PARKER Aquasonic 100 Ultrasound Transmission Gel Instruction Manual

June 16, 2024
Parker

PARKER Aquasonic 100 Ultrasound Transmission Gel

PARKER-Aquasonic-100-Ultrasound-Transmission-Gel-
product

Product Information

Specifications

  • Product Name: Aquasonic 100 Ultrasound Transmission Gel
  • Product Type: Gel
  • Sterility: Non-sterile
  • Water-soluble: Yes
  • Non-staining: Yes
  • Intended Use: External use only
  • Compatibility: Compatible with all commercially available ultrasound devices

Description

Aquasonic 100 Ultrasound Transmission Gel, also known as Aquasonic Clear Ultrasound Gel, is a non-sterile, water-soluble, and non-staining gel. It is designed for external use only and can be used with all commercially available ultrasound devices.

Indications for Use

Aquasonic 100 Ultrasound Transmission Gel can be used on intact, unbroken skin and on all patients in facilities where cross-contamination is of minimal concern. It is recommended to discard the empty dispenser after use. Refill containers and refillable dispensers (product numbers 01-50, 03-50, and 03-54) are suitable for low-risk patients and procedures in non-acute care facilities. Please follow the enclosed instructions for use or your facility’s protocol if it differs.

Storage Conditions

The gel should be stored in a cool, dry place away from direct sunlight.

Warnings and Precautions

  • Discard the product if the package is damaged or shows evidence of contamination.
  • Avoid contact between the tips of containers and the patient, staff, or instruments to prevent contamination.
  • Apply the gel to the transducer surface and not directly onto the patient.
  • Any serious incidents related to the device should be reported to the manufacturer and the competent authority of the EU Member State where the user and/or patient is located.

Product Usage Instructions

Step 1: Preparation

Ensure that the ultrasound device is clean and in proper working condition.

Step 2: Application

  1. Open the Aquasonic 100 Ultrasound Transmission Gel container.
  2. Apply a sufficient amount of gel to the transducer surface.
  3. Ensure that the transducer surface is evenly covered with the gel.

Step 3: Ultrasound Procedure

Follow the standard ultrasound procedure using the ultrasound device as per your facility’s protocol or professional guidelines.

Step 4: Post-Procedure

After completing the ultrasound procedure, discard any remaining gel and clean the transducer surface according to the manufacturer’s instructions.

Step 5: Storage

Store the Aquasonic 100 Ultrasound Transmission Gel in a cool, dry place away from direct sunlight.

Frequently Asked Questions (FAQ)

  • Q: Can Aquasonic 100 Ultrasound Transmission Gel be used on broken skin?
    A: No, it is recommended to use the gel only on intact, unbroken skin.

  • Q: Can Aquasonic 100 Ultrasound Transmission Gel be used with all ultrasound devices?
    A: Yes, it is designed to be used with all commercially available ultrasound devices.

  • Q: What should I do if the package of Aquasonic 100 Ultrasound Transmission Gel is damaged?
    A: Discard the product if the package is damaged or shows evidence of contamination.

Description

Aquasonic 100 Ultrasound Transmission Gel and Aquasonic Clear Ultrasound Gel (Parker Laboratories Ultrasound Gel) are non-sterile, water-soluble, and non- staining gels intended for external use only and are used with all commercially available ultrasound devices.

Indications for Use

Parker Laboratories Ultrasound Gel can be used on intact, unbroken skin and on all patients in facilities where cross-contamination is of minimal concern.

Discard the empty dispenser after use.
Refill containers and refillable dispensers (product numbers 01-50, 03-50, and 03-54) are for use on low-risk patients and procedures in non-acute care facilities. Follow the enclosed instructions for use or your facility’s protocol, if it is different.

Contraindications

  • Parker Laboratories Ultrasound Gel, in multi-use packaging, is for external use only and should not be used in:
  • Any invasive procedures in which a device is passed through the tissue, e.g. needle aspiration, needle localization, tissue biopsy, or other surgical procedures.
  • Any procedure on or near broken skin, such as a fresh surgical site or an open wound
  • Patients with immunodeficiency or immunosuppressive therapy.
  • Any neonates or critically ill pediatric patients.
  • Mucous membranes
  • Critically ill patients or patients in contact-, airborne- or droplet transmission-based precautions

Storage Conditions

Store in a cool dry place. Store away from direct sunlight.

Warnings and Precautions

  • Discard the product if the package is damaged or evidence of contamination is present.
  • To avoid contamination, the tips of containers should not come into contact with patients, staff or instruments.
  • Apply Parker Laboratories Ultrasound Gel to the transducer surface, and not directly onto the patient.
  • Any serious incident that has occurred about the device should be reported to the manufacturer and the competent authority of the EU Member
  • State in which the user and/or patient is established.

Directions for Refilling Dispenser Bottles

  • Consult your facility policy before refilling from bulk containers.
  • For refilling dispenser bottles, wipe the bottleneck and dispenser tip with isopropyl alcohol or a hospital-grade disinfectant, such as Protex® ULTRA
  • Disinfectant Wipes, just before filling.
  • Reusable containers should be washed in hot soapy water, rinsed, and thoroughly dried before being refilled.
  • Isopropyl alcohol or a hospital-grade disinfectant, such as Protex ULTRA
  • Disinfectant Wipes can be used to clean dispenser bottles.
  • Only refill the product into the corresponding labeled dispenser, and mark it with lot number.
  • Reusable bottles should be marked with the date filled and then discarded after one month.
  • Cracked or damaged bottles should be discarded immediately. Reusable bottles should not be topped off. Contents should be consumed, or remaining gel should be disposed of prior to refilling

Symbols

  • Catalog number
  • Batch code
  • Manufacturer
  • Authorized representative in the European community
  • Nonsterile
  • Caution
  • See Instructions for Use
  • Do not Reuse
  • Protect from Sunlight
  • Do not use if the package damaged
  • Medical Device
  • Authorized Representative for Switzerland

PARKER LABORATORIES, INC.
parkerlabs.com
Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004 USA 973-276-9500
parkerlabs.com
Parker Laboratories BV Bedrijvenpark Twente 305 7602 KL Almelo The Netherlands
MDSS CH GmbH Laurenzenvorstadt 61 5000 Aarau Switzerland
© 2022 Parker Laboratories, Inc.

References

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