Spacelabs Ultraview 91341 Operation Manual Download

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Exhibit H:

User

Manual

FCC ID: CM676A91341-600

Summary of Contents for Ultraview 91341

Page 1: ...Exhibit H User Manual 2 FCC ID CM676A91341 600...

Page 2: ...Ultraview Digital Telemetry 91341 91343 91347 Operations Manual 071 0774 00 Rev A...

Page 3: ...616 52 37 11 Spacelabs Medical B V Airport Boulevard Office Park Bessenveldstraat 25A 1831 Diegem BELGIUM Telephone 32 2 7164026 Fax 32 2 7164114 Spacelabs Medical Products Ltd 151 Superior Boulevard...

Page 4: ...nada To call for service or to contact your assigned customer service representative Technical Support Monitoring Anesthesia 800 522 7025 U S A or 425 882 3700 or call your local office For technical...

Page 5: ...4 Monitoring Paced ECG Patients 2 5 Restoring Default Settings 2 6 Changing the Display Resolution 2 6 Selecting Options for Lead Display 2 7 ECG Alarm Message Summary 2 9 SpO2 91343 only Overview 3 1...

Page 6: ...Ultraview Care Network ii 071 0774 00 Rev A Alarms Alarm Message Summary 5 1 ECG Alarm Messages 5 2 SpO2 Alarm Messages 5 3 NIBP Alarm Messages 5 4 Telemetry Alarm Messages 5 5 Symbols...

Page 7: ...EVIEW 2nd LEAD xx 1st LEAD xx ON OFF ECG ART UA SPO2 Enable alternate rate source s ARR ON OFF UA ON OFF ART ON OFF SPO2 ON OFF TM SETUP RESTORE SETTINGS AUTO LEAD SWITCH ASSIGN TM BED PT RECORD YES N...

Page 8: ...ed with the 91343 digital telemetry multi parameter transmitter and the 90217 Ambulatory Blood Pressure ABP monitor monitoring of electrocardiographic signals is augmented by the availability of conti...

Page 9: ...rected or the device must immediately cease operation on the occupied frequency Further the operator of the biomedical telemetry device must accept whatever level of intereference is received from oth...

Page 10: ...ver only two leads may be displayed simultaneously The 91343 is also capable of transmitting numerical NIBP and SpO2 data This data is displayed simultaneously with that of the ECG waveform data Each...

Page 11: ...u in reconfiguring your equipment frequencies to reduce the risk of interference Spacelabs Medical cannot and does not guarantee interference free telemetry operation CAUTION This device has a limited...

Page 12: ...varies depending on jurisdiction The recommended disposal procedure for alkaline batteries is to transport them to a hazardous waste landfill Since these batteries may not be classified as hazardous w...

Page 13: ...try systems may be more susceptible to interference than hardwired systems which may impact signal quality Operation of hand held wireless telephone equipment e g cordless telephones cellular telephon...

Page 14: ...to ECG ECG MENU ALARM LIMITS SIZE SETUP LEAD SELECT CHANNEL FORMAT SUSPEND PROCESSING UCW bedside or central remote module 91341 91347 SDLC NOTE The UCW bedside connects to the remote module housing a...

Page 15: ...mitter Tuning telemetry receiver modules to transmitter channels at the central monitor must be done by a qualified service person Your central monitor can be configured to remember beds that are assi...

Page 16: ...plays PURGES DATA ARE YOU SURE Touch YES to discharge the patient and erase all patient data The intermittent signal loss alarm is then canceled Touch NO to cancel the discharge operation and cause th...

Page 17: ...ide or central is configured to do so The factory default setting for low battery alarm is ON Controlling Patient Initiated Recordings If the Patient Record function is activated PT RECORD is YES in t...

Page 18: ...ctrode 392015 001 SpO2 Accessories Nellcor SpO2 adapter cable 700 0014 00 Nellcor SpO2 sensors Adult Neonatal N 25 690 0006 00 Pediatric P 20 690 0007 00 Adult disposable D 25 690 0001 00 Finger clip...

Page 19: ...A 1 13 ABP Report Management System Adaptor Cable 012 0097 02 90121 ABP Report Management System Operations Manual 070 0529 xx 90217 ABP Monitor Operations Manual 070 0137 xx Ultraview Care Network O...

Page 20: ......

Page 21: ...g ECG monitoring begins when the telemetry receiver module detects a signal sent by a telemetry transmitter The telemetry transmitter sends a signal as soon as its battery is installed ECG telemetry r...

Page 22: ...ient monitor by the RF link WARNING Operating television receivers or other CRT displays near the transmitter within 2 to 3 feet or operation of some pacemaker programmers may suppress the ECG wavefor...

