EXHIBIT C – User Manual 1 FCC ID CM676A90343-WMTS
1 Ultraview Digital Telemetry Directory of Keys - UCW and Ultraview 1700 MONITOR SETUP SCREEN FORMAT ADMIT/ DISCHARGE TONES MONITOR CONFIGURATION MONITOR SETUP PRIVILEGED ACCESS.
1 Ultraview Digital Telemetry Contents General Telemetry Overview...............................................................................3 Cleaning .................................................................................................................9 Assigning a Telemetry Channel .............................................................................9 Tuning a Receiver for a Bedside............................................................................
Ultraview Digital Telemetry General Telemetry Overview The 90478-A digital telemetry receiver module, when used in conjunction with Spacelabs Medical telemetry transmitters, an Ultraview™ monitor, and 90479-A modular receiver housing, provides continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including asystole, ventricular fibrillation, and ventricular tachycardia.
Ultraview Care Network WARNING: • Changes or modifications not expressly approved by Spacelabs Medical will void the user’s authority to operate the equipment. Intended Use As an option, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations can be detected. The Ultraview Digital Telemetry System also provides a means for the episodic monitoring of NIBP signals to detect abnormal events such as high and low blood pressure.
Ultraview Digital Telemetry WARNING: • Medical telemetry spectrum allocations may be assigned to frequencies already allotted to other priority users. This means that telemetry operations may be exposed to radio frequency interference that may disrupt or impede telemetry patient monitoring during the life of this equipment. You are urged to regularly consult with applicable local and federal regulatory agencies (e.g., FCC, FDA, etc.
Ultraview Care Network Always observe the battery position and polarity as illustrated at the bottom of the battery compartment. After battery installation, close and latch the compartment cover. The transmitter begins transmitting as soon as the battery is in place. ! • Whenever the transmitter is not in use, the battery should be removed. Insert a battery only when the transmitter is being used with a patient.
Ultraview Digital Telemetry receiver module, displayed on the monitor and analyzed as described in the ECG, Arrhythmia, and ST Analysis chapters, and in the SpO2 and NIBP sections of this chapter. WARNING: • Telemetry 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 telephones) near telemetry systems may cause interference and should be discouraged.
Ultraview Care Network Diversity Antenna System NOTE: The UCW bedside connects to the remote module housing, and the UCW central connects to the digital telemetry module housing. E C G VI ST=0.
Ultraview Digital Telemetry Cleaning Clean the transmitter after each use. The transmitter does not require any preventive maintenance other than cleaning. To clean the transmitter, use only the following solutions per the manufacturer’s labeling: isopropyl alcohol (70%), hydrogen peroxide, Cidex, Betadine, and Clorox. Use of cleaning solutions other than those listed will VOID the warranty of the digital telemetry transmitter cases.
Ultraview Care Network Entering Patient Information To admit a patient: 1 2 3 Touch MONITOR SETUP Touch ADMIT/DISCH Select subnet (UCW and 1700 only) 4 Select bed/room number for channel 5 Touch ADMIT 6 Select YES 7 Use keyboard to enter patient info (UCW and 1700 only) 8 Select ID, NAME, HEIGHT, WEIGHT, or BSA (PC Scout, UV1050/1500 only) 9 Enter data using pop-up keypad or keyboard (PC Scout, UV1050/1500 only) 10 Touch ENTER 11 Repeat steps 7 - 10 until all data has been entered 12 Touch ACCEPT (UCW and
Ultraview Digital Telemetry Acknowledging Signal Loss When a telemetry signal is lost because the transmitter is out of range or the battery is removed, the receiver initiates a squelch condition indicated by a triangular waveform that replaces the normal ECG waveform and SQUELCH is included in the edge print for any strip chart recording. The ECG trace automatically begins again if the lost signal returns. After eight seconds of signal loss, the IS SIGNAL LOSS PERMANENT? message appears.
Ultraview Care Network ECG Overview Digital telemetry ECG monitoring provides continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening arrhythmias such as asystole, ventricular fibrillation, and ventricular tachycardia.
Ultraview Digital Telemetry ECG monitoring in telemetry is identical to hardwired ECG monitoring. Refer to the ECG, Arrhythmia, and ST Analysis chapters of this manual for detailed descriptions of configurations, displays, and controls. A brief overview of ECG monitoring follows. Electrodes For ECG tracing with telemetry, use silver/silver-chloride electrodes or their equivalent. Always connect all the electrodes required for a particular lead. Missing electrodes may result in the loss of ECG tracing.
