Product Manual

Ecacy: The Swaddler for Phototherapy transmits over 90% of the phototherapy
light to the patient and should not aect phototherapy ecacy. It also does not
aect infant temperature. As always, the decision to begin or continue
phototherapy on any patient should be based on accepted practice guidelines.
While no additional risk factors have been identied with the use of the Swaddler
for Phototherapy, all infants using the Swaddler while undergoing phototherapy
should be closely monitored for temperature rise, entrapment, suocation, or
strangulation.
Indications: The Swaddler for Phototherapy is intended to be used as an
adjunct to phototherapy systems used for the treatment of hyperbilirubinemia
in the clinical or home setting.
Caution: Always monitor swaddled infant for temperature, possible
entrapment, suocation, or strangulation.
Note: Use of the Swaddler for Phototherapy as an adjunct to phototherapy is
appropriate for any infant for whom phototherapy has been deemed clinically
necessary and who does not have contraindications to either phototherapy or
swaddling.
Contradictions to Use:
• Do not use the Swaddler for Phototherapy if any of the following
are present:
Xeroderma pigmentosum Omphaloceles
Cholestatic Jaundice Neural tube defects
Porphyria Ichthyosis or other severe skin diseases
Gastroschisis
• Do not use The Swaddler if phototherapy is contraindicated.
The Swaddler for Phototherapy is Available in the Following Sizes:
• #1100 (Preemie <1500g)
• #1105 (Newborn Regular >1500g)
Use Infants weight to select the proper size of The Swaddler.
5154 Enterprise Blvd. • Toledo, Ohio 43612
Phone: [phone] • Fax: [phone]
www.BionixMed.com
RM95-1100 Rev. 5/27/15 ©2015 Bionix Development Corp.
Swaddler for Phototherapy
Instructions for Use
• Made in the USA.
• Federal law restricts this device to sale by or on
the other of a licensed medical professional.
• For Single-Patient Use Only.
• Patent # 8,756,731