Page 23: ...he required input impedance and DC offset voltage affecting monitor performance Do not use stainless steel electrodes Do not allow conductive parts of electrodes and connectors including the reference...

Page 24: ...once per detected beat ECG lead designator Display resolution monitor or extended Paced operation indication pacemaker detection is enabled Abnormals per minute alarm limit ST segment level for first...

Page 25: ...mode with Arrhythmia detection enabled Only appears in adult mode with the ST segment analysis option Monitoring Paced ECG Patients When monitoring pacemaker patients use the paced feature to automati...

Page 26: ...rate alarms Keep pacemaker patients under close surveillance The system may insert pacemaker flags into the ECG signal in response to signals that are not pacemaker pulses Therefore if you use a Spac...

Page 27: ...X I II III AVR AVL AVF X X X I X X X II X X X III X X X II Combinations of leads not included above produce invalid lead vectors In general for at least one valid vector either RL or C and two limb l...

Page 28: ...des work correctly with or without the right leg electrode attached However for optimum performance the right leg electrode should always be used Connected Electrodes X 91341 Valid Lead Vectors C LA L...

Page 29: ...ad ECG Check that the transmitter is more than 3 feet from any television receiver or CRT display COUPLET ALARM Displayed for 10 seconds whenever a couplet is detected and the ABN IN ROW alarm limit i...

Page 30: ...tion of the alarm NEW DOMINANT Displayed for 1 minute when a switch to a different dominant ECG morphology occurs NOISY SIGNAL Displayed in ECG channel 1 when the ECG software suspends processing on e...

Page 31: ...arly warning device If a trend towards patient deoxygenation is indicated blood samples should be analyzed by a laboratory co oximeter With the Module Configuration Manager feature you can define your...

Page 32: ...1 and 2 as explained in Setting SpO2 Data Averaging Period and Sampling Interval on page 3 6 CAUTION Use only patient sensors specified by Spacelabs Medical Using sensors other than those specified ma...

Page 33: ...specific application procedures and the following general points will aid oximetry monitoring success Choose a site that provides proper alignment of the LEDs and receiving photodetector Reduce light...

Page 34: ...page 1 1 Refer to the Module Configuration Manager chapter of the UCN Operations Manual for SpO2 parameter tables that list available user settings and factory defaults for this parameter ALM DELAY K...

Page 35: ...will read MSG ALM DELAY xx where xx is the value in seconds of the delay To set the message delay time 1 Touch MSG ALM DELAY xx or MSG ALM DELAY OFF 2 Touch the up and down arrow keys until the value...

Page 36: ...ife of the battery Refer to the Ultraview Digital Telemetry Products data sheet Setting both DIP switches 1 and 2 to ON disables SpO2 data transmission To enable SpO2 remove the battery set the select...

Page 37: ...s Enabling the IABP feature permits the transmitter to reject irregular pulses providing a more accurate SpO2 measurement CAUTION No SpO2 monitoring occurs between episodic sampling intervals Clinical...

Page 38: ...2 UNAVAILABLE Displayed when the LED and or photodiode have failed Replace the sensor and or SpO2 adapter cable SpO2 AMBIENT LIGHT INTF Displayed when The sensor is receiving external light interferen...

Page 39: ...er electrically noisy devices Move the noisy device or move the sensor to another site SpO2 SENSOR OFF PATIENT Displayed when The transmitter is unable to detect a valid sensor input signal Check the...

Page 40: ...um Move sensor to a site which has better perfusion Align LED with sensor photodetector Sensor placed below blood pressure cuff Move sensor to an alternate limb Intermittent or complete failure to ope...

Page 41: ...tion is present Re attach ECG lead wires to patient and resume ECG monitoring to clear pending ECG alarms Clear current alarm condition and or reprioritize SpO2 alarms of interest in the Module Config...

Page 42: ......

Page 43: ...iastolic D and mean M arterial blood pressures The pressure readings are sent from the 90217 ABP monitor to the 91343 transmitter by a connecting cable The 91343 transmitter then includes the NIBP rea...

Page 44: ...ith the 91343 Digital Telemetry System must also involve ECG monitoring The ECG lead wires of the 91343 must be connected to the patient in order to perform ECG and NIBP monitoring The 90217 ABP when...

Page 45: ...es measuring a cuff pressure may be impossible or give misleading results Direct blood pressure measurements invasive should be considered in patients with signs of shock or any patient who rapidly be...

Page 46: ...l of the cuff on the arm should be near the level of the heart Cuff Size Limb Circumference Pediatric 13 to 20 cm Small adult 17 to 26 cm Average adult 24 to 32 cm Large adult 32 to 42 cm Extra large...

