Spot Vital Signs Monitor Series 420 Service Manual Ver A March 2001

Welch Allyn, Inc. Spot Vital Signs Service Manual Revision A

Spot Vital Signs Service Manual

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Welch Allyn, Inc. Spot Vital Signs Service Manual Revision A

Revision History Version A

Date 3/31/01

Author JDB

Description Introduction of Service Manual

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Welch Allyn, Inc. Spot Vital Signs Service Manual Revision A

Table of Contents Section 1 General Information ...5 1.1-To Service Personnel:...5 1.2 Limited Warranty...6 Service Policy...6 Technical Assistance ...6 1.3 Basic System Description ...8 Introduction...8 1.4 Basic System Operation ...9 1.5 Specifications ...13 1.6 Identification Label and Serial Numbering System Defined ...16 1.7 Firmware Identification ...17 Section 2 Service ...18 2.1 Intent of Manual and Product Scope. ...18 2.2 Test Equipment Bench Layout:...19 2.3 Required Tools and Fixtures for Service ...20 2.4 Required Tools and Fixtures for Service ...21 2.5-Replacement Parts :...22 2.6-Supplies and Accessories:...22 2.7 Maintenance and Service Support...25 Section 3 Problem Diagnosis...26 3.1 Diagnostic Procedure for Returned Units...26 3.2 Calibration Procedure : Voltage ...29 3.3 Calibration Procedure : Pressure...30 3.4 SELF DIAGNOSTIC FAULT CODES ...31 3.5 COMPLAINT / CAUSE / CORRECTIVE ACTION...33 Section 4 Removal/Replacement of Parts...39 4.1 Battery...39 4.2 Temperature Pod and Temperature Connector PCB removal ...40 4.3 Front Housing and Switch Array ...41 4.4 Display PCB...42 4.5 Remove Power and Battery Cable ...43 4.6 Main PCB Removal...44 4.7 SpO2 PCB Removal (If configured with SpO2) ...45 4.8 Pump and Valve Removal...46 Section 5 Test Procedures...47 Section 5.1 Calibration Tests...47 Section 5.2 Current Tests ...48 Section 5.3 Noise Levels...49 Section 5.4 Button Test ...50 Section 5.5 Interface Test ...51 Section 5.6 Print Quality ...52 Section 5.7 Pneumatic Tests ...53 Section 5.8 SpO2 Tests...54 Section 5.9 Temperature Tests...55 Section 5.10 Fail Safe Testing ...56 Section 5.11 Check List For Spot Vital Signs Service Work ...57 Section 6 Drawings ...59 Section 7 Repair Test Specifications...60

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Section 1 General Information 1.1-To Service Personnel: Read and understand the Spot Vital Signs Operator’s Manual and this Service Manual. The information contained in both of these publications is subject to change without notice and should not be construed as a commitment by Welch Allyn, Inc. Welch Allyn assumes no responsibility for any errors that may appear in this manual. If the product and/or its operation varies significantly from any description herein, please contact the following: WELCH ALLYN,, INC. TECHNICAL SERVICE DEPARTMENT: 1-800-450-9275 (828) 684-4895 Fax (828)687-1002 Welch Allyn,, Inc. . 95 Old Shoals Road Arden, North Carolina 28704 This product has been designed to provide a high degree of safety and reliability. However, we can not guarantee against: deterioration of components due to aging, normal wear, tampering, and abuse. All service and repairs must be performed by authorized Welch Allyn personnel or agents, using approved Welch Allyn replacement parts and approved process materials. Failure to so will invalidate the product warranty. Please refer to the product warranty for specific coverage. Welch Allyn, Inc. 95 Old Shoals Road Arden, North Carolina 28704 USA 1 800 450-9275

