Philips IntelliVue TRx Instructions For Use Manual Download Page 239 | Manualshive

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Draft - 1 Aug 08

Regulatory Information

Safety Standards & Specifications

12-3

Safety
Standards

The device complies with the following safety requirements for medical
electrical equipment:

•

IEC 601-1:1988 + A1:1991 + A2:1995 General Requirements for Safety
(with worldwide deviations, including U.S. deviations)

•

IEC 60601-1-1:2000 System Safety

•

IEC 60601-1-2:2001 Electromagnetic Compliance

•

IEC 60601-1-4:1996 Safety for Programmable Electrical Medical Systems

•

ISO 10993-1:2003 Biocompatibility (for lead wires and pouch)

•

ISO 9919:2005 Pulse Oximeters

•

EN 865:1997 Particular Requirements for Pulse Oximeters

•

AAMI EC 13:2002 Performance Standard, Cardiac Monitors

Essential Performance

The IntelliVue Telemetry System provides Essential Performance (EP) under
normal operating conditions (includes EMC exposure) only as a complete
Medical Electrical System, consisting of the TRx4841A or TRx4851A
Transceivers, the IntelliVue Telemetry Network Infrastructure, the M3150
Information Center, the M2636C TeleMon Companion Monitor (optional), and
the M8105A/T MP5/5T, M8102A MP2, and M3002A X2 IntelliVue Patient
Monitors (optional).

The IntelliVue Telemetry System achieves its Essential Performance exclusively
through alarm generation at the M3150 Information Center.

The IntelliVue Telemetry System protects the patient from unacceptable
immediate clinical risk by generating specific Physiological Alarms when
appropriate. If the System cannot generate Physiological Alarms, then relevant
Severe or Hard Technical Alarms (Inoperative Conditions) are created.

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Summary of Contents for IntelliVue TRx

Page 1: ... part 15 of the FCC Rules Operation is subject to the following two conditions 1 these devices may not cause harmful interference and 2 these devices must accept any interference received including interference that may cause undesired operation Notice ITS4852A TRx4851A These devices comply with part 15 of the FCC Rules ETSI RSS 210 and other international radio standards that govern operation in ...

Page 2: ...and or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication Equipment specifications are subject to alteration without notice All changes will be in compliance with regulations governing manufacture of medical equipment OxiCliq and OxiMax are registered trademarks of Nellcor Incorporated Duracell ...

Page 3: ...te to change The document part number changes when extensive technical changes are incorporated First Edition September 2008 IntelliVue TRx4841A C 00 Transceivers are compatible with IntelliVue Telemetry System Revision A 00 and B 00 IntelliVue Information Center Software Revision F 00 and later M2636C TeleMon Companion Monitor Revision C 00 full functionality requires IIC Rev L 00 and monitor rev...

Page 4: ...althcare environment Additional resources for Philips products used in conjunction with the IntelliVue TRx and TRx Transceivers include IntelliVue Information Center Instructions for Use IntelliVue Information Center Online Help M2636C TeleMon Companion Monitor Instructions for Use IntelliVue Telemetry System Training Program IntelliVue MP5 Patient Monitor Instructions for Use IntelliVue MP2 Patie...

Page 5: ...on Warnings Warning Warning Warnings are information you must know to avoid injuring patients and personnel Cautions Caution Cautions are information you must know to avoid damaging your equipment and software Notes Note Notes contain additional information on use of the IntelliVue Telemetry System Procedures Procedures are indicated in the following table Step Action 1 2 3 ...

Page 6: ...Draft 1 Aug 08 About this Book vi ...

Page 7: ...k 1 8 Transceiver Use with Other Equipment 1 9 2 Product Safety 2 1 General Safety 2 2 Battery 2 5 ECG 2 6 For Paced Patients 2 8 ST AR Arrhythmia 2 8 For Paced Patients 2 10 ST AR ST Segment 2 11 ST AR QT Interval 2 11 SpO2 2 12 Cleaning 2 16 Accessories 2 17 3 Transceiver Controls 3 1 Transceiver Controls Front 3 2 Buttons 3 3 Power On Off 3 4 Indicators 3 4 Labels 3 5 Ports 3 6 Transceiver Cont...

Page 8: ...3 Battery Safety Information 4 13 Inserting Removing Batteries 4 14 Checking the Battery Power Level 4 17 5 Alarms 5 1 Alarm Indicators 5 2 Testing Alarm Indicators 5 2 Suspending Pausing Alarms 5 2 Unsuspending Resuming Alarms 5 4 Physiologic Alarms 5 4 Technical Alarms INOPs 5 10 6 ECG Monitoring 6 1 ECG Safety Information 6 2 For Paced Patients 6 3 Measuring ECG 6 4 ECG Configuration 6 4 ECG Le...

Page 9: ... Indications for Use 7 2 Safety Information 7 2 For Paced Patients 7 3 Intended Use 7 4 ST AR Arrhythmia Analysis 7 5 ST AR ST Segment Algorithm 7 7 Intended Use 7 7 The Measurement 7 8 Algorithm Processing 7 8 Displayed ST Data 7 9 EASI ST Analysis 7 9 ST Operation 7 9 ST Alarm Settings 7 12 ST AR QT Interval Algorithm 7 14 Intended Use 7 14 What is QT Interval Monitoring 7 15 QT Definitions 7 16...

Page 10: ...n Center 9 2 Telemetry Controls in the Patient Window 9 2 Locating the Transceiver Find Device 9 3 Viewing Device Location in the Patient Window optional 9 4 Viewing Device Location History optional 9 4 Using the Device Location Client optional 9 5 Patient Configurable Settings in Telemetry Setup 9 6 Unit Configurable Settings 9 9 RF Auto Shutoff 9 18 Transceiver Operation when Connected to TeleMo...

Page 11: ...ization 11 4 Cleaning the Transceiver 11 5 EO Sterilization 11 7 Troubleshooting 11 14 Basic Troubleshooting 11 14 Information Signals 11 15 12 Safety Standards Specifications 12 1 Regulatory Information 12 2 Intended Use 12 2 Indications for Use 12 2 Rx 12 2 Patient Population 12 2 Authorized EU Representative 12 2 Safety Standards 12 3 Essential Performance 12 3 System Classification 12 4 FCC Co...

Page 12: ...SpO2 Sensor Accuracy 12 20 A Accessories A 1 Accessory Safety A 1 Transceiver Accessories A 2 Pouches A 2 Protective Covers A 2 Monitor Interface Cable A 2 Short Range Radio Adapter A 3 ECG Accessories A 3 Electrodes A 3 Skin Prep Paper A 3 Leadsets A 4 Alignment Guides A 5 Detachable Shields A 5 SpO2 Accessories A 6 Reusable Sensors A 6 Disposable Sensors Single Use A 7 Adapter Cables A 9 Wristba...

Page 13: ...r introduces the IntelliVue TRx and TRx Transceivers the patient worn device of the IntelliVue Telemetry System with Smart Hopping Technology It includes the following sections The IntelliVue Transceiver 1 2 IntelliVue Telemetry System 1 4 IntelliVue Clinical Network 1 8 Transceiver Use with Other Equipment 1 9 ...

Page 14: ...tion Small lightweight ECG only device Audio feedback for out of range and lost device Battery gauge on device and at Information Center Powered by 2 AA batteries Alarm suspend and resume from standby at device and Information Center SpO2 Spot Check measurement without using any controls Easy for clinicians to use and comfortable for patients to wear Protective covers preventing debris from access...

Page 15: ...3 5 M2601B EASI 3 5 6 IntelliVue TRx M4841A IntelliVue TRx M4841A EASI FCCID XXXXXXXX EASI I E A S 2 344 55 66 1 back front IntelliVue TRx Transceiver ECG Only EASI 3 5 6 IntelliVueTRx M4841A EASI FCCID XXXXXXXX EASI I E A S 2 344 55 66 1 front IntelliVue TRx Transceiver ECG SpO2 back ...

Page 16: ...ed from the patient travel from the transceiver to an access point in the ceiling or wall and then to the Information Center Bi directional capability enables you to remotely control certain transceiver functions from the Information Center Physiological data is transported from the transceiver and a reverse data channel enables data to be transported to the transceiver Bi directional operations i...

Page 17: ... the RF spectrum used by each transceiver This technology allows a virtually unlimited number of transceivers to operate simultaneously within the IntelliVue Telemetry System by creating a frequency agile system that changes frequency without user involvement or awareness whenever interference occurs Bi directional Signal Flow in the IntelliVue Telemetry System ...

Page 18: ... degrading the signal the telemetry signal then hops over the interference to a location that provides optimal signal to noise performance In cases of excessive intermittent wireless interference such as machinery operation or construction activity you should identify patterns of interference This information may assist your service provider in helping you resolve a problem with interference Norma...

Page 19: ...ug 08 IntelliVue Telemetry System Introducing IntelliVue Telemetry 1 7 Excessive Interference Hop to New Frequency Time Slot 1395 1400 1427 1432 FREQUENCIES TIME SLOTS 1395 1400 1427 1432 FREQUENCIES TIME SLOTS ...

Page 20: ...M band with up to six RF channels using a similar Smart hopping technology as described on page 1 5 The system also scans the selected six RF channels to determine whether the spectrum is sufficiently clear If the system is too congested a system level alert is provided IntelliVue Clinical Network The IntelliVue Clinical Network ICN is the communication infrastructure necessary to tie together all...

Page 21: ...nter The transceiver s bi directional capability enables remote control from the Information Center for alarm setup and general monitoring functions In addition the system supports Telemetry Overview the pairing of a telemetry bed with an IntelliVue Patient Monitor for bedside ECG viewing of a single patient Telemetry Overview provides the telemetry monitored waveforms numerics and alarms in an in...

Page 22: ...e transceiver to MP5 MP5T MP2 or X2 Patient Monitors The connection is made through a monitor interface cable MP5 MP5T only or short range radio adapter SRRA inserted in the Monitor Service port and connected to the monitor Non networked MP5 MP5T monitors can source patient data that includes SpO2 NBP and predictive temperature measurements to the Information Center Please refer to the MP5 Instruc...

Page 23: ...apply to use of the IntelliVue Transceivers in a IntelliVue Clinical Network These warnings are repeated throughout the book in context where relevant The chapter includes the following sections General Safety 2 2 Battery 2 5 ECG 2 6 ST AR Arrhythmia 2 8 ST AR ST Segment 2 11 SpO2 2 12 Cleaning 2 16 Accessories 2 17 ...

Page 24: ...upersede established medical procedures Warning Warning Do not touch the patient or table or instruments during defibrillation The battery door must be closed during defibrillation These steps protect the clinician from high defibrillator voltage Warning Warning This device is not to be used in the vicinity of electrosurgical units because such use may interrupt or interfere with the transmission ...

Page 25: ...ing fluorescent lights and construction equipment See Electromagnetic Compatibility on page 12 5 Warning Warning The product should not be used next to or stacked with other equipment If you must stack the product you must check that normal operation is possible in the necessary configuration before the product is used on patients Warning Warning Do not use the transceiver for patient monitoring i...

Page 26: ...abled for IntelliVue monitors connected to the Information Center remote silencing for these beds may be enabled in other clinical units Warning Warning Place the transceiver in a pouch or over clothing or both during patient use The transceiver should not touch the patient s skin during use Warning Warning To avoid the risk of strangulation do not tie a pouch solely around the patient s neck Warn...

Page 27: ...y recommended Warning Warning Certain failure conditions such as short circuits can cause a battery to overheat during use High temperatures can cause burns to the patient and or user If the transceiver becomes hot to the touch place it aside until it cools Then remove the batteries and discard them Have the transceiver operation checked by your service provider to identify the cause of overheatin...

Page 28: ...nce Cleaning Troubleshooting Wash hands ECG Warning Warning Always confirm Information Center observations with clinical observation of the patient before administering interventions Warning Warning Non manufacturer supplied accessories and supplies can corrupt the performance of the equipment Use only AAMI EC 12 compliant electrodes with this device Use of electrodes that are non compliant may pr...

Page 29: ... the monitored lead and the label and prevent any possible confusion Warning Warning EASI derived 12 lead ECGs and their measurements are approximations to conventional 12 lead ECGs As the 12 lead ECG derived with EASI is not exactly identical to the 12 lead conventional ECG obtained from an electrocardiograph it should not be used for diagnostic interpretations EASI lead placement is supported fo...

