PARKER 18-04 Signaspray Electrode Solution and Skin Prep Instruction Manual

June 5, 2024
Parker

PARKER 18-04 Signaspray Electrode Solution and Skin

Prep

Instructions for Use:

Description

SignaSpray Electrode Solution and Skin Prep is a non-sterile, electrically conductive, non-gritty spray electrolyte. It is bacteriostatic.

Indications for Use

SignaSpray is recommended for electromedical procedures (except defibrillation) or for use with muscle stimulation equipment.

Contraindications

  • SignaSpray is not indicated for defibrillation procedures.

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.

Precautions

  • For external use only on intact, unbroken skin.
  • Discard product if package is damaged or evidence of contamination is present.
  • To avoid contamination of product, spray nozzle or refill dispenser pump should not come into contact with the patient, staff or instruments.

Directions for Use

Spray SignaSpray on the skin and apply the electrodes. Refer to the Instructions For Use provided by the manufacturer of the electromedical device being used for information on how SignaSpray should be used with their product. SignaSpray is water soluble and can be removed using a moistened soft cloth.

Directions for Refilling Dispenser Bottles

Consult your facility policy before refilling from bulk dispenser container. For refilling spray bottles, wipe the bottleneck and dispenser tip with isopropyl alcohol or a hospital grade disinfectant, such as Protex Disinfectant Wipes, prior to filling. Reusable containers should be washed in hot soapy water, rinsed and thoroughly dried before being refilled. Only refill product into corresponding labeled spray bottle, and mark it with lot number and expiry date. Cracked or damaged bottles should be discarded immediately. Reusable bottles should not be topped off. Contents should be consumed, or the remaining contents should be disposed of prior to refilling.

Handling

No special handling required.

Storage

Protect product from direct sunlight.

Disposal

Follow all federal, state, and local regulations for non-hazardous waste disposal.

Instruction

  • Catalogue number
  • Batch code
  • Manufacturer
  • Authorized representative in the European community
  • Non sterile
  • Use by date
  • Protect from Sunlight
  • Do not use if package damaged
  • See Instructions for Use
  • Medical Device

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References

Read User Manual Online (PDF format)

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