Ultraview Care Network Display Detail Signal detection is indicated on your monitor when an ECG signal appears next to the ECG parameter key in the zone assigned to receive the transmitted telemetry channel. The transmitter’s channel number is always identified above the waveform, to the left of the ECG key. ➊ ➋ 20 18 ➌ ➍ ➎ ➑* II CHAN 2241 21 ➏ E C G Full Screen Central/Bedside MON PACED 70 NIBP=120/68(94) 10:20 SpO2=98% 10:20 ➒ ** A/M 10 ROW 4 120 40 ST=0.
Ultraview Digital Telemetry 17 NIBP measurements: systolic/diastolic (mean) at hours:minutes; SpO2 measurement at hours:minutes (90343 only; hh:mm not seen on continuous SpO2). Depending on the patient monitor’s display size, the title “NIBP” may not appear. 18 SpO2 SensorWatch bar: shaded area (waveform index) expands up proportionally to signal strength; horizontal line is minimum signal level. Waveform Index (WFI) is used for displaying signal strength in SensorWatch.
Ultraview Care Network Restoring Default Settings To restore default settings: 1 2 3 4 Touch ECG Touch SETUP Touch RESTORE SETTINGS Select YES With the Module Configuration Manager feature, you can restore all default settings. User-configurable options are listed in the Module Configuration Manager chapter. ! • RESTORE SETTINGS changes the user-configurable options for all parameters in the module.
Ultraview Digital Telemetry Table Telemetry-2: Lead Display Options Connected Electrodes (X) R L C LL L A X X X X X V1-6, I, II, III, AVR, AVL, AVF X X X X I X X X X II X X X X X X X I, II, III, AVR, AVL, AVF X X I X II X X 90343/90347 Valid Lead Vectors III X X X X X X X X I, II, III, AVR, AVL, AVF X X I X II X X ! R A X X X X X X X III III X II • Combinations of leads not included above produce invalid lead vectors.
Ultraview Care Network Displayed whenever no beat is detected for 5 seconds. This message is displayed for 10 seconds or the duration of the alarm. An ASYSTOLE message means it has been 5 seconds or more since a QRS complex has been detected. Check the patient. If the patient is stable: • • • • Check that the lead wires are inserted into the proper receptacle. Using the continuity tester, check that there is no damage to the lead wires.
Ultraview Digital Telemetry LO RATE ALARM Displayed during low rate alarms for either 10 seconds or the duration 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 either channel because of excessive noise on the ECG signal. After 10 seconds in this condition, an alarm tone sounds if ECG alarms are enabled and alarm tones have not been turned OFF or suspended.
ECG Troubleshooting Guide Clinical Situation Noisy signal Baseline wanders Low amplitude ECG ECG will not learn Excessive alarms Possible Cause Solution ■ ECG frequency response set to extended mode ■ Select monitor mode ■ Electrodes dry or poor skin adhesion ■ Repeat skin preparation and apply new, moist electrodes ■ Patient moving excessively ■ Secure lead wires by stress-looping to the patient ■ Respiration artifact ■ Re-position electrodes ■ Electrodes dry or poor skin adhesion
Ultraview Care Network SpO2 Overview (90343 only) Pulse oximetry enables you to noninvasively monitor a patient’s hemoglobin oxygen saturation either continuously or episodically. The oximetry sensor contains two light emitting diodes (LEDs) that transmit specific wavelengths (approximately 660 and 940 nanometers) of light that are received by a photodetector. Oxygen saturated blood absorbs light differently than unsaturated blood.
Ultraview Digital Telemetry All sensors require an adapter cable between the sensor and the transmitter. Because the adaptor cable is reusable, do not discard it when you have finished using a disposable oximetry sensor. Disconnect the sensor cable from the adapter cable before discarding the sensor. To connect the SpO2 adapter cable to the transmitter, align the cable with the notch on the front of the transmitter connector, and push the cable straight down into the transmitter.
Ultraview Care Network Ensuring Accurate Monitoring Each sensor requires site 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 interference when monitoring under bright light by using a light block over the sensor. • Select a site that has unrestricted blood flow and can remain as immobile as possible to reduce or eliminate movement artifact.
