SmartMonitor 2 PS SmartMonitor 2 PSL …

1 SmartMonitor 2 PSSmartMonitor 2 PSLP rofessional Operator s ManualWa r r a n t yChildren s Medical Ventures, LLC warrants that the monitor will be free from defects in materials and workmanship for a period of two years from the time of purchase. Children s Medical Ventures, LLC accessories are warranted to be free of defects in materials and workmanship for a period of 90 days from the time of purchase. The Children s Medical Ventures, LLC equipment and authorized accessories are designed to function as described in the operator s manual. The user/owner of this equipment shall have sole responsibility and liability for any injury to persons or damage to property (including this equipment) resulting from Operation not in accordance with supplied operating instructions; Maintenance not in accordance with authorized maintenance/operational instructions; Service by anyone other than a factory authorized service representative; Modification of the equipment or accessories; or Use of damaged or unauthorized components and LIMITED WARRANTY IS IN LIEU OF ANY AND ALL OTHER WARRANTIES, EX-PRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

2 TO THE EX-TENT THAT STATE OR FEDERAL LAW PROHIBITS EXCLUSIONS OF IMPLIED WAR-RANTIES, ANY SUCH IMPLIED WARRANTY IMPOSED BY LAW SHALL BE LIMITED TO A PERIOD OF NINETY (90) DAYS FROM THE DATE OF THE INITIAL PURCHASE FROM Children s Medical Ventures, e r/OWn e r re s pO n s i b i l i t yThis Philips Children s Medical Ventures equipment and the authorized accessories are designed to work as described in the operator s manual. The user(s) of this equipment should not use parts that have failed, exhibit excessive wear, are contaminated, or are otherwise ineffective. The monitor and its accessories should not be modified. The following list incorporates the owner s responsibilities: Periodic check, maintenance, and calibration of equipment; Replacement of components as required for safe and reliable operation; Replacement of ineffective parts with parts supplied by Philips Children s Medical Ventures; Equipment which is not functioning properly must not be used until all necessary maintenance has been completed and a factory-authorized service representative has certified the equipment as ready for use; The monitor and any of its accessories should not be modified; As a general rule, the proper performance of this monitor should be verified with a Philips Chil-dren s Medical Ventures Model 5000 Simulator according to the Checkout Procedure Manual between each patient use and/or every 6 to 12 months, whichever is more user of this equipment is responsible for reading, understanding, and following the Warning and Caution statements throughout this manual.

3 2012 Koninklijke Philips Electronics All rights 2 PS professional ManualSmartMonitor 2 PS2 SmartMonitor 2 PS professional ManualManufactured forChildren s Medical Ventures, LLC191 Wyngate DriveMonroeville, PA 15146 USA0086 Respironics DeutschlandGewerbestrasse 1782211 Herrsching, Germany3 SmartMonitor 2 PS professional ManualTa b l e o f Co nT e nT sIn t r o d u c tI o n ..7un p a c kI n g a n d In s p e c tI o n ..7ab o u t th I s Ma n u a l ..7In dI c a tI o n s f o r us e ..7su M Ma r y o f cl I n I c a l pe r f o rM a n c e ev a l u a tI o u d y de sI g n ..8Me t h o d s ..8Wa r nI n g s a n d ca u tI o n s ..13Wa r nI n g s ..13ca u tI o n s ..15ho M e c a r e pr o vI d e r pr e p a r a tI o n f o r ho M e se t u p ..16ho W do e s t h e sM a r tMo nI t o r 2 ps Wo r k? ..17sy M b o l s ta b l e ..18fcc pa r t 68 te l e c oM In f o rM a tI o n ..20re gI s t r a tI o n nu M b e r a n d ren ..20usoc Ja c k ..20co M p lI a n t ac c e s s o rI e s.

