Viasys Healthcare Infant Flow - SiPAP paediatric respiratory support
Viasys Healthcare Infant Flow - SiPAP paediatric respiratory support
Viasys Healthcare Infant Flow - SiPAP paediatric respiratory support
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SAFETY ACTION NOTICE<br />
By arrangement with the Scottish Government Health Directorates<br />
VIASYS HEALTHCARE INFANT FLOW ® SIPAP<br />
PAEDIATRIC RESPIRATORY SUPPORT DEVICE:<br />
CHANGES TO OPERATOR MANUAL<br />
SUMMARY<br />
SAN(SC)07/56<br />
11 DEC 2007<br />
Medical Devices<br />
Page 1 of 2 Pages<br />
The operator manual of <strong>Viasys</strong> <strong>Healthcare</strong>’s <strong>Infant</strong> <strong>Flow</strong> ® <strong>SiPAP</strong> <strong>paediatric</strong> <strong>respiratory</strong> <strong>support</strong><br />
device has been updated. All relevant staff should be made aware of this change.<br />
BACKGROUND<br />
1. The <strong>Infant</strong> <strong>Flow</strong> ® <strong>SiPAP</strong> <strong>paediatric</strong> <strong>respiratory</strong> <strong>support</strong> device, manufactured by <strong>Viasys</strong><br />
<strong>Healthcare</strong>, provides a non-invasive form of <strong>respiratory</strong> <strong>support</strong> designed for infants in hospital<br />
environments and for transporting these patients within the hospital. <strong>Infant</strong> <strong>Flow</strong> ® <strong>SiPAP</strong><br />
provides bi-level nasal CPAP for the spontaneously breathing neonate.<br />
2. The operator manual used to state incorrectly that changes to parameters will only be set if<br />
confirmed by pressing the control button. In fact, changes are automatically accepted in the event<br />
that no other button is pressed within 15 seconds.<br />
3.<br />
The operator manual has been corrected. Revision G, page 23 ‘Changing a control’ now states:<br />
“When a control setting such as Ti (inspiratory time) is selected, increase and decrease buttons<br />
appear. The control and displayed value for the selected parameter are highlighted. Use the<br />
decrease or increase keys to adjust the parameter. Accept the action by pressing the control button<br />
again.<br />
“In normal treatment screens, parameter changes take immediate effect.<br />
“If no button is pressed for 15 seconds during this procedure, highlighted controls are<br />
automatically adjusted according to the last key stroke and the screen is restored to its previous<br />
configuration.”<br />
ACTION<br />
4. This notice should be brought to the attention of all appropriate managers, staff and users.<br />
5. A copy of the current operator manual should be obtained from the <strong>Viasys</strong> <strong>Healthcare</strong> website (see<br />
References). At the time of publishing this is Revision G dated May 2006.<br />
6. All relevant staff should be made aware of the change to the operator manual and have access to a<br />
copy of the current instructions.<br />
Suggested Distribution Accident & Emergency Anaesthetics Device Managers<br />
Health & Safety Intensive Therapy Units Maternity Medical<br />
Medical Physics Neonatal Nursing Operating Departments<br />
Paediatrics Resuscitation Teams Risk Management Special Care Baby Units<br />
SCOTTISH HEALTHCARE SUPPLIES<br />
Gyle Square Edinburgh EH12 9EB<br />
A Division of the National Service Scotland for NHSScotland<br />
CONTACT EMAIL: iric@shs.csa.scot.nhs.uk FAX: 0131 314 0722<br />
WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html N:\WORD\HAZ\IRIC PUBLICATIONS\FINAL SAN\PUBLIC SAN\PSAN0756.DOC
SAFETY ACTION NOTICE<br />
By arrangement with the Scottish Government Health Directorates<br />
VIASYS HEALTHCARE INFANT FLOW ® SIPAP<br />
PAEDIATRIC RESPIRATORY SUPPORT DEVICE:<br />
CHANGES TO OPERATOR MANUAL<br />
ENQUIRIES<br />
Enquiries to the manufacturer should be address to:<br />
Mr Detlef Grotheer<br />
<strong>Viasys</strong> <strong>Healthcare</strong> GmbH<br />
7 Leibnizstrasse<br />
97204 Hoechberg<br />
Germany<br />
Tel: 0049 931 4972 111<br />
E-mail: detlef.grotheer@viasyshc.com<br />
REFERENCES<br />
1. <strong>Infant</strong> <strong>Flow</strong> ® <strong>SiPAP</strong> Operator Manual, Revision G May 2006:<br />
http://www.viasyshealthcare.com/prod_serv/downloads/197_PN_675-101-101G_<strong>Infant</strong><br />
<strong>Flow</strong>_<strong>SiPAP</strong>_OM.pdf<br />
2. Product website:<br />
SCOTTISH HEALTHCARE SUPPLIES<br />
Gyle Square Edinburgh EH12 9EB<br />
A Division of the National Service Scotland for NHSScotland<br />
SAN(SC)07/56<br />
11 DEC 2007<br />
Medical Devices<br />
Page 2 of 2 Pages<br />
http://www.viasyshealthcare.com/prod_serv/BUOverview.aspx?config=ps_appdtl&id=53<br />
CONTACT EMAIL: iric@shs.csa.scot.nhs.uk FAX: 0131 314 0722<br />
WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html N:\WORD\HAZ\IRIC PUBLICATIONS\FINAL SAN\PUBLIC SAN\PSAN0756.DOC
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