Ultraview Digital Telemetry MSG ALM DELAY Key This key sets the number of seconds the system will wait before it issues an alarm tone following any of the following messages: • • • • • • • SpO2 UNAVAILABLE SpO2 FAULTY SENSOR SpO2 SENSOR DISCONNECTED SpO2 SENSOR OFF PATIENT SpO2 INSUFFICIENT SIGNAL SpO2 AMBIENT LIGHT INTF. SpO2 NOISY SIGNAL When this feature is OFF, the key label will read “MSG ALM DELAY OFF”.
Ultraview Care Network Setting SpO2 Data Averaging Period and Sampling Interval To set SpO2 data averaging period and sampling interval, set transmitter DIP switches 1 through 4 to correct configuration SpO2 data averaging is used to smooth the oximetry saturation value by averaging the patient input values over 4, 8, or 16 seconds. This selection is made by setting the DIP switches 1 and 2 beneath the battery compartment in the 90343 digital telemetry multi-parameter transmitter.
Ultraview Digital Telemetry P/N 061-0801-xx, for more information on battery service life.) This selection is made by setting DIP switches 3 and 4 beneath the battery compartment. The default setting is in continuous. CAUTION: • No SpO2 monitoring occurs between episodic sampling intervals. Clinical practice or medical judgement should be used in selecting continuous or episodic SpO2 monitoring mode for each specific patient.
Ultraview Care Network Using SpO2 with Neonates Enabling neonatal operation, by setting transmitter DIP switch 7, changes the sensor detection operation in the transmitter, improving the signal quality for neonatal patients. This switch must be set ON for neonatal use and set OFF for adult use. When the neonate operation is selected the SpO2 status key in the Channel Format menu indicates NEO.
Ultraview Digital Telemetry • Poor sensor application or site. Correctly re-apply or reposition to a more perfused site, massage the site, or apply a new sensor. SpO2 NOISY SIGNAL Displayed when: • The sensor signal is disturbed by motion or other interference. Eliminate sensor movement. The message disappears when a value is obtained. • The sensor is placed adjacent to power cords or other electrically noisy devices. Move the noisy device or move the sensor to another site.
SpO2 Troubleshooting Guide Clinical Situation No SpO2 label is displayed SpO2 value displays ??? Insufficient signal or noisy signal Intermittent or complete failure to operate Factors that cause significant variances in sensor accuracy Possible Cause Solution ■ SpO2 is not enabled at the 90343 ■ Be sure transmitter DIP switch 1 and 2 are set correctly ■ SpO2 is not enabled at the 90478 receiver ■ Be sure transmitter DIP switch 8 is OFF ■ Sensor not connected to patient ■ Re-attach sensor
Ultraview Care Network NIBP Overview (90343 only) The 90343 digital telemetry multi-parameter transmitter sends NIBP patient data, acquired by the 90217 ambulatory blood pressure (ABP) monitor, to the 90478 digital telemetry receiver. The 90478 displays the patient’s episodic NIBP data and trigger alarms based on thresholds set at the patient monitor. The 90217 ABP monitor is a small, lightweight, battery-powered unit designed to take blood pressure measurements.
Ultraview Digital Telemetry During blood pressure measurement, the inflated cuff reduces blood flow to the limb to which it is applied. Do not apply a cuff to a limb that has restricted blood flow. Check the patient periodically. ! • Do not apply a blood pressure cuff to a limb being monitored with a pulse oximetry sensor, because SpO2 is affected during NIBP readings. Avoid applying a cuff to a limb that has an intravenous line in place. Do not apply a cuff to a limb that has restricted blood flow.
Ultraview Care Network After the monitor has been initialized, prepare the patient for monitoring as follows: 1. Turn on the monitor and wait for the monitor to perform self-tests. When the LCD displays the current time, the monitor is ready for operation. 2. Strap the monitor to the patient on the hip opposite the side on which the cuff is worn. Secure the monitor using the patient’s own belt or the ABP pouch strapped over the opposite shoulder.
Ultraview Digital Telemetry CAUTION: • Avoid compression or restriction of pressure in the NIBP patient connector tubes. Check that operation of the equipment does not result in prolonged impairment of circulation. • Do not apply cuff to areas of breached or injured skin. • Cuff hose connections use luer fittings. Be careful not to connect the ABP monitor into an intravenous fluid line when working close to them.
Ultraview Care Network the main menu. Touch CHANNEL FORMAT, then NIBP ON. The monitor will display the NIBP measurement in a numeric format in the display zone. The values of the measurement are displayed as ??? until a valid NIBP measurement has been taken. 11. Interconnect the adapter cable between the communications port on the 90217 and the NIBP port on the 90343 as shown in Figure Telemetry-7: Transmitter and ABP Monitor Connections.
