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Olympic Cool Cap Service Manual

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Cool

3 hh-32-r cool cap arm 1. hh-51-r cool cap arm 1 4 hh-32-l cool cap arm 1. hh-51-l cool cap arm 1 ref. Description qty. Description qty. 5 hh-33 adjustment plate 2 6 hh-34-r handle 1 7 hh-34-l handle 1 8 hh-35as clamp adjuster 2 9 hh-36 linkage 2 10 hh-38 handle bushing 4.

Olympic Cool Cap Service Manual

A medical head-cooling system for newborns is being recalled because of a software problem, which may cause it to fail while treating infants.

The Olympic Cool-Cap System recall was announced by the FDA on December 12, impacting selective head cooling systems for full-term infants suffering from hypoxic-ischemic encephalopathy (HIE), which are manufactured by Natus Medical.

Manual

Natus originally sent out an Urgent: Medical Device letter to its customers in May, alerting them that the screen on the Control Module of the device can freeze. This means that despite information being shown on-screen that the caps are working, the infant may not be receiving cooling treatment.

This week the FDA determined that the letter constituted a Class I medical device recall, the highest designation a recall can receive. The Class I designation means that the FDA believes the cooling cap problem creates the reasonable probability that a patient will suffer severe injury or death. However, there have been no injuries or deaths reported in relation to the Olympic Cool-Cap problems.

The recall affects the Olympic Cool-Cap System, catalog/part number 60010, distributed between January 18, 2007 through April 20, 2012. The recall affects all serial numbers.

The caps are cooling water caps placed on the head of the infant while the body is warmed with radiant warmers. When working properly the caps provide 72 hours of monitored cooling for moderate to severe cases of HIE to prevent or reduce neurologic injury.

Customers with questions should contact Natus Technical Service at (888)496-2887.

Tags: Children, Medical Device Recall

Natus Medical Incorporated offers medical equipment, software, supplies and services for the diagnosis, monitoring and treatment of impairments and disorders affecting newborns, the brain, nerves, muscles, balance, mobility and hearing. Natus products are used in hospitals, clinics and laboratories worldwide.

The coronavirus (COVID-19) outbreak continues to evolve as does the related impact on local and global health and related economies. We at Natus are working hard to monitor the situation closely and assess any impact on supply and daily operations. Click here to read the full statement on product availability and service and support.

Neuro Products & Services

Neurodiagnostic and monitoring solutions including EEG, LTM, ICU, PSG, EMG, EP, IOM and obstetric and vascular handheld dopplers. Neurocritical solutions include intracranial pressure (ICP) monitoring and external ventricular drainage. Neurosurgery solutions include shunts for cerebrospinal fluid (CSF) and dural graft implants.

Newborn Care Products & Services

Devices and supplies for neonatal assessment and treatment, including hearing screening, brain injury, eye imaging, thermoregulation, jaundice management and more. Diagnostic products and support for neonatology units and pediatric clinics in hearing, balance and mobility assessments.

Hearing & Balance Products & Services

Devices and supplies for hearing screening, hearing assessment, hearing aid fitting and verification and vestibular assessment in more than 80 countries.

Olympic Cool Cap Service Manual
Neuro Training Academy

The Natus Neuro Training Academy is focused on educational programs for neuro-healthcare professionals, promoting advanced clinical knowledge and support for our customers in the use and optimization of Natus neurology products.

Olympic Cool Cap Service Manual Download

Hearing & Balance Academy

The Natus Hearing & Balance Academy explores the latest technological and scientific developments in hearing assessment and screening, hearing aid fitting and balance assessment.

Neonatal Care Academy

Olympic Cool Cap Service Manual 2017

The Natus Neonatal Care Academy is our educational program for neonatology and neonatal care - designed to help clinicians and careers stay at the forefront of their profession.

Vision Care Academy

The VCA (Vision Care Academy) is here to help Natus – RetCam equipment users around the globe stay at the forefront of this field.

