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Exhibit H: User Manual 2
FCC ID: CM676A91341-600

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Summary of Contents for Spacelabs 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 Copyright 2002 Spacelabs Medical, Inc. All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Spacelabs Medical, Inc. Products of Spacelabs Medical are covered by U.S. and foreign patents and/or pending patents. Printed in U.S.A.
  • Page 4 Spacelabs Medical is committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Medical equipment. If you need our help along the way, we offer these guidelines for fast, efficient response.
  • Page 5: Table Of Contents

    Contents Chapter Page Introduction Directory of Keys - UCW and Ultraview 1700 ........1-1 Overview .
  • Page 6 Ultraview Care Network Alarms Alarm Message Summary ........... 5-1 ECG Alarm Messages .
  • Page 7: Introduction

    Introduction Directory of Keys - UCW and Ultraview 1700 MONITOR SETUP MONITOR SCREEN ADMIT/ MONITOR PRIVILEGED TONES SETUP FORMAT DISCHARGE CONFIGURATION ACCESS. CLINICAL LEVEL: Select Parameter SCALED TIME/ RECORDER PRESELECTED UNITS OF USER ACCESS ALARM select bed select bed DISPLAY DATE DESTINATION RECORDINGS...
  • Page 8: Overview

    Overview The 90478-A digital telemetry receiver module, when used in conjunction with ™ Spacelabs Medical telemetry transmitters, an Ultraview or PCMS 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.
  • Page 9 80-km (54-mile) radius. 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...
  • Page 10 ECG monitoring. SpO2 and NIBP alarms are inhibited by ECG leads-off condition. The Spacelabs Medical 91341, 91343, and 91347 Ultraview Digital Telemetry Systems are intended for use with either adult or neonatal patients in a hospital environment.
  • Page 11 Medical service representatives may be able to assist you in reconfiguring your equipment frequencies to reduce the risk of interference. Spacelabs Medical cannot, and does not, guarantee interference-free telemetry operation. Up to five standard disposable silver/silver chloride chest electrodes are connected to the patient.
  • Page 12 Ultraview Digital Telemetry Transmitter Batteries A 9-volt alkaline battery is recommended for standard use in the digital telemetry transmitter. A 9-volt lithium battery may also be used for applications requiring more extended battery service life. Always observe the battery position and polarity as illustrated at the bottom of the battery compartment.
  • Page 13 Introduction Digital Telemetry Receiver Module The 90478 telemetry receiver module plugs into a bedside, central, or transport monitor, or into a digital telemetry module housing. The receiver module receives patient vital signs data from the transmitter. This data is reconstructed by the receiver module, displayed on the monitor and analyzed as described in the ECG, Arrhythmia, and ST Analysis chapters of the UCN Operations Manual, and in the and NIBP sections in this chapter.
  • Page 14 Ultraview Digital Telemetry Diversity Antenna System NOTE: The UCW bedside connects to the remote module housing, and the ETHERNET UCW central connects to the digital te- lemetry module housing. ST=0.00 Ultraview 1700 shown with flat panel display HELP: Access controls that pertain to ECG ECG MENU ALARM LEAD...
  • Page 15: Cleaning

    Introduction 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 agents. • Mild soap and water solution • U.S. Pharmacopoeia (USP) green soap •...
  • Page 16: Entering Patient Information

    Ultraview Digital Telemetry Entering Patient Information To admit a patient: The ADMIT/DISCHARGE menu enables you to enter a patient identification (ID) number, name, height, weight, and body surface area (BSA). Touch MONITOR SETUP Touch ADMIT/DISCH Select subnet (UCW and 1700 •...
  • Page 17: Acknowledging Signal Loss

    Introduction 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.
  • Page 18: Accessories

    Ultraview Digital Telemetry Accessories Refer to the Spacelabs Medical Supplies Products Catalog for availability of accessories. Some of the more commonly used accessories are listed below. Digital Telemetry Accessories 91341/91343/91347 telemetry transmitter pouch 015-0500-00 Belt clip 344-0020-00 Receiver whip antenna (UHF)
  • Page 19 Introduction 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 Operations Manual 070-1001-xx 071-0774-00 Rev. A 1-13...
  • Page 21: Ecg

    The telemetry receiver module must be connected to an Ultraview or PCMS monitor, either directly or through a module housing, with the power ON and a Spacelabs Medical diversity antenna connected. • ECG electrodes must be properly attached to the patient; and lead wires must be properly attached to the transmitter.
  • Page 22 Ultraview Digital Telemetry • All system connections must be made by Spacelabs Medical personnel only. • Leakage currents are not affected by the high level output. The patient is electrically isolated from the patient monitor by the RF link. WARNING: •...
  • Page 23 • Only use patient cables and lead wires specified by Spacelabs Medical. Other cables and lead wires may degrade performance and may damage the monitor during defibrillation. Non-Spacelabs Medical cables and lead wires may also change the required input impedance and DC offset voltage, affecting monitor performance.
  • Page 24: Display Detail

