Instruction Manual - Sentec
Sentec Digital Monitoring SystemInstruction ManualSoftware version SW-V08.03 and higher
Sentec Digital Monitoring SystemNoninvasive Ventilation and Oxygenation Monitoring
123461Trend Display Area2Numerical Display Area3Menu/Previous Level ButtonmmHg4AUDIO PAUSED/OFF Button%SpO25AUDIO PAUSED/OFF Indicator (yellowLED)6Door Handle7Docking Station Door8Enter Button9Display Button57525- 15 min0 min10070100% -- 15 min0 min12 secAD7.7h0 min42.00 C RHP[John Smith]39.49684503010085140507PCO22.0 PIPRbpm2020-04-28 15:28:3114111312151610 AC Power/Battery Indicator(green/yellow LED)910178182021UP/DOWN Buttons12ON/OFF Indicator (green LED)13Status Bar14Speaker (on the side)15Sensor Connection Port16Multipurpose l/O-Port(Nurse Call & Analog Output)17Serial Data Port (RS-232)18Network Port (LAN)19Gas Bottle Slot20 FanSentec AGRingstrasse 39GmbHCH-4106 Therwil SentecCarl-Hopp-Straße 19ADE-18069 Rostock191121222324Equipotential Terminal Connector (ground)22 Fuse Holder23 AC Power Connector24 ON/OFF Switch
WarrantyThe manufacturer warrants to the initial purchaser that each new component of the Sentec Digital Monitoring System will be free from defects inworkmanship and materials. The manufacturer’s sole obligation under this warranty is to at its own choice repair or replace any component – forwhich the manufacturer acknowledges the warranty cover – with a replacement component.Warranty Exclusions and System PerformanceSentec AG can neither guarantee or verify instrument performance characteristics nor accept warranty claims or product liability claims if therecommended procedures are not carried out, if the product has been subject to misuse, neglect or accident, if the product has been damagedby extraneous causes, if accessories other than those recommended by Sentec AG are used, if the warranty seal on the lower side of the monitoris broken, or if instrument repairs are not carried out by Sentec authorized service personnel.CAUTION:Federal law (U.S.) restricts this device to sale by or on the order of a l Industrial Design No. DM/054179, Japanese Design No. 1137696, U.S. Design Patent No. D483488. Canadian Patent No. 2466105,European Patent No. 1335666, German Patent No. 50111822.5-08, Spanish Patent No. 2278818, Hongkong Patent No. HK1059553, U.S. PatentNo. 6760610. Chinese Patent No. ZL02829715.6, European Patent No. 1535055, German Patent No. 50213115.2, Spanish Patent No. 2316584,Indian Patent No. 201300, Japanese Patent No. 4344691, U.S. Patent No. 7862698. Sentec , V-Sign , O xiVenT TM, V‑STATS , V‑CareNeT ,V‑Check , Staysite , Illuminate Ventilation and Advancing Noninvasive Patient Monitoring are trademarks of Sentec AG / 2021 Sentec AG. Allrights reserved. The contents of this document may not be reproduced in any form or communicated to any third party without the prior writtenconsent of Sentec AG. While every effort is made to ensure the correctness of the information provided in this document, Sentec AG assumes noCLASSIFIEULRMEDICAL – PATIENT-MONITORING EQUIPMENTDCresponsibility for errors or omissions. This document is subject to change without notice.USWITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLYIN ACCORDANCE WITH IEC 60601-1:2012 (ed 3.1); ANSI/AAMI ES60601-1:2005/(R)2012; CAN/CSA-C22.2 No. 60601-1:2014, IEC 60601-1-6:2010 (ed. 3) A1:2013, IEC 60601-1-8:2006 (ed. 2) Am. 1: 2012, IEC 60601-2-23: 2011 (ed. 3), ISO 80601-2-61:2011 (ed.1), 60601-1-11:2015 (ed. 2)Manufacturer: Sentec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland0123 www.sentec.com
ContentsThe Sentec Digital Monitoring System (SDMS).5Intended Use / Intended Purpose. 5Transcutaneous PCO2 and PO2.15Pulse Oximetry. 17Sentec TC Sensors.18Minimum Requirements . 20Setting up the SDMS.22Connect SDM to AC Power.22Battery Operation of the SDM.22Turning on the SDM.23Installation of the Gas Bottle (Service Gas-0812).23Connection/Disconnection of Digital Sensor Adapter Cable.24Connection of a Sentec TC Sensor.25Sensor Check, Sensor Calibration/Storage and Membrane Change. 26Checking a Sentec TC Sensor.26Sensor Calibration and Storage. 27Changing the Sensor Membrane.28Patient Monitoring with the SDMS. 31Patients with potentially impaired skin perfusion.31Characteristics requiring special attention.31Selection of Patient Type, Measurement Site, and Sensor Attachment Accessory.32Check SDM Settings and System Readiness.34Sensor Application Using a Multi‑Site Attachment Ring.36Sensor Application Using an Ear Clip.39Patient Monitoring.42Sensor Removal with Multi‑Site Attachment Ring.50Sensor Removal with Ear Clip.52Additional Warnings. 54Page 3 .
