070-1163-03 Rev A - 91496 service manual

Ultraview SL™ Command Module 91496 For use with modules with serial number 1496-1xxxx and higher and software version 2.07.00.

070-1163-0 3 Rev. A | www.spacelabshealthcare.com

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91496 U LTRAVIEW SL COMMAND M O D U L E S E R V I C E M A N U A L

©2017 Spacelabs Healthcare All rights reserved. Contents Contents of of this publication may not be reproduced reproduced in any any form without without the written permission permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending patents. Printed Printed in U.S.A. U.S.A. Specifications and and price change privileges privileges are reserved. Spacelabs Healthcare Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if: • assembly operations, operations, re-adjustments, modifications modifications or repairs are carried out by persons authorized authorized by Spacelabs Healthcare, and • the electrical installation of the relevant room complies with the requirements requirements of the standard standard in force, force, and • the equipme equipment nt is used in in accordan accordance ce with the the operation operationss manual. manual. Spacelabs Healthcare Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist appropriately qualified technical technical personnel to repair those parts of the equipment which are classified by Spacelabs Healthcare Healthcare as field repairable. Spacelabs Healthcare Healthcare is committed committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Healthcare Healthcare equipment. CORPORATE OFFICES

Corporate Headquarters Headquarters Spacelabs Healthcare, Inc. 35301 SE Center Street Snoqualmie, WA 98065 U.S.A. Telephone: (1) 800-287-7108 Telephone: (1) 425-396-3300

Authorized EC EC Representative Representative Spacelabs Healthcare, Ltd. 43 Moray Place Edinburgh, EH3 6BT United Kingdom Telephone: 44 (0) 131 240 6481 Fax: 44 (0) 131 240 6459 Please refer to http://www.spacelabshealthcare.com/en/company/trademarks for a full listing of Spacelabs Healthcare trademarks. Other brands and product names used herein are trademarks of their respective owners. • Rx Only physician.

U.S. Federal law restricts the devices documented herein to sale by or on the order of a

• Before use, use, carefully read read the instructions, instructions, including including all warnings warnings and cautions.

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Table of Contents 1

Int r odu ct i on

Overview ............................................................................................................................. 1-1 Expected Service Life...........................................................................................................1-3 Module Configurations........................................................................................................1Configurations........................................................................................................1- 4 Specifications.......................................................................................................................1-5 Physical Dimensions Dimensions ............................... ............................................... ................................. .................................. ................................. ................... ...1-5 1-5 Electrical Electrical Specifications Specifications ............................... ................................................... ..................................... .................................. .......................... .........1-5 1-5 Environmental Environmental Requirements Requirements ................................. .................................................. ................................. ................................. ................... ..1-5 1-5 Operating ........................................................................................................................1-5 Transport and Storage ............................. .......................................................................1-5 Setup ................................................................................................................................... 1-5 Unpacking Unpacking ............................... ................................................ .................................. .................................. .................................. ................................. ................1-5 1-5

2

Th eo r y

Overview ............................................................................................................................. 2-1 CPU/NIBP.............................................................................................................................2-2 Main Processor ................................. .................................................. ................................. ................................. ................................. ........................ ........2-2 2-2 Memory ............................... ............................................... ................................ ................................ ................................ ................................. ....................... ......2-2 2-2 Synchronous Data Link Control (SDLC) Interface ........ .......... ......... ......... .......... .......... 2-2 Front-End Front-End Communication Communicationss Interfaces Interfaces ............................... ................................................ .................................. ....................... ......2-2 2-2 NIBP Front-End Front-End Controllers Controllers ................................ ................................................. .................................. .................................. ....................... ......2-3 2-3 Analog Front End (AFE)........................................................................................................2-6 Patient Inputs .......................................... ....................................................................... 2-6 Front-End Controllers ............................................. ........................................................2-7 A/D Converters ...............................................................................................................2-7 Isolated Power Supplies Supplies .................................................. ................................................2-7

3

M ai nt ena nce

Overview ............................................................................................................................. 3-1 Cleaning/Disinfecting Cleaning/Disinfecting .......................................................................................................... 3-2 General ................................ ................................................ ................................ ................................. ................................. ................................ ...................... ......3-2 3-2 To clean monitors, modules, and cables.......................................................................3-3 3-3 Safety...................................................................................................................................3-4 Maintenance Maintenance ..................................................................................................................... ..3-4 Preventive Preventive Maintenance Maintenance ............................... ............................................... ................................ ................................. .............................. .............3-4 3-4 Electrical Safety Safety Testing...................................................................................................... .3-5 Definitions Definitions ................................. ................................................. ................................ ................................ ................................. ................................. ................3-5 3-5 Equipment Required: Electrical Safety Analyzer, Fluke model 232D or equivalent ..... 3-6 Ground Resistance Resistance ............................... ................................................ ................................. ................................ ................................ ...................... ......3-6 3-6 To test ground resistance .............................................................................................3-6 3-6 Chassis Leakage Current Tests .................................. .................................................. ................................ ................................. ...................3-6 To test chassis leakage..................................................................................................3-6 Patient Lead Leakage Current Tests (Patient Modules) ......... .......... .......... .......... ....... 3-7 To test patient patient leads current leakage leakage ...........................................................................3-7 3-7 To test leakage current to ground with 50/60 Hz.................................... .....................3-7 .....................3-7 Hardware and and Mechanical Mechanical Checks ......................................................................................3-7 Performance Performance Verification Verification ....................................................................................................3-8 ECG ............................... ................................................ .................................. .................................. ................................. ................................. ........................... ..........3-8 3-8 To verify ECG performance performance ...........................................................................................3-8 3-8 Respiration Respiration (Option (Option R) ................................. ................................................. ............................... ............................... ................................ ................3-9 3-9 To verify respiration performance...... performance...... ..........................................................................3-9 3-9 Invasive Pressure (Option B or Option C) ................................ ................................................. ................................. ................... ...3-9 3-9 To verify invasive pressure performance......................................................................3-9 3-9 Temperature Temperature .................................. ................................................... .................................. .................................. .................................. ........................ .......3-10 3-10 To verify temperature performance performance ...........................................................................3-10 3-10 Cardiac Output ............................... ................................................ ................................. ................................. ................................. ......................... .........3-10 3-10


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91496 U LTRAVIEW SL COMMAND M ODULE S E R V I C E M A N U A L

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To verify cardiac output performance... performance... .....................................................................3-10 3-10 SpO2 ................. ................... .................... ................... .................... .................... .......... ..................... ...... 3-10 To verify SpO2 performance performance .......................................................................................3-10 To set up the Fluke 2XLFE simulator simulator ...........................................................................3-11 3-11 To test SpO2 accuracy .................................................................................................3-11 To test SpO2 alarms ....................................................................................................3-11 NIBP .................................. .................................................. ................................. .................................. .................................. .................................. ..................... ....3-12 3-12 To verify NIBP performance................... performance................... .....................................................................3-12 3-12 To perform an optional optional accuracy test of NIBP......................... ...................................3-13 3-13 NIBP Calibration, Leakage, and Accuracy Tests................................................................. 3-13 Required Required Test Equipment for NIBP Calibration ................................. .................................................. ........................ .......3-13 3-13 Equipment Equipment Setup .......................................................................................................... 3-14 To set up the equipment for NIBP calibration, calibration, accuracy, and leakage leakage tests ..............3-14 .............. 3-14 NIBP Calibration Calibration Procedure Procedure ................................ ................................................ ................................. .................................. ..................... ....3-15 3-15 To calibrate NIBP.........................................................................................................3-15 To zero the transducers transducers ..............................................................................................3-15 3-15 To calibrate the primary primary pressure transducer transducer ............................................................ ............................................................3-16 3-16 To calibrate the low range of the safety pressure transducer....................................3-17 transducer....................................3-17 To calibrate the high range for safety pressure transducer........................................3-17 transducer........................................3-17 NIBP Leakage Test in Adult Mode .................................................................................3-18 To test leakage in Adult Adult Mode............... .....................................................................3-18 3-18 NIBP Accuracy Accuracy Test ........ ...............................................................................................3-18 To test NIBP accuracy..................................................................................................3-18 To test over-pressure over-pressure in Adult Mode....................................................... ...................3-19 3-19 To perform a functional functional check............... .....................................................................3-19 3-19 NIBP Leakage Test in Neonatal Mode ........................................................................... 3-20 To test leakage in Neonatal Mode Mode ..............................................................................3-20 3-20 To test over-pressure in Neonatal Mode....................................................................3-20 3-20 To perform a functional functional check............... .....................................................................3-21 3-21 Disassembly/Assembly Disassembly/Assembly Procedures................................................................................... 3-21 To disassemble/reassemble disassemble/reassemble the module module ....................................................................3-21 3-21

4

Tr o ubl es ho ot i ng

Module Information............................................................................................................4-1 To show the Module Info report...................................................................................4-1 4-1 Problem Solving...................................................................................................................4-1 Troubleshooting Troubleshooting Flow Charts ..............................................................................................4-2 ECG/Resp ................................ ................................................. .................................. .................................. .................................. ................................. ................4-3 4-3 Pressure ............................... ................................................ .................................. .................................. ................................. ................................. .................... ...4-4 4-4 SpO2 ........................................................................................................................................................... 4-5 Nellcor OxiMax SpO 2 Messages ................................ ................................................. ................................. ................................. ................. 4-6 OXIMETER FAILURE FAILURE Error XXX XXX ........................................................................................4-6 OXIMETER FAILURE FAILURE Error XXX XXX — Contact Contact Service Service .........................................................4-6 To attempt to restore communications communications with the module ............................................ ............................................4-6 4-6 HARDWARE INCOMPATIBILITY INCOMPATIBILITY Contact Service Service .............................................................4-6 Masimo SET SpO 2 Messages ................................ ................................................. ................................. ................................ ...................... ...... 4-7 FAULTY OXIMETER—Contact OXIMETER—Contact Service Service .............................................................................4-7 To attempt to restore communications communications with the module ............................................ ............................................4-7 4-7 HARDARE INCOMPATIBILITY Contact Contact Service ................................................................. 4-7 Spacelabs SpO2 Messages ............................... ................................................ .................................. .................................. .......................... ......... 4-7 FAULTY OXIMETER—Contact OXIMETER—Contact Service Service .............................................................................4-7 To attempt to restore communications communications with the module ............................................ ............................................4-8 4-8 HARDARE INCOMPATIBILITY Contact Contact Service ................................................................. 4-8 Cardiac Output ............................... ................................................ ................................. ................................. ................................. ........................... ...........4-9 4-9 Temperature Temperature .................................. .................................................. ................................ ................................ ................................. ........................... ..........4-10 4-10 NIBP .................................. .................................................. ................................ ................................ ................................. ................................. ....................... .......4-11 4-11

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91496 U LTRAVIEW S L COMMAND MODULE S E R V I C E M A N U A L

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NIBP Event Log .................................................................................................................. 4-12 Accessing the NIBP Event Log ................................ ................................................. ................................. ................................ .................. ..4-12 4-12 NIBP Hardware Calibration Calibration Constants Constants ................................ ............................................... ............................... ....................... .......4-13 4-13 Event Log Entries Entries .................................. ................................................... .................................. .................................. ................................. ..................4-13 Summary Summary Statistics Statistics ................................ ................................................. .................................. .................................. ................................. ..................4-14 Automatic Automatic Measurement Mode........................................................................ ................4-14

5

P ar t s

Field-Replaceable Field-Replaceable Parts (for Configurations A through L on serial numbers below 1496-1xxxxx).............................................................................................................5-1 Field-Replaceable Field-Replaceable Parts (for Configurations A through L on serial numbers above 1496-2xxxxx).............................................................................................................5-4 Assembly Drawings .............................................................................................................5 -6

A


Appen endi dix x A — Sy Symb mbo ols

III

91496 U LTRAVIEW SL COMMAND M ODULE S E R V I C E M A N U A L

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T A B L E

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C ONTENTS


91496 U LTRAVIEW SL C OMMAND MODULE S E R V I C E M A N U A L

Introduction

Overview The Spacelabs Healthcare Ultraview SL™ Command Module (91496) can acquire various physiologic data in a clinical setting. The 91496 module, a lightweight, slim modular unit, is intended for use with a Spacelabs Healthcare Ultraview® monitoring system. The 91496 module is designed to acquire and process electrocardiographic electrocardiographic (ECG), respiration, invasive pressure, noninvasive blood pressure (NIBP), temperature, cardiac output, and pulse oximetry (SpO 2) data for a single adult, pediatric, or neonatal patient. Each parameter within the module manages its own set of alarm conditions and defines its own user interface. Both waveform and numeric data are provided to the monitor via SDLC communications, for display to the care provider. Each parameter also provides the capability to output recordings of selected information to a variety of recording devices.