Page 30: ...e the possibility of interference position electrodes electrode wires and the transceiver as far away from the pacemaker as possible Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the IntelliVue Telemetry System See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced ...

Page 31: ...arning takes place during ventricular rhythm the ectopics can be incorrectly learned as the normal QRS complex This can result in missed detection of subsequent events of V Tach and V Fib For this reason you should 1 Respond promptly to any technical alarm 2 Ensure that the arrhythmia algorithm is labeling beats correctly When using EASI ECG monitoring Relearn happens automatically when there is a...

Page 32: ...ng Warning For paced patients who exhibit only intrinsic rhythm the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them resulting in missed detection of cardiac arrest The risk of missing cardiac arrest can be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic demand pacemaker rate A low heart rate alarm...

Page 33: ...change information the clinical significance of the ST level change information should be determined by a physician ST AR QT Interval Warning Warning The device provides QT and QTc interval change information the clinical significance of the QT and QTc interval change information should be determined by a clinician ...

Page 34: ...evere burns To minimize this risk ensure that the cable is positioned so that no inductive loops are formed If the sensor does not appear to be operating properly remove it immediately from the patient Warning Warning Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive Warning Warning Disposable SpO2 sensors can be damaged and lead to patient harm if they becom...

Page 35: ...and attachment Check the application site at regular intervals and change the site if any compromise in skin quality should occur More frequent checking can be required due to an individual patient s condition Warning Warning Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin can lead to inaccurate over estimated measurements Warning Wa...

Page 36: ...sensor being attached to one location for too long To avoid skin irritations and ulcerations inspect the sensor application site every 2 3 hours and change the application site at least every 4 hours or according to clinical practice guidelines Venous Pulsation Do not apply sensor too tightly as this results in venous pulsation and can severely obstruct circulation and lead to inaccurate measureme...

Page 37: ...tus such as sudden pulse loss or hypoxia Warning Warning Removal of the SpO2 sensor during Continuous SpO2 monitoring results in a No Sensor technical alarm Silencing this technical alarm turns the SpO2 measurement off There is no technical alarm for a No Sensor condition in Spot Check mode Warning Warning This equipment is not suitable for use in the presence of a flammable anesthetic mixture or ...

Page 38: ...or country environmental regulations Do not vent sterilant indoors Vent aerator exhaust only to the outdoors See References on page 11 11 Warning Warning Comply with OSHA standards Do not vent sterilizer gas to the room but vent only outdoors or to a suitable evacuated container depending upon state provincial or country environmental regulations If the mixture is captured it can be separated comm...

Page 39: ...ic emissions or decreased immunity of the product Warning Warning Reuse Never reuse disposable sensors and other accessories that are intended for single use or single patient use only Packaging Do not use a sterilized accessory if the packaging is damaged Warning Warning Alignment guides may present a choking hazard Handle with appropriate care Warning Warning The SpO2 and Monitor Service port pr...

Page 40: ...Draft 1 Aug 08 Accessories 2 18 Product Safety ...

Page 41: ...ated on the front and back of the device The chapter includes the following sections Transceiver Controls Front 3 2 Buttons 3 3 Power On Off 3 4 Indicators 3 4 Labels 3 5 Ports 3 6 Transceiver Controls Back 3 7 Labels 3 8 Safety Symbols Other Marks 3 8 Audible Tones 3 10 Clinical Use 3 11 Adjustable Sounds 3 12 Service Sounds 3 13 Note For the purpose of the following diagrams the transceiver mode...

Page 42: ...ransceiver Controls Transceiver Controls Front IntelliVue TRx Transceiver Front View I 3 I 2 I 1 I 4 B1 B2 O1 L3 P1 P2 P3 L1 L2 The labeled items in the diagram include Buttons B1 B2 Power On Off O1 Indicators I1 I4 Labels L1 L3 Ports P1 P3 TRx4851A ...

Page 43: ...ns Alarm Suspend Pause on off not when connected to TeleMon or networked IntelliVue MP5 Patient Monitor See Suspending Pausing Alarms on page 5 2 B2 Check Button Initiates a Status Check of the transceiver See Status Check on page 4 12 Resumes monitoring after Standby See Standby Mode on page 4 4 Indicates association with the Information Center single beep See Audible Tones on page 3 10 When pres...

Page 44: ...ator Definition I 1 Lead Indicator Illuminates momentarily during leadset insertion to indicate attached leads Illuminates when Check button is pressed to indicate attached leads During a Leads Off condition illuminates to indicate the lead s that need to be reapplied Reference lead indicator only on indicates all leads are off Momentarily illuminates all lead indicator lights indicating the trans...

Page 45: ...nt of power remaining in the batteries Note Valid only for recommended battery type See Checking the Battery Power Level on page 4 17 Callout Indicator Definition EASI EASI 3 5 6 IntelliVueTRx M4841A L1 L2 L3 Callout Label Definition L1 Leadset Insertion Guide Assists in aligning the ECG cable for different leadsets See Connecting the ECG Cable on page 6 21 Note If your unit uses only one monitori...

Page 46: ...CG Leadset Port Connection for 3 5 or 6 wire leadset P2 SpO2 Sensor Port IntelliVue TRx only Connection for SpO2 sensor See Note P3 Monitor Service Port Connection for the Short Range Radio Adapter the cable to the TeleMon Companion Monitor and MP5 IntelliVue Patient Monitor or to the Service Tool See Note Note The SpO2 and Monitor Service ports can be covered with protective covers when not in us...

Page 47: ...r Controls 3 7 Transceiver Controls Back S8 S13 not shown inside battery compartment IntelliVue TRx Transceiver Back View EASI S3 S4 S5 S8 S7 S1 L1 The labeled items in the diagram include Labels L1 L2 Safety symbols and other marks S1 S14 L2 EASI S6 S2 ...

Page 48: ...trode Placement Diagram for Standard ECG See 5 Wire Placement Standard Mode on page 6 14 EASI EASI I E A S 1 2 3 4 5 6 S1 14 Callout Label Definition S1 FCC ID PQCXXXXX IC 3549B XXXX Federal Communications Commission FCC ID Canadian ID S2 CE Marking S3 Non Ionizing Radiation Interference to electronic equipment may occur in the vicinity of devices marked with this symbol S4 Disposal Dispose of in ...

Page 49: ...rican standards S8 Defibrillation Proof Patient connections are protected against defibrillation DEFIBRILLATION PROOF and are a TYPE CF APPLIED PART Labels on Inside of Battery Compartment S9 Catalog Number Use to identify the equipment during a call to the Philips Response Center S10 Serial Number Use to identify the equipment during a call to the Philips Response Center Callout Label Definition ...

Page 50: ...es seven different auditory information signals to inform you of measurement and transceiver conditions during normal use Most are generated automatically S11 MAC Address of device S12 Date of manufacture S13 Battery Polarity S14 Attention See Instructions for Use Callout Label Definition MAC ...

Page 51: ...th the Information Center e g when transceiver is brought back into range Sound 2 low pitch tone Indicates pulse detected during Spot Check SpO2 measurement Note The pulse tone can be muted from the Information Center See Patient Configurable Settings in Telemetry Setup on page 9 6 Sound 3 alternating pitch repeated tone Continuous tone to help you locate a missing transceiver Initiated by clickin...

Page 52: ... cases where the transceiver is not assigned to a sector at the Information Center but is assigned to a monitor via short range radio the transceiver is not in contact with the monitor Sound 5 beep beep every 5 seconds Indicates transceiver is out of range or not associated with a sector Sound stops when contact is re established with the Information Center or it can be silenced by pressing the Ch...

Page 53: ...sound Function How Used Sound 1 beep Spot Check Announces a successful SpO2 Spot Check measurement Sound 1 beep Check Button Confirms contact with the Information Center Sound 2 low pitch tone Pulse Detection Tone Indicates pulse during SpO2 Spot Check measurement Service Sound Description beep beep repeated every 3 seconds and all visual indicators flashing Unlabeled Device Equipment Label needs ...

Page 54: ...Draft 1 Aug 08 Audible Tones 3 14 Transceiver Controls ...

Page 55: ...ation This chapter describes the basic operation of the transceiver It includes the following sections Transceiver Safety Information 4 2 Turning the Transceiver On Off 4 2 Briefing the Patient 4 6 Testing Transceiver Functionality 4 11 Battery Information 4 13 ...

Page 56: ...ailing fluorescent lights and construction equipment See Electromagnetic Compatibility on page 12 5 Warning Warning Place the transceiver in a pouch or over clothing or both during patient use The transceiver should not touch the patient s skin during use Turning the Transceiver On Off Warning Warning Arrhythmia relearning is initiated whenever the transceiver is powered down for one minute or lon...

Page 57: ...ce either the device has failed the automatic Self Test in which case you should use a replacement device or the device cannot establish contact with the Information Center check that a sector has been assigned to the device and that the device is within the coverage area Turning Off Turn off the transceiver by removing the batteries A No Signal technical alarm will be in effect at the Information...

Page 58: ...attach leads to the patient insert the SpO2 sensor cable in the SpO2 sensor port and press the Check button to verify association with the Information Center Standby Mode Standby mode is used to temporarily suspend monitoring at the Information Center for example when a patient goes out of access point range or is discharged Standby does not power down the transceiver so if the standby period is p...

Page 59: ...tandby only will be displayed Step Action Step Action 1 If the standby period has not expired Press the Check button to re establish contact with the Information Center The single beep at the transceiver verifies that monitoring has resumed If you hear a double beep click Resume Monitoring at the Information Center If there s still no association contact the service provider If the standby period ...

Page 60: ...mpartment while the transceiver is in use If the Telemetry button has been configured to generate a Nurse Call recording at the Information Center or both instruct the patient to use the button when needed If desired you can turn off patient use of the button at the Information Center See Patient Configurable Settings in Telemetry Setup on page 9 6 ...

Page 61: ... clear front is an appropriate means for holding the transceiver See Appendix A Accessories for ordering information Securing the Pouch Step Action 1 Insert the transceiver into the pouch with lead wires and SpO2 sensor cable if used exiting from the top opening of the pouch Pinch the velcro enclosures together to close the pouch around the cables Important Do not coil the cables inside the pouch ...

Page 62: ...e pouch on the patient with the upper ties around the patient s head and arm and the lower ties around the patient s torso Warning Warning To avoid the risk of strangulation do not tie a pouch solely around the patient s neck Step Action Place Tie a under the arm Place Tie b around the neck Tie a and b together around the neck Tie c and d together around the torso c d b a ...

Page 63: ...Draft 1 Aug 08 Briefing the Patient Basic Operation 4 9 3 Check that the patient is comfortable wearing the pouch with transceiver Step Action ...

Page 64: ...e electrodes 2 Wipe the lead wires with care 3 If wet dry the outside of the transceiver with a non lint producing cloth 4 If wet wipe dry the inside of the battery compartment Dry the batteries 5 If wet disconnect the ECG leadset and shake out any water Dry the connector pin area with a cotton swab 6 If wet allow the SpO2 and Monitor Service ports to air dry Note The transceiver should not be use...

Page 65: ...t The leadset can be inserted after the self test A self test of the transceiver functions is automatically performed each time that the transceiver is turned on that is when batteries are inserted This test should be performed before ECG leads and or an SpO2 sensor is attached In Case of Failure If any portion of the self test fails the transceiver will attempt to report the failure to the monito...

Page 66: ... indicators EASI if in use 2 If one or more of the expected indicators do not light up check the following Power and position of batteries see Checking the Battery Power Level on page 4 17 Leadset insertion Make sure the leadset is correctly inserted in the transceiver and the colored line at the base of the cable is not visible see Connecting the ECG Cable on page 6 21 Lead positions and connecti...

Page 67: ...kaline batteries is strongly recommended Warning Warning Certain failure conditions such as short circuits can cause a battery to overheat during use High temperatures can cause burns to the patient and or user If the transceiver becomes hot to the touch place it aside until it cools Then remove the batteries and discard them Have the transceiver operation checked by your service provider to ident...

