Parker 01-02 100 Ultrasound Transmission Gel Instruction Manual (+ PDF)

Contents hide

1 Aquasonic® 100 Ultrasound Transmission Gel Aquasonic CLEAR® Ultrasound Gel

1.1 Instructions for use

1.2 Description

1.3 Indications for Use

1.4 Contraindications

1.5 Storage Conditions

1.6 Warnings and Precautions

1.7 Directions for Refilling Dispenser Bottles

2 Documents / Resources

2.1 References

3 Related Posts

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