91496 — A

91496 — B

91496 — C

91496 — I

91496 — L

Figure 1-1 91496 Ultraview SL Command Module


1-1

INTRODUCTION


The patient is connected to the module via parameter-spe parameter-specific cific cables and/or sensors that provide the module with the patient’s physiologic data. Connectors on the front panel of the module are color coded to allow easy identification of the corresponding correspond ing cables. The input connectors are labelled as follows: Table 1-1 Input Connectors Label

Input Connector

ECG

ECG/Respiration

P1-2

Invasive Pressures 1 and 2

P3-4

Invasive Pressures 3 and 4

SpO2

Pulse Oximetry

SpO2D

Pulse Oximetry (dual)

CO

Cardiac Output

T1-2

Temperatures 1 and 2

T3-4

Temperatures 3 and 4 Noninvasive Blood Pressure (NIBP) — neonate

Noninvasive Blood Pressure (NIBP) — adult

Two user-configurable user-configurable high-level outputs are available on the front panel of the module (not available on 91496-I). The connectors are labeled as: • hlo1 • hlo2 Due to varying applications for high l evel outputs, pre-built HLO cables are not offered. A TT-253 style analog output plug is available as Spacelabs Healthcare P/N 354171-001. Cables constructed for use with HLO should incorporate a ferrite bead with 200 Ω impedance at 100 Mhz within 1 inch of the TT-253 plug to maintain EMI compliance. The TT-253 plug will have the signal on the tip, the ring is defibrillator synchronized, and the sleeve is grounded grounded.. The cuff deflate button, located on the front panel of the module, is labelled STOP. This button is used to deflate the pressure in the noninvasive blood pressure cuff. All other functions of the module can be controlled through the Ultraview or PCMS™ monitor using keys located on the monitor screen.

1-2


91496 U LTRAVIEW SL COMMAND MODULE S E R V I C E M A N U A L

INTRODUCTION

Spacelabs Healthcare equipment is intended for use under the direct supervision of a licensed healthcare prac titioner, or by personnel trained in proper use of the equipment in a hospital environment.

Do not perform safety tests when a patient is connected to the device.

The use of cellphones, RF emitting, or electrical equipment near the monitoring system could cause electromagnetic interference. Do not operate electronic devices (for example, portable communication transmitters, cellular telephones, personal computers, electronic toys, and other medical devices) within one meter (approximately 40 inches) of the patient, patient leads, or associated monitoring equipment until evaluated by the biomedical engineering staff.

The use of unapproved accessories, transducers, and cables may compromise patient and user safety, result in increased EMC EMISSIONS or decreased EMC IMMUNITY performance. •

Accessories Acces sories,, transducer transducers, s, and cables sold by Spacelabs Spacelabs have been been evaluated for performance, safety, and EMC.

•

Contact your Spacela Contact Spacelabs bs Healthcar Healthcare e represen representative tative or refer refer to to http://sa.spacelabshealthcare.com/ to purchase approved items.

Expected Service Life The expected service life of the 91496 Ultraview SL™ Command Module is seven years from the date of first use. Perform safety checks and maintenance of the device regularly. Spacelabs Healthcare offers a refurbishmen refurbishmentt program for equipmentt that has passed its expected service life. Contact your local service equipmen representative represent ative for more information. To protect the environment, properly dispose of all batteries, electronic assemblies, plastics, and metals. Follow your internal procedures or local (provincial) laws regarding disposal or recycling.


1-3

INTRODUCTION


Module Configurations The Ultraview SL Command Module (91496) is available in five multiple parameter configurations: Table 1-2 Parameter Configurations Configuration

Parameters

A

ECG/RESP/NIBP/TEMP/SPO2

B

ECG/RESP/NIBP/TEMP/SPO2/P1-2

C

ECG/RESP/NIBP/TEMP/SPO2/P1-2/P3-4/CO

I

NIBP/TEMP/SPO2

L

TEMP/SPO2D/P1-2/P3-4

Options for the following features are also available: Table 1-3 Options Option

Features

Option D

Diagnostic 12-lead reports with interpretation.*

Option E

Diagnostic 12-lead reports without interpretation.*

Option F

Basic Arrhythmia; provides alarms for high and low heart rate, asystole and ventricular fibrillation.* fibrillat ion.*

Option G

Multiview™ I: enables users to review trends of abnormals per minute; provides alarms for high and low heart rate, asystole, ventricular fibrillation, abnormals per minute and abnormals in a row.*

Option H

Multiview II: enables users to review the dominant morphology as well as episodes or classes of ventricular fibrillation, ventricular tachycardia (runs), couplets, single abnormals, tachycardia, pauses, ventricular and atrio-ventricular pacing; provides alarms for high and low heart rate, asystole, ventricular fibrillation, abnormals in a row, abnormals per minute, and tachycardia.*

Option M

Pulse oximetry (SpO 2); compatible with Masimo SET sensors.

Option N

Pulse oximetry (SpO 2); compatible with Nellcor OxiMax sensors.

Option O

Pearl white color option (Ultraview SL monitors).**

Option R

Respiration.*

Option S

ST segment analysis, review, and trends.

Option U

Pulse Oximetry (SpO 2); compatible with Nellcor and Novametrix sensors.

Option V

Varitrend® 4; define, trend, and document critical physiological events containing data from up to four parameters, including heart rate, SpO2 (pre- and post-ductal sites), respiration rate, EtCO2, TcpCO2, and TcpO2*

Option W

Arctic white color option. * Not available available with with the 91496-I 91496-I and and 91496-L 91496-L configurati configurations. ons. ** Not available available with the 91496-L 91496-L configuration. configuration.

1-4



INTRODUCTION

Specifications Physical Dimensions Height: 11.3 cm (4.45 inches) Width: 5.66 cm (2.23 inches) Depth: 18.0 cm (7.10 inches) Weight: 0.8 kg (1.75 pounds)

Electrical Specifications Operating Voltages: +%, +12, and -12 VDC Power Consumption: Consumption: 3.0 watts nominal, 5.5 watts maximum with pump active Battery Backup: 10 minutes

Environmental Requirements Operating Temperature:: 0° C to 50° C (32 ° F to 122° F) Temperature Humidity: 95% (non-condensing) up to 30 ° C (86° F) 10% to 75% up to 40 ° C (104° F) 10% to 45% up to 50 ° C (122° F) Altitude: 0 to 3,000 meters (0 to 9,843 feet)

Transport and Storage Temperature:: -40° C to 75 ° C (-40° F to 167° F) Temperature Humidity: 95% (non-condensing) up to 50 ° C (122° F) 10% to 50% up to 75 ° C (167° F) Altitude: 0 to 12,192 meters (0 to 40,000 feet)

Setup Unpacking Before unpacking the module, inspect the shipping container for visible damage. Unpack and remove the module from the container and verify that all parts on the order are included. Inspect each item for signs of damage. If damage is detected, notify the freight company and Spacelabs Healthcare immediately.


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1-6

INTRODUCTION



Theory

Overview The module has a main processor and three specialized front ends. The main processor performs the following functions: • Send Sendss configura configuration tion and and control control commands commands to the the front front end. end. • Proce Processes sses data data and status status informati information on received received from from the front front ends. • Sends Sends waveform, waveform, numer numeric, ic, and alarm alarm data data to the monito monitorr via an SDLC communications link. • Proce Processes sses comma commands nds rece received ived from the moni monitor. tor. Each of the front ends performs the following functions: • Amplifies Amplifies and preco preconditi nditions ons the input input signals signals acquired acquired from from the patientpatientconnected sensors. • Scans the prep preproces rocessed sed analo analog g inputs inputs.. • Conve Converts rts the the signals signals to to a digital digital repre represent sentation ation.. • Sen Sends ds the the data data to the the main main proces processor sor..


2-1


THEORY

CPU/NIBP The main processor and the noninvasive blood pressure front end are located on a single PCBA, which is referred to as the CPU/NIBP board. The CPU controls and acquires data from the analog front-end board. The NIBP front end, which consists of a pump, valve assembly, and two microprocessors, controls the inflation and deflation of the cuff.

Main Processor The main processor is an MPC860 Power PC quad integrated communications controller (QUICC) operating at 50 MHz. The cl ock reference is provided by a 32.768 kHz crystal connected to the main clock oscillator pins of the MPC860.

Memory Program memory consists of 8 MB flash memory and 8 MB SDRAM. SDRAM is powered by 3.3 volts. There is also a 64 KB EEPROM that is used to store the module’s configuration programming (sysgen).

Synchronous Data Link Control (SDLC) Interface The SDLC interface uses the SCC2 serial port of the MPC860 operating at a data rate of 1.892532 MHz.

Front-End Communications Interfaces The front ends communicate with the main processor using the SCC and SMC serial channels of the MPC860 in the UART mode. Each channel is configured for one stop bit and odd parity. The communication communicationss interface for the ECG and respiration front end use the SCC3 port operating at 250 kbaud. The communications interface for invasive pressure, temperature, cardiac output, and SpO 2 front end uses the SCC4 port operating at 125 kbaud. The communications interface for noninvasive blood pressure uses the SMC2 port operating at 9.6 kbaud (refer to Assembly Drawings on Drawings on page 5-6 for 5-6 for the block diagram).

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THEORY

NIBP Front-End Controllers Two processors are associated with the NIBP front end, a PIC16C63 (the Communicationss Processor) and a PIC16C711(the Safety Processor). Communication The PIC16C63, Communications Processor, performs the following functions: • Initializes Initializes the the primary primary A/D converter converter per per commands commands received received from from the MPC860. • Samples Samples the primary primary A/D conver converter ter and transm transmits its the pressur pressure e samples samples to the MPC860. • Turns Turns ON the pump and and adjusts adjusts the pump pump speed speed per commands commands receive received d from the MPC860. • Opens Opens or closes the the vent, bleed, bleed, and mode mode valves valves per commands commands receive received d from the MPC860. • Turns OFF the pump pump or closes the bleed valve when the the targeted targeted pressure pressure has been reached (Adult Mode) or a specified time has elapsed (Neonatal Mode). • Responds Responds to to a press of of the red red STOP button button,, on the face face of the the module, module, by stopping the pump, opening the vent valve, and sending a message to the MPC860 indicating that the reading has been canceled. • Relay Relayss messages messages betwee between n the MPC860 MPC860 and the the Safety Safety Processo Processor. r. The PIC16C711, Safety Processor, performs the following functions: • Communica Communicates tes with the the Communicat Communications ions Process Processor, or, which which in turn relays relays its messages to the MPC860. The Safety Processor also receives messages from the MPC860, which have been relayed by the Communications Processor. Processor. • Posts the the cuff pressur pressure e obtained obtained from the the backup backup transduce transducerr and A/D converter to the MPC860 (through the Communications Processor). Processor). The MPC860 compares these pressures to those obtained from the primary transducer A/D converter. • Monit Monitors ors the the amount amount of of time the cuff cuff is infla inflated. ted. • Monitors Monitors the amount amount of time time the cuff cuff is deflated deflated to insure insure that the minimum minimum deflation time has expired. • Monitors Monitors the cuff cuff pressure pressure,, with a backup transd transducer ucer and and A/D converte converter, r, to insure that the maximum allowed pressure limit has not been exceeded. • Disables Disables the pump pump and and valves valves if any of the above above safet safety y limits are violat violated. ed. When the valves are disabled, they default to an open condition which allows the air to be vented from the cuff. The Safety Processor also posts a notification message to the MPC860 (through the Communication Processor) when it disables the pump and valves. • Receives Receives notificat notifications ions of the the start of reading readings, s, and whether whether the the start was a result of a manual or short-term auto initiation.


2-3

THEORY


Refer to Figure 2-1. 2-1.

TOUCH STAT KEY

CLOSE VALVE START PUMP

NO

DOES CUFF PRESSURE = 170 mmHg?

YES STOP PUMP

BLEED CUFF BY 7 - 9 mmHg

LARGE OSCILLOMETRIC PEAKS DETECTED?

YES

START PUMP NO BLEED CUFF BY 7 - 9 mmHg

INCREASE CUFF PRESSURE BY 50 mmHg

SAMPLE AND STORE AMPLITUDE OF OSCILLOMETRIC PEAKS AND CUFF PRESSURE

NO

STOP PUMP

YES

NO IS CUFF PRESSURE > 290 mmHg?

IS CUFF PRESSURE LESS THAN 80 mmHg?

YES CAN SYSTOLE & DIASTOLE BE DETERMINED?

YES

NO

NO

IS CUFF PRESSURE LESS THAN 20 mmHg?

YES

OPEN SYSTEM (READING COMPLETED)

REPORT DATA TO MONITOR

STOP

Figure 2-1 NIBP front-end controllers

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THEORY

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ON = COM PROCESSOR Controls Pump and the Valves OFF = SAFETY PROCESSOR Shuts off the Pump and Valves

Figure 2-2 NIBP front end


2-5

THEORY


Analog Front End (AFE) The analog front ends which support ECG, respiration, invasive pressure, temperature, cardiac output, and SpO 2 are located on a single printed circuit board assembly (PCBA), which is referred to as the Analog Front End (AFE) (refer to Drawing 1 in 1 in the attachments for the block diagram). The ECG/Resp front end is based on a discrete circuit design. The BP/Temp/CO/Option U (SpO 2) front end includes an application-specific integrated circuit (ASIC) that is proprietary to Spacelabs Healthcare. Amplifier gain values, multiplexer address selections, and calibration modes within the ASIC are configured by programming an internal set of registers, which are accessed through a serial interface. The ASIC serial interface is connected to the front-end controller through the same serial peripheral interface bus that the A/D converters use to output their data streams. Refer to Drawing 7 in in the attached schematics for a diagram of analog front end P/N 670-0842-xx. Options M and N SpO 2 require a revised AFE PCB (Spacelabs Healthcare P/N 670-1305-xx). This AFE allows the OEM SpO2 PCBA to be mounted as a daughter board. The OEM SpO 2 PCB drives the SpO 2 sensor and calculates all SpO 2 values, and then it transmits the values serially to the main CPU PCBA. Refer to Drawing 8 in the attached schematics for a diagram of analog front end P/N 670-1305-xx.