Page 68: ...ries Warning Warning Arrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer Be sure to check your patient s arrhythmia annotation for accuracy whenever relearn has occurred Caution Remove the batteries before storing a transceiver for an extended period of time The battery compartment is located at the bottom of the transceiver behind a swinging door I...

Page 69: ...ockwise into an open hinged position 2 Insert two AA 1 5V Alkaline batteries matching the polarity with the indications inside the compartment Note Both batteries are inserted with the polarity in the same direction 3 Close the battery compartment door 4 Listen for the start up sounds See Turning On on page 4 3 Watch for the indicators on the front of the transceiver to illuminate briefly 5 Connec...

Page 70: ... is not in use or is being stored Important DO NOT STORE BATTERIES BY LEAVING THEM IN THE INCORRECT POLARITY POSITION IN THE TRANSCEIVER Be careful not to short circuit the batteries Batteries can get hot when shorted Short circuits are caused when a piece of metal touches both the positive and negative terminals simultaneously More than a momentary short circuit will generally reduce the battery ...

Page 71: ... to closely monitor battery status for example after a change of shift To check the power level of the transceiver Step Action 1 If connected disconnect the transceiver from Telemon or MP5 1 Press the Check button to determine the level see Battery Levels following 2 If no indicators flash 1 Check that the batteries are inserted properly 2 Replace both batteries 3 If there are still no indicators ...

Page 72: ...r 25 to Battery Low level 15 minutes Normal operation 1 red indicator Battery Low level to Replace Battery level 15 minutes Normal operation see note no indicator Replace Battery level Check batteries for correct polarity none Transceiver shutdown RF shutoff Battery life times are based on use of Duracell MN 1500 batteries in a TRx transceiver Times for TRx are somewhat lower Life times when other...

Page 73: ...d under normal operating conditions battery life may be reduced by up to 25 See Cross Ref For battery life estimates see the table on page 12 8 You can optimize battery life by Removing the batteries when the transceiver is not in use Keep them paired for future use Disconnecting the SpO2 adapter cable if used When the SpO2 sensor is disconnected the SpO2 functionality is automatically powered dow...

Page 74: ...Draft 1 Aug 08 Battery Information 4 20 Basic Operation ...

Page 75: ...s Physiologic Patient Alarms and Technical Inoperative Condition Alarms It also describes how to pause suspend alarms temporarily It includes the following sections Alarm Indicators 5 2 Suspending Pausing Alarms 5 2 Physiologic Alarms 5 4 Technical Alarms INOPs 5 10 ...

Page 76: ...nformation Center These positive test results indicate that the Alarm Suspend icon on the transceiver is functioning correctly see Self Test on page 4 11 Suspending Pausing Alarms Warning Warning If the Alarms Suspend indicator on the transceiver remains illuminated after the button combination to unsuspend alarms is pressed a transceiver malfunction may have occurred Alarms resume automatically a...

Page 77: ...larm Suspend Pause Step Action 1 Press the Telemetry and Check buttons simultaneously to activate Alarm Suspend Pause While alarms are suspended The transceiver illuminates the Alarms Suspend icon The message Alarms Suspended or Alarms Paused is displayed in the Patient Sector at the Information Center Note For paired bedsides in Telemetry Overview the message is Tele Alarms Suspend 2 For instruct...

Page 78: ...e no physiologic alarm signals generated by the transceiver All physiologic alarms are generated at the IntelliVue Information Center and all alarm signals must be acknowledged at the Information Center Step Action 1 Press the Telemetry and Check buttons simultaneously until the indicator turns off The Alarm Suspend icon is turned off The message Alarms Suspended or Alarms Paused is removed from t...

Page 79: ...vidual measurement alarms on off and reviewing alarm messages are described in IntelliVue Information Center Instructions for Use There are two levels of arrhythmia analysis available at the Information Center Basic and Enhanced Enhanced analysis includes Basic alarms NBP alarms are listed in the TeleMon Instructions for Use and the Information Center Online Help In the following table Red alarms ...

Page 80: ...mit and Heart Rate greater than V Tach limit xxx ST AR Basic Enhanced Arrhythmia MULTI ST Lx Ly Yellow Two ST leads Lx and Ly exceed alarm limit elevation or depression for 60 seconds EASI mode or when selected ST AR ST NURSE CALL Yellow The Telemetry button on the transceiver has been pressed and the system is configured to alarm and the Telemetry button is on Also initiated if the installation i...

Page 81: ...Heart Rate yyy lower than the lower Heart Rate limit xxx ST AR Basic Enhanced Arrhythmia IRREGULAR HR Yellow Consistently irregular rhythm irregular R R intervals ST AR Enhanced Arrhythmia MISSED BEAT Yellow No beat detected for 1 75 x average R R interval for Heart Rate greater than 120 or no beat for 1 second with Heart Rate greater than 120 non paced patient only ST AR Enhanced Arrhythmia MULTI...

Page 82: ...terval paced patient only ST AR Basic Enhanced Arrhythmia PAIR PVCs Yellow Two consecutive PVCs between non PVCs ST AR Enhanced Arrhythmia PAUSE Yellow No QRS detected for x seconds Choices of 1 5 to 2 5 seconds ST AR Enhanced Arrhythmia PVCs xxx MIN Yellow PVCs within one minute exceed by the PVCs min limit xxx ST AR Basic Enhanced Arrhythmia QTc High Yellow QTc value has exceeded the QTc High li...

Page 83: ...o 2 ST AR Enhanced Arrhythmia SVT Yellow Run of SVPBs greater than or equal to SVT Run limit and with SVT Heart Rate greater than the SVT Heart Rate limit ST AR Enhanced Arrhythmia VENT BIGEMINY Yellow A dominant rhythm of N V N V where N supraventricular beat V ventricular beat ST AR Enhanced Arrhythmia VENT RHYTHM Yellow A dominant rhythm of adjacent Vs greater than Vent Rhythm limit and ventric...

Page 84: ...ditions reliably There are four levels of Technical Alarms Severe Monitoring and alarms disabled Audible tone at the Information Center Must be acknowledged by a clinician Hard Monitoring and alarms are disabled Audible tone at the Information Center If the hard INOP is latched the sound will be silenced but the message will remain on the display until resolution of the offending condition Soft Mo...

Page 85: ...er Hard Arrhythmia algorithm cannot reliably analyze the ECG data on any monitored leads Assess the lead selections initiate relearn and validate analyzed rhythm Check other INOPs for possible source of problem CANNOT ANALYZE QT Source Information Center Soft There have been two consecutive invalid 5 minute values See Limitations for QT Monitoring on page 7 23 CANNOT ANALYZE ST Source Information ...

Page 86: ...een networked and non networked monitoring this INOP will display Pressing the Silence button will dismiss the INOP CHECK ECG SOURCE Source Patient Monitor Yellow Technical Alarm The transceiver and the monitor both have valid ECG signals Unpair the transceiver and monitor or remove the leadset from the device that is no longer the ECG source CHECK PAIRING Source Telemetry Yellow Technical Alarm T...

Page 87: ...P5 MP2 or X2 Patient Monitor has failed Re attach ECG leads to patient Identify and remove the interference source Reduce the number of devices equipped with short range radio capability electrode LEAD OFF Source Telemetry Hard Single lead is off Note If primary lead is MCL lead will be identified as V C in INOP text Re attach ECG lead to patient INVALID LEADSET Source Telemetry Hard Wrong leadset...

Page 88: ...ays as All ARRH ALRMS OFF at the IIC Source Information Center Soft All basic ST AR ECG alarms have been turned off Turn arrhythmia alarms on NO ECG AT CENTRAL Source Patient Monitor Hard The ECG measured with the monitor is not being sent to the Information Center via the transceiver Check equipment connections and configuration settings NO ECG SOURCE Source Telemetry Hard The transceiver is pair...

Page 89: ...Contact Service OUT OF AREA Source Information Center Hard The transceiver is communicating with an access point designated as a boundary limit For more information only REPLACE BATTERY REPLACE BATTERY T Note This INOP may also be configured to display as a Red or Yellow Technical Alarm Source Telemetry Red or Yellow or Hard Technical Alarm Latched Dead battery No monitoring is occurring Replace b...

Page 90: ... not active check the sensor placement Reposition the sensor on patient or replace sensor SpO2T INTERFERENCE Source Telemetry Hard Level of ambient light or level of electrical interference are so high that the SpO2 sensor cannot measure SpO2 and pulse rate Reduce ambient light to sensor or electrical noise sources SpO2T LOW PERFUSION Source Telemetry Soft Accuracy may be reduced due to low perfus...

Page 91: ...place sensor SRR INTERFERENCE Source Patient Monitor Hard The short range radio connection has interference from another device Move transceiver away from other interference sources If INOP persists contact Service SRR INVALID CHAN Source Patient Monitor Hard The channel configuration of the short range radio is invalid Check channel and channel mask configuration Contact Service SRR MALFUNCTION S...

Page 92: ... interface cable Identify and remove interference sources such as bluetooth devices DECT phones microwaves etc Reduce the number of devices equipped with short range radio capability TELE INCOMPATIBLE Source Patient Monitor Hard Transceivers equipped with SRRA are not supported with this revision of the Information Center Check equipment configuration compatibility Contact Service TELEMETRY STANDB...

Page 93: ...s at outer range of the radio coverage area Telemetry pack is receiving a weak signal with high data loss from the AP Condition exists for multiple devices in a specific area Return patient to the coverage area If patient is in close proximity to AP replace telemetry pack Contact service The AP covering the specific area is suspect Contact Service TRANSMITTER MALF Source Telemetry Hard Transceiver...

Page 94: ...Draft 1 Aug 08 Technical Alarms INOPs 5 20 Alarms ...

Page 95: ...he specifics of ECG measurement It includes the following sections ECG Safety Information 6 2 Measuring ECG 6 4 Positioning ECG Electrodes 6 10 Connecting the ECG Cable 6 21 Verifying Electrode Connections 6 25 Monitoring during Leads Off 6 27 Optimizing ECG Measurement Performance 6 29 ...

Page 96: ...d label only to reflect the physical placement of electrodes This will ensure a match between the monitored lead and the label and prevent any possible confusion Warning Warning When switching from EASI to standard monitoring there is a loss of data for 30 seconds Warning Warning EASI derived 12 lead ECGs and their measurements are approximations to conventional 12 lead ECGs As the 12 lead ECG der...

Page 97: ...ize the possibility of interference position electrodes electrode wires and the transceiver as far away from the pacemaker as possible Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the IntelliVue Telemetry System See the IntelliVue Information Center Instructions for Use for additional information on monitoring pace...

Page 98: ...sceiver ECG Configuration The IntelliVue Transceiver supports 3 5 and 6 wire leadsets The 5 wire leadset can be used for either standard or EASI electrode configurations The transceiver leadset configuration choices are as follows Leadset Mode ALL default This configuration allows you to switch the leadset type and position during use The transceiver will automatically reconfigure itself according...

Page 99: ...he condition An INVALID LEADSET INOP is generated at the Information Center Note The labels and colors of the ECG electrodes differ according to the standards that apply for your hospital The electrode placement references and illustrations in this chapter use the AAMI labels and colors See the table below for additional label and color information Electrode Labels Electrode Colors AAMI EASI IEC A...

Page 100: ...t configuration ECG Leads Monitored Depending on the leadset connected to the transceiver a different set of viewable leads are available at the Information Center The transceiver can source up to four raw ECG waves If you are using these leads can be selected at the Information Center 3 wire I II III Sourced raw waves are received as Channel 1 I II or III Default is II 5 wire Standard mode I II I...

Page 101: ... Channel 1 Vector 1 A I Channel 2 Vector 2 A S Channel 3 Vector 3 E S Defaults are II V2 III V5 Note Arrhythmia monitoring is performed only on the primary and secondary leads selected at the Information Center although you can view and perform ST analysis on all 12 EASI derived leads If you are using these leads can be selected at the Information Center ...

Page 102: ...b V5 The two chest leads Va and Vb can be placed on the patient in any of the V lead positions V1 through V9 V3R V4R V5R Lead assignment is available at the Information Center When unassigned the chest leads use the defaults Note The lead label assigned to Vb cannot be selected for Va even though Vb does not appear to be used Note When display of the pleth wave is enabled at the Information Center...