    Ultraview Digital Telemetry 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.
  • Page 25: Monitoring Paced Ecg Patients

    ¹ Abnormals per minute counter * Current heart rate ECG lead designator for second lead ST segment level for second lead** ECG key for second lead NIBP measurements: systolic/diastolic (mean) at hours:minutes; SpO measurement at hours:minutes (91343 only; hh:mm not seen on continuous ).
  • Page 26: Restoring Default Settings

    The system may insert pacemaker flags into the ECG signal in response to signals that are not pacemaker pulses. Therefore, if you use a Spacelabs Medical monitor to observe pacemaker performance, you must take into account all possible sources of pacemaker flags.
  • Page 27: Selecting Options For Lead Display

    Selecting Options for Lead Display To select ECG leads: One operational mode is available with the 91343 and 91347 multi-lead transmitters. When all electrodes are connected to the patient, leads I, II, III, AVR, Touch ECG AVL, AVF, and Vx, where x = 1 to 6, are available. When no chest lead is applied, Touch LEAD SELECT leads I, II, III, AVR, AVL, and AVF are available using the remaining connected Touch 1ST or 2ND LEAD...
  • Page 28 Ultraview Digital Telemetry Two Operational Modes Two operational modes are available with the 91341 dual-lead transmitter: • the standard mode that offers a choice of one V lead (V1-6), plus lead II; or • the limb lead mode that offers choices of the leads I, II, III, AVR, AVL, or AVF. The standard mode is available if the chest lead is applied.
  • Page 29: Ecg Alarm Message Summary

    ECG Alarm Message Summary To set or adjust ECG alarms: Refer to the ECG Problem Solving section in the ECG chapter of the UCN Touch ECG Operations Manual for additional conditions and solutions. Touch ALARM LIMITS CHECK XX Touch ECG ALARMS Select ECG ALARM ON Displayed in the waveform zone, where XX is the name of the faulted electrode.
  • Page 30 Ultraview Digital Telemetry HI RATE ALARM Displayed during high rate alarms for either 10 seconds or the duration of the alarm. IN LEARN Displayed when the software is in learn mode. CHAN 1 & 2 LEADS OFF Displayed when lead failures preclude ECG monitoring in both ECG channels 1 and 2.
  • Page 31: Spo2 (91343 Only)

    (91343 only) Contents Overview ............1 Setting Up SpO2 Monitoring .
  • Page 32 Setting Up SpO Monitoring To set up SpO monitoring: The 91343 digital telemetry multi-parameter transmitter uses Spacelabs Medical sensors as well as those from other manufacturers. Refer to Accessories on page Open the battery cover and 1-12 for information concerning specific sensors.
  • Page 33: Ensuring Accurate Monitoring

    SpO2 (91343 only) PACED XX YYY CHECK XX CHAN 2241 A/M 10 ECG WAVEFORM ZONE A=XX ROW 5 SpO2=98% 10:22 BED NAME PATIENT NAME Figure 3-2: Display Zone — Full Screen HR=XXX A=XX LEAD CHAN 2241 ECG WAVEFORM ZONE SpO2=98% 10:22 347-2 Jane Doe Figure 3-3: Display Zone —...
  • Page 34: Setting Or Adjusting Alarm Limits

    Ultraview Digital Telemetry Setting or Adjusting Alarm Limits To set or adjust SpO alarms: Pulse oximetry alarm limits and delays are based either on factory default limits or user-defined limits. The factory default settings for alarm limits are 100% for high Touch ECG and 85% for low.
  • Page 35 SpO2 (91343 only) MSG ALM DELAY Key This key sets the number of seconds the system will wait before it issues an alarm tone after any of the following messages: • UNAVAILABLE • FAULTY SENSOR • SENSOR DISCONNECTED • SENSOR OFF PATIENT •...
  • Page 36 Ultraview Digital Telemetry Setting SpO Data Averaging Period and Sampling Interval To set SpO data averaging data averaging is used to smooth the oximetry saturation value by period and sampling interval, set averaging the patient input values over 4, 8, or 16 seconds. This selection is made transmitter DIP switches 1 by setting the DIP switches 1 and 2 beneath the battery compartment in the 91343 through 4 to correct...
  • Page 37: Viewing Pulse Rate

    SpO2 (91343 only) 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 SpO monitoring occurs between episodic sampling intervals.
  • Page 38: Using Spo2 With Neonates