Patient Inputs (Refer to Drawing 1 in 1 in the attachments for the block diagram). The ECG inputs are routed first to a defibrillator and electrosurgical interference suppression suppressio n interface. The defibrillation voltage protection network consists of a 1K,1 watt resistor in series with each leadwire located in the ECG cable yoke and a neon bulb for each input located on the AFE board, which clamps any input over voltage to approximately 70 volts. This is followed by a 3-pole passive low-pass filter with cut-off at approximately 6 k Hz, which provides current limiting into the input buffers and removes high-frequency interference signals. The respiration excitation is a 65 kHz square wave at approximately 200 µA ±20 µA peak-to-peak, filtered by a 78 kHz single-pole R/C low-pass filter. The filtered signal is coupled to the limb leads through a series resistor and capacitor, which limits the patient-applied patient-applie d current to a nominal 120 µA RMS. The invasive pressure, temperature, and cardiac output inputs are routed first to an electro-surgical electro-surg ical interferen interference ce suppression and electrostatic discharge protection interface. Each interface consists of a 2-pole passive low-pass filter with cut-off from approximately 400 Hz to 2.5 kHz, which removes high frequency interference interference signals. The SpO2 (Option U) inputs are protected from EMI radiation by a single-pole filter with a cut-off at approximately 850 kHz.

2-6



THEORY

Front-End Controllers The controller for the ECG/Resp front-end is a Motorola 68HSC705C8A microcontroller with on-board ROM and RAM. The front-end controller includes a serial peripheral interface (SPI) port, which is used to program and read data from a 14-bit A/D converter, and an on-board serial UART port, which communicates across the isolation barrier with the main processor at 250 kbaud. Two optical couplers (one in each direction) provide a minimum isolation voltage of 4000 VRMS. The controller for the BP/Temp/CO/SpO 2 front-end is a Motorola 68HC705C8A micro-controller with on-board ROM and RAM. The front-end controller includes a serial peripheral interface (SPI) port, which is used to program and read status from the ASIC and data from the three A/D converters, and an on-board serial UART port, which communicates across the isolation barrier with the main processor at 125 kbaud. Two optical couplers (one in each direction) provide a minimum isolation voltage of 4000 VRMS.

A/D Converters A/D conversion of the input signals is performed by one of four low-power A/D converters: • ECG and and respiratio respiration n data are are routed routed to a 14-bit 14-bit A/D conver converter. ter. • Invasive Invasive pressure pressure,, temperature temperature,, and cardiac cardiac output data data are routed routed to a 16-bi 16-bitt A/D converter. • SpO2 data are routed to two 20-bit A/D converters.

Isolated Power Supplies DC voltages are generated by a DC/DC converter, which operates off the +12 VDC supply from the monitor. A switching inverter circuit, located on the non-isolated side of the isolation barrier, switches the +12 volts into a transformer which spans the isolation barrier. On the isolated side, the square wave AC is rectified and filtered to provide a nominal ±6 DC and +11 VDC. Separate linear regulators reduce this to +5 VDC for the logic, ±5 VDC for the analog circuits, and +10 VDC for the ASIC.


2-7


2-8

THEORY



Maintenance

Overview If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.


•

Observe Observ e precautio precautions ns for handlin handling g electrosta electrostatic-s tic-sensiti ensitive ve devices! devices!

•

Never touch elect electrostat rostatic-se ic-sensitive nsitive elect electronic ronic compone components nts without without following proper anti-static procedures, including the use of an ESD wrist band and mat. An electrostatic discharge from your fingers can permanently damage electronic components.

•

All static-sen static-sensitive sitive elect electronic ronic compone components nts are are packaged packaged in in staticstaticshielding bags. Retain the bag for repackaging the component, should you need to store it or return it to Spacelabs Healthcare for any reason.

•

Cleaning, Cleanin g, preventiv preventive e maintenan maintenance, ce, and and safety safety checks checks should be performed annually and following any product disassembly/assembly. Preventive maintenance and safety checks must be performed by trained personnel only.

3-1

M A I N T E N A N C E


Cleaning/Disinfecting General •

Use only only recomm recommend ended ed cleanin cleaning g solutio solutions, ns, or you you may void void the manufacturer’s warranty.

•

Harsh chemic chemical al agents agents degrade degrade plastics plastics and and will compro compromise mise the the safety safety of the device. Some germicidal and other harsh cleaning compounds are known to damage some plastics by weakening the structural integrity and compromising the electrical insulating properties.

•

Disconnect the Disconnect the equipment equipment from the the patient patient and and the electr electrical ical supply supply before cleaning.

•

Do not allow liquid liquid to enter the interior interior of the module or monitoring monitoring equipment.

•

Do not immers immerse e the equipme equipment nt or cables in in water water or cleaning cleaning solutions. solutions.

•

Do not not au auttoc ocla lave ve..

•

Accelerated Hydroge Accelerated Hydrogen n Peroxide Peroxide (AHP) and quaterna quaternary ry ammonia-b ammonia-based ased products ARE NOT RECOMMENDED for cleaning monitors and cables. These chemicals degrade plastics used in patient monitors and cables, and can cause serious safety hazards as the electrical insulating properties and structural integrity of the equipment break down.

•

Cavicide, Cavicid e, Virex, Virex, Virex Virex 256, PDI Sani-Clot Sani-Cloth h Bleach Bleach Plus, Super Sani-Clo Sani-Cloth, th, and Sani-Cloth AF3 are common quaternary ammonia germicidal products. The manufacturers of these solutions advertise that these germicidal products are safe for use on hard, non-porous surfaces, such as linoleum floors, formica countertops, and stainless steel. The manufacturers discourage the use of quaternary ammonia germicidal products on computer-grade plastics and on data, pa tient, and power cables, which are classified as porous materials.

•

Use caution caution when when cleaning cleaning cable connect connectors ors so that that liquid liquid is not not permitted to collect around the electrical contacts or seep inside the connector. Trapped liquids and surface residues provide an unintentional electrical path, which may cause noisy si gnals and false alarms.

•

Questions Quest ions and and concerns concerns about about cleaning cleaning issues issues should should be direct directed ed to a Spacelabs Healthcare field service engineer.

Note: For cleaning instructions for an Original Equipment Manufacturer (OEM) device, refer to the user manual for that product. For cables, use only the following recommend recommended ed cleaning solutions:

3-2

•

Mild Mi ld so soap ap an and d wa wate terr so solu luti tion on

•

U.S.. Pha U.S Pharma rmacop copoei oeia a (US (USP) P) gr green een soa soap p




•

Sodium hypochlo Sodium hypochlorite rite soluti solution on (1:10 (1:10 dilution dilution of of househo household ld chlorine chlorine bleach bleach in water)

•

Pheno Phe nolic lic germi germicid cidal al deterg detergen entt (1% aque aqueous ous solu solutio tion) n)

•

Glut Gl utar aral alde dehy hyde de (2 (2.4 .4%) %) (C (Cid idex ex))

•

Isop Is opro ropy pyll alco alcoho holl (70% (70% sol solut utio ion) n)

•

PDI Sani Sani-Cl -Cloth oth Blea Bleach ch (sodi (sodium um hypo hypochl chlori orite te 0.63% 0.63%))

For modules and monitors, use only the following recommend recommended ed cleaning solutions: •

Mild Mi ld so soap ap an and d wa wate terr so solu luti tion on

•

U.S.. Pha U.S Pharma rmacop copoei oeia a (US (USP) P) gr green een soa soap p

•

Sodium hypochlo Sodium hypochlorite rite soluti solution on (1:10 (1:10 dilution dilution of of househo household ld chlorine chlorine bleach bleach in water)

•

Pheno Phe nolic lic germi germicid cidal al deterg detergen entt (1% aque aqueous ous solu solutio tion) n)

•

Glut Gl utar aral alde dehy hyde de (2 (2.4 .4%) %) (C (Cid idex ex))

•

Isop Is opro ropy pyll alco alcoho holl (70% (70% sol solut utio ion) n)

•

Diversey Oxivir wipe Diversey wipess (benzyl (benzyl alcoh alcohol ol 1 to 5% and hydro hydrogen gen pero peroxide xide 0.5 to 2%)

•

Clorox Healthc Clorox Healthcare are wipes wipes (ben (benzyl zyl alcohol alcohol 1 to 5% and hydro hydrogen gen pero peroxide xide 0.5 to 2%)

Notes: •

Accelerated Accelerate d Hydrogen Hydrogen Peroxide Peroxide (AHP) (AHP) contains contains hydrogen hydrogen peroxid peroxide e and low concentrations of phosphoric acid. AHP is different from cleaners containing hydrogen peroxide mixed with alcohols and specifically NOT recommended for cleaning Spacelabs Spacelabs Healthcare products. products.

•

Over time, time, repeated repeated use of of a chlorine chlorine bleach bleach solution solution may may cause cause some some colors colors to fade.

•

Tape adhe adhesive sive can can be remo removed ved with with Spacel Spacelabs abs Healt Healthcar hcare e adhesive adhesive tape remover pads (P/N 392196-001).

To clean monitors, modules, and cables 1

Prepare the cleaning solution according to the manufacturer’s instructions.

2

Wet a clean cloth with the selected cleaning solution.

3

Remove excess liquid from the cloth and squeeze dry.

4

Wipe exposed surfaces of the equipment and cables.

5

Remove any soap residue by gently wiping with a clean damp cloth.

6

Wipe dry with a clean dry cloth.

Notes:


•

After cleani cleaning ng ECG lead lead wires, wires, remove remove the the ECG lead lead wires from the the lead block and thoroughly dry them at the lead block ends and at the lead connector ends. Thorough drying will prevent residual moisture from providing a low-current low-current path between leads, leads, which can interfere interfere with lead off detection and cause false asystoles.

•

Follow Follo w your hospit hospital al protocol protocol for the the handling handling of blood blood and and body fluids fluids..

3-3



Safety The defibrillation protection scheme of this device relies upon isolated circuitry and the insulation of patient cables and applied parts. Note: Spacelabs Healthcare’s products and parts are designed and manufactured in accordance with FDA’s Quality System Regulation (QSR) and in compliance with all applicable regulatory requirements. To ensure proper operation in accordance with these guidelines, Spacelabs Healthcare products must be maintained by trained technicians using only authorized replacement parts. Spacelabs Healthcare replacement parts have been thoroughly tested to ensure reliable performance. Inputs in the module are electrically isolated. Leakage current between the module and ground-related ground-related circuits is less than 10 µA and meets UL 60601-1, AAMI ES1, and IEC 60601-1 standards. All input circuits are electronically protected from electrosurgical electrosurgical devices. For maximum patient and operator safety, adhere to the following recommendations: recommendations: • Do not not use use the the mod module ule if it is wet. wet. • Do not use the the module module or any any cable if it shows shows signs signs of damag damage. e.

Maintenance Use the latch on the lower portion of the module to remove it from the monitor. Inspect the connector on the rear of the module for bent or damaged connector pins. If the module has been damaged in any way, a qualified service technician should check it for acceptable equipment integrity and electrical safety. Visually inspect all cables for cracks, acute bends, etc. Do not use cables, sensors, cuffs, or transducers that show damage. Clean cables and accessories according to the manufacturer’s instructions.

Preventive Maintenance A qualified service technician should check the module for acceptable performance at 12-month intervals, or at an interval determined to be appropriate by an effective risk-based equipment managemen managementt program. There are no internal adjustments to perform on this module. If the module has been damaged, check it for proper operation, and make sure its measuremen measurements ts are accurate. Test equipment (required): • Sa Safe fety ty an anal alyz yzer er • Patie Patient nt simula simulator, tor, Fluke 217A (or equi equivalen valent) t) • SpO2 simulator, Novametrix TB500B (option U only), or Fluke 2XLFE (or equivalent) or OxSIM OX-1 for options M, N, and U • Ma Mano nome mete terr (re (refe ferr to to NIBP NIBP on on page 3-12) 3-12 )

3-4




Note: According to the international international performance performance standard ISO 9919:2005, SpO2 simulators and functional functional testers can only be used to make sure that pulse oximeter monitors and the electrical integrity of the pulse oximeter probes function properly. They cannot characterize characterize or validate the complex complex interaction between the probe optics and the skin that determine the true accuracy of the probe, pulse oximeter oximeter monitor, and probe/pulse probe/pulse oximeter oximeter monitor combinations. • Cal Calibr ibrati ation on cable cable (P/N (P/N 175175-102 1023-0 3-00) 0) Test equipment (optional): • NIBP simul simulator, ator, Fluke Cuff Link (or equi equivalen valent) t) • Cardiac Cardiac output output simulator simulator,, Med Sim 300B with with cardiac cardiac output output option option (or equivalent)

Electrical Electr ical Safety S afety Testing Testing Safety testing protects the patient from electrical shock, especially micro-shock. It has been determined experimentally experimentally that current values i n the microampere ( µA) range may cause fatal arrhythmias in electrically susceptible patients. A patient is deemed electrically susceptible when connected to monitoring equipment.

