Escort M8 Vital Signs Monitor Service Manual Release 1

User Assistance If you have a question or need help operating the Escort M8 Vital Signs Monitor, please contact InvivoMDE Technical Service: US: (888) 221-1593 Int’l: (407) 275-3220 For the latest information about InvivoMDE products, please consult out web site: www.intermagnetics.com

ii

3800 Vital Signs Monitor Service Manual

Revised October 2004

Table of Contents Paragraph Number Page Number General Information... vi Precautions... ix Patents and Licensing ... xiv 1. 1.1 1.2 1.3

OVERVIEW... 1-1 Escort M8 Vital Signs Monitor Diagrams ... 1-1 Escort M8 Vital Signs Monitor User Interface ... 1-4 Main Features of the Escort M8 Vital Signs Monitor ... 1-5

2. INSTALLATION AND CHECKOUT... 2-1 2.1 Preinstallation ... 2-1 2.2 How to Connect the Escort M8 Vital Signs Monitor to Power ... 2-1 2.2.1 Operational Checkout Procedure ... 2-2 3. CONFIGURING THE MONITOR... 3-1 3.1 System Setup... 3-1 3.1.1 Setup Menu ... 3-1 3.1.2 Setup Biomedical Menu... 3-1 4.

BATTERY OPERATION ... 4-1

5.

FUNCTIONAL VERIFICATION... 5-1

6. 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.3 6.3.1 6.3.2 6.3.3 6.4

TROUBLESHOOTING ... 6-1 Power-up Malfunctions... 6-1 Display Is Blank At Power-Up (No Power LED Illuminated) ... 6-1 Display Is Blank At Power-Up (with Power LED Illuminated) ... 6-1 Monitor Only Displays the Power-Up (“Invivo)MDE M8”) Banner ... 6-2 Power-Up Banner Is Followed by A Blank Screen ... 6-3 Monitor Does Not Run on Battery Power ... 6-3 Physiological Monitoring Malfunctions ... 6-3 Monitor Won’t Display an ECG or Respiration Signal ... 6-3 Monitor Displays Constant ECG Pacer Annotations... 6-4 Monitor Displays an “SPO2 Replace Sensor” Message ... 6-4 Monitor Displays a “Temp Needs Service” Message... 6-4 Monitor Displays an “NBP Needs Service” Message ... 6-4 Non-Physiological Monitoring Malfunctions ... 6-5 Optional Recorder Not Working... 6-5 Missing Rows or Sections of Display Pixels ... 6-6 Other Technical Messages ... 6-6 Reducing EMI... 6-6

7. 7.1 7.2 7.3

REPAIR ... 7-1 External Chassis Components ... 7-2 Functional Block Diagram... 7-3 Cable Interconnection/Wiring Diagram... 7-4

Revised October 2004

3800 Vital Signs Monitor Service Manual

iii

Table of Contents (Continued) Paragraph Number Page Number 7.4 Major Assembly Views ... 7-5 7.4.1 Assembly/Subassembly Views ... 7-7 7.5 Monitor Disassembly Procedure... 7-14 7.6 Monitor Reassembly Procedure... 7-14 7.7 Replacing the Display ... 7-14 7.8 Replacing the Optional Recorder Assembly... 7-14 7.9 Replacing the SPO2 Masimo Board ... 7-15 7.10 Replacing the Power Supply Board ... 7-15 7.11 Replacing the Battery Charger Board... 7-15 7.12 Replacing Cracked Case Pieces ... 7-15 8.

ACCESSORIES ... 8-1

9.

SPARE PARTS ... 9-1

10.

CLEANING... 10-1

11. 11.1 11.2 11.3 11.4

MAINTENANCE AND STORAGE... 11-1 Battery Replacement... 11-3 Storage ... 11-4 Warranty ... 11-4 Password Control ... 11-4

12.

DISPOSAL ... 12-1

13.

