not place the products near fire.

8. Do not use if the package is damaged or open.

9. Dispose of the products following hospitals and/or authorities instructions.

Contact a GHC representative to schedule an appointment 

Please consult the instruction manual, product labels, and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.