Spot Vital Signs LXi Service Manual Ver D

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Welch Allyn Spot Vital Signs LXi

Copyright 2008 Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual. Welch Allyn®, Spot Vital Signs®, SureBP® Technology, and SureTemp® are registered trademarks of Welch Allyn. Braun ThermoScan® is a registered trademark of the Braun Company. LNCS™ is a trademark of, and SET®, LNOP®, and Masimo® are registered trademarks of, Masimo Corporation. Possession or purchase of a Masimo SpO2-equipped device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device. Nellcor® and Oxi-Max® are registered trademarks of Nellcor Puritan Bennett Inc. Software in this product is Copyright 2008 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors. For information about any Welch Allyn product, call Welch Allyn Technical Support: USA +1 800 535 6663 + 1 315 685 4560

Australia +61 2 9638 3000

Canada +1 800 561 8797

China +86 21 6327 9631

European Call Center +353 46 90 67790

France + 331 6009 3366

Germany +49 7477 9271 70

Japan +81 3 3219 0071

Latin America +1 305 669 9003

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Reorder #4500-89 Manual Material No. 704432 Ver. D

Welch Allyn 4341 State Street Road Skaneateles Falls, NY 13153 USA

Printed in USA

EC

REP

European Regulatory Manager Welch Allyn Ltd. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: +353 46 90 67700 Fax: +353 46 90 67755

Service Manual

Contents

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Contents 1 - Safety Summary... 1 Introduction... 1 Warnings and Cautions... 1 Electrostatic Discharge (ESD)... 8 Symbols... 9

2 - Overview... 11 Purpose and Scope... 11 Other Applicable Documents... 11 Miscellaneous Mounting Accessories... 12 Mobile Stand Kit... 14 Radio Mounting Accessory... 16 Barcode Reader Mounting Accessory... 17 Warranty... 18 Service... 19 Spot Vital Signs LXi Configurations... 20 Controls... 20 Display Window... 22 Connections... 24

3 - Functional Overview... 29 Self Test... 29 Internal Configuration Mode... 30

4 - Spot Vital Signs LXi Technical Overview... 35 System Description... 35 SpO2 Description... 37 Radio Description... 38 Bar Code Scanner Description... 38 Printer Description... 40 Interconnect Diagram... 42

5 - Maintenance and Service... 43 Cleaning... 43 Battery Replacement... 46 Spot Vital Signs LXi Firmware Upgrade CD... 48 Spot Vital Signs LXi Radio Configuration CD... 48 Product Disposal... 48

6 - Calibration and Verification... 49 Terms... 49 Pneumatic test assembly setup... 50 Voltage Calibration... 51 Pressure verification test... 52

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Contents

Welch Allyn Spot Vital Signs LXi

Blood pressure calibration... 54 Functional tests... 56 Temperature Functional Check... 58 Masimo SpO2 Functional Check... 61 Nellcor SpO2 Functional Check... 61

7 - Specifications... 63 Performance... 63 SpO2 Specifications... 65 Mechanical... 67 Electrical... 67 Patents... 67 Battery... 67 Environmental... 67 Radio... 68 Guidance and Manufacturer’s Declaration For Spot Vital Signs LXi Radio... 69

8 - Troubleshooting... 73 Error Codes... 73 Radio Test... 83 Service Work Checklist... 84 Radio Configuration Utility... 85

9 - Supplies and Accessories... 87 Blood Pressure... 87 Temperature... 88 Pulse Oximetry... 89 Miscellaneous... 92 Service Contracts... 94

10 - Field Replaceable Units... 95 11 - Disassembly and Repair... 101 Tool list... 101 Key Pad Disassembly... 105 SpO2 Circuit Board Disassembly... 106 Blood Pressure Circuit Board Disassembly... 108 LCD Inverter Ballast Board Disassembly... 109 LCD Disassembly... 109 Pump Disassembly... 110 RS232-Communication Circuit Board Disassembly... 110 Fan and Power Circuit Board Disassembly... 111 Thermometry Circuit Board Disassembly... 111

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Contents

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12 - Repair Test Specifications... 115 General Unit Test... 115 Temperature Option Requirements... 116 SpO2 Option Requirements... 117 Fail Safe Test... 117

1

1 Safety Summary Introduction All users of the Spot Vital Signs LXi must read and understand the safety summary, and all additional specific warnings and cautions located throughout the documentation.

Warnings and Cautions Familiarize all operating personnel with the general safety information in this summary. Specific warnings and cautions are also found throughout this manual.