Controls, Indicators and Alarms. 55Controls (Buttons). 55LED Indicators. 58Auditory Indicators/Signals. 58Alarms. 59Status Bar with Status Icons and Status Messages.61Maintenance of the SDMS.63Routine Checks.63Service. 64Waste Disposal . 65Specifications.67SDM. 67tcPCO2 and tcPO2. 68Pulse Oximetry. 69Incident Reporting. 70Glossary of Symbols.71
The Sentec Digital Monitoring System (SDMS)Intended Use / Intended PurposeThe Sentec Digital Monitoring System – consisting ofmonitors, sensors, cables, accessories and disposables forsensor application/maintenance and PC-based software – isindicated for noninvasive patient monitoring of oxygenationand ventilation.The Sentec Digital Monitoring System is for prescription useonly. Devices are non-sterile and non-invasive.The monitor is not in direct contact with the patient duringmonitoring. The V-Sign Sensor 2, the OxiVenT Sensor,the Ear Clip, the Multi-Site Attachment Rings, the Staysite Adhesive and the Contact Gel are in contact with the intactskin of the patient during monitoring.Intended patient population: tcPCO2 and tcPO2 monitoringis indicated in adult/pediatric (older than term birth plus12 months) and neonatal (younger than term birth plus 12months) patients. Pulse oximetry monitoring is indicated inadult/pediatric patients only.The target user population of the Sentec Digital MonitoringSystem (SDMS) is professional medical personnel, e.g.nurses, physicians, and – if under clinical supervision – layoperators. The correct and safe application of tcPCO2 andtcPO2 measuring equipment requires training of the user (e.g.physiological restrictions, technical aspects such as membranechange, meaning of drift, calibration). Home care providersalso require specific training to be allowed to install the SDMSin home environments and to instruct lay persons how to applythe sensors correctly. The lay operator cannot modify theSDM’s configuration by using the SDM’s menu.Training: Professional medical personnel and instructedhome care personnel are trained by Sentec or a qualified andauthorized distributor. The instructed home care personnelprovides the lay user with the lay user manual and explainsattachment and detachment of the sensor. The instructedhome care personnel also defines the application site for theattachment of the sensor.Environment of use: In clinical and non-clinical settingssuch as hospitals, hospital-type facilities, intra-hospitaltransport environments, clinics, physician offices, ambulatorysurgery centers and – if under clinical supervision – homeenvironments. Hospital use typically covers areas such asgeneral care floors, operating rooms, special procedure areas,intensive and critical care areas. Hospital type facilities typicallycover facilities such as surgical centers, special nursing facilitiesand sleep labs outside of the hospital. Intra-hospital transportincludes transport of a patient within the hospital or hospitaltype facilities.The SDMS fulfils the requirements of a non-transit operableand portable device to be used in home environments.Page 5 . The Sentec Digital Monitoring System (SDMS)