    Ultraview Digital Telemetry Using SpO 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.
  • Page 39 Tissue between the LED and photodiode is too transmissive. If sensor placement seems correct and the message persists, try a sensor site with a thicker tissue bed. • Adapter cables and sensors are ordered separately through the Spacelabs Medical Supplies Products Catalog. 071-0774-00 Rev. A...
  • Page 40: Spo2 Troubleshooting Guide

    Troubleshooting Guide Clinical Situation Possible Cause Solution No SpO label is is not enabled at the 91343 Be sure transmitter DIP switch 1 and 2 displayed are set correctly is not enabled at the 90478 Be sure transmitter DIP switch 8 is receiver value displays ??? Sensor not connected to patient...
  • Page 41 Troubleshooting Guide (continued) Clinical Situation Possible Cause Solution No SpO alarms are ECG “Leads Off” condition exists Re-attach ECG lead wires to patient and displayed Higher priority alarm condition is resume ECG monitoring to clear present pending ECG alarms Clear current alarm condition and/or reprioritize SpO alarms of interest in the Module Configuration Manager...
  • Page 43: Nibp (91343 Only)

    NIBP (91343 only) Contents Overview ............1 Setting Up NIBP Monitoring.
  • Page 44: Setting Up Nibp Monitoring

    Do not apply a cuff to a limb that has restricted blood flow. • Use only single hose cuffs to ensure proper operation. Spacelabs Medical’s hoses are non-conductive with respect to defibrillator discharge effects. 071-0774-00 Rev. A...
  • Page 45: Setting Up The Abp Monitor

    NIBP (91343 only) Patient Factors Affecting Readings Excess patient movement, speech, or muscle contractions as a result of severe pain or shivering can interfere with automated NIBP readings. Ensure that the patient is quiet and not moving during NIBP readings just as you would manual readings.
  • Page 46 • Use only Spacelabs Medical cuffs with this monitor. Using other manufacturer’s cuffs may result in inaccurate readings, even if the manufacturer’s recommended size is observed.
  • Page 47 NIBP (91343 only) Lead the hose up the arm with the cuff and place it across the back of the patient. Drape the hose so it does not cause the patient discomfort and is not pinched shut by too tight a radius. Figure 4-1 shows the most common positions for the cuff hose.
  • Page 48 Ultraview Digital Telemetry 11. Interconnect the adapter cable between the communications port on the 90217 and the NIBP port on the 91343 as shown in Figure 4-2. adapter cable NIBP cuff sensor 91343 NIBP adapter cable 90217 & 91343 mount in pouches to patient’s belt.
  • Page 49: Setting Or Adjusting Alarm Limits

    NIBP (91343 only) PACED XX YYY CHAN xxxx A/M 10 A=XX ROW 5 ECG WAVEFORM ZONE NIBP=120/68(94) hh:mm SpO2=98% hh:mm BED NAME PATIENT NAME Figure 4-3: Display Zone — Full Screen HR=XXX A=XX LEAD CHAN xxxx ECG WAVEFORM ZONE NIBP=120/68(94) hh:mm SpO2=98% hh:mm BED NAME PATIENT NAME Figure 4-4: Display Zone —...
  • Page 50: Displaying New Or Previous Readings

    Ultraview Digital Telemetry Refer to the Module Configuration Manager chapter in the UCN Operations Manual for NIBP parameter tables that list available user settings and factory defaults for this parameter. • The following ECG alarm messages take priority over other ECG and NIBP alarm messages for display.
  • Page 51: Nibp Alarm Message Summary

    NIBP (91343 only) Tabular Trends Display Bed: ICU1 Patient: John Smith Date: 26 FEB 2001 Time 11:32 11:33 11:34 11:35 11:36 11:37 11:38 11:39 HR (ECG) b/min b.min b/min (WFI) NIBP/s Time 11:32 11:37 mmHg NIBP/d Time 11:32 11:37 mmHg NIBP/m Time 11:32...
  • Page 52 Ultraview Digital Telemetry NIBP LOOSE OR NO CUFF Displayed when the cuff was able to be inflated in a manner indicating that it was not attached to the patient correctly. NIBP PATIENT CANCELLED Displayed when the patient has pressed the START/STOP button on the 90217, halting a reading in progress.
  • Page 53: Nibp Troubleshooting Guide

    NIBP Troubleshooting Guide Clinical Situation Possible Cause Solution No NIBP displays Adapter cable not inserted correctly Remove and re-insert adapter cable NIBP not enabled on 91343 or 90478 Enable NIBP function by setting transmitter DIP switch 5 ON and setting DIP switch 8 90217 ABP not properly initialized Reinitialize 90217 ABP using 90121 91343 Low battery indicator constantly...
  • Page 54 Cuff too tight Cuff placed on patient too tightly Reposition the cuff Air pump staying on too long Return unit to Spacelabs Medical for service Cuff too loose Cuff placed on patient too loosely Reposition the cuff Air pump not staying on long enough...
  • Page 55: Alarms