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1.2 Limited Warranty Welch Allyn, Inc. warrants the Spot Vital Signs, when new, to be free of defects in material and workmanship and to perform in accordance with manufacturer's specifications for a period of two years from the date of purchase from Welch Allyn, Inc. or its authorized distributors or agents. Welch Allyn, Inc. will either repair or replace any components found to be defective or at variance from manufacturer's specifications within this time at no cost to the customer. It shall be the purchaser's responsibility to return the instrument to Welch Allyn, Inc. or an authorized distributor, agent or service representative. This warranty does not include breakage or failure due to tampering, misuse, neglect, accidents, modification or shipping. This warranty is also void if the instrument is not used in accordance with manufacturer's recommendations or if repaired by other than Welch Allyn, Inc. or an authorized agent. Purchase date determines warranty requirements. No other express warranty is given. To receive service assistance or to ask questions regarding this warranty, please call or write: Welch Allyn, Inc. Technical Services Dept. 95 Old Shoals Road Arden, North Carolina 28704 USA 1 (800) 450-9275 or (828) 684-4895 Fax: (828) 687-1002 Service Policy All repairs on products under warranty must be performed or approved by a Welch Allyn, Inc. Service Center. Unauthorized repairs will void the warranty. Products out of warranty should be repaired by qualified electronics personnel or a Welch Allyn, Inc. Service Center.

Technical Assistance If you have an equipment problem that you cannot resolve, call the Welch Allyn, Inc. Service Center nearest you for assistance. Technical service support is available to you by telephone on normal business days at the locations listed on the next page

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Before returning a product for repair you must obtain authorization from Welch Allyn, Inc. An RMA (Return Material Authorization) number will be given to you by our service personnel. Be sure to note this number on the outside of your shipping box. Returns without an RMA number will not be accepted for delivery.

Welch Allyn, Inc. Service Centers For Service or Repair USA Customers Welch Allyn, Inc. Technical Service Centers 95 Old Shoals Road Arden, NC 28704-9739 USA Phone: 828-684-4895 Fax: 828-687-1002

CANADA Customers Welch Allyn Canada Limited Technical Service Centers 160 Matheson Blvd., East Mississauga, Ontario L4Z CANADA Phone: 905-890-0004 or 1 800-561-8797 Fax: 905-890-0008 INTERNATIONAL Customers

Welch Allyn GmbH Technical Service Center Zollerstrasse 2-4 Road D-72417 Jungingen GERMANY Phone: [49]-7477-927-10 Fax: [49]-7477-9271-90

Welch Allyn Australia Pty. Ltd. Technical Service Center 5/38-46 South Street Rydalmere NSW 1701 AUSTRALIA Phone: [61] 29-4183-155 Fax: [61] 29-4183 650

Welch Allyn Ltd. 21-09 Golden Mile to 6001 Beach Road Singapore 199589 REPUBLIC OF SINGAPORE Phone: [65]-291-0882 Fax: [65]-291-5780

Welch Allyn UK Ltd. Cublington Road Aston Abbots Buckinghamshire HP22 4ND UNITED KINGDOM Phone: [44] 129-668-2140 Fax: [44] 129-668-2104 LATIN AMERICA Customers

MDI International Technical Service Centers 7324 SW 48th Street Suite A Miami, FL 33155 USA Phone: (305)-669-9591 Fax: (305)-669-1971

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1.3 Basic System Description

Introduction The Welch Allyn Spot Vital Signs is designed to non-invasively and automatically measure systolic and diastolic pressure, pulse rate, temperature and oxygen saturation (SpO2 ) for adult and pediatric patients. THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED TO BE USED ON NEONATAL PATIENTS. All blood pressure, pulse, temperature and SpO2 values can be viewed on a large, easy-to-read display, and may be printed via the IrDA port to an external printer as desired. The rechargeable lead acid battery and variety of mounting accessories make the Welch Allyn Spot Vital Signs convenient for many locations. The operator may choose any combination of simultaneous measurement modalities. The Welch Allyn Spot Vital Signs is intended for use in a wide variety of health care settings. This includes hospital departments, as well as alternate care settings, such as physicians offices, clinics, and long term care facilities. The Welch Allyn Spot Vital Signs is not intended for continuous monitoring of patients, or for use during transport of a patient. The Welch Allyn Spot Vital Signs is not intended for use in environments that are not supervised by a health care practitioner.

Refer to the Spot Vital Signs Operator’s Manual for complete information on Indications For Use, Special Features, Supplies and Accessories

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1.4 Basic System Operation

Blood Pressure Measurements A single blood pressure determination is made when the blood pressure START/STOP button is pushed.