WARNING: Use only equipment, accessories, disposables or parts supplied or recommended by Sentec. Use of otherparts may result in injury, inaccurate measurements and/or damage to the rDescriptionIntended PurposeVariantsExpected Reusableuseful lifeThe Sentec Digital Monitor,model SDM, is a portable standalone patient monitor intendedfor continuous, noninvasivepatient monitoring of carbondioxide partial pressure (PCO2),oxygen partial pressure (PO2),functional oxygen saturation(SpO2) and pulse rate (PR), usingeitherStand-alone patient monitor.Transport/storagetemperature: 0 – 50 CTransport/storagehumidity: 10 – 95%non-condensingOperating temperature:10 – 40 C a single, digital sensor (V-Sign n/aSensor 2) for PCO2, SpO2 and PRmeasurement, OR7 yearsYesPO2 measurement with SDMis only possible when used incombination with an OxiVenT Sensor.VS-A/P/NV-Sign Sensor 2Digital carbon dioxide tensionand oximetry sensor.In neonatal patients, the use ofV-Sign Sensor 2 is indicated fortcPCO2 monitoring only.Operating humidity:15 – 95% non-condensingOperating altitude:-400 – 4000 m(-1300 – 13120 ft) abovesea level if connected tomains; -400 – 6000 m(-1300 – 19600 ft) abovesea level if operated onbattery. a single, digital sensor(OxiVenT Sensor) for PCO2,PO2, SpO2 and PR measurementThe V-Sign Sensor 2, modelVS-A/P/N, is intended for usewith the SDM when continuous,noninvasive monitoring oftcPCO2, SpO2, and PR arerequired for adult and ransport temperature:0 – 50 Cn/aup to 36monthsYesLong term storagetemperature: 15 – 26 CTransport/ store sensorwith membrane andprotected from light/radiation.
REFOV-A/P/NProduct(Brand)Name OxiVenT SensorDescriptionIntended PurposeDigital carbon dioxide tension,oxygen tension and oximetrysensorThe O xiVenT Sensor, modelOV-A/P/N, is intended for usewith the SDM when continuous,noninvasive monitoring oftcPCO2, and tcPO2, as well asSpO2, and PR monitoring arerequired for adult and pediatricpatients.VariantsExpected Reusableuseful lifeEnvironmental/StorageconditionsTransport temperature:0 – 50 Cn/a12 monthsYes7 yearsYesIn neonatal patients, the use of OxiVenT Sensor is indicated fortcPCO2 and tcPO2 monitoringonly.Long term storagetemperature: 15 – 26 CTransport/ store sensorwith membrane andprotected from light/radiation.tcPO2 monitoring iscontraindicated for patientsunder gas anesthesia.AC-XXXDigitalSensorAdapterCableAdapter cable required toconnect digital Sentec sensorsto the Sentec Digital Monitor. Ittransfers the power needed torun the micro-/optoelectroniccomponents (LEDs) and toheat the sensor. It furthermoretransmits digitized data betweenthe digital sensor and the SDM.AC-XXX is intended to connectdigital Sentec sensors (V-Sign Sensor 2, O xiVenT Sensor) tothe Sentec Digital Monitor.AC-150:length150 cmAC-250:length250 cmAC-750:length750 cmPage 7 . The Sentec Digital Monitoring System (SDMS)Transport/storagetemperature: 0 – 50 CTransport/storagehumidity: 10 – 95%
REFPSGCable Ato PSGCable er Cable to interface theSDM to Polygraphs (PG) orPolysomnographs (PSG). A PSGCable transfers analogue datafrom the SDM to the PG or PSGsystem.Intended PurposeVariantsPSG Cables are intended tointerface the Sentec DigitalMonitor to Polygraphs (PG) orPolysomnographs (PSG).PSG Cable APSG Cable BPSG Cable CPSG Cable DPSG Cable EPSG Cable FPSG Cable GPSG Cable H 7 yearsPSG Cable JPSG Cable KPSG Cable LPSG Cable NPSG Cable PPSG Cable QPSG Cable XIsolation Transformers areintended ensure a galvanicRFT100VA- IsolationIsolates the SDM from mains forseparation of the Sentec DigitalXXTransformer use in home use environments.Monitor from supply voltage inhome care installation settings.V-STATSCDV-STATS RFT100VAV1: 100-120VACRFT100VAV2: 230V AC 10%V-STATS is an optional PCbased