Definitions Chassis Leakage

Current flowing from the enclosure (or from conductive parts accessible to the operator) through the ground conductor.

Classification

IEC/EN/UL 60601-1 Safety standard designation for the class of equipment and type of patient applied parts that indicate the degree of protection provided against electrical shock.

Leakage Current

Current that is not functional. It includes patient leakage, ground leakage, and enclosure (or chassis) leakage.

Normal Condition

Condition in which all means provided for protection are intact. Includes ground connections, insulation, creepage and clearance distances.

Patient Lead Leakage

Current that flows from the applied part of the patient lead to ground.

Single Fault Condition

Open ground, open neutral, line voltage on a patient connection, or any single state other than normal condition that could compromise patient safety.

UUT

Unit Under Test

Spacelabs Healthcare does not endorse standards to the exclusion of others. BE SURE TO CHECK YOUR LOCAL REQUIREMENTS TO ENSURE YOUR EQUIPMENT SAFETY TESTS COMPLY WITH LOCAL STANDARDS . Generally accepted standards for medical monitoring equipment, such as the Underwriters Laboratory (UL) and the National Fire Protection Association (NFPA) standards, are summarized in Table 3-1. 3-1.


3-5



Table 3-1 Summary of Standards for Medical Monitoring Equipment International Mains to Chassis Leakage

US (120 V) Mains to Chassis Leakage

100 µA - normal condition, ground attached (AC connector to chassis)

300 µA - normal condition, ground attached (AC connector to chassis)

500 milliohms*

500 µA - single fault condition, open ground or reverse polarity

300 µA - single fault condition, open ground or reverse polarity

500 milliohms*

Mains Resistance

* Measured Measured from the AC Power Power cord third third wire ground ground to the most distant distant ground ground attachment attachment

Equipment Required: Electrical Safety Analyzer, Fluke model 232D or equivalent These tests should be done according to the hospital’s scheduling requirements, requirements, at least annually, or after repair or modification.

Before starting safety tests, make sure that no patient is connected to the device under test. If safety tests must be done on equipment currently monitoring a patient, obtain permission to disconnect the cables from the monitor and from the patient. Note: All tests must be done done according to the the safety analyzer’s operations manual, manual, and any local requirements.

Ground Resistance To test ground resistance 1

Attach the power cord to the monitor under test, then measure the resistance from the AC power cord third wire ground to a chassis location, such as the equipotential post on the rear of the monitor.

2

Make sure that the resistance is less than 500 milliohms (0.5 ohms).

Chassis Leakage Current Tests To test chassis leakage

3-6

1

Plug the leakage analyzers into mains power.

2

Plug the equipment into the analyzer’s AC receptacle.

3

Make sure that the leakage current from the chassis to ground is less than the values in Table 3-2. 3-2.




Table 3-2 Enclosure Leakage Test Conditions and Limits Neutral Condition

Ground Condition

Polarity

International Limit

Domestic Limit

Closed neutral

Closed ground

Normal polarity

100 µA

300 µA

Open neutral

Open ground

Normal polarity

500 µA

300 µA

Closed neutral

Open ground

Normal polarity

500 µA

300 µA

Patient Lead Leakage Current Tests (Patient Modu les) Before you can do the Patient Lead Leakage Current Test, make sure that the monitor passes the ground resistance and chassis current leakage tests. Spacelabs Healthcare recommends recommends that the equipment be operating for 30 minutes prior to the test to allow thermal stabilization. If a 12-lead patient cable is used with the test module, do the tests using the 12-lead cable.

To test patient leads current leakage 1

Measure the leakage current between each of the patient leadwires and the ground lug on the monitor back panel. Also, measure the leakage current between all combinations of ECG leads and ground. The current must be less than 10 µA with the ground connected, and 50 µA with the ground open.

To test leakage current to ground with 50/60 Hz 1

Apply AC mains voltage to leads and measure the leakage current between each of the ECG l eadwires and the ground lug on the monitor back panel. The current must be less than 50 µA at any li ne voltage.

Hardware and Mechanical Checks Make sure that: • th the e mod modul ule e is is clea clean n • al alll scr screw ewss ar are e tig tight ht • the fron frontt panel panel connec connectors tors are not not damage damaged d • the rear pane panell connect connector or pins pins are are not not damage damaged d • th the e case case is is not not dama damage ged. d.


3-7



Performance Verification Before you insert the module into a module housing or monitor, check the model and option numbers against the list of module configurations. Connect one or more of the simulators listed under test equipment to the module to complete the procedures that follow. Note: The procedures that follow are for software version 2.04.00 and newer. Refer to earlier revisions of this manual for modules with earlier software versions.

ECG To verify ECG performance

3-8

1

Display Response —Make — Make sure that the ECG key is shown. Connect the simulator to the ECG input connector on the module’s front panel.

2

Accuracy — Set — Set the simulator input to normal sinus rhythm (NSR) at 60 beats per minute (bpm). Wait for rate alarms to be enabled, then turn the alarms OFF. Make sure that the rate shown is accurate within 2 bpm. Change the simulator input to 30, 120, and 240 bpm and make sure that the rate shown is accurate within 2 bpm or 1% (whichever is greater).

3

Rate Alarms — Turn the alarms ON. Change the simulator input to violate the high and low rate alarm limits. Make sure that the alarms function properly. properly.

4

Arrhythmia Detection — Detection — Change the input to PVC 12/mi n (found under VENT RHYTHMS 1). When the fifth PVC leaves the display, make sure that VE/Min = 1. After approximately 60 to 70 seconds, make sure that VE/Min = 12.

5

Asystole — Change the input to asystole (found under VENT RHYTHMS 2). Asystole — Make sure that an alarm sounds and the rate shown is 0 within approximately 5 ±1 seconds.

6

Lead Select — Select — Change the simulator input to 80 bpm. Make sure that all lead configurationss for the ECG cable selected are available. configuration

7

Lead Fault — Fault — Disconnect each lead, one at a time. Make sure that the message CHECK XX (where XX is the selected lead) is temporarily shown in the ECG waveform zone for each lead removed.

8

Pacer Detection — Detection — Enable the pacer detection. Change the simulator input to ASYNC 75 bpm. Make sure that a pacer flag is superimpo superimposed sed on the ECG waveform.




Respiration (Option R) To verify respiration performance 1

Display Response — Response — Make sure that the RESP key is shown. If not, enable the respiration function through the ECG menu (refer to the Clinical Parameters Operations Manual (P/N 070-2113-xx) located on the Bedside, Central, and Telemetry Systems CD-ROM CD-ROM (P/N (P/N 084-1101-xx) for instructions). Connect the simulator to the ECG input connector on the module’s front panel.

2

Rate Accuracy — Accuracy — Set the simulator input to a respiration rate of 20 breaths per minute (BPM). Make sure that the rate display is accurate within 1 BPM or 5%. Change the simulator input to 15, 40, and 60 BPM and make sure that the rate shown is approximately 1 BPM or 5% (whichever is greater).

3

Rate Alarms — Alarms — Turn the alarms ON. Change the simulator input to violate the high and low rate alarm limits. Make sure that the alarms function properly. properly.

4

Apnea — Set the apnea alarm limit to 5 seconds. Change the simulator input Apnea — to Apnea. Make sure that within approximately 5 ±1 seconds, an alarm sounds and the rate shown is 0.

Invasive Pressure (Option B or Option C) Note: Your pressure labels may differ, depending upon your Module Configuration Manager settings.

To verify invasive pressure performance


1

Display Response — Response — Connect the simulator to the P1 pressure input and make sure that the parameter key is labelled ART.

2

Zero — Set the simulator to atmosphere and make sure that the module Zero — zeros properly.

3

Accuracy — Change the simulator input to pressure values of 0, 100, and Accuracy — 200 mmHg. Make sure that the pressure display is accurate within ±2% or ±2 mmHg, whichever is greater.

4

Alarms — Turn the alarms ON. Change the simulator input to violate alarm Alarms — limits and make sure that the alarms function properly. Test systolic, mean, and diastolic alarms where applicable.

5

Connect the simulator to the P2 pressure input. Make sure that the parameter key is labelled PA. Repeat steps 2 through 5.

6

Connect the simulator to the P3 pressure input. Make sure that the parameter key is labelled CVP. Repeat steps 2 through 5.

7

Connect the simulator to the P4 pressure input. Make sure that the pressure key is labelled PRS. Repeat steps 2 through 5.

3-9



Temperature To verify temperature performance 1

Display Response — Response — Connect the simulator to the T1 (or T2) temperature input connector and make sure that the parameter key is labeled T1 (T2).

2

Accuracy — Set the simulator input to 30 ° C. Make sure that the temperature Accuracy — shown for T1 (T2) is accurate within ±0.2 ° C.

3

Alarms — Turn the alarms ON. Change the simulator input to violate the Alarms — alarm limits and make sure that the alarms function properly.

4

Repeat steps 1 through 3 for T2.

Cardiac Output To verify cardiac output performance 1

Display Response — Response — Connect the simulator to the CO input connector. Make sure that the blood temperature (T B) and injectate temperature (T I) are shown.

2

Curve Display — Display — Enter the appropriate computational computational constant for the simulator and touch ENTER. Set the simulator for AUTO SENSE and initiate a curve. Make sure that a CO curve is shown. Repeat this step for two more curves.

3

Average — Touch AVERAGE and then touch YES. Make sure that the three CO Average — values are averaged.

SpO Sp O2 To verify SpO 2 performance 1

3-10

For option M modules, connect the Masimo SET adapter cable (P/N 700-0789-xx or P/N 700-0906-xx) and appropriate Masimo sensor to the SpO2 connector of the module. •

For option option N modul modules, es, conne connect ct the Nellco Nellcorr OxiMax OxiMax adapter adapter cable cable (P/N 700-0792-xx) and appropriate Nellcor sensor to the SpO 2 connector of the module.

•

For optio option n U module modules, s, connect connect the appro appropriat priate e SpO 2 cable adapter (P/N 700-0030-xx for TruLink sensors, or P/N 700-0029-xx for Digital (Novametrix) sensors) and the appropriate sensor to the SpO 2 connector of the module.

2

Connect the SpO 2 sensor to the Fluke 2XLFE (or equivalent) simulator.

3

Complete the SpO 2 test procedures that follow.




To set up the Fluke 2XLFE simulator 1

Power ON the simulator. Use the ? keys at the bottom of the display to make selections or to change the values of the parameters.

2

more.. Press more

3

make.. Press make

4

Press + or - to select the correct probe for the test. Select Nellcor, Masimo, or Novametrix.

5

Press esc esc..

6

Press more more..

7

Press sim sim..

8

man.. Press man

9

Press + or - to change the parameters, or to change the bpm values or saturation levels. If you are using a simulator other than the Fluke 2XLFE, confirm that the simulator in use is compatible with Masimo sensors (for option M modules), Nellcor OxiMax sensors (for option N modules), and TruLink or Dixtal sensors (for option U modules). Refer to the simulator user’s guide for setup instructions.

To test SpO 2 accuracy 1

Set the simulator to the bpm and saturation settings in Table 3-3. 3-3. Table 3-3 Accuracy

Simulator Setting Monitor Display Saturation (%) bpm

Saturation (%)

100

100

100 ±2

100

74

74 ±3

100

50

50 ±2

75

100

100 ±2

75

74

74 ±3

75

50

50 ±2

50

100

100 ±2

50

74

74 ±3

50

50

50 ±2

2

Confirm that the monitor shows the saturations levels indicated in Table 3-3. 3-3.

To test SpO 2 alarms


1

Enable the ALARMS key on the monitor.

2

Change the alarm values to test that the alarms feature functions properly.

3-11



NIBP To verify NIBP performance 1

Connect the NIBP adapter hose to an NIBP cuff.

2

Wrap the cuff around a solid object.

3

ADULT.. Touch ECG and make sure that the module is set to ADULT

Notes: •

Figure 3-1 and 3-1 and Figure 3-2 show 3-2 show menus and keys for the XPREZZON™ monitor. Keys on the Ultraview and Ultraview SL monitors may look different, but the key stroke sequence is the same.

•

Depending on the Module Depending Module Configur Configuratio ation n Manager Manager settings, settings, the patient patient type type menu can have different selections. If the ADULT key is not present, you will need to change the AVAILABLE the AVAILABLE PATIENT TYPE setting. setting. Refer to the Module Configuration Operations Manual for more information.

•

After doing doing the NIBP NIBP procedure procedure,, make sure sure you reconfi reconfigure gure the the module module to the default MCM settings.

Figure 3-1 ECG MENU 4

If ADULT is not shown, touch the current patient type key.