    Alarms Contents Alarm Message Summary ......... 1 ECG Alarm Messages .
  • Page 56: Ecg Alarm Messages

    Ultraview Digital Telemetry ECG Alarm Messages The following messages apply when either the 91341, 91343, or 91347 is in use. CHECK XX Displayed in the waveform zone, where XX is the name of the faulted electrode. The message clears after 60 seconds for V1 – V6 and RL. It is not cleared for limb lead (RA, LA, LL) faults.
  • Page 57: Spo2 Alarm Messages

    Alarms CHAN 1 LEADS OFF Displayed when a lead failure occurs on ECG channel 1 when automatic lead switching is disabled. CHAN 2 LEADS OFF Displayed when a lead failure occurs on ECG channel 2. The message is displayed in the waveform zone for both ECG channels 1 and 2. LO RATE ALARM Displayed during low rate alarms for the greater of 10 seconds or the duration of the alarm.
  • Page 58: Nibp Alarm Messages

    Ultraview Digital Telemetry 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.) INSUFFICIENT SIGNAL The signal amplitude from the sensor is not sufficient.
  • Page 59: Telemetry Alarm Messages

    Alarms 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 the 91341, 91343, and 91347 transmitters. INTERMITTENT SIGNAL LOSS Displayed in the waveform zone whenever a minimum of the previous 100 samples were missed.
  • Page 61: Symbols

    Symbols The following list of international and safety symbols describes all symbols used on Spacelabs Medical products. No one product contains every symbol. Symbol Description Symbol Description UCW or Ultraview 1700 UCW or Ultraview 1700 HELP Key MONITOR SETUP Key...
  • Page 62 Ultraview Digital Telemetry Symbol Description Symbol Description ON — Part of the Instrument Only OFF — Part of the Instrument Only Partial ON/OFF STAND-BY Key All batteries should be disposed of properly to protect the environment. Caution - hazardous voltages. To reduce Lithium batteries should be fully risk of electric shock, do not remove the discharged before disposal.
  • Page 63 Symbols Symbol Description Symbol Description ENTER Key PRINT REPORT Key Attention - Consult Operations or Risk of Explosion if Used in the Service Manual for Description Presence of Flammable Anesthetics Indicator — Remote control Indicator — Local Control Return Unit to Monitor Mode Indicator —...
  • Page 64 Ultraview Digital Telemetry Symbol Description Symbol Description Electrocardiograph or Gas Exhaust Defibrillator Synchronization IEC 601-1 Type BF equipment. The unit displaying this symbol contains an F- Arterial Pulse type isolated (floating) patient-applied part providing an adequate degree of protection against electric shock. IEC 601-1 Type BF equipment which is defibrillator-proof.
  • Page 65 Symbols Symbol Description Symbol Description Open Padlock Closed Padlock Down Arrow Up Arrow TEMP Event Temperature temp 12,200 m Environmental Shipping/Storage Antenna Altitude Limitations Network Connection Audio Output, Speaker Remote Alarm; Nurse Alert Nurse Call Serial Port 1 Serial Port 2 External marker push button connection SDLC Port SDLC...
  • Page 66 Ultraview Digital Telemetry Symbol Description Symbol Description Microphone Mermaid Connector Note Video Output Warning About Potential Danger to Caution About Potential Danger to Human Beings Equipment Non-Invasive Blood Pressure (NIBP), Fetal Monitor Connection (Analog) Neonate Fetal Monitor Connection Physiological Monitor Connection RS232 (Digital) RS232 (Digital) Input...
  • Page 67 Symbols Abbreviations used as symbols are shown below. Symbol Description Symbol Description Access Codes 1 - 32 1 Through 32 ANT 1 Diversity Antenna System 1 Arr1 Arrhythmia Net 1 ANT 2 Diversity Antenna System 2 ArrNet2 Arrhythmia Net 2 EEG, EMG, or ECG Channel EEG Channels - CH1, CH2, CH3, CH4 Centimeters of Water...
  • Page 68 Quicknet, Spaceview, Sensorwatch, TRU-CAP, TRU-CUFF, TRU-LINK, UCW, Ultralite, Ultraview, Ultraview Care Network, Ultraview Clinical Messenger, Uni-Pouch, Universal Flexport, Varitrend, Vita-Stat, Web Source and WinDNA are trademarks of Spacelabs Medical, Inc. Other brands and product names are trademarks of their respective owners.

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Ultraview 91343Ultraview 91347

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