software, which is intendedfor use with the monitor SDMwhen remote monitoring and/or trend reporting and statisticalV-STATS : PC baseddownload, data analysis, remote analysis of data measured by then/amonitor is required.monitoring, and monitormanagement software.V-STATS is not intended toprovide diagnosis; it is intendedto supplement and not to replaceany part of the monitoringprocedures.Expected Reusableuseful oragetemperature: 0 – 50 CTransport/storagehumidity: 10 – 95%Temperature: -10 – 50 C7 yearsYesNotspecifiedn/aHumidity: not specifiedOperating altitude: 2000 m above sea levelNot specified
REFProduct(Brand)NameDescriptionIntended PurposeVariantsExpected Reusableuseful lifeEnvironmental/StorageconditionsNot specifiedSDM Water This cover provides an IPX2SDM WPC protection protection for the SDM againstcoverthe ingress of water.SDM WPC is intended to protectthe Sentec Digital Monitor fromn/adripping water when the monitoris tilted up to 15 (IPX2).7 yearsYesREFIntended PurposeShelf nvironmental/StorageconditionsNo.EC-MIEar ClipSentec’s Ear Clip, model EC-MI,is intended to attach the Sentecsensors to the earlobe of thepatient, recommended forSingle use sensor application Ear patients with mature/intact skin.Clip, recommended for patientsThe use of the Ear Clip iswith mature/intact skincontraindicated for patientswhose earlobes are too smallto ensure adequate sensorapplication (e.g. neonates).Reusing the EarClip may cause:- Re- and/orcross-infectionn/a2 yearsPage 9 . The Sentec Digital Monitoring System (SDMS)- loss offunctionality- impropersensorapplicationand incorrectmeasurementsTemperature: 10 – 30 CHumidity: 25%-60%
REFProduct(Brand)NameDescriptionIntended PurposeVariantsShelf MIMulti-SiteAttachmentRing formature/intact skinReusing aMAR-MI maycause:Single use sensor applicationring, recommended for adult,pediatric and neonatal patientswith mature/intact skin- Re- and/orcross-infection- loss offunctionalitySentec’s Multi-Site AttachmentRings, models MAR-MI andMARe-MI, are intended to attachthe Sentec sensors to conventional n/ameasurement sites, recommendedfor adult, pediatric, and neonatalpatients with mature/intact skin. MARe‑MIMulti-SiteAttachmentRing Easyfor mature/intact skinSingle use sensor applicationring, recommended for adult,pediatric and neonatal patientswith mature/intact skinTemperature: 10 – 30 CHumidity: 25%-60%- improper sensor applicationand incorrectmeasurements2 yearsNo.Reusing aMARe-MI maycause:- Re- and/orcross-infection- loss offunctionality- impropersensorapplicationand incorrectmeasurementsTemperature: 10 – 30 CHumidity: 25%-60%
REFProduct(Brand)NameDescriptionIntended PurposeVariantsShelf ing a MARmay cause:MAR-SF MARe‑SFMulti-SiteAttachmentRing forsensitive/fragile skinMulti-SiteAttachmentRing Easyfor sensitive/fragileskin- Re- and/orcross-infectionSingle use sensor applicationring, recommended for adult,pediatric and neonatal patientswith sensitive/fragile skin- loss offunctionalitySentec’s Multi-Site AttachmentRings, models MAR-SF andMARe-SF, are intended to attachthe Sentec Sensors to conventional measurement sites, recommended for adult, pediatric, andneonatal patients with sensitive/fragile skin.n/a1.5 yearsSingle use sensor applicationring, recommended for adult,pediatric and neonatal patientswith sensitive/fragile skinPage 11 . The Sentec Digital Monitoring System (SDMS)Temperature: 10 – 27 CHumidity: 40%-60%- impropersensorapplicationand incorrectmeasurementsNo.Reusing a MARmay cause:- Re- and/orcross-infection- loss offunctionality- impropersensorapplicationand incorrectmeasurementsTemperature: 10 – 27 CHumidity: 40%-60%