Figure 3-2 ECG - PATIENT TYPE options 5

Touch ADULT, and then touch APPLY.

Note: Depending on the Module Configuration Manager settings, the patient type menu may have different selections. 6

Touch START. Make sure that: a

The cuff inflates to approximately 165 mmHg (adult).

b

The cuff begins to deflate in approximately 8 mmHg steps (adult).

c

The cuff deflation continues until the pressure is approximately 15 mmHg (adult).

d

Data is shown. The message Insufficient Data is

e

The message Second Reading Required is Required is shown.

f Do Step a through a through Step c again. c again.

3-12




7

START,, then touch the STOP STOP button. Touch START button. Make sure that the pump stops and that the cuff deflates to less than 15 mmHg within 30 seconds. Unwrap the cuff and disconnect the manometer.

8

Take a reading.

9

ON.. Turn S/D/M alarms to ON

10 Adjust the alarm limits to make an alarm condition occur on the next measurement. 11 Take another reading and make sure that the alarms function properly.

To perform an optional accuracy test of NIBP 1

Connect the simulator to the NIBP adapter hose.

2

Set the simulator input to a specific pressure setting.

3

Select automatic readings at 1-minute intervals.

4

Allow the module to acquire several readings.

5

Make sure that the readings are within 5 mmHg or 5% of the simulator setting, whichever is greater.

6

Change the simulator input to a different pressure setting and repeat as desired.

Note: An auscultatory auscultatory standard standard is used used by Spacelabs Healthcare Healthcare and certain simulator simulator manufacturers to validate their products. Other simulator manufacturers (and manufacturers of NIBP modules) use an invasive arterial standard. The auscultatory standard standard for diastole is approximately 7 mmHg more than the invasive arterial standard. Therefore, the Spacelabs Healthcare NIBP diastole may be approximately 7 mmHg more than the settings on those simulators.

NIBP Calibration, Leakage, and Accuracy Tests Spacelabs Healthcare recommends performance performance checks every two years or after maintenance and repair.

Required Test Equipment for NIBP Calibration Table 3-4 Required Test Equipment Description

Part Number

Kit, NIBP Calibration, 90496 and 91496

025-0200-00

• NIBP calibration cable (quantity 1)

175-1023-00

• Tu Tubing, polyurethane (2 ft)

166-0011-00

• Tubing, silicone (2 ft)

162-0019-00

• 10 1 00 cc container (quantity 1)

066-0609-00

• Te Tee, Tubing (quantity 2)

214-0159-00

• Fitting, Female, with barb (quantity 1)

376-0010-00


3-13



Table 3-4 Required Test Equipment Description

Part Number

• Fitting, Male, with barb (quantity 2)

134-0045-00

• Hand Pump (quantity 1)

706-0178-00

• Cl Clamp, Hose (quantity 1)

343-0389-00

• Label, NIBP Calibration, 90496, (quantity 1)

334-4832-00

• Label, NIBP Calibration, 91496, (quantity 100)

334-4834-00

Table 3-5 Digital Manometer Minimum Requirements Requirement s Description

Minimum Requirement

Measurement range

0 to 350 mmHg

Measurement accuracy

0.05% of Full Scale (350 mmHg x 0.05% = 0.175 mmHg)

Measurement resolution

A minimum of one decimal point resolution on the display

Equipment Setup To set up the equipment for NIBP calibration, accuracy, and leakage tests 1

Connect the NIBP calibration cable (P/N 175-1023-xx) to the module SDLC connector of the monitor and module. Refer to Figure 3-3. 3-3.

manometer T3 100 cc container

T1

tee

T2

module

T4

monitor

tee

clamp within 2 feet of tee

NIBP calibration cable

T5

squeeze bulb

Figure 3-3 NIBP calibration setup 2

3-14

Power ON the monitor.




NIBP Calibration Procedure Note: The procedures that follow are for software version 2.04.00 and newer. Refer to earlier versions of this manual for modules with earlier software versions.

To calibrate NIBP 1

Connect the NIBP test fixture to the adult port on the module’s front panel (T4).

Note: The length of the tubing (P/N 166-0011-xx) interconnecting the 100 cc container, manometer, bulb, and module (shown as T1+T2+T3+T4 in Figure 3-3 on page 3-14 ) must not exceed 0.61 meters (20 (20 inches). No restrictions restrictions apply to the length of the tubing T5 (P/N 162-0019-xx). 2

Set patient type to ADULT ADULT.. a

Touch ECG ECG and and make sure that the module is set to ADULT ADULT..

b

To change the patient type, touch the current patient type key.

c

ADULT,, and then touch APPLY APPLY.. Touch ADULT

Note: Refer to Figure 3-1 on page 3-12 and 3-12 and Figure 3-2 on page 3-12 for 3-12 for reference. 3

4

Enter the Calibration menu. a

Touch NIBP NIBP..

b

AUTO and AUTO is ON.. Touch AUTO and make sure that AUTO is ON

c

CONFIG, touch DIAG MENU, MENU , and then touch the CAL CAL key. Touch CHANGE CONFIG, key.

Complete the procedures that follow.

To zero the transducers


1

VALVE key OPN.. Make sure that the VALVE key is set to OPN

2

Make sure that the CPU CPU key key is set to COM COM..

3

ZERO (to zero the primary pressure transducer). Touch SET ZERO (to

4

CPU key SAFE.. Touch the CPU key and make sure that it is set to SAFE

5

RANGE key HI.. Make sure that the RANGE key is set to HI

6

ZERO (to zero the high range of the safety pressure transducer). Touch SET ZERO (to

7

RANGE key CPU key COM.. Touch the RANGE key and make sure that the CPU key is set to COM

8

Touch SET ZERO (to ZERO (to zero the low range of the safety pressure transducer). transducer).

3-15



To calibrate the primary pressure transducer Note: You must complete this procedure within 2½ minutes or the safety processor will vent the pressure. If this happens, do the calibration procedure again, starting at Step 3 of 3 of To calibrate NIBP on NIBP on page 3-15. 3-15 . 1

Touch the CPU CPU key. key. Make sure that the CPU CPU key key is set to COM COM..

2

Touch the VALVE VALVE key. key. Make sure that the VALVE VALVE key key is set to CLS CLS..

3

Manually pressurize the system to 305 ±2 mmHg, as necessary. Wait until the pressure reading is less than 2 mmHg (as indicated by the manometer) before going on.

Note: The safety overpressure is NOT set in a board that has NOT been previously calibrated. However, if the board has been previously calibrated, the pressure cannot exceed 295 mmHg or the safety system may automatically cause a release of pressure. If this happens: •

Do the the calibr calibration ation proce procedure dure again start starting ing at Step 3 of 3 of To To calibrate NIBP on NIBP on page 3-15. 3-15.

•

Then sta Then start rt thi thiss proc proced edur ure e ( To To calibrate the primary pressure transducer ) again.

4

Make sure that the pressure is steady.

5

SCALE. Touch SET FULL SCALE.

Note: After you touch the the SET FULL SCALE key, key, the calibration menu keys will be unavailable and the pressure will drop to approximately 200 mmHg.

3-16

6

Use the squeeze bulb to adjust the pressure to 200 ±2 mmHg, as necessary.

7

When the pressure is steady, change the pressure shown on the monitor to match the indication on the manometer by using the up and down arrow keys.

8

When the pressure shown on the monitor matches the pressure shown on the manometer, touch the STORE GAIN key. GAIN key. (Do this step only if the message FULL SCALE IS SET TOO LOW shows—the LOW shows—the pressure was too low when the SET FULL SCALE key SCALE key was touched). a

VALVE key. Touch the VALVE key.

b

OPN and allow the pressure to vent. Make sure that the key is set to OPN and

c

AUTO and AUTO is ON.. Touch AUTO and make sure that AUTO is ON

d

Touch the VALVE VALVE key. key. Make sure that the VALVE VALVE key key is set to OPN OPN..

e

Wait until the pressure reading is less than 2 mmHg (as indicated by the manometer) before continuing to the next procedure.




To calibrate the low range of the safety pressure transducer 1

CPU key. Touch the CPU key.

2

CPU key SAFE.. Make sure that the CPU key is set to SAFE

3

Make sure that the RANGE RANGE key key is set to LO LO..

4

VALVE key CLS.. Touch the VALVE key and make sure that it is set to CLS

Note: You must complete Step 5 through 5 through Step 8 within 8 within 2½ minutes or the safety processor will vent the pressure. pressure. If this happens: happens: •

Do the calib calibratio ration n proce procedure dure agai again n start starting ing at Step 3 of 3 of To calibrate NIBP on page 3-15. 3-15.

•

Then sta Then start rt thi thiss proc proced edur ure e ( To To calibrate the low range of the safety pressure transducer ) again.

5

Pressurize the system to 15 ±2 mmHg manually.

6


7

Touch STORE GAIN when GAIN when the pressure shown on the monitor matches the pressure shown on the manometer.

8

Touch the VALVE key and make sure that it is set to OPN OPN and and that the pressure is released from the system.

9

Continue only when the pressure indication by the manometer is less than 2 mmHg.

To calibrate the high range for safety pressure transducer 1

CPU key SAFE.. Make sure that the CPU key is set to SAFE

2

RANGE key HI.. Touch the RANGE key and make sure that it i s set to HI

3

VALVE key CLS.. Touch the VALVE key and make sure that it is set to CLS

Note: You must complete Step 4 through 4 through Step 7 of of this procedure within 2½ minutes or the safety processor will vent the pressure. If this happens:


1

Do the calibration procedure again, starting at Step 3 of 3 of To calibrate NIBP on NIBP on page 3-15. 3-15 .

2

Then start this procedure ( To To calibrate the high range for safety pressure transducer transducer ) again.

4

Pressurize the system to 200 ±2 mmHg manually.

5


6

Touch STORE GAIN when the pressure shown on the monitor matches the pressure shown on the manometer.

7

Note the pressure value (for the safety pressure transducer).

8

Touch the CPU key (if the CPU key is enabled) and make sure that the CPU key is set to COM.

9

Make a note of the pressure value (for the primary pressure transducer).

3-17



10 Make sure that the pressure values for the primary and safety pressure transducers differ by 2 mmHg or less. 11 If the difference is greater than 2 mmHg, do the steps that follow: a

CPU key. SAFE.. Touch the CPU key. Make sure that it is set to SAFE

b

Make sure that the RANGE RANGE key key is set to HI.

c

Touch and hold the down the arrow key for approximately 25 counts.

d

GAIN. Touch STORE GAIN.

e

Release the pressure by pressing the VALVE VALVE key key and selecting OPN OPN..

f Do the calibration procedure again, starting at Step 3 of 3 of To calibrate NIBP on page 3-15. 3-15 . Then complete the procedure To calibrate the primary pressure transducer on transducer on page 3-16. 3-16 . Finally, start this procedure ( To calibrate the high range for safety pressure transducer on page 3-17) 3-17 ) again. -OR•

If the diff differen erence ce is 2 mmHg mmHg or less, less, do the the steps steps that that follow: follow: a

CPU key COM.. Touch the CPU key and make sure that it is set to COM

b

Touch the VALVE VALVE key key and make sure that it is set to OPN OPN and and that the pressure is released from the system.

12 Continue to the remaining procedures only when the pressure reading is less than 2 mmHg (as indicated by the manometer).

NIBP Leakage Test in Adult Mode To test leakage in Adult Mode 1

Touch the NIBP NIBP key. key.

2

Touch the AUTO AUTO key key and make sure that AUTO AUTO is is ON ON..

3

Touch the CHANGE CONFIG key, CONFIG key, touch the DIAG MENU key, MENU key, and then touch the LEAKAGE TEST key. TEST key.

4

Allow the system to pump between 260 and 280 mmHg, using the bulb valve to adjust the pressure as necessary.

5

Pinch off the tube to the bulb with a clamp and wait 30 seconds.

6

Make sure that the pressure leakage is less than 1.0 mmHg over 15 seconds.

7

Touch the VENT PRESSURE key and then release the cl amp. Make sure that the pressure is less than 5 mmHg for 2 to 3 seconds before you continue.

NIBP Accuracy Test To test NIBP accuracy

3-18

1

Make sure that the bulb valve is closed.

2

Touch LEAKAGE TEST and allow the system to pump.

3

Release the pressure slowly using the bulb valve to match the values shown in the column labelled Manometer Display in Table 3-6. 3-6. Make sure that the readings shown by the monitor and the manometer differ by less than the limits in Table 3-6. 3-6.




Table 3-6 Leakage Test Limit Manometer Display (mmHg)

Monitor Display (mmHg)

250 ±5 mmHg

Within 3 mmHg

150 ±5 mmHg

Within 2 mmHg

50 ±5 mmHg

Within 2 mmHg

4

Touch VENT PRESSURE. PRESSURE .

To test over-pressure in Adult Mode 1

Touch the VENT PRESSURE key. PRESSURE key. Before you do the next step, make sure that the pressure is less than 15 mmHg for 2 to 3 seconds.

2

Close the bulb valve and touch the LEAKAGE TEST key. TEST key.

3

Allow the system to pump up; slowly increase the pressure using the bulb, until the pressure is released. Make sure that the pressure is released between 295 and 300 mmHg, inclusive.