TECHNICAL DATA ... 13-1

iv

3800 Vital Signs Monitor Service Manual

Revised October 2004

List of Figures Figure Number Page Number 1-1 Escort M8 Vital Signs Monitor - Front View ... 1-1 1-2 Escort M8 Vital Signs Monitor - Left Rear View ... 1-2 1-3 Escort M8 Vital Signs Monitor - Right Rear View ... 1-2 1-4 Escort M8 Vital Signs Monitor - Left Side View ... 1-3 1-5 Front Panel Keypad ... 1-4 1-6 Example of Escort M8 Vital Signs Monitor Normal Screen ... 1-5 2-1 Escort M8 Vital Signs Monitor Normal Screen... 2-2 3-1 Setup Menu ... 3-1 3-2 Setup Biomedical Menu... 3-1 3-3 Setup Configuration Menu... 3-2 3-4 Enter Password Menu ... 3-2 3-5 Setup Alarm System Menu ... 3-3 3-6 Setup System Menu ... 3-4 3-7 Setup Service Menu ... 3-4 4-1 Normal Screen Showing Battery Icon ... 4-1 7-1 External Chassis Components ... 7-2 7-2 M8 Overall Functional Block Diagram ... 7-3 7-3 M8 Cable Interconnection/Wiring Diagram ... 7-4 7-4 Monitor Major Assembly View ... 7-5 7-5 Battery Cover Major Assembly View ... 7-6 7-6 Battery Cover Assembly View ... 7-7 7-7 Monitor Front Bezel Assembly View A (Rear)... 7-8 7-8 Monitor Front Bezel Assembly View B (Front) ... 7-9 7-9 Monitor Rear Case Assembly View ... 7-10 7-10 Input Panel Assembly View ... 7-11 7-11 Recorder Subassembly View ... 7-12 7-12 Input Panel Subassembly View ... 7-13

Revised October 2004

3800 Vital Signs Monitor Service Manual

v

General Information This Service Guide provides information for the Invivo Research Escort M8 Vital Signs Monitor. The Escort M8 Vital Signs Monitor is a small, lightweight patient monitor designed to acquire and display physiological waveforms and parameters. Before using the Escort M8 Vital Signs Monitor, be sure to read carefully and understand all sections of this Service Guide. Failure to read and understand the instructions may lead to misuse of the Escort M8 Vital Signs Monitor, which could result in harm to the patients.

vi

3800 Vital Signs Monitor Service Manual

Revised October 2004

Typographical Conventions in this Service Guide This guide contains warnings, cautions and notes to help call your attention to the most important safety and operational aspects of the system. To help identify these items when they occur in the text, they are shown using the following typographical conventions:

WARNING - Statements that call attention to the possibility of injury, death or other serious adverse reactions associated with the use or misuse of the device.

CAUTION - Statements that call attention to the possibility of a problem with the device

associated with its use or misuse. Such problems include device malfunction, device failure, damage to the device or damage to other property.

NOTE - Statements that provide supplemental information.

Revised October 2004

3800 Vital Signs Monitor Service Manual

vii

Indications for Use The Escort M8 Vital Signs Monitor is indicated for use in adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (e.g. Physician, Nurse, Technician) when: 1. The professional determines that a device is required to measure any or all of the following patient parameters: • Heart Rate • Respiration Rate • Temperature • Systolic, Mean and Diastolic Blood Pressure • Functional Oxygen Saturation of Arterial Hemoglobin (SpO2) • Pulse Rate And, 2. The professional determines that a device is required to issue visible and audible alarms when any or all of the following parameters exceed preset limits: • Heart Rate • Respiration Rate • Temperature • Systolic, Mean and Diastolic Blood Pressure • Functional Oxygen Saturation of Arterial Hemoglobin (SpO2) • Pulse Rate

viii

3800 Vital Signs Monitor Service Manual

Revised October 2004

Precautions General Electrosurgery. The Escort M8 Vital Signs Monitor is suitable for use in the presence of electrosurgical (ESU) equipment. The following precautions should be taken: • To minimize the risk of patient burns, only use ESU equipment that monitors the impedance of the ESU return wires. • Users should be properly trained in the operation of the ESU equipment. • Keep patient applied cables (e.g. ECG lead wires) off of earth ground and away from the ESU knife and return wires. • Only use Invivo Research recommended accessories. • While cutting, use the SpO2 parameter instead of the ECG parameter to determine heart rate. Alarm Monitoring. Failure to respond to alarms that are annunciated by the Escort M8 Vital Signs Monitor will cause a lapse in patient monitoring. Always respond promptly to alarms. Flammable Anesthetics. An explosion hazard exists if the monitor is used in the presence of flammable anesthetics. Anesthesia Patients. Constant attention by a qualified individual is needed whenever a patient is under anesthesia or connected to a ventilator. Device Interconnections. Through its Network Connector port, the Escort M8 Vital Signs Monitor can be connected to external devices. The following precautions should be taken: • The Network Connector cable should not be applied to the patient. • Connected devices should be located outside of the patient vicinity (greater than 1.5 meters) if they do no comply with IEC 60601-1. • The Escort M8 Vital Signs Monitor should not be connected to devices that are not described in this manual. • The over-all system leakage current should be tested and should comply with IEC 60601-1-1. Do not operate the Escort M8 Vital Signs Monitor near high frequency emissions (e.g. microwaves). Single use devices should not be reused. The accuracy of the measurements can be affected by the position of the patient, the patient’s physiological condition, and other factors. Always consult a physician for interpretation of measurements made by this monitor. If any system failure occurs (e.g. an unexplained continuous audible alarm) remove the monitor from use, and refer it to qualified service personnel. Perform operational checkout before each use. If monitor fails to function properly, refer to qualified service personnel. For safe and accurate operation, use only recommended Invivo Research patient cable, lead wires, cuffs, hoses, sensors, tubing, etc. A listing of these can be found in the Accessory Listing within this manual, or by contacting Invivo Research directly. The system may not conform to all performance specifications if stored or used outside the environmental specifications identified in Section 12. For proper equipment maintenance, perform the service procedures at the recommended intervals as described in the monitor’s service manual.