4 20nu M b e r o f rens ..20ch a n g e s I n se r vI c e ..20pr o b l eM s ..21re p aI r s ..21pa r t y lI n e s ..21In d u s t r y ca n a d a re q uI r eM e n t s ..21Ic ab b r e vI a tI o n ..21ren ..21In d u s t r y ca n a d a cs-03 no tI c e ..22fcc pa r t 15 ..22ge t tI n g t o kn oW t h e Mo nI t o r ..23sM a r tMo nI t o r 2 ps fe a t u r e s ..24to p pa n e l fe a t u r e s ..24fr o n t pa n e l fe a t u r e s ..25spo2 lI g h t s ..25sp e a k e r ..264 SmartMonitor 2 PS professional Manualsy s t eM lI g h t s ..26sI d e pa n e l fe a t u r e s ..26se l f-te s t co n n e c t o r ..26Me M o r y ca r d (op tI o n a l) ..27ba c k pa n e l fe a t u r e r s e ca l l (op tI o n a l) ..27Mo d eM (op tI o n a l) ..27I/o co n n e c tI o n s ..28dc po W e r ..28st a n d ..28se t tI n g al a rM a n d re c o r dI n g lI M It n u a l se t u p ..29th e sM a r tMo nI t o r 2 ps pa r aM e t e r s t eM se t u p Me n u ..41vI e W Me n u Mo d e ..43us I n g au xI l I a r y eq uI p M e n t.

5 43us I n g nu r s e ca l l eq uI p M e n t ..44pa tI e n t se t u p ..47ho s pI t a l Mo d e ..53re s p o n dI n g t o al a rM s ..55pa tI e n t al a rM ..55te s tI n g t h e al a rM ..55If a n al a rM so u n d s ..56re s p o n dI n g t o sy s t eM al a rM s ..59re d u cI n g fa l s e al a rM s ..61Mo nI t o rI n g ..63tu r nI n g t h e M o nI t o r o n ..63tu r nI n g t h e Mo nI t o r o f f - sI b lI n g al a rM ..64Mo nI t o rI n g br e a t hI n g ..65re s pI r a tI o n lI g h t/dI s p l a y ..65ap n e a lI g h t ..65Mo nI t o rI n g he a r t ac tI v I t y ..66he a r t ra t e lI g h t/dI s p l a y ..65hI g h he a r t ra t e lI g h t ..65lo W he a r t ra t e lI g h t ..665 SmartMonitor 2 PS professional ManualMo nI t o rI n g t h e pa tI e n t s ox y g e n co n c e n t r a tI o n le v e l ..67spo2 lI g h t ..67hI g h spo2 al a rM lI g h t ..68lo W spo2 al a rM lI g h t ..68po r t a b l e op e r a tI o n o f t h e sM a r tMo nI t o r 2 a r gI n g t h e Mo nI t o r s ba t t e r y.

6 71sM a r tMo nI t o r 2 ps ba t t e r y pa c k ..72ba t t e r y In s t a l l a tI o n In s t r u c tI o n s ..72tr a n s f e r rI n g sM a r tMo nI t o r 2 ps In f o rM a tI o n ..73Me M o r y Ma n a g eM e n t I n t h e Mo nI t o r ..73to re c o v e r t h e ol d da t a us I n g a Me M o r y ca r d ..73to re c o v e r t h e ol d da t a b y do W n l o a dI n g us I n g sy n e r g y-e ..73Mo d eM do W n l o a d ..74Mo d eM au t o dI a l ..74Mo d eM au t o an sW e r I n co M Mu nI c a tI o n s Mo d e ..75Mo d eM au t o an sW e r I n Mo nI t o r Mo d e ..76tr a n s f e r rI n g Mo nI t o r da t a t o a Me M o r y ca r d ..76tr a n s f e r rI n g Mo nI t o r da t a us I n g a co M p u t e r ..78co M Mu nI c a tI o n s Mo d e se t u p ..78ca rI n g f o r t h e sM a r tMo nI t o r 2 ps ..79cl e a nI n g In s t r u c tI o n s ..79el e c t r o d e s ..79so f t ca r r yI n g ca s e ..79In s e c t In f e s t a tI o n de c o n t aM In a tI o n pr o c e d u r e s.