Ultraview Digital Telemetry split screen central monitor appear in a format slightly different from that of bedside or full screen central monitors. Depending on the patient monitor’s display size, the title “NIBP” may not appear.
Ultraview Care Network To display the current reading: 1 2 3 Touch ECG Touch CHANNEL FORMAT Select NIBP ON To display previous readings in tabular format (PC Scout): 1 2 3 4 5 Touch SPECIAL FUNCTIONS Select LOCAL TRENDS or REMOTE TRENDS Select subnet and bed number Touch TABULAR TRENDS Select TIME INTERVAL or ARROWS to adjust the time interval and period (UCW and 1700): 1 2 3 4 5 Touch SPECIAL FUNCTIONS Touch TABULAR TRENDS Select LOCAL BED or REMOTE BED Select bed number Select TIME INTERVAL or ARROW
Ultraview Digital Telemetry Tabular Trends Display Bed: ICU1 Patient: John Smith Time Date: 26 FEB 1999 11:32 11:33 11:34 11:35 11:36 11:37 11:38 HR (ECG) b/min 60 60 59 60 61 60 59 60 ABN b.
Ultraview Care Network NIBP KINKED HOSE Displayed when the pressure value increased too rapidly indicating a kinked hose or other restriction. NIBP EVENT CODE (xx) Displayed when the event code returned from the 90217 monitor is not defined into one of the other messages.
NIBP Troubleshooting Guide Clinical Situation Possible Cause Solution ■ Adapter cable not inserted correctly ■ Remove and re-insert adapter cable ■ NIBP not enabled on 90343 or 90478 ■ Enable NIBP function by setting transmitter DIP switch 5 ON and setting DIP switch 8 OFF ■ 90217 ABP not properly initialized ■ Reinitialize 90217 ABP using 90121 ■ 90343 Low battery indicator constantly illuminated ■ Call qualified service person ■ Incorrect or inoperative cuff in use ■ Replace with cuf
NIBP Troubleshooting Guide (continued) Clinical Situation Possible Cause Solution ■ Some arrhythmias may cause beat-tobeat 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 respiratory phases on blood pressure (inspiratory fall in blood pressure; expiratory rise) ■ NIBP software usually compensates for normal variation No NIBP readings or questionable
Ultraview Care Network Alarm Message Summary Unless otherwise specified in their description, the following messages are left on the top line (full screen monitors, medium font) or second line (split screen monitors, small font) of the waveform zone. They are displayed for the duration of the condition that caused the message or for the period specified in their description unless replaced by a higher priority message. The conditions under which these messages can be displayed are outlined below.
Ultraview Digital Telemetry IN LEARN Displayed when the module is in learning mode. CHAN 1 & 2 LEADS OFF Displayed when lead failures preclude ECG monitoring in both ECG channels 1 and 2. The message in displayed in the waveform zone for the first ECG channel. An alarm tone sounds if the module has completed its initial period of learning and ECG processing has not been suspended. CHAN 1 LEADS OFF Displayed when a lead failure occurs on ECG channel 1 when automatic lead switching is disabled.
Ultraview Care Network SPO2 SENSOR DISCONNECTED The sensor is not connected properly to the adapter cable or the adapter cable is not connected properly to the 90343 transmitter. SpO2 AMBIENT LIGHT INTF. The ambient light present is causing interference with the signal from the sensor. Attempt to reduce the amount of ambient light. SENSOR OFF PATIENT The sensor is not properly applied to the patient. (This alarm is available only with non-disposable, finger-clip type sensors.
Ultraview Digital Telemetry NIBP EVENT CODE (xx) The event code returned from the 90217 monitor is not defined as one of the other messages. Telemetry Alarm Messages The following are general telemetry messages and apply to both 90343 and 90347 transmitters. INTERMITTENT SIGNAL LOSS Displayed in the waveform zone whenever a minimum of the previous 100 samples were missed. A level 2/low priority alarm tone sounds after 10 seconds in this condition.
Ultraview Care Network 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 (DS-100A) 690-0003-00 Nasal (R-15) 690-0005-00 Oxiband A/N 690-0004-00 Oxiband pediatric/infant reusable sensor P/I 690-0039-00 NIBP Accessories 48 ABP adapter cable 700-0015-00 ABP Pouch 015-0501-00 ABP Shoulder Strap 016-0262-00 ABP Waist Belt 016-0080-00 Cuff assembly, c