A measurement cycle may be cancelled at any time by pressing the BP START/STOP button again. This action immediately initiates a rapid cuff deflation.

The blood pressure measurement data will appear on the display immediately following the measurement and remain displayed for two minutes. After two minutes, the display goes blank, and the device will go into standby mode. The most recent BP measurement may be recalled by pressing the Print, Mode, Next Patient/Clear or BP Start/Stop button. Max/Min Blood Pressure Ranges The maximum and minimum ranges of blood pressure are detailed below:

Mean Arterial Pressure (MAP) Ranges 40 - 190mmHg Calculated from Systolic and Diastolic data (not directly measured).

Temperature Operating Modes Thermometry measurements are made with the Welch Allyn SureTemp ™ technology. Oral and rectal probes utilize single-use disposable probe covers that limit cross-contamination. Oral, axillary or rectal temperatures are taken using ‘Normal or ‘Monitor operating modes. Axillary temperatures are taken using the (blue) oral probe.

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Rectal temperatures are taken using the (red) rectal probe. In the Normal mode the thermometer's microprocessor "predicts" body temperature in about 4 seconds for oral temperatures, about 10 seconds for axillary temperatures, and in about 15 seconds for rectal temperatures. The monitor mode displays the patient’s actual temperature after 3 minutes for oral/ rectal mode and 5 minutes for axillary mode, and will continue to display an updated temperature as long as the probe remains in place. Temperature readings may be displayed in Fahrenheit or Celsius scales. Max/Min Temperature Ranges

Temperature Normal Mode In Normal Mode, the Spot Vital Signs will measure temperature at discrete intervals and then calculate the rate of change according to a proven algorithm. This allows the thermometer to predict the end point that the thermistor would reach if it were left in the mouth until it reached mouth temperature. This predictive feature allows the thermometer to arrive at an accurate oral temperature reading in approximately 4 seconds. Normal mode is the default operating mode for the temperature determinations. Operator selectable patient alarm limits are not available in temperature Normal mode. However, temperatures that are outside of the operating range of the device will be noted on the temperature display. Temperature Monitor Mode Continuous Monitor Mode operation is normally used when difficult situations prevent accurate temperatures from being taken in the Normal mode. The probe must be in contact with tissue for at least three minutes for accurate oral/rectal temperature measurement and five minutes for accurate axillary temperature measurement. Monitor mode temperatures may not be identical to predicted ‘Normal’ temperatures because of ambient temperature influence and other factors The trend in temperature is the important standard to be observed when in the Monitor mode. Operator selectable patient alarm limits are not available in temperature monitor mode. However, temperatures that are outside of the normal operating range of the device will be noted on the temperature display.

SpO2 Operating Mode * The Spot Vital Signs incorporates the Nellcor Puritan Bennett ™ pulse oximetry system which determines arterial oxyhemoglobin saturation (SpO2 %) by measuring the absorption of red and infrared light passed through the tissues.

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* Changes in absorption caused by pulsation of blood in the vascular bed are used to determine arterial saturation and pulse rate. Oxygen saturation percent is calculated with each pulse detected, and thus the device display is continually updated. The pulse signal bar graph is an indicator of the strength and quality of the detected pulses. * The Spot Vital Signs is capable of determining pulse rate as an adjunct to the blood pressure measurement and the SpO2 measurement. * The pulse rate, in beats per minute, will be determined primarily from the SpO2 measurement methodology. In the case where SpO2 is not available, or is disabled, the pulse rate display will be driven from data collected as part of the blood pressure measurement method. * Removal of the SpO2 sensor from the patient will initiate an audible beep, to alert the user that the sensor has been disconnected. * SpO2 is generally measured via pulses detected using a finger sensor, and performs most accurately with the finger clip sensor. The finger clip sensor may be used on all fingers except the thumb. For certain situations SpO2 may be measured at alternate sites including the earlobe, forehead and toes. Special sensors must be employed in these situations. The finger clip sensor is recommended for spot checks or short-term evaluation (less than 60 minutes). Patient supervision is required as the Spot Vital Signs has no alarm capability. * Oxygen Saturation and pulse rate is displayed on the LCD display. On each detected pulse, the pulse signal bar graph flashes. The intensity of this signal is a simple visual indicator of waveform signal strength, and can identify situations where the pulsatile nature of the tissue may not be adequate for an accurate SpO2 reading. The update interval bar of the bar graph should correspond to the patient’s pulse rate. This is an indication of the quality of the SpO2 signal. Max/min SpO2 Ranges The SpO2 sensor is designed to detect oxygen saturation as follows:

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Pulse Rate Feature The Welch Allyn Spot Vital Signs is capable of determining pulse rate as an adjunct to the blood pressure measurement and the SpO2 measurement. The pulse rate, in beats per minute, will be determined primarily from the SpO2 measurement methodology. In the case where SpO2 is not available, or is disabled, the pulse rate display will be derived by data from the blood pressure measurement method. Max/Min Pulse Rate Ranges The maximum and minimum pulse rate ranges are as follows:

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1.5 Specifications The performance specifications of the Spot Vital Signs are as follows: Patient Population The Welch Allyn Spot Vital Signs is designed for use with adult and pediatric patients. Welch Allyn defines a pediatric patient as 29 days old and above. THE SPOT VITAL SIGNS IS NOT INTENDED FOR USE WITH NEONATES. Welch Allyn defines neonates as children 28 days or less of age born at term (37 weeks gestation or more): otherwise, up to 44 gestational weeks. Cuff Pressure Range 0 mmHg - 300mmHg Initial Cuff Inflation 160 mmHg, smart inflation Systolic Determination Maximum: 250 mmHg Minimum: 60 mmHg Diastolic Determination Maximum: 160 mmHg Minimum: 30 mmHg Blood Pressure Accuracy Blood pressure accuracy meets or exceeds SP10-1992 AAMI standards for non-invasive blood pressure accuracy (AAMI standard: ± 5 mmHg mean error; 8 mmHg standard deviation). Blood pressure accuracy is validated for pressure measurement using the upper arm only. Blood Pressure Determination Time 20 seconds to 45 seconds typical, 165 seconds maximum. Pulse Rate Determination (Using SpO2 determination) Maximum: 245bpm Minimum: 25bpm Pulse Rate Accuracy SpO2 Module Heart Rate ±3.0 bpm Blood Pressure Algorithm Heart Rate ±5.0

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Overpressure Cutoff 315 mmHg ±15 mmHg Temperature Ranges

Temperature Accuracy Temperature accuracy meets or exceeds ASTM E112-86: "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature." Temperature Determination Time (Oral) 4 seconds typical, 15 seconds maximum (Axillary) 10 seconds typical (Rectal) 15 seconds typical Oxygen Saturation Range (SpO2 %) 40-100% oxygen saturation SpO2 Accuracy ±3% in the range of 70-100% oxygen saturation (1 Standard Deviation) <70% unspecified by the OEM. Battery Charging To 90%-100% capacity in 12 hours. Unit will operate and charge battery simultaneously when connected to power source.

Mechanical Specifications Dimensions Height 9.70 inches (24.64 cm) Length 5.72 inches (14.53 cm) Depth 4.73 inches (12.01 cm)

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Weight Approximately 4.25 pounds Mounting Self-supporting on rubber feet Custom Mobile Stand Custom Made Wall Mount Portability May be hand carried when held by the rear handle.

Electrical Specifications Power Requirements Patient-Rated isolation transformer is connected to AC mains: North American Version: 120VAC, 60 Hz. 0.20A Input Source, 8VDC, 0.75A Output Source International Version: 220-240VAC, 50-60Hz 0.20A Input Source, 8VDC, 0.75A Output Source Battery Lead acid, with external charger. A fully charged battery will support 150"typical" blood pressure determinations taken at 7 minute intervals. Battery is 90-100% charged after 6-12 hours of charging. The battery automatically charges when the Spot Vital Signs is powered through the AC power transformer. The battery will charge faster when the instrument is not in operation.

Environmental Specifications Operating Temperature +10°C to +40°C (Except temperature 16°C to 40° C) +50°F to +104°F Storage Temperature -20°C to +50°C -4°F to +122°F Relative Humidity 15 to 90% (non-condensing) Operating Altitude -170m to +4877m -557ft. to +16,000ft.