Page 47: ...START STOP key to begin a measurement 9 The 91343 transmitter must be configured for use with the 90217 ABP monitor by opening the battery compartment door removing the battery and setting DIP switch...

Page 48: ...4 4 on page 4 7 illustrate typical NIBP displays You can view NIBP readings from any Ultraview bedside or central monitor on a network NIBP displays on a split screen central monitor appear in a forma...

Page 49: ...en NIBP alarms are enabled and any of Systolic Diastolic or Mean is exceeded high or low the corresponding SYS XXX DIA XXX or MEAN XXX alarm key will blink in the color of the highest priority alarm p...

Page 50: ...pter in the UCN Operations Manual for details The following ECG alarm messages take priority over other ECG and NIBP alarm messages for display Other ECG and NIBP alarm messages can be adjusted in pri...

Page 51: ...ssages include an event code in parentheses to provide more detailed analysis of the event A complete list of the event codes can be found in the 90217 ABP Monitor Operations Manual 070 0137 xx NIBP U...

Page 52: ...e patient has pressed the START STOP button on the 90217 halting a reading in progress NIBP LOW BATTERY Displayed when the primary 3xAA battery voltage is low Replace with fresh batteries NIBP KINKED...

Page 53: ...ollow hospital procedure for care of this type of patient Excessive patient motion or muscle contractions associated with shivering or severe pain Ensure that patient is quiet with minimal movement du...

Page 54: ...t to beat pressure and NIBP readings Document arrhythmia if present verify pressure using another method then follow hospital procedure for care of this type of patient Larger than normal influence of...

Page 55: ...ociated alarm message is displayed The alarm message s with a LOWER priority setting s in MCM is displayed when and only when the alarm message with the HIGHER priority is cleared Prior to any clinica...

Page 56: ...Displayed in reverse video whenever ECG alarms are OFF ECG ALARMS SUSPENDED Displayed in reverse video whenever alarms have been suspended with the monitor s TONE RESET ALM SUSPEND hard key ECG PROCES...

Page 57: ...OW limit is set lower than or equal to the number of beats in the run This message is displayed for the greater of 10 seconds or the duration of the alarm V FIB Displayed whenever ventricular fibrilla...

Page 58: ...gure 4 4 on page 4 7 will blink yellow if the alarm priority is Low or Medium and will blink red if the alarm priority is High This is done independently of any other ECG or SpO2 alarm indications NIB...

Page 59: ...samples were missed A level 2 low priority alarm tone sounds after 10 seconds in this condition LOW BATTERY Displayed in the waveform zone when the transmitter voltage is low This message is accompani...

Page 60: ......

Page 61: ...LARMS Key UCW or Ultraview 1700 RECORD Key UCW or Ultraview 1700 PREVIOUS MENU Key UCW or Ultraview 1700 NORMAL SCREEN Key UCW or Ultraview 1700 mouse connection UCW or Ultraview 1700 Keyboard Connect...

Page 62: ...Caution hazardous voltages To reduce risk of electric shock do not remove the cover or back Refer servicing to a qualified service personnel U S A DANGER High Voltage International PAUSE or INTERRUPT...

Page 63: ...o Monitor Mode Indicator Out of Paper Activate Recorder for Graphics Recorder Paper Indoor Use Only Auto Mode NIBP Output No Output Terminated Data Input Output HELP Explain Prior Screen Key Clock Tim...

Page 64: ...g this symbol contains an F type isolated floating patient applied part providing a high degree of protection against electric shock IEC 601 1 Type CF equipment The unit displaying this symbol contain...

Page 65: ...P temp Temperature Antenna Environmental Shipping Storage Altitude Limitations Network Connection Audio Output Speaker Remote Alarm Nurse Alert Nurse Call Serial Port 1 Serial Port 2 External marker p...

Page 66: ...nger to Equipment Non Invasive Blood Pressure NIBP Neonate Fetal Monitor Connection Analog Fetal Monitor Connection RS232 Digital Physiological Monitor Connection RS232 Digital Input Reset Hard Drive...

Page 67: ...s of Water CMV Controlled Mechanical Ventilation C O CO co Cardiac Output DIA dia Diastolic ECG ecg Electrocardiogram EEG eeg Electroencephalogram EMG emg Electromyogram ESIS Electrosurgical Interfere...

Page 68: ...port Varitrend Vita Stat Web Source and WinDNA are trademarks of Spacelabs Medical Inc Other brands and product names are trademarks of their respective owners PRESS press PRS Pressure Pmin Minimum In...

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