Page 103: ...ombination of all three raw EASI leads ECG Lead Clinical Calculations in terms of electrodes 3 Wire 5 Wire Standard 6 Wire I I I LA RA II default II default II default LL RA III III default III default LL LA MCL V LA where V C aVR aVR RA LA LL 2 aVL aVL LA RA LL 2 aVF aVF LL LA RA 2 V default V RA LA LL 3 where V C Va Va RA LA LL 3 where Va V2 default position Vb Vb RA LA LL 3 where Vb V5 default ...

Page 104: ...and to provide protection against signal noise and other interference use only ECG electrodes and cables specified by Philips Correct lead placement is always important for accurate diagnosis Especially in the precordial leads which are close the heart QRS morphology can be greatly altered if an electrode is moved away from its correct location Each electrode is color coded Use the diagrams for 5 ...

Page 105: ...g no soap residue Note Philips does not recommend using ether or pure alcohol because they dry the skin and increase the resistance Dry thoroughly Use ECG skin preparation paper abrasive to remove dead skin cells and to improve the conductivity of the electrode site 2 Check electrodes for moist gel and attach to the clips If you are not using pre gelled electrodes apply electrode gel to the electr...

Page 106: ...e This can be done using the Angle of Lewis 1 Locate the second intercostal space by first palpating the Angle of Lewis the bony protuberance where the body of the sternum joins the manubrium This rise in the sternum is where the second rib is attached and the space just below this is the second intercostal space 2 Palpate and count down the chest until you locate the fourth intercostal space Angl...

Page 107: ...ing ECG Electrodes ECG Monitoring 6 13 3 Wire Placement Lead Placement RA directly below the clavicle and near the right shoulder LA directly below the clavicle and near the left shoulder LL on the left lower abdomen RA LA LL ...

Page 108: ...e and near the right shoulder LA directly below the clavicle and near the left shoulder LL on the left lower abdomen RL on the right lower abdomen V on the chest the position depends on your required lead selection The typical position is V1 although this may vary according based on your hospital s protocol V2 V3 V4 V5 V6 V1 RA LA RL LL ...

Page 109: ...fourth intercostal space at the left sternal border V3 midway between the V2 and V4 electrode positions V4 on the fifth intercostal space at the left midclavicular line V5 on the left anterior axillary line horizontal with the V4 electrode position V6 on the left midaxillary line horizontal with the V4 electrode position Lead Placement ...

Page 110: ...ostal space A LL on the left midaxillary line at the same level as the E electrode S LA on the upper sternum I RA on the right midaxillary line at the same level as the E electrode N Reference can be anywhere usually below the sixth rib on the right hip Note Make sure that the S and E electrodes line up vertically on the sternum and that the I E and A electrodes align horizontally E S A I ...

Page 111: ...or Vb the brown white lead is at the V5 position The lead placement for the Va and Vb lead labels must be appropriate If your unit uses other precordial leads for Va and Vb they may be assigned in Unit Settings as defaults for your whole unit or you may need to assign the new positions on a per patient basis in the Patient Window at the Information Center see Telemetry Controls in the Patient Wind...

Page 112: ...lower abdomen Va on the chest the position depends on your required lead selection see below The default position is V2 For other positions relabel the lead at the Information Center Vb on the chest the position depends on your required lead selection see below The default position is V5 For other positions relabel the lead at the Information Center Lead Placement ...

Page 113: ...r V2 on the fourth intercostal space at the left sternal border V3 midway between the V2 and V4 electrode positions V4 on the fifth intercostal space at the left midclavicular line V5 on the left anterior axillary line horizontal with the V4 electrode position V6 on the left anterior axillary line horizontal with the V4 electrode position ...

Page 114: ...ght line from V6 V8 on the left midscapular line straight line from V7 V9 on the left paraspinal line straight line from V8 V3R midway between the V1 and V4R electrode positions V4R on the fifth intercostal space at the right midclavicular line V5R on the right anterior axillary line straight line from V4R ...

Page 115: ...hen using 3 or 5 wire leadsets alignment guides should be used to prevent the build up of debris in open lead ports Step Action 1 Match the arrow on the ECG cable with the arrow on the Lead Insertion Guide according to the lead type you have chosen and insert the ECG cable into the transceiver Important Make sure that the cable is pushed completely into the transceiver otherwise the device may not...

Page 116: ...le 6 22 ECG Monitoring 2 3 wire Step Action Match the arrow on the cable with the left arrow labeled EASI 3 on the Leadset In sertion Guide Note Leadset is keyed for only one insertion position EASI 3 5 6 IntelliVue TRx M4841A colored line ...

Page 117: ... lip facing the leads Then press down firmly so that the guide is securely under the leadset and the colored line is not visible Step Action Match the arrow on the cable with the right arrow labeled 5 6 on the Leadset Insertion Guide EASI 3 5 6 IntelliVue TRx M4841A line colored line Match the arrow on the cable with the left arrow labeled EASI 3 on the Leadset In sertion Guide EASI 3 5 6 IntelliV...

Page 118: ...dset you are using and that the EASI indicator light is illuminated appropriately See Verifying Electrode Connections on page 6 25 When using 5 lead standard the EASI indicator does not illuminate When using EASI the EASI indicator illuminates momentarily 5 6 wire 6 For 6 lead select the lead label s at the Patient Window Step Action EASI 3 5 6 IntelliVue TRx M4841A Match the arrow on the cable wi...

Page 119: ...verify that the leads are available for the desired monitoring Pressing and holding the Check button enables you to view the leadset status During routine use of the transceiver for monitoring all lead indicators are off To verify electrode connections use the following procedure Step Action 1 Press and hold the Check button for 2 seconds ...

Page 120: ...e cable is attached Red White Black Green Solid Brown and Brown White indicators illuminate then all turn off If all leads are off the green indicator will be lit 3 Unexpected Response Any other response indicates a problem with the transceiver or lead set Check the leadset connection The colored line should not be visible otherwise the wrong leadset type may be detected If the INOP INVALID LEADSE...

Page 121: ... are supported for the transceiver when the primary and or secondary leads are in a Leads Off INOP condition Both of these states are entered into after 10 seconds of Leads Off in an attempt to maintain monitoring and arrhythmia analysis ECG Fallback ECG Fallback occurs when the primary lead is in Leads Off for 10 seconds and a secondary lead is available Multilead Analysis If there is a Leads Off...

Page 122: ...ns automatically if learning takes place during ventricular rhythm the ectopics can be incorrectly learned as the normal QRS complex This can result in missed detection of subsequent events of V Tach and V Fib For this reason you should 1 Respond promptly to any technical alarm 2 Ensure that the arrhythmia algorithm is labeling beats correctly Using EASI Leads to Troubleshoot If there is artifact ...

Page 123: ...cy telemetry technologies Reception problems are less frequent because Smart Hopping avoids interference and moves to a different access point if the signal strength is too low The level of radio frequency activity is always fluctuating in the environment If the level becomes high enough to significantly interfere with transceiver operation the system responds by moving to another cleaner area whe...

Page 124: ...adius of coverage of the receiving wireless network A patient location strategy is critical to a telemetry system If a life threatening event occurs the clinician must be able to locate the patient quickly The importance of this increases as the coverage area increases Frequency management is the responsibility of the hospital Philips Medical System has no control over the RF environment in the ho...

Page 125: ...tandby Mode See Standby Mode on page 4 4 3 If the patient is in the coverage area and is stationary try moving the transceiver about 15 cm 6 inches 4 Check for INOP and information signals at the Information Center 5 Check for interference activity in other sectors at the Information Center to see if the problem is occurring with other transceivers 6 If the problem is persistent call service Radio...

Page 126: ...iminated Try moving or removing other wireless devices transmitting in the Wireless Medical Telemetry Service WMTS USA only Such devices can be identified by the presence of an antenna and or the following symbol Important The IntelliVue Telemetry System emits radio frequencies that can affect the operation of other devices Contact the manufacturer of other equipment for possible susceptibility to...

Page 127: ...e engineering check grounding Muscle Artifact Tense uncomfortable patient Poor electrode placement Tremors Diaphoresis Make sure patient is comfortable Check that electrodes are applied on flat non muscular areas of the torso apply fresh electrodes if necessary using good skin preparation see Positioning ECG Electrodes on page 6 10 Irregular Baseline Poor electrical contact Respiratory interferenc...

Page 128: ...rodes using good skin preparation see Positioning ECG Electrodes on page 6 10 Check that patient cable is not pulling electrodes Move electrodes away from areas with greatest movement during respiration Poor Electrode Contact Loose electrodes Defective cables Leadset not firmly connected Change electrodes using good skin preparation see Positioning ECG Electrodes on page 6 10 Replace cables Proble...

Page 129: ... 7 ST AR Arrhythmia Monitoring This chapter describes the ST AR algorithms used for telemetry at the IntelliVue Information Center It includes the following sections ST AR Arrhythmia Algorithm 7 2 ST AR ST Segment Algorithm 7 7 ST AR QT Interval Algorithm 7 14 ...

Page 130: ... monitor the adequacy of treatment or to exclude causes of symptoms Safety Information Warning Warning During complete heart block or pacemaker failure to pace or capture tall P waves greater than 1 5 of the average R wave height can be erroneously counted by the arrhythmia algorithm resulting in missed detection of cardiac arrest Warning Warning Learning If you initiate learning during ventricula...

Page 131: ...any technical alarm 2 Ensure that the arrhythmia algorithm is labeling beats correctly When using EASI ECG monitoring Relearn happens automatically when there is a LEADS OFF technical alarm If learning takes place during ventricular rhythm the ectopics can be incorrectly learned as the normal QRS complex This can result in missed detection of subsequent events of V Tach and V Fib Be sure to check ...

Page 132: ...g is severely compromised due to the high energy level in the pacer pulse This can result in the arrhythmia algorithm s failure to detect pacemaker non capture or asystole Warning Warning It is possible that pacemaker pulses will not be detected when the ECG analog output of a defibrillator is plugged into a bedside monitor This can result in the arrhythmia algorithm s failure to detect pacemaker ...

Page 133: ...Arrhythmia algorithm is always on for all IntelliVue Telemetry patients and cannot be turned off ST AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the following table There are two detection levels Basic and Enhanced Enhanced includes the Basic alarms Basic Enhanced Arrhythmia Detection Basic Arrhythmia Detection Enhanced Arrhythmia Detection Asystole...

Page 134: ...rhythm If the analysis is inaccurate perform a relearn of the rhythm When monitoring is initiated when the Primary Wave is changed or if Relearn is selected a question mark is displayed next to HR and the annotation L appears on the annotated wave until the HR is calculated and the rhythm is learned Annotation Beat Classification Display Color A Artifact Blue I Inoperative Red L Learning Red M Mis...

Page 135: ...r each available telemetry ECG lead and produces events alarms simultaneously ST values update with every measurement period and enunciate depending upon the severity of the change events and alarms as they are detected The ST AR ST algorithm is approved for use only with non paced and atrially paced adult telemetry monitored patients With EASI monitoring ST analysis is performed on up to 12 leads...

Page 136: ...sis analyzes ECG signals to classify the heart beats Only beats classified as normal or Supraventricular atrially paced are used to calculate ST elevations and depressions The ST AR ST algorithm processing includes special ST filtering beat selection and statistical analysis calculation of ST segment elevations and depressions and lead reconstruction and wave generation When ST analysis is being p...

Page 137: ...Review and Event Review windows EASI ST Analysis The Information Center generated ST values presented in the patient sector and Patient Window for EASI derived leads is STindx ST Index STindx is a summation of three ST segment measurements using the leads that can indicate ST segment changes in the different locations of the heart anterior lead V2 lateral lead V5 inferior lead aVF ST Operation Tur...

Page 138: ...k The purpose of the J point is to correctly position the ST measurement point The ST measurement cursor positions the ST point a fixed distance from the J point Note The ST measurement points may need to be re adjusted if the patient s heart rate or ECG morphology changes significantly Perform the following steps at the Information Center to adjust the ST measurement points Step Action 1 Access t...

Page 139: ...saved beyond the 24 hour review window but you can update it to any beat within the last 24 hours Please refer to the IntelliVue Information Center Instructions for Use or Online Help for directions 3 Adjust the J point if necessary by placing the cursor over the J point button to access the adjustment arrows Then use the arrows to position the bar at the end of the QRS complex and the beginning o...