REFProduct(Brand)NameDescriptionIntended PurposeVariantsShelf ARStaysite AdhesiveSingle-use adhesive for MultiSite Attachment Rings (attachescomplementary the MAR-SF /MARe‑SF / MAR-MI / MARe‑MIto the skin with an additionaladhesive film)MCMembrane Membrane change toolChangersingle-useMC-RMembrane Membrane change tool,ChangerreloadableMC-ISeparately bagged, singleMembraneuse inserts required to reloadChangera Membrane Changer prior toInsertreuse.Sentec’s Staysite Adhesive,model SA-MAR, is an optional,single-use adhesive which isindicated for use with MultiSite Attachment Rings, modelsMAR-MI, MARe‑MI, MAR-SF,and MARe‑SF, if more secureattachment is required.Reusing theSA-MAR maycause:- Re- and/orcross-infectionn/aThe Membrane Changersingle-use (MC), the MembraneChanger reloadable (MC-R) andthe Membrane Changer Insert(MC-I), serve as tools to changethe electrolyte and membraneof the V-Sign Sensor 2 and theOxiVenT Sensor. The MembraneChanger reloadable (MC-R) canbe reused by replacing its insert n/a(MC-I).MC, MC-R and MC-I are notintended for sterilization (e.g. byirradiation, steam, ethylene oxideor plasma method).1.5 years- loss offunctionalityTemperature: 10 – 27 CHumidity: 40%-60%- impropersensorapplicationand incorrectmeasurementsNo.The MC singleuse is notintended to bereloaded withthe MC-I.2 yearsYes, max. 10times reloadablewith MC-I.Temperature: 10 – 30 CNo.Reusing theMC-I maycause:- loss offunctionalityof the sensorand incorrectmeasurementsHumidity: 10%-95%
REFGAS-0812Product(Brand)NameDescriptionIntended PurposeCalibration gas for dockingService Gas station, cylinder of 0.56 l atfor SDM9.5 bar. Mixture of 8–vol % CO2,12-vol% O2 and 80-vol% N2VariantsThe Service Gas, model GAS0812, serves as calibration gas forthe Sentec sensors that monitortcPCO2 and/or tcPO2 (V-Sign Sensor 2 and O xiVenT Sensor). n/aThe Service Gas, model GAS0812, is intended for use only withthe docking station integrated inSentec Digital Monitor.Shelf Life2 yearsReusableYes, for aboutone month,depending onuse scenariosand perature: 0 – 50 CDo not useHumidity: not specifiedService Gasif it is expired,this may resultin incorrectmeasurements.Yes.GEL-04GEL-SDDo not useContact GelTemperature: 10 – 30 Cif it is expired,to avoidHumidity: 10% – 95%infections orpotential allergicreactions.Contact gel for SentecContact Gel transcutaneous sensors, bottleof 5 mlSingle Dose Contact gel for SentecContacttranscutaneous sensors, singleGeldose vials of 0.3 g eachThe Contact Gel, GEL-04 andGEL-SD, serves as contact gel toachieve proper gas conductionand heat transfer betweenthe patient’s skin and Sentec’ssensors.No.n/a2 yearsDo not useContact Gelif it is expired,to avoidinfections orTemperature: 10 – 30 Cpotential allergicHumidity: 10% – 95%reactions.Reusing theGEL-SD maycause:- Contamination(non-resealable)Page 13 . The Sentec Digital Monitoring System (SDMS)
Note: Throughout this manual, the term ‘Sentec TC Sensor’refers to Sentec sensors providing transcutaneous blood gasmeasure ments (i.e. V-Sign Sensor 2 and O xiVenT Sensor).Note: The components listed above do not necessarilycorrespond to the scope of delivery. Please contact us for a listof available disposables and accessories:www.sentec.com/contact.