Neuro Congresses & Tradeshows

Olympic Cool Cap Service Manual 2016

Newborn Care Congresses & Tradeshows

Olympic Cool Cap Service Manual Pdf

Cool

3 hh-32-r cool cap arm 1. hh-51-r cool cap arm 1 4 hh-32-l cool cap arm 1. hh-51-l cool cap arm 1 ref. Description qty. Description qty. 5 hh-33 adjustment plate 2 6 hh-34-r handle 1 7 hh-34-l handle 1 8 hh-35as clamp adjuster 2 9 hh-36 linkage 2 10 hh-38 handle bushing 4.

A medical head-cooling system for newborns is being recalled because of a software problem, which may cause it to fail while treating infants.

The Olympic Cool-Cap System recall was announced by the FDA on December 12, impacting selective head cooling systems for full-term infants suffering from hypoxic-ischemic encephalopathy (HIE), which are manufactured by Natus Medical.

Natus originally sent out an Urgent: Medical Device letter to its customers in May, alerting them that the screen on the Control Module of the device can freeze. This means that despite information being shown on-screen that the caps are working, the infant may not be receiving cooling treatment.

This week the FDA determined that the letter constituted a Class I medical device recall, the highest designation a recall can receive. The Class I designation means that the FDA believes the cooling cap problem creates the reasonable probability that a patient will suffer severe injury or death. However, there have been no injuries or deaths reported in relation to the Olympic Cool-Cap problems.

The recall affects the Olympic Cool-Cap System, catalog/part number 60010, distributed between January 18, 2007 through April 20, 2012. The recall affects all serial numbers.

The caps are cooling water caps placed on the head of the infant while the body is warmed with radiant warmers. When working properly the caps provide 72 hours of monitored cooling for moderate to severe cases of HIE to prevent or reduce neurologic injury.

Customers with questions should contact Natus Technical Service at (888)496-2887.

Tags: Children, Medical Device Recall

Natus Medical Incorporated offers medical equipment, software, supplies and services for the diagnosis, monitoring and treatment of impairments and disorders affecting newborns, the brain, nerves, muscles, balance, mobility and hearing. Natus products are used in hospitals, clinics and laboratories worldwide.

The coronavirus (COVID-19) outbreak continues to evolve as does the related impact on local and global health and related economies. We at Natus are working hard to monitor the situation closely and assess any impact on supply and daily operations. Click here to read the full statement on product availability and service and support.

Neuro Products & Services

Neurodiagnostic and monitoring solutions including EEG, LTM, ICU, PSG, EMG, EP, IOM and obstetric and vascular handheld dopplers. Neurocritical solutions include intracranial pressure (ICP) monitoring and external ventricular drainage. Neurosurgery solutions include shunts for cerebrospinal fluid (CSF) and dural graft implants.

Newborn Care Products & Services

Devices and supplies for neonatal assessment and treatment, including hearing screening, brain injury, eye imaging, thermoregulation, jaundice management and more. Diagnostic products and support for neonatology units and pediatric clinics in hearing, balance and mobility assessments.

Hearing & Balance Products & Services

Devices and supplies for hearing screening, hearing assessment, hearing aid fitting and verification and vestibular assessment in more than 80 countries.

Neuro Training Academy

The Natus Neuro Training Academy is focused on educational programs for neuro-healthcare professionals, promoting advanced clinical knowledge and support for our customers in the use and optimization of Natus neurology products.

Olympic Cool Cap Service Manual Download

Hearing & Balance Academy

The Natus Hearing & Balance Academy explores the latest technological and scientific developments in hearing assessment and screening, hearing aid fitting and balance assessment.

Neonatal Care Academy

Olympic Cool Cap Service Manual 2017

The Natus Neonatal Care Academy is our educational program for neonatology and neonatal care - designed to help clinicians and careers stay at the forefront of their profession.

Vision Care Academy

The VCA (Vision Care Academy) is here to help Natus – RetCam equipment users around the globe stay at the forefront of this field.

Neuro Congresses & Tradeshows

Olympic Cool Cap Service Manual 2016

Newborn Care Congresses & Tradeshows

Olympic Cool Cap Service Manual Pdf

Olympic Cool Cap Service Manual Download

Hearing & Balance Congresses & Tradeshows




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