Page 140: ...n on Smart Limits back to unit default settings You adjust the ST alarm limits in the ST Alarms Window Each ST parameter has its own alarm limit The alarm is triggered when the ST value exceeds its alarm limit for more than 1 minute The alarm will be a yellow alarm When more than one ST parameter is in alarm only one alarm message displays For multilead alarms when using an EASI transceiver an ala...

Page 141: ...the specific limits that are pre set for your unit Smart Limits Click on this button to set high and low limits around your patient s current ST value The difference above and below the patient s ST value are pre set for your unit Note Smart Limits can be configured to automatically be activated when the patient is connected See the IntelliVue Information Center Instructions for Use for additional...

Page 142: ...without symptoms of arrhythmia QT measurement is intended to be used by qualified health professionals in hospital or clinical environments Composite QT single or multi lead derived measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements Warning Warning The device provides QT and QTc interval change information the clinical significance of th...

Page 143: ... the onset of the earliest deflection in the QRS complex to the end of the T wave For patients being monitored by an IntelliVue Telemetry System device the Information Center measures the QT values once every minute during startup during the learning phase and on lead mode change After that the Information Center updates the QT values every five minutes The QT interval has an inverse relationship ...

Page 144: ... the Q wave and the end of the Twave QTc QTc represents the heart rate corrected QT interval By default the Information Center uses the Bazett correction formula to correct the QT interval for heart rate Your system however may be set up to use the Fridericia correction formula dQTc The difference between the current QTc value and the QTc baseline value QT HR The heart rate used to calculate QTc ...

Page 145: ...the difference between the current value and the baseline value exceeds the set limit for two consecutive 5 minute dQTc values The dQTc alarm has a lower priority than the QTc High alarm Cannot Analyze QT When there are two consecutive invalid 5 minute values the Information Center generates a Cannot Analyze QT soft INOP and displays a question mark for the QT parameter value The Information Cente...

Page 146: ...f normal beats have been falsely labelled so that the algorithm does not have enough valid beats to make QT measurements No QT value is calculated if the QT HR is 150 bpm Adult or 180 bpm Pedi Neo Because of the different algorithm approaches a QT QTc measurement from a diagnostic 12 lead program may differ from the realtime measurement For QT interval monitoring to be effective basic or enhanced ...

Page 147: ...ys in the check box When the QT measurement is on a QT status message is displayed in the QT Setup window along with the current values for QT QTc dQTc and QT HR The lead labels indicating the leads used to calculate the baseline and current values also appear Note Turning QT analysis off does not clear the baseline value This allows you to turn QT analysis off during prolonged arrhythmias such as...

Page 148: ...II V and V1 through V6 are used For EASI placement directly acquired AI AS and ES leads are used Note This may include leads that are not being stored Primary if you want to use the primary lead for the QT measurement If the primary lead becomes unavailable or is changed the QT measurement continues with the new primary lead A single lead from the list to use that lead for QT measurement If the le...

Page 149: ...e to the first valid value after measuring QT for five minutes Setting a new baseline discards the previous baseline Notes Since the dQTc alarm is based on the difference between the baseline and the current value setting an inappropriate new baseline may prevent a dQTc alarm from being generated Turning QT analysis off does not clear the baseline value This allows you to turn QT analysis off duri...

Page 150: ... alarm on by placing a checkmark in the checkbox next to the QTc High or dQTc High field The Alarm is off when no checkmark displays in the checkbox Adjusting QT Alarm Limits Set the high alarm limits based on your assessment of the patient s clinical condition unit protocols physician orders or medication specified limits Normal Values for Adults Men QTc 420 milliseconds Women QTc 430 millisecond...

Page 151: ... as the QT Lead on the QT window The Information Center will use the lead or leads that have a T wave with sufficient amplitude and can be detected Alternatively select a single lead with a good T wave amplitude and no visible flutter activity and without a predominant U wave or P wave QRS Changes QRS changes such as widened QRS can affect QT monitoring If a long QTc is observed verify that is not...

Page 152: ...Draft 1 Aug 08 How the QT Analysis Algorithm Works 7 24 ST AR Arrhythmia Monitoring ...

Page 153: ... SpO2 measurement and its application It includes the following sections SpO2 Safety Information 8 2 Pulse Oximetry Measurement 8 5 Selecting a SpO2 Sensor 8 7 Applying the Sensor 8 11 Connecting the SpO2 Cable 8 15 Measuring SpO2 8 16 Understanding SpO2 Alarms 8 20 Optimizing SpO2 Measurement Performance 8 22 ...

Page 154: ...onitoring can increase the risk of changes in skin characteristics such as irritation reddening blistering or pressure necrosis particularly on patients with impaired perfusion and varying or immature skin morphology Specific attention must be given to sensor site inspection for changes in skin quality proper optical path alignment and attachment Check the application site at regular intervals and...

Page 155: ...rations greater than 25 or partial pressures greater than 27 5 kPa 206 27 mmHg Warning Warning Disposable SpO2 sensors can be damaged and lead to patient harm if they become wet Wet sensors must be replaced immediately SpO2 Information for the User The pulse oximeter is calibrated to indicate functional oxygen saturation fractional oxyhemoglobin and displayed results can range from 0 to 100 A 10 s...

Page 156: ...e in 1 increments The maximum delay between the physiological alarm condition and alarm signal generation at the central station is 10 seconds Pulse rate is also derived from the pulsatile SpO2 measurement and displayed results can range from 30 to 300 bpm There is no alarm function for pulse rate The pleth wave is auto scaled to maximum display size It decreases only when the signal quality becom...

Page 157: ...leMon the transceiver will provide Continuous SpO2 measurement after disconnection see Transceiver Operation when Connected to TeleMon on page 9 19 The SpO2 parameter measures the arterial oxygen saturation that is the percentage of oxygenated hemoglobin in relation to the total hemoglobin If for example a total of 97 of the hemoglobin molecules in the red blood cells of the arterial blood combine...

Page 158: ... initiated at the transceiver the pulse signal is detected and communicated to you via an auditory signal at the transceiver The indicator is a single low pitched tone for each pulse detected it ceases when a measurement is complete The tone is controlled by the Volume and Mute controls at the Information Center Since it is possible to have a strong pulse but fail an SpO2 measurement you should li...

Page 159: ...missions or decreased immunity of the product Warning Warning Reuse Never reuse disposable sensors accessories and so forth that are intended for single use or single patient use only Packaging Do not use a sterilized accessory if the packaging is damaged Warning Warning Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive Warning Warning When the specified Nell...

Page 160: ...Philips and Nellcor disposable sensors If you are using Nellcor sensors see the Directions for Use supplied with these sensors Caution Do not use OxiCliq disposable sensors in a high humidity environment or in the presence of fluids These can contaminate sensor and electrical connections and thereby cause unreliable or intermittent measurements ...

Page 161: ...d to another site every 2 3 hours or in accordance with your clinical practice guidelines See the Directions for Use supplied by Nellcor Incorporated for instructions on preparation and application of reusable sensors Disposable Use disposable sensors only once and then discard However you can relocate them to a different patient site if the first location does not give the desired results Do not ...

Page 162: ...a 50 kg patient is the M1191A applied to the finger or toe Alternatively you could use M1194A applied to the ear For a complete listing of available sensors see SpO2 Accessories on page A 6 Selecting an SpO2 Sensor Preferred sensor types Alternative sensor types Disposable sensor M1192A M1191B M1194A Philips M1901B N 25 N M1903B D 20 P M1904B D 25 A 110 88 66 44 33 Pedi Adult Patient Weight kg 50 ...

Page 163: ...ia and tissue malnutrition Skin irritations or ulcerations can occur as a result of the sensor being attached to one location for too long To avoid skin irritations and ulcerations inspect the sensor application site every 2 3 hours and change the application site at least every 4 hours or according to clinical practice guidelines Venous Pulsation Do not apply sensor too tightly as this results in...

Page 164: ... site of your patient to obtain measurements Select an appropriate sensor and apply the sensor properly to avoid incorrect measurements Applying a small amount of pressure at the application site can improve the measurement Use one of the preferred application sites for your sensor Selecting the most suitable sensor and application site will help you to ensure that The light emitter and the photo ...

Page 165: ...otrude from the end of the sensor The fingertip must be uppermost and the cable must lie on the back of the hand This ensures that the light source cover the base of the fingertip giving the best measurement results The cable can be held in place by the accompanying wristband Step Action 1 Select the site and appropriate sensor see Selecting a SpO2 Sensor on page 8 7 2 Apply the sensor to the appr...

Page 166: ...ing mechanism helps to minimize artifact generated by patient motion Do not position the probe on cartilage or where it presses against the head The clip sensor can be used as an alternative if the adult finger sensor does not provide satisfactory results The preferred application site is the ear lobe although other application sites with higher perfusion such as the nostril can be used Due to the...

Page 167: ...s to avoid electrical interference Step Action 1 Connect the sensor cable to IntelliVue TRx Connect reusable sensors directly into the transceiver Connect disposable sensors into the adapter cable then connect the adapter cable to the transceiver Remove the protective backing 2 Adjust SpO2 alarms in the Patient Window see Telemetry Controls in the Patient Window on page 9 2 3 Make other adjustment...

Page 168: ... pulse loss or hypoxia SpO2 measurements can be made manually on an as needed basis in Spot Check mode or continuously in Continuous mode depending on the transceiver configuration While operating in Continuous mode you can also measure pulse and display the pleth wave at the Information Center The SpO2 parameter is turned on by inserting removing the sensor cable into the transceiver or by contro...

Page 169: ...ck that The SpO2 sensor light turns on A low pitch tone detecting each pulse is audible unless sounds are muted 3 After approximately 30 seconds if the measurement was successful you ll hear a single beep from the transceiver The value with the measurement time will be displayed at the Information Center The sensor light will extinguish If the measurement was unsuccessful you ll hear a double beep...

Page 170: ...de via telemetry Displaying Pleth Wave The transceiver can be configured to transmit the Pleth wave for display at the Information Center See Patient Configurable Settings in Telemetry Setup on page 9 6 Step Action 1 Insert the SpO2 cable into the IntelliVue TRx and check that the sensor light turns on 2 Attach the sensor to the patient 3 After approximately 15 seconds the value with the measureme...

Page 171: ...the transceiver thereby conserving battery life It is important to disconnect the sensor from the transceiver in order to conserve battery life Unplugging the sensor from an adapter cable that is connected to the transceiver does NOT provide SpO2 power down mode SpO2 should also be turned off at the Information Center If the transceiver is configured for Continuous SpO2 measurement and the sensor ...

Page 172: ...ontinuous SpO2 mode When a patient is discharged and the transceiver is in Continuous mode the SpO2 parameter is disabled To reactivate the SpO2 parameter Auto ON feature from the transceiver remember to do one of the following when a patient is discharged remove the SpO2 cable from the transceiver wait 15 seconds then reinsert the cable or if using TeleMon reset the transceiver to Manual mode Not...

Page 173: ...exists beyond the alarm limit for more than a maximum of 16 seconds Setting the high SpO2 alarm limit to 100 is equivalent to switching off the high alarm Therefore the upper alarm limit for oxygen saturation must be carefully selected in accordance with accepted clinical practices The default setting for SpO2 yellow alarms is latched That is when an SpO2 limit is exceeded you will need to acknowl...

Page 174: ...curate measurements cannot be made shock hypothermia use of vasoconstrictive drugs anemia Wavelength Absorption The measurement also depends on the absorption of particular light wavelengths by the oxyhemoglobin and reduced hemoglobin If other substances are present which absorb the same wavelengths they will cause a falsely high or falsely low SpO2 value to be measured For example carboxyhemoglob...

Page 175: ...m it for up to two years Harsh treatment will drastically reduce the lifetime of the sensor Moreover Philips Medical Systems warranty agreement shall not apply to defects arising from improper use To get the best results from your SpO2 reusable sensor Always handle the sensor and cable with care The soft finger sleeve houses a sensitive electronic device that can be damaged by harsh treatment Alwa...

Page 176: ...Draft 1 Aug 08 Optimizing SpO2 Measurement Performance 8 24 SpO2 Monitoring ...