7 80pe r f o rM In g a fu n c tI o n a l se l f-te s t ..80se l f-te s t tr o u b l e s h o o tI n g ..82tr o u b l e s h o o tI n g ..83sp e cI f I c a tI o n s ..87de vI c e sI z e ..89el e c t rI c a l ra tI n g s ..89en vI r o nM e n t a l co n dI t I o n s ..89dI s p o s a l ..89eMc re q uI r eM e n t s ..91gl o s s a r 2 PS professional Manual7 SmartMonitor 2 PS professional ManualIn T r o d uC T Io nun p aC k I n g a n d In s p eC T Io nWhen you receive the SmartMonitor 2 PS, unpack the shipping case and do the following: Carefully examine the contents. Save the shipping carton. Make sure you have all the necessary items and that they are not damaged. Report anything missing or damaged to Philips Children s Medical o uT Th I s Ma n u a lThis manual provides all the information you need to set up and operate the SmartMonitor 2 PS and explains how to use it to monitor the patient s vital functions. Carefully read and understand this manual before using the dI Ca T Io n s f o r us eThe SmartMonitor 2 PS is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 levels of infant, pediatric, and adult patients.

8 It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environ-ment. Wh aT Is T h e pu r p o s e o f T h e sMa rTMo nI T o r 2 ps? SmartMonitor 2 PS is an apnea monitor designed to monitor and record the patient s breathing (respi-ration), heart (cardiac) activity and SpO2 (functional oxygen concentration) levels. The monitor alerts you if any of these activities exceed the limits prescribed by the physician. Patient alarm limits are set by the health care professional before the monitor is delivered to the pa-tient. During monitoring, when the breathing effort, heart activity and SpO2 level are not within these set boundaries, an indicator light comes on and an alarm sounds. This manual explains how to set up the monitor how to monitor the patient, and how to transfer devices may be used with the SmartMonitor 2 PS.

9 Refer to the section Using Auxiliary Equip-ment for more 2 PS professional Manualsu M Ma r y o f Cl I n I Ca l pe r f o rMa nC e ev a l u aT Io nNOTE: The following study involved the SmartMonitor 2 predicate device and is being used as the basis for perfor-mance evaluation of the SmartMonitor 2 PS. The study was done with infant patients SmartMonitor 2 was evaluated in a clinical study according to the most recent FDA recommenda-tions. These recommendations are available in the Guidance for Apnea Monitor 510(k) u d y de sI g nThis was a multi-center, prospective, non-randomized study carried out at six clinical sites in the United States. Infants in nurseries and other settings appropriate for attended monitoring, who were considered to be appropriate candidates for cardio-respiratory monitoring, were recruited and enrolled in the study. Me T h o d sEnrollment was competitive, and each site was instructed to continue patient enrollment until a sample size of at least 100 qualified central apneas was obtained.

10 In C l u sI o n Cr I T e rI aSpontaneously breathing, newborn infant (less than or equal to 12 months of age), either gender without regard to candidate for cardio-respiratory monitoring including any one or more of the following: diagnosis of cardiac, respiratory or neurological disease witnessed or suspected episodes of apnea or periodic breathing gestational age less than or equal to 36 weeks history of sibling(s) experiencing ALTE s or SIDS patients requiring supplemental oxygenex C l u sI o n Cr I T e rI aAny candidate with one or more of the following was excluded from enrollment: presence of an artificial airway receiving mechanical ventilation receiving continuous positive airway pressure (CPAP) presence of a cardiac or diaphragmatic pacemakerEach patient was connected to a data acquisition system that included the Philips Children s Medical Ventures SmartMonitor and SmartMonitor 2, and the Alice system. Respiration and heart rate signals were recorded using infant electrocardiogram electrodes.