Transcutaneous PCO2 and PO2Principles of Operations of tcPCO2 and tcPO2Carbon dioxide (CO2) and Oxygen (O2) are gases that readilydiffuse through body and skin tissue and, therefore, can bemeasured by an adequate noninvasive sensor being appliedat the skin surface. If the skin tissue beneath the sensor site iswarmed up to a constant temperature local capillary blood flowincreases, metabolism stabilizes, gas diffusion improves and,hence, reproducibility and accuracy of CO2/O2 measurementsat the skin surface improves.CO2 tensions measured at the skin surface (PcCO2) are usuallyconsistently higher than arterial PCO2 values (PaCO2) inpatients of all ages. It is therefore possible to estimate PaCO2from the measured PcCO2 using an adequate algorithm.TcPCO2 designates an estimate of PaCO2 calculated fromthe measured PcCO2 with an algorithm developed by J.W.Severinghaus. The ‘Severinghaus Equation’ first correctsPcCO2 measured at the sensor temperature (T) to 37 C byusing an anaerobic temperature factor (A) and then subtractsan estimate of the local ‘Metabolic Offset’ (M).Note: Hence, the tcPCO2 values displayed by the SDM arecorrected/normalized to 37 C and provide an estimate ofPaCO2 at 37 C. On the SDM and throughout this manual(unless explicitly stated otherwise) ‘tcPCO2’ is displayed/labeled as ‘PCO2’.TcPO2 designates an estimate of PaO2 and corresponds tothe measured PcO2. In newborns, PO2 measured at the skinsurface (PcO2) correlates with arterial PO2 (PaO2) almost in aone-to-one relationship at a sensor temperature of 43 to 44 C.The accuracy of PcO2 compared to PaO2 is best up to a PaO2of 80 mmHg (10.67 kPa), above which it increasingly tends toread lower than PaO2. As target PaO2 levels in newborns areusually below 90 mmHg (12 kPa), a correction of PcO2 valuesmeasured at a sensor temperature of 43 to 44 C is normallynot necessary. In adults, local variations in skin physiologycan affect the correlation between PcO2 and PaO2, which canresult in lower readings even at a target PaO2 below 80 mmHg(10.67 kPa).The recommended (and default) ‘Sensor Temperature’ and‘Site Time’ for Sentec TC Sensors depends on the selectedpatient type and the enabled parameters, as summarized inthe following table:Patient TypeNeonatal(if youngerthan term birth 12 months)Adult/PediatricPO2enabledRecommended Sensor RecommendedTemperatureSite Time[ C][hrs]No41.08.0Yes43.02.0No42.08.0Yes44.02.0Note: On the SDM and throughout this manual (unlessexplicitly stated otherwise) ‘tcPO2’ is displayed/labeled as‘PO2’.Page 15 . The Sentec Digital Monitoring System (SDMS)
Good to know!Warming the skin tissue beneath the sensor to a constanttemperature improves accuracy as it a) increases capillaryblood flow/induces local arterialization, b) stabilizesmetabolism, and c) improves gas diffusion through skintissue. With increasing sensor temperature the applicationduration (‘Site Time’) must be evaluated carefully andadjusted accordingly to reduce the risk of burns. Specialattention must be given to patients with sensitive skin at thesensor site (p. 32).Please refer to Technical Manual for the SDM (HB-005752)and the references cited therein for additional information ontranscutaneous blood gas monitoring.Limitations of tcPCO2 and tcPO2The following clinical situations or factors may limit thecorrelation between transcutaneous and arterial blood gastensions: Hypo-perfused skin tissue beneath the sensor site dueto low cardiac index, circulatory centralization (shock),hypothermia (e.g. during surgery), use of vasoactive drugs,arterial occlusive diseases, mechanical pressure exercisedon measurement site, or inadequate (too low) sensortemperature. Arterio-venous shunts, e.g. ductus
2, and tcPO 2, as well as SpO 2, and PR monitoring are required for adult and pediatric patients. In neonatal patients, the use of OxiVenT Sensor is indicated for tcPCO 2 and tcPO 2 monitoring only. tcPO 2 monitoring is contraindicated for patients under gas anesthesia. n/a 12 mont
60601-1, IEC 60601-1-2, IEC 60601-2-23, ISO 80601-2-61. Contents SenTec Digital Monitoring System i Contents Contents i Figures ii Tables ii Abbreviations ii 1 INTRODUCTION 1 1.1 Related Documents 2 1.2 Safety Information 4 2 THE SENTEC DIGITAL MONITORIN
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