Page 177: ...ansceiver operation when connected to TeleMon It includes the sections listed below For additional information consult the IntelliVue Information Center Instructions for Use and TeleMon Instructions for Use Telemetry Functions at the Information Center 9 2 Telemetry Controls in the Patient Window 9 2 Locating the Transceiver Find Device 9 3 Patient Configurable Settings in Telemetry Setup 9 6 Unit...

Page 178: ... adjusting the limit After adjusting the limit move the cursor away from the area to dismiss the limit controls To Change ECG Waveform Size Move the cursor over the ECG waveform to display the ECG Waveform Size control Select the desired size from the list To Select Lead Move the cursor over the ECG waveform to display the Lead Selection control Select the desired lead from the list Important Do n...

Page 179: ...tandby Mode on page 4 4 Locating the Transceiver Find Device The Find Device feature enables you to generate an alternating pitch repeated tone at the transceiver to assist in locating a missing device This function is initiated in the Telemetry Setup Window Find Device requires that the transceiver has good working batteries and is within the coverage area The device will not return from out of r...

Page 180: ... is updated within 5 seconds of the location change Viewing Device Location History optional You can view the location history for a particular transceiver in the Device Location History field in the Telemetry Setup window The field displays the five most recent Device Location descriptions in ascending order and updates every time there is a change in location for the device The total timespan of...

Page 181: ...empting to locate a patient Displaying and Locating Devices The left side of the Client display screen contains a list of clinical units associated with the current Floor Plan Each unit contains a list of bed labels You view the beds listed within a unit by clicking on the plus sign next to the unit name Note The beds listed are only those equipped with IntelliVue telemetry devices To identify and...

Page 182: ...le Settings in Telemetry Setup Control Function Setting Choices Factory Default Telemetry Button Determine the Information Center response when Telemetry Button is pressed Nurse Call generate nurse call alarm Record generate a recording strip Nurse Call and Record generate nurse call alarm and recording strip None Nurse Call Telemetry Device Volume Set the volume level for all adjustable sounds on...

Page 183: ...ovides manual measurements so the clinician can check as needed Measurement initiated by plugging the SpO2 cable into the transceiver or by selecting the Spot Check SpO2 icon in the Patient Window No pulse or successful failed measurement tones are generated when measurement is initiated at Information Center Continuous Sends an SpO2 parameter value to the Information Center every second If select...

Page 184: ...e a delay of up to 60 seconds in indicating critical patient status such as sudden pulse loss or hypoxia enable disable enable Pleth Wave Enable disable the transmission of the Pleth wave and its subsequent display to the Information Center For Continuous SpO2 mode only Note When enabled the Pleth wave replaces the Vb wave in the Patient Window during 6 lead monitoring enable disable disable Pleth...

Page 185: ... through All Controls Unit Settings Telemetry Setup The setting for telemetry non arrhythmia yellow alarms is located in All Controls Unit Settings Alarms Unit Settings For all other information on unit settings see IntelliVue Information Center Instructions for Use SpO2 Alarm Turn SpO2 alarms on off at the Information Center enable on disable off enable Unit Settings Change current settings back ...

Page 186: ...all Telemetry Device Volume Set the volume level for all adjustable sounds on the transceiver 1 low to 5 high 3 Telemetry Device Mute Enable disable all adjustable sounds on the transceiver enable unchecked sound disable checked mute mute Standby Duration Sets the standby duration on the device Infinite 10 minutes 20 minutes 30 minutes 1 hour 2 hours 3 hours 4 hours Infinite Enable Remote Suspend ...

Page 187: ...ttery gauge is displayed RF Auto Shutoff Enable disable RF operation during an extended situation of all leads off for more than 10 minutes and the SpO2 sensor is not connected enable disable enable Fixed Pacer Amplitude Sets the appearance of the pacer spikes to a fixed size as they appear in the patient window enable disable disable Autopair Enable disable the autopairing of the transceiver and ...

Page 188: ...ician can check as needed Measurement initiated by plugging the SpO2 cable into the transceiver or by selecting Spot Check SpO2 icon in the Patient Window No pulse or successful failed measurement tones are generated when measurement is initiated at Information Center Continuous Sends an SpO2 parameter value to the Information Center every second If selected Pulse Rate and Pleth Wave may also be s...

Page 189: ...lay of up to 60 seconds in indicating critical patient status such as sudden pulse loss or hypoxia enable disable enable Pleth Wave Enable disable the transmission of the Pleth wave and its subsequent display to the Information Center For Continuous mode only enable disable Note When enabled during 6 lead monitoring the Pleth wave will replace the Vb wave in the Patient Window disable Pleth wave i...

Page 190: ...diatric SpO2 Limits Low Increment decrement SpO2 low alarm limit by 1 in Limit maximum is 99 Limit minimum is 50 adult or 30 pediatric High and low limit must be at least 1 apart 90 adult pediatric Unit Settings Telemetry Setup Control Function Settings Factory Default Unit Settings Default Leads Control Function Settings Factory Default Leadset Allowed Set the unit default leadset type All EASI N...

Page 191: ...e unit default lead I II III AVR AVL AVF V1 V2 V3 V4 V5 V6 III 5 wire EASI ECG4 Set the unit default lead I II III AVR AVL AVF V1 V2 V3 V4 V5 V6 V5 6 wire ECG1 Set the unit default lead I II III MCL AVR AVL AVF V1 V2 V3 V4 V5 V6 V7 V8 V9 V3R V4R V5R II 6 wire ECG2 Set the unit default lead I II III MCL AVR AVL AVF V1 V2 V3 V4 V5 V6 V7 V8 V9 V3R V4R V5R V2 V lead choice is determined by Va and Vb s...

Page 192: ...gs Default Leads Control Function Settings Factory Default Unit Settings NBP Setup Control Function Settings Factory Default Patient Type Set patient type used for NBP alarm limits Adult Pediatric Adult NBP Alarm Set NBP alarm notification Systolic or Diastolic Systolic Diastolic Mean Off Systolic or Diastolic Systolic High Increment decrement NBP high alarm limit by 1 Limit Maximum is 260 Limit M...

Page 193: ... Limit Minimum is 45 Ped 90 Adult 70 Pediatric Diastolic Low Increment decrement NBP high alarm limit by 1 Limit Maximum is 85 Limit Minimum is 28 Adult Limit Maximum is 40 Limit Minimum is 28 Ped 50 Adult 40 Pediatric Mean High Increment decrement NBP high alarm limit by 1 Limit Maximum is 260 Limit Minimum is 65 Adult Limit Maximum is 260 Limit Minimum is 55 Ped 110 Adult 90 Pediatric Mean Low I...

Page 194: ...nsmitter Off INOP will be displayed at the Information Center Remove the batteries to conserve battery charge However if there is no ECG signal for 10 minutes but the SpO2 cable is inserted the transceiver does not stop broadcasting the signal This feature can be disabled in Unit Settings Unit Settings Alarms Control Function Settings Factory Default Non arrhythmia Yellow Alarms Set latched non la...

Page 195: ...rom TeleMon not from the transceiver or the Information Center The alarm suspend indicator on the transceiver will accurately reflect the current state of alarm pause Note If the transceiver is connected to TeleMon silencing an active alarm at TeleMon silences the alarm at TeleMon only It has no effect on the alarms at the Information Center ECG Operation Vb the second V lead in 6 wire lead set is...

Page 196: ...ation Center Visual and auditory indicators for the No Sensor Alarm are not active at Telemon Battery The transceiver battery status is not available When the Check button is pressed the battery gauge on the transceiver and at the Information Center indicates full power regardless of actual battery strength Defibrillation In the event of patient defibrillation it may take several seconds for the E...

Page 197: ...erences in device behavior based on network connection status Devices can be connected and or paired via the methods below The transceiver is paired with the monitor at the Information Center networked devices only The transceiver is directly connected to the monitor using an interface cable IntelliVue MP5 MP5T Patient Monitor only The transceiver is directly connected to a non networked monitor u...

Page 198: ... Networked 10 8 Alarm Behavior Networked with Cable or Short Range Radio Connection 10 12 Paired Device Synchronized Alarm Settings Networked 10 14 Pairing Non networked Devices 10 16 Alarm Behavior Non networked 10 19 More Bed Alarms 10 21 Warning Warning Pairing of TRx4841 51A IntelliVue Telemetry Transceivers with IntelliVue Patient Monitors operating via a short range radio connection is only ...

Page 199: ... automatically displays as a permanent overview session in the Telemetry Data Window on the IntelliVue Patient Monitor At the Information Center the telemetry data and any patient monitor data e g NBP are integrated in the patient sector See your IntelliVue Information Center Instructions for Use or IntelliVue Patient Monitor Instructions for Use for information on how to pair unpair devices Funct...

Page 200: ...or perform the following steps Warning Warning When the transceiver is directly connected to the monitor arrhythmia relearning is initiated and again when the transceiver is disconnected from the monitor During relearn a short dropout period may occur Be sure to check your patient s arrhythmia annotation for accuracy whenever relearn has occurred Controls on the transceiver e g nurse call will be ...

Page 201: ...abels with an IntelliVue Patient Monitor by either directly connecting the devices with an interface cable as described on page 10 3 by pairing the devices through the Setup Telemetry menu on the IntelliVue Patient Monitor or if equipped to do so via short range radio capability For information on the Setup Telementry menu see your IntelliVue Patient Monitor Instructions for Use When the transceiv...

Page 202: ...ep Action 1 Remove the protective cover from the transceiver s monitor service port 2 Position the rubber cover over the top of the SRRA Attach the connected strap around the transceiver above the Leadset Insertion Guide 3 Insert the SRRA connector in the monitor service port ...

Page 203: ...tains the equipment label of the transceiver Check that this is the correct label If a monitor is already paired to another device you cannot assign a transceiver to that monitor If the transceiver goes out of range or loses the short range radio connection it will switch over to standard telemetry transmission to the Information Center In this case the telemetry data is displayed in the Telemetry...

Page 204: ...Instructions for Use and the IntelliVue Information Center Instructions for Use Note This table assumes the two devices are paired without a cable connection or short range radio connection When paired with a cable connection or short range radio connection controls work in the same manner as a single bedside monitor Warning Warning For MP5 monitors all data presented in the telemetry data window ...

Page 205: ...ences bedside alarms Silences telemetry alarms if Enable Global Silence for Paired Beds is on at the Information Center Bedside from Telemetry Data Window Silences bedside and telemetry alarms Silence Overview Alarms at Bedside must be enabled at the Information Center Silences bedside and telemetry alarms Silence Overview Alarms at Bedside must be enabled at the Information Center Information Cen...

Page 206: ...ter Suspends Pauses bedside and telemetry alarms Suspends Pauses bedside and telemetry alarms Alarms Suspend Alarms Paused INOP displayed All Arrh Alrms OFF displayed Note Suspends bedside alarms for the minimum of the transceiver configuration and the bedside configuration Standby Bedside Bedside put into standby state Monitor Standby INOP displayed Information Center Bedside and telemetry put in...

Page 207: ...er clinical units Alarm INOPs at the Information Center The alarms and INOPs that are displayed recorded and stored at the Information Center depend on the type of alarm Type of Alarm INOP Effect at Information Center All ECG alarms and INOPs based on ECG source Displayed recorded if configured and stored Note INOPs are only displayed Bedside and telemetry non ECG alarms and non ECG INOPs Displaye...

Page 208: ...r with a direct cable or short range radio connection Warning Warning As long as the ECG is being measured with the transceiver there will be no ECG signal available at the ECG analog output or ECG Sync Pulse output Where Initiated Effect at Bedside Effect at Information Center Silence Bedside Silences bedside and telemetry alarms Silences bedside and telemetry alarms Information Center Silences b...

Page 209: ... and telemetry put into standby Monitor Standby and Arrhythmia Off INOPs displayed Standby location displayed Information Center Bedside and telemetry put into standby Monitor Standby and Arrhythmia Off INOPs displayed Standby location displayed Resume Monitoring Bedside Bedside and telemetry resumes monitoring Bedside and telemetry resumes monitoring Information Center Bedside and telemetry resum...