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1.6 Identification Label and Serial Numbering System Defined The identification label for the 420 Series Spot Vital Signs is shown below. It is located on the bottom of the unit.

The serial number for the device would consist of nine (9) numbers and a bar code. These would be located in the square below the words “420 Series.” An example of the number and the explanation is shown below:

200100001 The four digits on the left Are the year of manufacture of the device. The five digits on the right are the sequence of build starting with 00001 annually. (The example number above would be the first unit built in 2001)

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1.7 Firmware Identification To confirm the software levels of the 420 Series Spot Vital Signs, place the unit into the “Configuration Test” mode by holding down the Start button while the unit is being powered up. The main software versions will appear as follows: * In the SW1 Screen, the top two numbers is the software version of the Spot Module and the other numbers are for the SpO2 module (if installed). Press the “Start” or “Clear” button to cycle through the SpO2 software number. In the SW2 screen, The two numbers represent the NIBP module software and the Temperature Algorithm Version (If temperature is active.).

Note: Verify the firmware levels by reviewing the Repair Test Specifications document.

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Section 2 Service 2.1 Intent of Manual and Product Scope.

This manual provides technical service and re-calibration information to technicians authorized to repair and recalibrate Welch Allyn, Inc. products. When used in conjunction with the required test equipment and tools, technicians will be able to diagnose, repair, and recalibrate, and test the Spot Vital Signs. The manual includes: Re-calibration instructions, fault/cause analysis, step by step disassembly and reassembly procedures, repair, adjustment, and re-test procedures.

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2.2 Test Equipment Bench Layout: Figure 2.2 depicts recommended layout of test equipment and special tools for service and recalibration of the Spot Vital Signs. 500 CC Volume

250 CC Volume

100 CC Volume

DMM Voltage

+

Power Supply

-

+

DMM Current

-

+

Setra Meter Or Netech Meter To black wire To red wire Connect To Power of the Spot Check Device 2” Tubing 3” Tubing 4” Tubing 15” Tubing

Welch Allyn Spot Device 10” Tubing To the Spot Vital Signs

Nellcor Patient Simulator SRC-2

3” Tubing To Bulb and Valve

Diatek Calibrator 9600

PC, IBM Comp. 486 133 MHz, 8 Mb RAM Windows 95 OS

FIGURE 2.2 BENCH LAYOUT FOR RE-CALIBRATING AND TESTING SPOT VITAL SIGNS

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2.3 Required Tools and Fixtures for Service Special tools below can be ordered from Welch Allyn, Inc. DESCRIPTION

TOOL #

100cc TEST VOLUME T112819 250cc TEST VOLUME T112818 500cc TEST VOLUME T112854 DIGITAL TIMER 8456T12 PLIERS T112458 BULB AND VALVE 5088-01 WIRE CUTTERS T112486 TWEEZERS T112511 PNEUMATIC TUBING (3 ea.) 5089-12 "Y" FITTING 9586TPK4 "T" FITTING (3) 9585TPK4 TEST CABLE (IR) 66P824 TEST CABLE (Service Cable Kit) 66S553 PNEUMATIC CLAMPS (3) 21730-001 TORQUE SCREWDRIVER T112917 TORQUE SCREWDRIVER T112918 TORQUE DRIVER T112918A CUSTOM REPAIR SOFTWARE 130S57 #4 PHILLIPS BIT T112919 T10 TORX BIT T114030 3/8 HEX SOCKET T114135 CABLE TIE TOOL T112845 DIATEK 9600 CALIBRATOR 01800-210 DIATEK CAL. KEY 06137-000 NELLCOR PATIENT SIMULATOR SRC-2 NELLCOR TEST CABLE EC-8 SERVICE MANUAL 4200-145E DIGITAL PRESSURE METERS SETRA METER (0-10 PSIG) 2270-01 NETECH METER 200-2000IN Notes: The entire set of equipment listed above can be ordered through Welch Allyn by the following number: Eleckit A Setra Meter (2270-01) or a Netech Meter (200-2000 IN) must to be ordered along with the Eleckit. Individual equipment numbers can be ordered by themselves. NO DISCOUNTS

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