4

NIBP test Disconnect the NIBP test fixture from the adult connector.

5

NIBP key. Touch the NIBP key.

6

STAT key Touch the STAT key in the waveform zone.

7

STOP button Depress the STOP button on the front panel after the pump starts. Make sure that the pump stops.

To perform a functional check 1

Disconnect the NIBP NIBP test test fixture from the adult port.

2

Touch the NIBP NIBP and and START START keys. keys.

3

Make sure that the pump starts.

Note: If the pump does not start, repeat the calibration procedure by starting at Step 1 of the procedure To calibrate NIBP on NIBP on page 3-15. 3-15 . Then perform the following procedures:

4


•

To zero the transducers on transducers on page 3-15

•

To calibrate the primary pressure transducer on on page 3-16

•

To calibrate the low range of the safety pressure transducer on on page 3-17

•

To calibrate the high range for safety pressure transducer on on page 3-17 .

Touch the deflate switch on the module’s front panel after the pump starts. Make sure that the pump stops.

3-19



NIBP Leakage Test in Neonatal Mode To test leakage in Neonatal Mode 1

Connect the NIBP test fixture to the neonatal port on the module’s front panel.

2

Touch ECG ECG and and make sure that the module is set to NEONATE NEONATE..

3

To change the patient type, touch the current patient type key.

4

NEONATE.. Touch NEONATE

5

APPLY.. Touch APPLY

6

NIBP and START keys. Touch the NIBP and START keys.

7


Note: If the pump does not start, repeat the calibration procedure by starting at Step 1 of the procedure To calibrate NIBP on NIBP on page 3-15. 3-15 . Then perform the following procedures: •

To zero the transducers on transducers on page 3-15

•

To calibrate the primary pressure transducer on on page 3-16

•

To calibrate the low range of the safety pressure transducer on on page 3-17

•

To calibrate the high range for safety pressure transducer on on page 3-17 .

8

Touch the STOP STOP key. key.

9

NIBP key. Touch the NIBP key.

10 Touch the AUTO AUTO key AUTO is ON.. key and make sure that AUTO is ON 11 Touch the CHANGE CONFIG key. CONFIG key. 12 Touch the DIAG MENU key. MENU key. 13 Then touch the LEAKAGE TEST key. TEST key. 14 Allow the system to pump to 140 ±10 mmHg, using the bulb valve as necessary. 15 Pinch off the tube to the bulb with the clamp and wait 15 seconds. 16 Make sure that the pressure leakage is less than 1.0 mmHg over 15 seconds. 17 Touch the VENT PRESSURE key. PRESSURE key.

To test over-pressure in Neonatal Mode 1

Touch the VENT PRESSURE key. PRESSURE key. Before continuing, make sure that the pressure is less than 15 mmHg for 2 to 3 seconds.

2

Close the bulb valve and touch the LEAKAGE TEST key. TEST key. Allow the system to pump up; slowly increase the pressure using the bulb, as necessary, until the module releases the pressure. Make sure that the pressure is released between 145 and 150 mmHg.

3-20

3

Make sure that the bulb valve is closed and then touch the NIBP key.

4

Touch the STAT the STAT key key in the waveform zone.

5

STOP button Depress the STOP button on the front panel after the pump starts.

6

Make sure that the pump stops.




To perform a functional check 1

Disconnect the NIBP test fixture from the neonatal port.

2

NIBP and STAT keys. Touch the NIBP and STAT keys.

3


Note: If the pump does not start, repeat the following procedures:

4

•

To test leakage in Neonatal Mode on Mode on page 3-20

•

To test over-pressure in Neonatal Mode on Mode on page 3-20

•

To perform a functional check on on page 3-21. 3-21 .

Touch the deflate switch on the module’s front panel after the pump starts. Make sure that the pump stops.

Disassembly/Assembly Procedures To disassemble/reassemble the module


1

Follow proper anti-static procedures for electrostatic sensitive electronic components.

2

Remove the screws from the outer covers and remove the covers (refer to Parts on Parts on page 5-1). 5-1 ).

3

Separate the circuit board assemblies carefully.

4

Remove any interconnecting cables.

5

Remove any shields.

6

Reassemble the module by performing these steps in reverse order. When reinstalling the side covers, take care not to bend the EMI gasket fingers that provide connection between side covers and internal shield ground.

3-21


3-22




Troubleshooting

Module Information The Module Info report Info report shows which CPU is installed as well as the module options and software version.

To show the Module Info report 1

Access the Module Configuration Manager menu. Manager menu. Refer to the Ultraview SL Module Configuration Manager System Operations Manual (P/N 070-1245-xx, which is located on CD-ROM P/N 084-1101-xx) for specific information.

2

Sweep your finger to the right of the Factory Defaults key Defaults key when the Default Storage menu Storage menu is accessed to locate the hidden key.

3

Press the hidden key three times to view the Module Info report. Info report.

Figure 4-1 Example of the Module Info report

Problem Solving Before initiating board-level troubleshooting, troubleshooting, first establish if there is a fault with the module. The troubleshooting troubleshooting flow chart on the next page will help you to determine whether the module is operating properly.


4-1

TROUBLESHOOTING


Troubleshooting Flow Charts      



   



  

 

         



         xx 

      



   

 

 



4-2

 



TROUBLESHOOTING

ECG/Resp Check the mainframe power supplies with module connected. +/- 12 V ±5% 5 V ±5%

START

Menu appears when ECG key is pressed?

Plug in the module with the patient cable connected

NO

ECG key appears on display?

YES

Voltage correct?

NO

NO

Troubleshoot Mainframe

YES

Sub-menus may be accessed?

NO YES

Replace CPU PCBA.

ECG key and waveform appears?

NO

YES

YES

ECG lead selection functions?

NO

Re-analyze problem YES

YES

Display ECG waveform?

NO

LEADS OFF Message?

NO

Replace AFE PCBA

YES

Problem resolved from previous stage?

NO

YES

Replace/reconnect cable and/or leads YES

Correct ECG and RESP waveforms appear on screen?

Replace CPU PCBA


NO

NO

YES NO

Pacer circuit detects paced ECG signals?

Re-analyze problem

LEADS OFF Message?

NO

YES YES

Lead fault circuit functions

Replace Front Panel PCBA

NO

YES

ECG and RESP alarms OK?

NO

YES


NO

YES

End

YES

Replace CPU PCBA


Problem resolved?

NO

Re-analyze problem

4-3

TROUBLESHOOTING


Pressure 

      

     



     

 

 

    

  



  





    

  





 

4-4



 





TROUBLESHOOTING

SpO Sp O2 Note: Refer to Nellcor OxiMax SpO2 Messages on Messages on page 4-6 , 4-6 , Masimo SET SpO2 Messages on Messages on page 4-7 , or Spacelabs SpO2 Messages on Messages on page 4-7 .



      

  2   



     

 

 

    

  





 







  

 




 



4-5

TROUBLESHOOTING


Nellcor OxiMax SpO 2 Messages Status messages display in the waveform zone and on the messages prompt line of the bedside monitor when certain conditions are detected. Each status message is SPO2 when preceded by SPO2 when displayed on the prompt line. The following messages relate to the Nellcor OxiMax SpO 2 technology (option N).

OXIMETER FAILURE Error XXX If there is a communications failure or an unexpected or fatal error in processing, the OXIMETER FAILURE message displays, with the corresponding error number (xxx). This message displays while the SpO 2 hardware is resetting. If the module cannot reset the SpO 2 hardware, the following message displays: OXIMETER FAILURE Error XXX—Contact Service

OXIMETER FAILURE Error XXX — Contact Service This is a non-recoverable hardware error. error. This error occurs as a result of failed or compromised Nellcor hardware. The error numbers correspond to the following:

Error Number

Error Condition

Below 600

Nellcor-specific error

600

Packet error; invalid packets from NELL-1

700

Message error; illegal or out-of-bounds

800

Time-out error; not responding

To attempt to restore communications with the module 1

Replace the SpO 2 sensor and adapter.

2

Pull out the module, and then reinsert it.

If this error recurs, contact a Spacelabs Healthcare field service engineer.

HARDWARE INCOMPATIBILITY Contact Service This is a non-recove non-recoverable rable hardware error. This condition is detected at power-ON, and indicates that the hardware in the module is not compatible with the configuration setting, or the wrong SpO 2 board was installed. Contact your Spacelabs Healthcare field service engineer.

4-6



TROUBLESHOOTING

Masimo SET SpO 2 Messages Status messages display in the waveform zone and on the messages prompt line of the bedside monitor when certain conditions are detected. Each status message is SPO2 when preceded by SPO2 when displayed on the prompt line. The following messages relate to the Masimo SET SpO2 technology (option M).

FAUL FAULTY TY OXIMETER— Contact Service This is a non-recover non-recoverable able hardware error. This error occurs as a result of one of more of the following: • Faile Failed d or comprom compromised ised Masimo Masimo SET sensor sensorss or adapte adapters rs • Failed Failed or compromised compromised Masimo Masimo SET hardwa hardware re or front-end front-end analog analog board board in the module



2



HARDARE INCOMPATIBILITY Contact Service This is a non-recove non-recoverable rable hardware error. This condition is detected at power ON and indicates that the hardware in the module is not compatible with the configuration setting, or the wrong SpO 2 board was installed. Contact your Spacelabs Healthcare field service engineer.

Spacelabs SpO 2 Messages Status messages display in the waveform zone and on the messages prompt line of the bedside monitor when certain conditions are detected. Each status message is SPO2 when preceded by SPO2 when displayed on the prompt line. The following messages relate to the Spacelabs SpO 2 technology (option U).

FAUL FAULTY TY OXIMETER— Contact Service This is a non-recoverable hardware error. This error occurs as a result of one of more of the following: • Failed Failed or compromised compromised TruLink TruLink or Nellcor/Nova Nellcor/Novametr metrix-co ix-compati mpatible ble sensors sensors or adapters • Faile Failed d or compromis compromised ed front-e front-end nd analog analog board board in the modul module e


4-7


TROUBLESHOOTING



2



HARDARE INCOMPATIBILITY Contact Service This is a non-recove non-recoverable rable hardware error. This condition is detected at power ON and indicates that the hardware in the module is not compatible with the configuration setting, or the wrong SpO 2 board was installed. Contact your Spacelabs Healthcare field service engineer.

4-8



TROUBLESHOOTING

Cardiac Output Connect cardiac output cable to simulator and module

Cardiac output key appears on display?

NO

Replace AFE board

Re-analyze problem

YES

Initiate a curve NO

YES

Curve appears on display?

Problem resolved?

NO

Replace AFE board

Replace CPU PCBA YES

NO

Three curves completed?

Problems resolved?

YES

END


NO

YES

END

4-9

TROUBLESHOOTING


Temperature Connect temperature cable to simulator and module Re-analyze problem

Temperature key appears on display?

NO

Replace AFE board

NO YES

YES Problems resolved?

Temperature numerics appear on display?

NO Replace AFE board

YES Replace CPU PCBA

NO

All temperature channels tested?

Problems resolved?

NO

YES

YES END END

4-10



TROUBLESHOOTING

NIBP 

          

      



   

 



 



         

   

  



      

  



  

 





  





         

      

    








4-11

TROUBLESHOOTING


If a hardware error is detected that causes the NIBP portion of the module to be inoperable, the message NIBP SYSTEM FAULT Error No xx will be displayed in the NIBP waveform zone, clearing any displayed trend data. Future readings will not be allowed until the module is reset by a key in the Change Config menu. Config menu. If the error message is repeated, replace the CPU/NIBP PCBA. The error numbers correspond to the following:

Error Number

Error Condition

10

Safety processor failure

20

Communication processor failure

30

Valve failure

NIBP Event Log The NIBP Event Log is intended to facilitate troubleshooting by providing information concerning the cause of NIBP measuremen measurementt failures. The NIBP Event Log is stored in RAM; all stored events will be cleared if the module is unpowered for more than 10 minutes. A maximum of 299 events can be stored. The summary statistics are stored in nonvolatile RAM and are only cleared by the UPDATE STATS key. The NIBP Event Log includes data about any measuremen measurementt attempt, either manually or automatically initiated, that fails to result in a valid measurement. Logged events do not necessarily indicate a malfunction. For example, attempts to take an NIBP measurement with the cuff not attached will be logged due to the measurement failure.

Accessing the NIBP Event Log The NIBP Event Log is accessed via a hidden key located in the NIBP Change Config menu. The hidden key is positioned in line with the NIBP NIBP key. key.

4-12

Key

Description

PREV PAGE

Displays the previous 5 events. If there are no events or the current page is the first page (events 1-5), touching the key has no effect.

NEXT PAGE

Displays the next 5 events. If there are no events or the current page is the last page of available events, touching the key has no effect.

UPDATE STATS

Retrieves any new events and updates the display with the last page of events.

CLEAR STATS

Clears all events and sets the summary statistics counters to 0.

PRINT PAGE

Prints the currently displayed events and the event statistics.