Page 210: ...CG Primary Lead Secondary Lead Va Lead Vb Lead Arrhythmia Analysis Mode Asystole Threshold Pause Threshold VTach HR VTach Run PVCs min Vent Rhythm SVT HR SVT Run PVCs min On Off Pacer not Capture On Off Pacer not Pace On Off Non sustain On Off Vent Rhythm On Off Run PVCs On Off Pair PVCs On Off Missed Beat On Off Pause On Off R on T On Off Vent Bigeminy On Off Vent Trigeminy On Off Multiform PVCs ...

Page 211: ...nd MP5 Patient Monitors are paired directly via an interface cable your ECG source must be connected before connecting or disconnecting the interface cable to maintain synchronized alarm settings The interface cable must be disconnected prior to unpairing devices at the Information Center or the monitor ...

Page 212: ...T s configuration disconnecting the monitor interface cable from the transceiver may discharge the MP5 MP5T This discharge does not affect the Information Center For more information see the IntelliVue Patient Monitor Instructions for Use Note When SpO2 is measured at the bedside monitor only the SpO2 numeric is transmitted to the Information Center however the pleth wave is only visible at the be...

Page 213: ...range radio capability the transceiver can be paired with the bedside monitor at the monitor Monitors which have this capability have a short range radio symbol on the model label If your transceiver is not already equipped with the SRRA follow the instructions and figures below to install the adapter Step Action 1 Remove the protective cover from the transceiver s monitor service port 2 Insert th...

Page 214: ... Step Action 1 Remove the protective cover from the transceiver s monitor service port 2 Position the rubber cover over the top of the SRRA Attach the connected strap around the transceiver above the Leadset Insertion Guide 3 Insert the SRRA connector in the monitor service port ...

Page 215: ...tle of the menu contains the equipment label of the transceiver Check that this is the correct label If the transceiver goes out of range or loses the short range radio connection monitoring at the Information Center remains however monitoring at the patient monitor is no longer possible ECG Leads Off and Tele Disconnected INOPs are displayed If the devices are unassigned the short range radio con...

Page 216: ... bedside and telemetry alarms Suspends Pauses telemetry alarms All Arrhythmia alarms are off Information Center No effect Suspend Pause not available at the Information Center No effect Suspend Pause not available at the Information Center Standby Bedside Bedside put into standby state Measurements from bedside disappear Telemetry monitoring continues Information Center N A Standby not available a...

Page 217: ... in the group of alarms that is transmitted to the Information Center by the transceiver The INOP will display using the corresponding severity color of the actual alarm For example should the bedside monitor generate a DESAT alarm it will display at the Information Center as a red More Bed Alarms INOP Warning Warning DESAT and Pressure HIGH alarms from the bedside monitor will appear as red More ...

Page 218: ... disconnection is not intentional Identify and remove the interference sources Reduce the number of devices equipped with short range radio capability No Signal INOP displayed at the Information Center The short range radio is not installed correctly There is interference from telemetry or ISM radio sources The transceiver is outside the coverage area Note The typical coverage area between the mon...

Page 219: ...side monitor and the transceiver are not communicating with each other Monitoring at the Information Center only Repeat the device assignment procedure Central Tele Only INOP When the transceiver is wirelessly paired with an X2 patient monitor no label docked with a larger networked MP series monitor and the network connection is lost Restore the monitor s network connection Check Pairing INOP An ...

Page 220: ...short range radio capability there are numerous causes of radio interference e g microwave ovens bluetooth devices DECT phones coverage area limitations that may disrupt monitoring momentarily or for extended periods For more information on reducing interference see Optimizing ECG Measurement Performance on page 6 29 ...

Page 221: ...scribed in detail in the service documentation accompanying the system This chapter provides procedures for maintaining the equipment after installation including assigning labels for replacement transceivers keeping the transceiver clean and troubleshooting common problems It includes the following sections Maintenance 11 2 Cleaning and Sterilization 11 4 Troubleshooting 11 14 ...

Page 222: ...pment failure and possible health hazards Testing Alarms Visual and auditory alarms appear at the Information Center One method of verifying visual and auditory alarms at the Information Center is to connect the transceiver to an ECG or ECG SpO2 simulator By varying the ECG rate and SpO2 value alarms can be generated and confirmed for proper operation Label Assignment for Replacement Transceiver D...

Page 223: ...vice before clearing the sector 2 Select All Controls then Label Assignment 3 Enter password Note The remaining screens will be in English only 4 Insert batteries into the replacement device and remove the leadset if present All transceiver indicators should flash and you should hear a double tone repeated every 3 seconds indicating that the transceiver has no Equipment Label 5 Select Refresh 6 Se...

Page 224: ...taminate cleaned equipment Important After exposure the transceiver must be cleaned or cleaned and EO sterilized as per the instructions contained herein 8 Select Assign Label to initiate programming of the Equipment Label into the replacement telemetry device AND within 10 seconds press the Check button on the telemetry device Note If 10 seconds pass without a button push then repeat starting wit...

Page 225: ...w Caution When cleaning the Monitor Service port do not use any stiff rigid instruments tools or other devices to clean debris in the port as such actions will damage the connector pins A forceful water stream may be used after soaking for 5 minutes to flush the port if necessary Approved Cleaners Cleaner Active Ingredient Isopropyl Alcohol based Isopropyl Alcohol 70 Ethyl Alchohol based Ethyl Alc...

Page 226: ...es Phenylphenol 0 28 Benzyl p chlorophenol 0 03 TechSpray General Purpose Cleaner Isopropyl Alcohol 70 Surgical Spirit Isopropyl Alcohol Ethyl Alcohol mixed for alcohol 70 Virahol Hospital Surface Disinfectant Towelette Isopropyl Alcohol 70 Cleaner Active Ingredient Active Ingredient Example Quaternary Ammonium based Virex Tb SaniCloth HB Purell Sanitizing Wipes Clorox Disinfecting Wipes Phenol ba...

Page 227: ...dure is performed Note If there is concern over cross contamination due to leadsets or sensors new leadsets or sensors should be used Caution The Short Range Radio Adapter cannot be sterilized Remove the adapter before sterilizing the transceiver Step Action 1 Remove the batteries and any cables or accessories 2 Wipe the transceiver clean by using a cloth dampened modestly with one of the approved...

Page 228: ...or exhaust only to the outdoors See References on page 11 11 Use the following equipment and material to process the transceiver 1 Ethylene Oxide gas Allied Signal Oxyfume 2002 or equivalent 2 Gas sterilizer manufactured by American Sterilizer Company or other appropriate manufacturer EO Sterilization The following generic procedure can be used to supplement the sterilizer manufacturer s instructi...

Page 229: ...tents to 54 4 2 8oC 130 5oF 6 Apply 26 inHg 1 12 77 psig 49 vacuum to the sterilizer chamber 7 Humidify the chamber at 50 10 relative humidity for 20 to 30 minutes 8 Taking a minimum of five minutes slowly introduce EO sterilant until the sterilizer unit pressure gauge reaches 11 1 psig Note At this pressure the concentration of sterilant in the chamber will be 600 50 mg liter regardless of the ch...

Page 230: ...eferences on page 11 11 a Pump the gas mixture out of the chamber until you ob tain a vacuum of 26 inHg 1 12 77 psig 49 re turning the mixture to a suitable evacuated container b Return the sterilizer chamber to ambient pressure by in troducing air that has been bacterially filtered 11 Air wash the chamber and material as follows a Apply 26 inHg 1 12 77 psig 49 vacuum to the chamber and processed ...

Page 231: ...3 7 in conjunction with AAMI Technical Information Report 19 that the FDA currently endorses References OSHA Standard for acceptable levels of personnel exposure to Ethylene Oxide Gas 1 ppm on an eight hour time weighted average basis Reference U S A Federal Regulations 49 FR 25734 29 CFR Part 1910 1047 June 22 1984 final approval 50 FR 9800 2 CFR Part 1910 1047 March 12 1985 Step Action 1 To diss...

Page 232: ...edside You can use this procedure with a Patient Simulator Note This test assumes that the telemetry system and Information Center are fully installed and that you have performed the procedure to learn the transceiver identity code Test the transceiver by performing the following steps If the test indications do not appear refer to your service provider Step Action 1 Perform a mechanical inspectio...

Page 233: ...2 sensor to yourself At TeleMon set the SpO2 sample rate to Continuous Result An ECG trace and SpO2 information should be visible on the Information Center display All transceiv er lights should be off c Disconnect the Right Arm lead for standard ECG or the I electrode for EASI Result The RA LED or the I lead LED should turn on and a Leads Off INOP should appear on the display at the Information C...

Page 234: ...will be unaffected by the reconfiguration For problems with see ECG measurement Optimizing ECG Measurement Performance on page 6 29 Using EASI Leads to Troubleshoot on page 6 28 Technical Alarms INOPs on page 5 10 SpO2 measurement Optimizing SpO2 Measurement Performance on page 8 22 Technical Alarms INOPs on page 5 10 Batteries Battery Information on page 4 13 Self Test on page 4 11 Nurse call Nur...

Page 235: ...a common Database Server The condition causing the failure will be described in the Wireless Status Log which is available in Service Mode Information Signals Information Signal Description What to Do Wireless monitoring loss Contact Service Note This information signal appears on ALL Information Centers connected to a common Database Server Problem with wireless network infrastructure device s Co...

Page 236: ...Draft 1 Aug 08 Troubleshooting 11 16 Maintenance Cleaning Troubleshooting ...

Page 237: ...standards that the product complies with along with product and measurement specifications It includes the following sections Regulatory Information 12 2 Electromagnetic Compatibility 12 5 Battery Specifications 12 8 Radio Specifications 12 9 Physical Specifications 12 13 Environmental Specifications 12 15 Measurement Specifications 12 16 ...

Page 238: ...g of multiple physiological parameters of adult and pediatric patients in transport and hospital environments Rx Federal Law restricts this device to sale by or on the order of a physician Patient Population This device is not for use with infant or neonatal patients Use of the transceiver is restricted to one patient at a time The components accessories which come into contact with the patient s ...

Page 239: ...formance The IntelliVue Telemetry System provides Essential Performance EP under normal operating conditions includes EMC exposure only as a complete Medical Electrical System consisting of the TRx4841A or TRx4851A Transceivers the IntelliVue Telemetry Network Infrastructure the M3150 Information Center the M2636C TeleMon Companion Monitor optional and the M8105A T MP5 5T M8102A MP2 and M3002A X2 ...

Page 240: ...subject to the condition that this device does not cause harmful interference Pursuant to Part 15 21 of the FCC Rules any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment Characteristic Definition Internally Powered Equipment The TRx4841Aand TRx4851A transcei...

Page 241: ...ve electromagnetic interference This product has been evaluated for electromagnetic compatibility EMC with the appropriate accessories according to IEC 60601 1 2 2001 the international standard for EMC for medical electrical equipment This IEC standard has been adopted in the European Union as the European Norm EN 60601 1 2 2001 Radio frequency RF interference from nearby transmitting devices can ...

Page 242: ...nd and 5 above and below i e the exclusion band according to IEC 60601 1 2 the short range radio connection is immune up to 3V m in the frequency range from 80MHz to 2 0 GHz and up to 1V m in the frequency range from 2 0 to 2 3 GHz Depending on the strength and duration of the interference the interruption may occur for an extended period Any interruption of the signal due to interference moving o...

Page 243: ...ing Is the interference due to misplaced or poorly applied electrodes or sensors If so re apply electrodes and sensors correctly according to directions in Chapter 6 ECG Monitoring Is the interference intermittent or constant Does the interference occur only in certain locations Does the interference occur only when in close proximity to certain medical electrical equipment Once the source is loca...

Page 244: ...eries Battery life for other brands may differ Equipment Specification Battery Type 2 fresh AA disposable alkaline batteries Operating Mode Battery Life ECG Only 50 hours ECG SpO2 Continuous 18 hours ECG SpO2 Spot Check between 18 hours and 50 hours depending on usage rate ECG Only w SRRA 38 hours ECG SpO2 Continuous w SRRA 14 hours ECG SpO2 Spot Check w SRRA between 14 and 38 hours depending on u...