Revised October 2004

3800 Vital Signs Monitor Service Manual

ix

Precautions Electrical Safety If monitor becomes accidentally wet during use, discontinue operation of the monitor until all affected components have been cleaned and permitted to dry completely. Contact your local Invivo Research, Inc. representative if additional information is required. Shock hazard exists if operated without chassis cover. Refer servicing to qualified service personnel only. For continued protection against fire hazard, replace fuses with same type and rating only. Connect the monitor only to a three-wire, grounded, hospital-grade receptacle. The threeconductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code. Do not under any circumstances remove the grounding conductor from the power plug. Avoid use of electrical power extension cords. Electrical power extension cords may create a safety hazard by compromising the grounding integrity of the monitor. This monitor and its listed accessories may be safely powered by the voltages 110-120/220-240 VAC having a frequency of 50 or 60 Hz. If the integrity of the earth ground conductor of the AC mains power cable is in doubt, operate the monitor on internal battery power until proper earth ground connection is confirmed. Patient Safety As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. ECG Pacemaker Patients. Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See the Technical Data chapter for disclosure of the pacemaker pulse rejection capability of this instrument. Arrhythmia Patients. The Escort M8 Vital Signs Monitor is designed to operate in the presence of cardiac arrhythmias. However, the heart rate meter may be adversely affected in some cases. An inoperative ECG monitor is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. For best ECG, Heart Rate, S-T Segment, and/or Respiration monitoring, always select the optimum lead configuration which has the least artifact and largest waveform(s) being detected for monitoring use. NIBP Always use recommended NIBP cuffs and hoses. Avoid compression or restriction of NIBP cuff hose. When using the NIBP portion of this instrument to measure blood pressure, remember that the patient’s blood pressure readings are not continuous, but are updated each time a blood pressure measurement is taken. Set a shorter interval for more frequent updating of the patient’s blood pressure. Do not attach the cuff to a limb being used for infusion. Cuff inflation can block infusion, possibly causing harm to the patient. Frequent NIBP measurements can cause pooling of the blood in the limb (hemostasis), and peripheral tissue/nerve damage. Allow sufficient time between measurements for blood recirculation to prevent pooling of the blood in the limb. x

3800 Vital Signs Monitor Service Manual

Revised October 2004

Precautions NIBP (Continued) Arrhythmic and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions) can result in inaccurate readings and/or prolonged measurements. If questionable readings are obtained, re-check patient’s vital signs by alternate means before administering medication. To prevent possible nerve damage to the limb, apply the NIBP cuff as recommended by current American Heart Association (AHA) guidelines for blood pressure monitoring. To ensure accurate and reliable measurements, use only recommended patient cuffs/hoses. For best accuracy, use the appropriate cuff size for each patient as recommended by the current AHA guidelines for blood pressure monitoring. Some reusable NIBP cuffs contain a medical-grade latex rubber. Patients sensitized to latex rubber can have an allergic reaction when exposed to this material. Avoid the use of cuffs which contain latex rubber on patients who are allergic to this material. Routinely inspect the cuff and hose assemblies for proper attachment and orientation. Replace cuff and/or hose assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the system. If cuff and/or hose assemblies with damage which could result in leaks are used, prolonged and/or inaccurate patient readings could result. SpO2 Avoid placement of the SpO2 sensor on the same limb with an inflated blood pressure cuff. Cuff inflation could result in inaccurate readings and false alarm violations. SpO2 monitoring requires the detection of valid pulses to correctly determine SpO2 and Heart Rate values. During conditions of gross artifact, or in the absence of valid pulses, the SpO2 /rate values may not be correct. The SpO2 monitoring portion of this monitor is intended to measure arterial hemoglobin oxygen saturation of functional hemoglobin (saturation of hemoglobin functionally available for transporting oxygen in the arteries). Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, may affect the accuracy of the measurement. Also, Cardiogreen and other intravascular dyes may, depending on their concentration, affect the accuracy of the SpO2 measurement. Always shield the SpO2 sensor from extraneous incident light sources. Such extraneous light can cause SpO2 reading or pulse detection errors. The numeric measurement values are updated every 1 second on the monitor display. A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. Use of this monitor may interfere with magnetic resonance imaging (MRI) procedures. The pulse oximeter feature in this monitor is designed to display functional SpO2 values. The pulse oximeter pulsatile waveform is not proportional to the pulse volume, but adjusts the waveform amplitude as needed for proper viewing. Arrhythmic and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions) can result in inaccurate readings and/or prolonged measurements. If questionable readings are obtained, re-check patient’s vital signs by alternate means before administering medication.