TROUBLESHOOTING

Figure 4-2 NIBP event log

NIBP Hardware Calibration Constants The hardware calibration constants information is the first line of the first page of the NIBP Event Log. CF 225 FS 0xFF9938CA SH 0x009D SL 0x000E

Event Log Entries Up to five events, in a one-line format, can be displayed per page in the alternate waveform zone on the monitor. The fields are defined as follows:

6 05\04 12:12 1035 41 410 170

1 A 35 62400 0

A

G H

B

C

F

Table 4-1 Event Codes


Code

Description

A

Event Number

B

Measurement Start Date (mm\dd)

C

Measurement Start Time (hh:mm)

F

Target Pressure (mmHg)

G

Start art Ty Type: pe: 1 = St Stat, 2 = Lon Long g Ter Term m Au Auto, 3 = Sho Shorrt Ter Term m Au Auto

H

Mode: A = Adult, N = Neonate

4-13

TROUBLESHOOTING


Summary Statistics Summary statistics display on the last line of the NIBP Event Log display. The fields are defined as follows:

G 1200 B 15 AS 17 AB 1 V 19 BV 7 NC 2 DS 104 05\03 10:20 A

B

C

D

I

J

Table 4-2 Summary Codes Code

Description

A

Number of measurement attempts that successfully completed

B

Number of of me measurement at attempts th that di did no not su successfully co complete

C

Number of of ti times a measurement at attempt wa was ab aborted by by to touching th the ST STOP ke key

D

Number of tim time es a me measur suremen ementt at attempt empt was ab abort orted by by pr pressin ssing g the the front pa panel defla flate bu button

I

Date of first NIBP measurement attempt since the event log was reset

J

Time of first measurement attempt since the event log was reset

Automatic Measurement Mode If three consecutive measurement attempts (six measurement attempts including the automatic retry) fail to successfully complete due to either no cuff being attached or cuff attached but no patient present, the automatic measurement ON/OFF OFF key OFF.. mode will be disabled and the AUTO ON/ key will be set to OFF This applies to automatically scheduled measurements only. Initiating a AUTO key measurementt manually, toggling the AUTO measuremen key off and on, or manually aborting a measurementt will reset this counter. measuremen

4-14



Parts

Field-Replaceable Parts (for Configurations A through L on serial numbers below 1496-1xxxxx) Notes:


•

When a Comma Command nd Module Module is returned returned from from the equipm equipment ent service service center center or if the CPU PCB was replaced, it will be required to verify that the customer’s Module Configuration Manager settings are restored to match the original site configuration.

•

The P/N P/N 670-1310670-1310-xx xx front front panel panel PBCA is is only compa compatible tible with with P/N 670-0842-03 analog front end (AFE) and higher-version PCBAs. Always replace PCBAs on a “like-for like” basis.

•

When the the CPU is repla replaced, ced, the the MCM settin settings gs will be be reset to to factory factory defaults.

5-1

P A R T S


Option U (Spacelabs SpO 2) Part Number

Option N (Nellcor OxiMax SpO2) Part Number

Option M (Masimo SET SpO 2) Part Number

PCBA, AFE

670-0842-02 (not compatible with 670-1310-00) 670-0842-03 (not compatible with 670-0843-01)

670-1305-xx

670-1305-xx

PCBA, AFE, SpO2, 91496, ROHS

670-0842-12

670-1305-xx

670-1302-02

PCBA, OEM, Nellcor NELL-1 SpO 2

not applicable

010-1635-01

not applicable

PCBA, OEM, Nellcor NELL-1SR SpO 2, ROHS

not applicable

010-1635-02

not applicable

PCBA, OEM, Masimo MS-11 SpO 2

not applicable

not applicable

010-1636-xx

PCBA, OEM, Masimo MS-2011 SB SpO 2, ROHS

not applicable

not applicable

010-1636-02

PCBA, Front Panel

670-0843-01 (for use only with 670-0842-02 AFE board)

670-1345-xx

670-1346-xx

Description

670-1310-00 (for use only with 670-0842-03 AFE board) PCBA, Front Panel, EMC, 91496, ROHS

670-1310-02

670-1345-xx

670-1346-xx

Panel, Front, 91496

333-0431-05

333-0431-06

333-0431-07

PCBA, MPC860 CPU/NIBP, 91496

670-0982-xx

670-0982-xx

670-0982-xx

PCBA, MPC860 CPU, W/O NIBP, 91496

670-1708-xx

670-1708-xx

670-1708-xx

Pump, Pneumatic, 91496 (P/O CPU Assy)

119-0493-xx

119-0493-xx

119-0493-xx

Jack, Phone, Right Angle, PC Mount (J990, J790)

131-0327-xx

131-0327-xx

131-0327-xx

Connector, DA15-M, Right Angle, PCB Mount, 3/8”

131-0904-xx

131-0904-xx

131-0904-xx

NIBP Connector, Neonatal (Coupling, Panel Mount, W/Barb 1/8”) 1/8”)

376-0010-xx

376-0010-xx

376-0010-xx

NIBP Connector, Adult (Plug, Pa Panel Mount, W/Barb 1/8”)

134-0045-xx

134-0045-xx

134-0045-xx

Tubing Assy. Tygon – all three internal NIBP hoses for CPU/NIBP board

166-0052-xx

166-0052-xx

166-0052-xx

Valve, Pneumatic Assy, 90496 (P/O CPU/NIBP Assy)

119-0258-xx

119-0258-xx

119-0258-xx

Pump Tie-Down Strap (P/O CPU/NIBP Assy)

346-0015-xx

346-0015-xx

346-0015-xx

Pad, Pump Mounting (P/O CPU/NIBP Assy)

348-0277-xx

348-0277-xx

348-0277-xx

Switch, Push, SPST, Right Angle (P/O 670-0882-00 Assy)

380245-001

380245-001

380245-001

Cap, Switch, Red (NIBP Deflate Switch Cap)

201-0017-xx

201-0017-xx

201-0017-xx

Cable Assy, NIBP Diagnostic — Required to access NIBP diagnostic menus

175-1023-xx

175-1023-xx

175-1023-xx

Kit, CM Upgrade, 91496

050-0559-xx

050-0559-xx

050-0489-xx

5-2



P A R T S

Description

Option U (Spacelabs SpO 2) Part Number




050-0559-xx

050-0491-xx

050-0491-xx

Kit, Service, Front Panel Assy, 91496-A, Arctic White

050-0563-xx

050-0566-xx

050-0569-xx

Kit, Service, Front Panel Assy, 91496-B, Arctic White

050-0564-xx

050-0567-xx

050-0571-xx

Kit, Service, Front Panel Assy, 91496-C, Arctic White

050-0565-xx

050-0568-xx

050-0572-xx

Kit, Service, Front Panel Assy, 91496-I, Arctic White

050-0603-xx

050-0605-xx

050-0607-xx

Label, Front Panel, 91496-A, Arctic White

334-6851-00

334-6853-00

334-6852-00

Label, Front Panel, 91496-B, Arctic White

334-6851-01

334-6853-01

334-6852-01

Label, Front Panel, 91496-C, Arctic White

334-6851-02

334-6853-02

334-6852-02

Label, Front Panel, 91496-I, Arctic White

334-6851-03

334-6853-03

334-6852-03

Label, Front Panel, 91496-L, Arctic White

334-6854-00

334-6854-01

334-6854-02

Latch Module

306965-001

306965-001

306965-001

Spring, Helical, Compression

306977-001

306977-001

306977-001

Spring Torsion (Mod)

306966-001

306966-001

306966-001

Pin, Dowel, .094 Dia × .70 L

214-0254-xx

214-0254-xx

214-0254-xx

Handle, Module, Pearl White

367-0016-01

367-0016-01

367-0016-01

Panel, Rear, Module, 91496

3069801-004

3069801-004

3069801-004

Cover, Module Side

200-0176-xx

200-0176-xx

200-0176-xx

Label, Rear Panel, Model/Serial Numbers

334-5586-xx

334-5586-xx

334-5586-xx

Label, Rear Panel, SW version

334-5588-xx

334-5706-xx

334-5711-xx

SpO2 Adapter Cable

700-0030-xx TruLink

700-0792-xx Nellcor OxiMax

700-0789-xx Masimo SET, LNOP

700-0029-xx Novametrix

700-0906-xx Masimo SET, LNCS 010-1649-xx Masimo RD SET 010-2146-xx Masimo LNOP to RD SET

Connector Color


Blue

Purple

Gray

5-3

P A R T S


Field-Replaceable Parts (for Configurations A through L on serial numbers above 1496-2xxxxx) Notes: •

When a Comman Command d Module Module is returned returned from from the equipmen equipmentt repair repair center or or if the CPU PCB was replaced, it will be required to verify that the customer’s Module Configuration Manager settings are restored to match the original site configuration.

•

The P/N P/N 670-1310-x 670-1310-xxx front front panel panel PBCA is only only compat compatible ible with with P/N 670-0842-03 analog front end (AFE) and higher-version PCBAs. Always replace PCBAs on a “like-for like” basis.

•

When the the CPU PCB PCB is replaced replaced,, the MCM MCM settings settings will will be reset reset to factory factory defaults.

Option U (Spacelabs SpO2) Part Number



PCBA, AFE

670-0842-02 (not compatible with 670-1310-00) 670-0842-03 (not compatible with 670-0843-01)

670-1305-xx

670-1305-xx

PCBA, AFE, SpO2, 91496, ROHS

670-0842-12

670-1305-xx

670-1302-02

PCBA, OEM, Nellcor NELL-2 SpO 2

not applicable

010-2015-02

not applicable

PCBA, OEM, Nellcor NELL-1SR SpO 2, ROHS

not applicable

010-1635-02

not applicable

PCBA, OEM, Masimo MS-11 SpO 2

not applicable

not applicable

010-1636-xx

PCBA, OEM, Masimo MS-2011 SB SpO 2, ROHS

not applicable

not applicable

010-1636-02

PCBA, Front Panel

670-0843-01 (for use only with 670-0842-02 AFE board)

670-1345-xx

670-1346-xx

Description

670-1310-00 (for use only with 670-0842-03 AFE board) PCBA, Front Panel, EMC, 91496, ROHS

670-1310-02

670-1345-xx

670-1346-xx

Panel, Front, 91496

333-0431-05

333-0431-06

333-0431-07

PCBA, MPC860 CPU/NIBP, 91496

670-0982-xx

670-0982-xx

670-0982-xx

PCBA, MPC860 CPU, W/O NIBP, 91496

670-1708-xx

670-1708-xx

670-1708-xx

Pump, Pneumatic, 91496 (P/O CPU Assy)

119-0493-xx

119-0493-xx

119-0493-xx

Jack, Phone, Right Angle, PC Mount (J990, J790)

131-0327-xx

131-0327-xx

131-0327-xx

Connector, DA15-M, Right Angle, PCB Mount, 3/8”

131-0904-xx

131-0904-xx

131-0904-xx

5-4



P A R T S




NIBP Connector, Neonatal (Coupling, Panel Mount, W/Barb 1/8”) 1/8”)

376-0010-xx

376-0010-xx

376-0010-xx

NIBP Connector, Adult (Plug, Pa Panel Mount, W/Barb 1/8”)

134-0045-xx

134-0045-xx

134-0045-xx

Tubing Assy. Tygon – all three internal NIBP hoses for CPU/NIBP board

166-0052-xx

166-0052-xx

166-0052-xx

Valve, Pneumatic Assy, 90496 (P/O CPU/NIBP Assy)

119-0258-xx

119-0258-xx

119-0258-xx

Pump Tie-Down Strap (P/O CPU/NIBP Assy)

346-0015-xx

346-0015-xx

346-0015-xx

Pad, Pump Mounting (P/O CPU/NIBP Assy)

348-0277-xx

348-0277-xx

348-0277-xx

Switch, Push, SPST, Right Angle (P/O 670-0882-00 Assy)

380245-001

380245-001

380245-001

Cap, Switch, Red (NIBP Deflate Switch Cap)

201-0017-xx

201-0017-xx

201-0017-xx

Cable Assy, NIBP Diagnostic — Required to access NIBP diagnostic menus

175-1023-xx

175-1023-xx

175-1023-xx


050-0559-xx

050-0559-00

050-0489-xx

Kit,CM Upgrade, 91496

050-0559-xx

050-0559-xx

050-0489-xx

Kit, Service, Front Panel Assy, 91496-A, Arctic White

050-0563-xx

050-0566-xx

050-0569-xx

Kit, Service, Front Panel Assy, 91496-B, Arctic White

050-0564-xx

050-0567-xx

050-0571-xx

Kit, Service, Front Panel Assy, 91496-C, Arctic White

050-0565-xx

050-0568-xx

050-0572-xx

Kit, Service, Front Panel Assy, 91496-I, Arctic White

050-0603-xx

050-0605-xx

050-0607-xx

Label, Front Panel, 91496-A, Arctic White

334-6851-00

334-6853-00

334-6852-00

Label, Front Panel, 91496-B, Arctic White

334-6851-01

334-6853-01

334-6852-01

Label, Front Panel, 91496-C, Arctic White

334-6851-02

334-6853-02

334-6852-02

Label, Front Panel, 91496-I, Arctic White

334-6851-03

334-6853-03

334-6852-03

Label, Front Panel, 91496-L, Arctic White

334-6854-00

334-6854-01

334-6854-02

Latch Module

306965-001

306965-001

306965-001

Spring, Helical, Compression

306977-001

306977-001

306977-001

Spring Torsion (Mod)