Page 245: ...Continuous 116 mA 2 4V Parameter Specification Frequency Ranges Bands 1395 1400 MHz and 1427 1432 MHz Channel Spacing 1 6 MHz RF Output Power 8 dBm 2 3 dB 3 2 mW to 10 mW into antenna load nominal battery voltage Transceiver Frequency Accuracy during normal operation 15 KHz relative to channel frequency includes temperature compensation and aging effects Modulation Type FSK with Root Raised Cosine...

Page 246: ...on Frequency Range ISM Band 2400 2483 5 MHz Channel Spacing 1 728 MHz RF Output Power FCC 17 dBm 1 dB 40 mW to 63 mW nominal 50 mW into antenna load nominal battery voltage ETSI 12 dBm 1 dB 13 mW to 20 mW nominal 16 mW into antenna load nominal battery voltage ARIB 13 5 dBm 1 dB 18 mW to 28 mW nominal 22 mW into antenna load nominal battery voltage Transceiver Frequency Accuracy during normal oper...

Page 247: ... Standards Specifications 12 11 Modulation Type GFSK Gaussian Frequency Shift keying 1M40Q7D Modulation Bandwidth Typically 1 4 MHz 20 dB Bandwidth Out of Band Spurious Emission Levels Meets ETSI RS210 FCC ARIB standards Parameter Specification ...

Page 248: ...Controlled via the bedside monitor selects clear channel at time of install RF Output Power 0 dBm 0 3dB 0 5 mW to 1 mW into Antenna load Transceiver Frequency Accuracy during normal operation 40ppm includes temperature compensation aging effects Modulation Type Direct Sequence Spread Spectrum DSSS O QPSK with half sine pulse shaping modulation 1M40Q7D Modulation Bandwidth 500KHz typically 950KHz 6...

Page 249: ...SpO2 Transceiver Parameter Specification Height 140 mm 5 6 in Width 75 mm 3 in Depth 28 5 mm 1 14 in Weight without batteries or leadset with batteries only with batteries and 3 wire leadset 165 g 5 8 oz 210 g 7 4 oz 284 g 10 oz Volume 215 cm3 Parameter Specification Height 140 mm 5 6 in Width 88 mm 3 52 in Depth 37 mm 1 48 in ...

Page 250: ...tions SRRA Weight without batteries or leadset with batteries only with batteries and 5 wire leadset 205 g 7 2 oz 255 g 9 0 oz 324 g 11 5 oz Volume 300 cm3 Parameter Specification Parameter Specification Height 88 mm 3 5 in Width 25 mm 1 in Depth 13 mm 5 in Weight 25g 1 oz ...

Page 251: ... Specifications Parameter Specification Temperature Operating Storage 0 t 37 oC 32 to 99o F 40o C to 60o C 40 to 140o F without batteries Humidity Operating Storage 95 RH at 37o C 99o F non condensing 90 RH at 60o C 140o F without batteries Altitude Operating Non operating 0 to 3 048 m 10 000 ft ...

Page 252: ...electrodes Channel 1 I II or III Channel 1 II Channel 2 III Channel 3 MCL Channel 1 Va i Channel 2 Va s Channel 3 Ve s Channel 1 II Channel 2 III Channel 3 Va Channel 4 Vb Resolution 5 μV ECG Input Differential defibrillator protected against 360 joules discharge into a 100 ohm load Input Impedance 5 megohms 10 Hz Input Dynamic Range 9 mV DC Offset Range 320 mV CMRR 90 dB 50 60 Hz Bandwidth 3 dB 0...

Page 253: ... yet centered monitoring bandwidth Pacer Rejection Performance Pace pulses with no tails Positive pacers1 Amplitude Width 2 to 700 mV 0 1 0 2 0 5 and 1 0 ms 2 to 500 mV 1 5 ms 2 to 400 mV 2 ms Negative pacers1 Amplitude Width 2 to 700 mV 0 1 0 2 0 5 and 1 0 ms 2 to 500 mV 1 5 ms 2 to 400 mV 2 ms 1 Philips does not claim verify or validate support for all available pacemakers EMC Performance Limits...

Page 254: ... measured on the same limb with a corresponding INOP message after a max of 30 s indicating that the displayed values are not current values The effect of SpO2 pulse oximetry on data averaging is internally controllable by the transmitter with no user controls SpO2 Pulse Numerics Update Rate Transmitted once per second Pleth Wave Sampling Rate 125 sps Technical Alarms INOPs Triggered if the sensor...

Page 255: ...nge can be especially useful to clinicians e g clinicians performing photodynamic therapy Pulse Rate Measurement available only with Continuous SpO2 Range 30 to 300 bpm Accuracy 2 Resolution 1 bpm Display of SpO2 numerics SpO2 values are displayed as xxx SpO2T to meet ISO EN standard EN 865 Maximum Optical Output Power 15 mW Parameter Specification ...

Page 256: ...Philips Reusable Sensors Adult Finger M1191A 2 0 Adult Finger M1191AL 2 0 Adult Finger M1191ANL 2 0 Adult Finger M1191T 3 0 Adult Finger M1196A 3 0 Adult Finger M1196T 3 0 Pediatric Finger M1192A 2 0 Pediatric Finger M1192T 3 0 Pediatric Finger M1192AN 2 0 Adult Pediatric Ear M1194A 3 0 Adult Pediatric Ear M1194AN 3 0 Requires M1943A or M1943AL adapter cable ...

Page 257: ... Standards Specifications 12 21 Type Description Model Number Accuracy Arms 70 100 Range Philips Disposable Sensors Adult Finger M1901B 2 0 Adult Finger M1902B 2 0 Pediatric Finger M1903B 2 0 Adult Finger M1904B 2 0 Adult Pediatric Finger M1131A 3 0 ...

Page 258: ...OxiCliq P Pediatric N A 3 0 OxiMax MAX A Adult 30 kg 66 lb N A 3 0 OxiMax MAX AL Adult 30 kg 66 lb N A 3 0 OxiMax MAX N Adult 40 kg 88 lb N A 3 0 OxiMax MAX P Pediatric 10 50 kg 22 110 lb N A 3 0 Oxisensor II D 20 Pediatric 10 50 kg 22 110 lb N A 3 0 Oxisensor II D 25 Adult 30 kg 66 lb N A 3 0 Oxisensor II N 25 Adult 40 kg 88 lb N A 3 0 Type Description Model Number Accuracy Arms 70 100 Range ...

Page 259: ...or contact your local Philips representative Accessory Safety Warning Warning Use only Philips approved accessories Use of product accessories ECG leadsets SpO2 sensors etc other than those specified in this manual may lead to patient injury result in increased electromagnetic emissions or decreased immunity of the product Warning Warning Reuse Never reuse disposable sensors accessories and so for...

Page 260: ...try Pouch case of 200 Order Number Description 989803140431 Protective Cover for Monitor Service port ECG only Transceiver package of 10 989803140451 Protective Cover for Monitor Service port ECG SpO2Transceiver package of 10 989803140441 Protective Cover for SpO2 port ECG SpO2 Transceiver package of 10 Order Number Description 989803143481 Transceiver tether cable 989803143491 Telemon tether cabl...

Page 261: ...0331 Short Range Radio Adapter Strap 1 package of 10 Order Number Description M2202A Radio Translucent Foam Electrodes 60 packages of 5 300 per box 40489E Paper Tape Electrodes 10 packages of 30 300 per box 40493D Foam Electrodes 60 packages of 5 300 per box 40493E Foam Electrodes 10 packages of 30 300 per box Order Number Description 989803134771 Skin Preparation Sheets 10 preps sheet package of ...

Page 262: ... 5 wire Color Leadset Grabber 79 cm 30 989803152151 AAMI 6 wire Color Leadset Snap 79 cm 30 989803152131 AAMI 6 wire Color Leadset Grabber 79 cm 30 989803152001 IEC 3 wire Leadset Snap 79 cm 30 989803151981 IEC 3 wire Leadset Grabber 79 cm 30 989803152081 IEC 5 wire Color Leadset Snap 79 cm 30 989803152061 IEC 5 wire Color Leadset Grabber 79 cm 30 989803152161 IEC 6 wire Color Leadset Snap 79 cm 9...

Page 263: ... Alignment Guide package of 10 989803140411 Single ECG Alignment Guide tethered package of 10 989803140421 Double ECG Alignment Guide package of 10 Order Number Description 989803153031 3 wire Leadset Detachable Shield package of 10 989803153041 5 wire Leadset Detachable Shield package of 10 989803153051 6 wire Leadset Detachable Shield package of 10 ...

Page 264: ...r Sensor 0 45 m 1 5 feet M1194A Philips Adult Pediatric Ear Sensor 1 5 m 4 9 feet M1196A Philips Adult Finger Clip Sensor 8 pin 3 m 9 8 feet M1196T Philips Adult Finger Clip Sensor 9 pin 0 90 m 2 9 feet N A from Phillips Nellcor Dura Y D YS Adult and Pediatric N A from Phillips Nellcor DS 100A Adult and Pediatric N A from Phillips Nellcor Oxiband OXI A N Adult and Pediatric N A from Phillips Nellc...

Page 265: ...dult 40kg 88 lb N A from Philips Nellcor Adhesive OxiCliq P Pediatric N A from Phillips Nellcor Adhesive OxiCliq I Infant 3 20 kg N A from Philips Nellcor OxiMax MAX A Adult 30 kg 66 lb M1904B equivalent N A from Philips Nellcor OxiMax MAX AL Adult 30 kg 66 lb N A from Philips Nellcor OxiMax MAX N Adult 40 kg 88 kg M1901B equivalent N A from Philips Nellcor OxiMax MAX P Pediatric 10 50 kg 22 110 l...

Page 266: ... Accessories A 8 Accessories 989803148231 Masimo LNCS ADTx Adult 989803148241 Masimo LNCS PDTx Pediatric N A from Philips Masimo LNCS Neo 3 Adult Uses Philips M1943A or Nellcor OC 3 Adapter Cable Order Number Description ...

Page 267: ... not available from Philips in Canada or Japan In those countries contact Nellcor Incorporated directly Wristband Order Number Description M1943A Adapter cable for Nellcor SpO2 sensor 2 m 6 6 ft M1943AL Adapter cable for Nellcor SpO2 sensor 3 m 9 8 ft Order Number Description M1627A Wristband package of 10 ...

Page 268: ...Draft 1 Aug 08 SpO2 Accessories A 10 Accessories ...

Page 269: ...regional office listed below for the location of your nearest sales office On the web www medical philips com Via email medical philips com By fax 31 40 27 64 887 By postal service Philips Medical Systems Global Information Center P O Box 1168 5602 BD Eindhoven The Netherlands Asia Tel 852 2821 5888 Europe Middle East Africa Tel 31 40 27 63005 Latin America Tel 55 11 2125 0764 North America Tel 1 ...

Page 270: ...Draft 1 Aug 08 B 2 Sales and Support Offices ...

Page 271: ...it settings 9 9 controls buttons 3 3 indicators 3 4 labels back 3 8 labels front 3 5 on off 4 2 other marks 3 8 ports 3 6 D device location 9 4 dropouts ECG 6 30 E ECG measuring 6 4 optimizing performance 6 29 electrodes placement 6 10 skin prep 6 11 electromagnetic interference 12 5 essential performance 12 3 F fallback 6 27 find device 9 3 G group settings 11 14 group settings 11 14 I Informatio...

Page 272: ... symbols 3 8 transceiver 4 2 self test alarm indicators 5 2 service log 11 15 shower transceiver use in 4 10 12 4 signal strength 6 31 skin prep 6 11 smart hopping 1 5 sounds see audible tones 3 10 specifications environmental 12 15 measurement 12 16 physical 12 13 SpO2 audible tones 3 12 8 17 8 18 auto on off 8 20 Continuous 8 18 measurement 8 5 mode selection 9 7 9 12 NBP inop suppression 9 8 9 ...

Page 273: ...p 9 6 TeleMon NBP measurement with 1 9 SpO2 measurement modes 8 19 9 20 transceiver use with 1 9 9 19 testing alarm indicators 5 2 alarms 5 2 status check 4 12 transceiver controls 3 2 models 1 2 troubleshooting 6 32 11 14 TRx ECG only see transceiver models 1 2 TRx ECG SpO2 see transceiver models 1 2 U unit settings 9 9 V volume 9 6 ...

Page 274: ...Draft 1 Aug 08 Index 4 ...

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