Revised October 2004

3800 Vital Signs Monitor Service Manual

xi

Precautions Temperature (SureTemp® P L U S ) To obtain accurate and reliable temperature measurements and to ensure patient safety, it is important that this manual be read thoroughly prior to use of the module, probe and accessories. Use single-use Welch Allyn disposable probe covers to limit patient cross-contamination. The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. Do not take a patient’s temperature without using a Welch Allyn disposable probe cover. Doing so can cause patient discomfort, patient cross-contamination, and erroneous temperature readings. Long-term continuous monitoring (beyond five minutes) is not recommended. Biting the probe tip while taking a temperature may result in damage to the probe. To ensure patient safety and accurate temperature measurement, use only Welch Allyn accessories and supplies. This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The probe and connector are not waterproof. Do not immerse or drip fluids on these items. Should immersion or wetting occur, dry the device with warm air and then check all functions for proper operation. The Welch Allyn SureTemp® P L U S probe consists of high-quality precision parts. Protect it from severe impact and shock. A qualified service technician must check any SureTemp® P L U S probe which is dropped or damaged to ensure proper operation prior to further use. Do not use the probe if you notice any signs of damage. Do not autoclave. To prevent damage to the module, probe, and accessories, refer to the cleaning procedures described in Section 10.

xii

3800 Vital Signs Monitor Service Manual

Revised October 2004

Precautions Other This product, or any of its parts, should not be repaired other than in accordance with written instructions provided by InvivoMDE, or altered without prior written approval of Invivo Research Inc. The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Invivo Research Inc., or its authorized service personnel. This monitor is equipped with a demonstration mode which displays simulated electronic patient data for training or demonstration purposes. Do not attach a patient to the monitor whenever this simulation is present on the monitor display (“Simulated data” can also be seen in the message area of the normal screen). Failure to properly monitor the patient could result. Access is only available with the use of the Service Passord. To exit this mode, the Simulation Mode is set to Off in the Setup Service menu then the monitor must be powered off. The patient connector inputs for all parameters are protected against the use of a defibrillator by internal circuitry, and when the recommended patient cables or accessories are used. The use of this circuitry and these recommended cables and accessories also protects against the hazards resulting from use of high frequency surgical equipment. There are no known electromagnetic or other hazardous interference between the monitor and other devices. Medical equipment requires special precautions regarding EMC and must be installed, and put into service, according to the EMC information provided in the Operations Manual. However, care should be taken to avoid the use of cellular phones or other unintended radio-frequency transmitters in the proximity of the monitoring system. Portable and mobile RF communications equipment can affect medical electrical equipment. This monitor uses rechargeable batteries that contain lithium. These batteries must be recycled or disposed of properly. For proper disposal methods, contact your local InvivoMDE. representative or distributor. Dispose of the monitor and parts thereof according to local regulations. Battery Handling. The Escort M8 Vital Signs Monitor contains a lithium ion coin cell battery and a transport battery pack. The following precautions should be taken regarding these batteries: • Do not immerse in water. • Do not heat or throw in fire. • Do not leave in conditions over 60 OC or in a heated car. • Do not attempt to crush or drop. • Follow the instructions in the disposal section of this manual when the Escort M8 Vital Signs Monitor is taken out of service. For continued operation, always connect the monitor to a wall outlet when a Low Battery alarm indication occurs. Failure to do this can lead to an interruption of monitoring. The battery may need to be recharged if the Escort M8 Vital Signs Monitor has been powered off for an extended period of time. See the Battery Operation section of this manual for details regarding charging the battery.

