PARKER 01-02 100 Ultrasound Transmission Gel Instruction Manual
- June 3, 2024
- Parker
Table of Contents
Aquasonic® 100 Ultrasound Transmission Gel
Aquasonic CLEAR® Ultrasound Gel
01-02, 01-08, 01-34, 01-50
03-02, 03-08, 03-34, 03-50, 03-54
Instructions for use
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 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 fresh surgical site or an open wound
- Patients with an immunodeficiency or on 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 product if package is damaged or evidence of contamination is present.
To avoid contamination, tips of containers should not come into contact with
patient, staff or instruments.
Apply Parker Laboratories Ultrasound Gel to transducer surface, and not
directly on to the patient.
Any serious incident that has occurred in relation to 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 container.
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 prior to 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 product into 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 prior to refilling.
**** Catalogue number
Batch code
Manufacturer
Authorized representative in the European community
Non sterile
Caution
See Instructions for Use
Do not Reuse
Protect from Sunlight
Do not use if package damaged
Medical Device
PARKER LABORATORIES, INC.
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
© 2020 Parker Laboratories, Inc. PM-010-0001D
Documents / Resources
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PARKER 01-02 100 Ultrasound Transmission
Gel
[pdf] Instruction Manual
01-02, 01-08, 01-34, 01-50, 03-02, 03-08, 03-34, 03-50, 03-54, 01-02 100
Ultrasound Transmission Gel, 01-02, 100 Ultrasound Transmission Gel,
Ultrasound Transmission Gel, Transmission Gel, Gel
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