306966-001

306966-001

306966-001

Pin, Dowel, .094 Dia × .70 L

214-0254-xx

214-0254-xx

214-0254-xx

Handle, Module, Pearl White

367-0016-01

367-0016-01

367-0016-01

Panel, Rear, Module, 91496

3069801-004

3069801-004

3069801-004

Cover, Module Side

200-0176-xx

200-0176-xx

200-0176-xx

Label, Rear Panel, Model/Serial Numbers

334-5586-xx

334-5586-xx

334-5586-xx

Label, Rear Panel, SW version

334-5588-xx

334-5706-xx

334-5711-xx

Description


5-5

P A R T S


Description

SpO2 Adapter Cable




700-0030-xx TruLink

700-0792-xx Nellcor OxiMax

700-0789-xx Masimo SET, LNOP

700-0029-xx Novametrix

700-0906-xx Masimo SET, LNCS 010-1649-xx Masimo RD SET 010-2146-xx Masimo LNOP to RD SET

Connector Color

Blue

Purple

Gray

Assembly Drawings

5-6

Title

Drawing Number

91496 block diagram

1 (2 sheets)

91496 block diagram (option L)

2 (2 sheets)

91496 (common)

3 (4 sheets)

914 91496-A front pan panel el assem ssemb bly (P/N 65 653-0077 0077-0 -00 0)

4 (1 (1 sh sheet eet)

914 91496-B front ont pan panel el asse ssembly bly (P (P/N 653-0 3-0078-00) -00)


914 91496-C fro front panel nel ass assem embl bly y (P (P/N 653-007 0079-00 -00)


CPU schematic (P/N 670-0982-xx)

7 (6 sheets)

AFE schematic (P/N 670-0842-xx)

8 (9 sheets)

AFE schematic (P/N 670-1305-xx)

9 (9 sheets)

Front Panel PCBA (P/N 670-1310-xx)

11 (1 sheet)

Front Panel assembly (P/N 670-0843-xx)

12 (2 sheets)



Appendix A — Symbols

The following list of international and safety symbols describes all symbols used on Spacelabs Healthcare products. No one product contains every symbol. Note: Graphic elements of certain keys and symbols may vary between product lines.

HELP Key

?

HELP (Explain Prior Screen) Key

MONITOR SETUP Key

REMOTE Key

TRENDS Key


A-1


A P P E N D I X A — S Y M B O L S

RECORD Key

Dynamic Network Access (DNA) Key

SPECIAL FUNCTIONS Key

NORMAL SCREEN Key

SAVE Key

No Network Connection

Network Connection

Do Not Connect to Network

No Connection to Intesys® Clinical Suite (ICS)

Compression

Magnifying Glass

File Cabinet

List of Rooms

Printer

A-2




Service Message

PREVIOUS MENU Key

HOME Key

Arrows

STANDBY Key Power ON/OFF Key ENTER Key

Delete x

Nurse Alert Interface

ALARM SUSPEND/TONE RESET Key

ALARMS Key

Alarm, General

Alarm Reset

Alarm Audio ON

Alarm Audio OFF


A-3



Alarm Audio Paused

Alarm Indicator. On the display, display, the color of the symbol designates the priority of the alarm: • cyan = lo low • yell yellow ow = med mediu ium m • red = high high On monitor hardware, this symbol indicates Alarm Output. Alarms Paused

Alarm OFF or equipment has no alarm system

--+++ ???

Parameter below measurement range

Parameter above measurement range

Parameter Parameter measurement indeterminate

Indicator — Remote Control

Normal Screen

Clock/Time Setting Key

Slow Run

Activate Recorder for Graphics

Reset

START (NIBP) Key

Power Indicator LED

A-4




Activate Telemetry Recorder

Output (Non-terminated) (Non-terminated)

Data Input/Output Input/Output

Input

No Output (Terminated)

Indicator — Local Control

Indicator — Out of Paper

Recorder Paper

Menu Keys

Waveform/Parameter Keys

1 2 3

Return to Prior Menu 1 2 3

Monitor Setup Select Program Options

1 2 3

Set Initial Conditions Menu 1 2

A

3

Access Access Special Function Menu 1 2

B

3

Return Unit to Monitor Mode 1 2 3


A-5



Keypad

Serial Port 1

1 Serial Port 2

2 Serial Port

Auto Mode (NIBP)

External Marker Push Button Connection

Arterial Pulse

Gas Exhaust

Video Output

Television; Video Display

Video Output, Primary

1 Video Output, Secondary

2 Enlarge, Zoom

Input/Output

PCMCIA Card

A-6




Touchscreen, External

Universal Serial Bus

SDLC Port

SDLC Hard Drive

Antenna

Electrocardiograph Electrocardiograph or Defibrillator Synchronization

Foot Switch

Audio Output, Speaker

Event

Gas Sampling Port

Gas Return Port

Battery Replace only with the appropriate battery.

Battery Status

Battery Replace only with the appropriate battery. Low Battery


A-7



Replace only with the appropriate battery. (+ / - signs may be reversed) Check battery switch on bottom of unit.

Battery off. Shipping and service mode.

Battery on. Regular operating mode.

All batteries should be disposed of properly to protect the environment. Lithium batteries should be fully discharged before before disposal. Batteries such as lead-acid (Pb) and nickel-cadmium (Ni-Cd) must be recycled. Please follow your internal procedures and or local (provincial) laws regarding disposal or recycling. This symbol indicates that the waste of electrical and electronic equipment disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

must not be be

Caution - hazardous voltages. To reduce risk of electric shock, do not remove the cover or back. Refer servicing to a qualified field service engineer (U.S.A.). DANGER - High Voltage (International) Protective Protective Earth Ground

Replace Fuse Only as Marked

Power supply jack polarity. (+ / - signs may be reversed) Alternating Current

Both Direct and Alternating Current

Functional Earth Ground

Fuse

A-8




Equipotentiality Terminal

Direct Current

Input Power. Use only Spacelabs Power Supply.

AC/DC Input

Loop Filter

Audio Output, Speaker

IEC 60601-1 Type Type B equipment. The unit displaying this symbol contains an adequate degree of protection against electric shock. IEC 60601-1 Type BF equipment which is defibrillator-proof. The unit displaying this symbol is an F-type isolated (floating) patient-applied part which contains an adequate degree of protection against electric shock, and is defibrillator-proof. defibrillator-proof. IEC 60601-1 Type Type BF equipment. The unit displaying this symbol is an F-type isolated (floating) patient-applied part providing an adequate degree of protection against electric shock. IEC 60601-1 Type Type CF equipment. The unit displaying this symbol is an F-type isolated (floating) patient-applied part providing providing a high degree of protection against electric shock, and is defibrillator-proof. defibrillator-proof. IEC 60601-1 Type Type CF equipment. The unit displaying this symbol is an F-type isolated (floating) patient-applied part providing providing a high degree of protection against electric shock. IEC 60601-1 Class II equipment, double-isolated. The unit displaying this symbol does not require a grounded outlet.

Warning: Warning: Do not modify this equipment without authorization of the manufacturer. Operates Operates on Non-Harmonized Radio Frequencies in Europe


A-9



Adult Noninvasive Blood Pressure (NIBP)

Fetal Monitor Connection (Analog)

Fetal Monitor Connection RS-232 (Digital)

Physiological Monitor Connection RS-232 (Digital)

Noninvasive Blood Pressure (NIBP), Neonate

Symbol Set, Adult/Pediatric Cuff Sizes

Symbol Set, Neonatal Cuff Sizes

NIBP Cuff, Neonatal 1





NIBP Cuff, Single Hose

NIBP Cuff, Dual Hose

NIBP Cuff, Surface Applied to Patient

THIS SIDE TO PATIENT

A-10




NIBP Cuff, Child Size (12 to 19 cm)

CHILD NIBP Cuff, Child Size, Long (12 to 19 cm)

CHILD, LONG NIBP Cuff, Small Adult Size, Long (17 to 25 cm)

SMALL ADULT, LONG NIBP Cuff, Small Adult Size (17 to 25 cm)

SMALL ADULT NIBP Cuff, Adult Size, Long (23 to 33 cm)

ADULT, LONG NIBP Cuff, Large Adult Size, Long (31 to 40 cm)

LARGE ADULT, LONG NIBP Cuff, Large Adult Size (31 to 40 cm)

LARGE ADULT NIBP Cuff, Adult Size (23 to 33 cm)

ADULT NIBP Cuff, Infant Size (8 to 13 cm)

INFANT NIBP Cuff, Neonatal 1 Size (3 to 6 cm)

NEONATAL 1 NIBP Cuff, Neonatal 2 Size (4 to 8 cm)




NEONATAL 5 NIBP Cuff, Thigh Size (38-50 cm)

THIGH NIBP Cuff, Nylon Material

NYLON


A-11



NIBP Cuff, Soft Material

SOFT NIBP Cuff, Vinyl Material

VINYL Quantity

QTY Place Artery Symbol and Arrow over Brachial or Femoral Artery

ARTERY eIFU = electronic Instructions for Use (CD-ROM or website) is available

Consult Instructions For Use

Follow Instructions For Use

Warning—Potential Warning—Potential danger to patient or user (consult accompanying documents)

Caution—Potential damage to equipment (consult accompanying documents) Note

Note

Keep Dry

Indoor Use Only

12,200 m

Altitude Limit

Temperature Range

Fragile

A-12




Handle with Care

This Way Up

Up Arrow

Down Arrow

Humidity Limit

Humidity limitation

Atmospheric pressure limitation

Open Padlock

Closed Padlock

PVC-Free (Polyvinyl Chloride)

PVC Do Not Reuse; Single Use Only

2 Reusable

IPX1 IPX7


Drip-Proof

Unit can withstand accidental immersion in one meter of water for up to 30 minutes

A-13



Reference Number or Order Number

REF Use by date [YYYY-MM-DD]

Recycle

Non Sterile NON STERILE

Latex-Free LATEX LA TEX

LATEX

Date of Manufacture

Manufacturer

Radio transmitting device; elevated elevated levels of non-ionizing radiation

A CE mark certifies that a product has met EU health, safety, and environmental requirements, requirements, which ensure consumer safety. safety.

XXXX

XXXX is the European Notified Body number. 0123 is the number for TÜV SÜD Product Service GmbH, München, Germany. Canadian Standards Association Approved Approved

Does not contain hazardous substances — Europe

Does not contain hazardous substances — China

Batch Code

LOT Nellcor Oxisensor II Compatible NE 2

A-14




Novametrix Compatible NV X

Spacelabs TruLink Compatible

Nellcor OxiMax Compatible

Spacelabs Compatible

UL recognized component in Canada and United States

Nellcor OxiMax Compatible

Masimo SET Compatible


A-15



ABBREVIATIONS USED AS SYMBOLS ARE SHOWN BELOW.

1 - 32 AIR A ANT 1 ANT 2 Arr1 ArrNet2 avDO2 CaO2 CH ch

cmH2O

Air Amperes Diversity Antenna System 1 Diversity Antenna System 2 Arrhythmia Net 1 Arrhythmia Net 2 Arterial/Venous Oxygen Difference Arterial Oxygen EEG, EMG, or ECG Channel EEG Channels - CH1, CH2, CH3, CH4 EMG Channel - CH5 Centimeters of Water

C.O. CO

Cardiac Output

CvO2

Venous Oxygen

CO2 CO2

Carbon Dioxide

DIA dia

Diastolic

ECG ecg

Electrocardiogram

EEG eeg

Electroencephalogram

EMG emg

Electromyogram

ESIS

Electrosurgical Interference Suppression

EXT

External

FECG

Fetal Electrocardiogram

FHR1 FHR2

Fetal Heart Rate, Channel 1 Fetal Heart Rate, Channel 2

GND gnd

Ground

Hz

Hertz

Hgb

Hemoglobin

HLO hlo

High-Level Output

Multiview

A-16

Access Codes 1 Through 32

Multi-Lead Electrocardiogram Electrocardiogram




N2O

Nitrous Oxide

NIBP nibp

Noninvasive Blood Pressure

O2AV

Oxygen Availability

O2 PaO2 PRESS press PRS PvO2 Ref.

Oxygen Partial Pressure of Arterial Oxygen Pressure

Partial Pressure of Mixed Venous Oxygen Oxygen reference gas port

RESP resp

Respiration

SDLC

Synchronous Data Link Control Serial number

SN Model number

MDL Option

OPT SVO2 SvO2 SvO2 SYS sys

Mixed Venous Oxygen Saturation

Systolic

T1 T2 T3 T4

Temperature Temperature Temperature Temperature

TEMP temp

Temperature

1 2 3 4

UA

Uterine Activity or Umbilical Artery

UV

Umbilical Venous

VAC

Vacuum Connection

VO2

Oxygen Oxygen Consumption

V

Volts

W

Watts


A-17


A-18



070-1163-03 Rev A - 91496 service manual

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