Revised October 2004

3800 Vital Signs Monitor Service Manual

xiii

Patents and Licensing This device is covered under one or more of the following U.S. Patents: 5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830; 6,157,850; 6,277,081 and international equivalents. U.S.A. and international patents pending. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

xiv

3800 Vital Signs Monitor Service Manual

Revised October 2004

Overview 1.

Overview

This chapter provides a basic overview of the Escort M8 Vital Signs Monitor user interface and a list of the Escort M8 Vital Signs Monitor’s main features.

1.1

Escort M8 Vital Signs Monitor Diagrams

Figure 1-1. Escort M8 Vital Signs Monitor - Front View

Revised October 2004

3800 Vital Signs Monitor Service Manual

1-1

Overview

Figure 1-2. Escort M8 Vital Signs Monitor - Left Rear View

Figure 1-3. Escort M8 Vital Signs Monitor - Right Rear View

1-2

3800 Vital Signs Monitor Service Manual

Revised October 2004

Overview

Figure 1-4. Escort M8 Vital Signs Monitor - Left Side View

Revised October 2004

3800 Vital Signs Monitor Service Manual

1-3

Overview 1.2

Escort M8 Vital Signs Monitor User Interface

The Escort M8 Vital Signs Monitor user interface makes use of a set of keys and rotary knob on the front panel. The front panel keypad looks like the following diagram:

Figure 1-5. Front Panel Keypad The Rotary Knob is used to select and rotate through the various monitoring features of this monitor. The SETUP key is used to bring up the SETUP Menu to allow for the configuration of the different features of this monitor. The ALARMS SETUP key is used to bring up a menu to allow for the adjustment of the Alarm Limits. The CLEAR TRENDS key is used to clear the stored trends. The NIBP START/STOP key is used to either start an NIBP determination or stop one in progress. The TRENDS key is used to display the stored trends. The NIBP INTERVAL key is used to set the time interval of the automatic NIBP determination feature. The RECORD key is used to output a manual strip chart to the recorder or to stop a recording in progress. The NORMAL SCREEN key is used to return the monitor screen to the regular monitoring display. The STANDBY key is used to place the monitor into the STANDBY mode of operation. The ALARM SILENCE key is used to silence active alarms.

1-4

3800 Vital Signs Monitor Service Manual

Revised October 2004

Overview

Figure 1-6. Example of Escort M8 Vital Signs Monitor Normal Screen The Normal Screen of the Escort M8 Vital Signs Monitor has four areas: one each for displaying messages, the time, waveforms and parameters. The message area is at the bottom of the display. Alarm and Technical Condition messages are displayed here. One message is displayed at a time. If multiple messages are active, the messages rotate with each message displayed for approximately three (3) seconds at a time. The time area is at the bottom right corner of the display. This area displays the current time and battery status. The waveform area has four (4) channels. Menu selections allow the operator to choose which waveform to display in the lower three (3) channels. The first channel is dedicated to the ECG waveform. The parameter area is actually in two (2) parts: one to the right of the waveform area and one below it. The parameter area displays the current values of the monitored parameters in a numerical format.

1.3

Main Features of the Escort M8 Vital Signs Monitor

The Escort M8 Vital Signs Monitor connects to a patient and monitors the patient’s vital signs. The Escort M8 Vital Signs Monitor contains the hardware and software needed to perform complex data gathering and signal processing tasks that allow it to produce measurements of physiological parameters, such as heart rate, which is labeled on the Escort M8 Vital Signs Monitor as HR. The patient’s physiological signals are shown as waveforms on the Escort M8 Vital Signs Monitor display, and the physiological parameters are shown as numbers on the Escort M8 Vital Signs Monitor display. The Escort M8 Vital Signs Monitor can be set up to generate an alarm when a physiological parameter goes beyond a preset limit. The chapters in the Service Manual explain the details of all the main features of the Escort M8 Vital Signs Monitor. These cover the basic monitoring tasks that may be required when using the Escort M8 Vital Signs Monitor. The main features covered in this Service Manual are as follows: • Overview. • Installation and Checkout. • Configuring the Monitor. • Battery Operation. • Functional Verification • Troubleshooting. Revised October 2004

3800 Vital Signs Monitor Service Manual

1-5

Overview • • • • • • •

1-6

Repair. Accessories. Spare Parts. Cleaning. Maintenance and Storage. Disposal. Technical Data.

3800 Vital Signs Monitor Service Manual

Revised October 2004