General Warnings A warning statement in this manual identifies a condition or practice, which if not corrected or discontinued immediately, could lead to patient injury, illness, or death. These warnings pertain entirely to Spot Vital Signs LXi. WARNING The information in this manual is a comprehensive guide to the operation of Spot Vital Signs LXi. For best results, read this manual thoroughly before using the device. WARNING Spot Vital Signs LXi is designed for medical clinician use. Although this manual may illustrate medical spot-check techniques, only a trained clinician who knows how to take and interpret a patient’s vital signs should use this device. WARNING Spot Vital Signs LXi is not intended for use in environments that are without health care practitioner supervision. WARNING Spot Vital Signs LXi is not intended for continuous monitoring. Do not leave the device unattended while taking measurements on a patient. WARNING To ensure data integrity, save readings and clear the Spot Vital Signs LXi display between patients. WARNING The Spot Vital Signs LXi is not defibrillator proof. WARNING Spot Vital Signs LXi is not intended for use during patient transport. WARNING This device is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. An explosion may result.

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Safety Summary

Welch Allyn Spot Vital Signs LXi

WARNING To ensure patient safety, use only accessories and supplies (i.e., cuffs, hoses, temperature probes, SpO2 sensors, etc.) recommended for or supplied with Spot Vital Signs LXi. Using unapproved accessories with Spot Vital Signs LXi can affect patient and/or operator safety. WARNING Take care to prevent water or other fluid from entering any connectors on the device. Should this occur, dry the connectors with warm air. Check the accuracy of all operating functions. WARNING Every three months, inspect the blood pressure cuff, SpO2 cable, and other accessories for fraying or other damage. Replace as necessary. WARNING Do not use Spot Vital Signs LXi on patients who are on heart/lung machines. WARNING Electric shock hazard. There are no user-serviceable parts inside Spot Vital Signs LXi other than battery replacement (see “Battery Replacement” on page 46). An operator may only perform maintenance procedures specifically described in this manual. For service, refer the device to an Authorized Service Center. WARNING This device is not intended for hand-held use during operation. WARNING Do not autoclave. WARNING This device complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other equipment. WARNING Welch Allyn is not responsible for the integrity of any mounting installation. Welch Allyn recommends that the customer contact their Biomedical Engineering Department or maintenance service to ensure professional installation for safety and reliability of any mounting accessory. WARNING The Spot Vital Signs LXi consists of high-quality precision parts. Protect it from severe impact and shock. A qualified service technician must check any Spot Vital Signs LXi that is dropped or damaged for proper operation prior to further use. Do not use the Spot Vital Signs LXi if you notice any signs of damage. Contact the Welch Allyn Customer Service Department for assistance. WARNING Do not use an SpO2 finger clip sensor and a blood pressure cuff simultaneously on the same limb. Doing so may result in inaccurate pulse rate and perfusion readings. WARNING All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (for example, IEC 60950) as appropriate to the device. Connecting additional devices to the Spot LXi may increase leakage currents. To maintain operator and patient safety, it is necessary to consider the requirements of IEC 60601-1-1. WARNING For proper patient electrical isolation, use only a Welch Allyn power supply (4500-101A) to charge Spot Vital Signs LXi and its attached peripheral devices. Do not use an external charger while the printer or weight scale is attached to Spot LXi.

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Safety Summary

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Blood Pressure Warnings These warnings pertain to the Spot Vital Signs LXi blood pressure feature. WARNING Spot Vital Signs LXi is not intended to measure BLOOD PRESSURE on neonatal patients. The AAMI SP10:2002 standard defines neonates as children 28 days or less of age if born at term (37 weeks gestation or more); otherwise up to 44 gestational weeks. WARNING To ensure pediatric blood pressure accuracy and safety, the Child Reusable Two-Piece Blood Pressure Cuff (4500-01), Infant Durable One-Piece Cuff (5082-82-4MQ), and the Infant Disposable One-Piece Cuff (5082-92-4MQ) are the smallest cuffs approved for use with young children and infants. The child’s arm must fit within the range markings on the cuff. WARNING Avoid compression of the blood pressure hose or cuff tubing of Spot Vital Signs LXi. This may cause system errors to occur in the device. WARNING Patients who are experiencing moderate to severe arrhythmias may give inaccurate blood pressure measurements. WARNING Spot Vital Signs LXi does not operate effectively on patients who are experiencing convulsions or tremors. WARNING Use only Welch Allyn blood pressure cuffs and/or hoses. Using other manufacturers’ blood pressure cuffs and/or hoses may produce inaccurate blood pressure readings. WARNING When several blood pressure measurements are taken on the same patient, regularly check the cuff site and extremity for possible ischemia, purpura, and/or neuropathy. WARNING Do not allow a blood pressure cuff to remain on the patient more than 10 minutes when inflated above 10 mmHg. This may cause patient distress, disturb blood circulation, and contribute to injury of peripheral nerves. WARNING Do not place the cuff on any extremity that is used for intravenous infusions or any area where circulation is compromised. WARNING Excessive cuff tightness may cause venous congestion and discoloration of the limb. WARNING Wrapping the cuff too loosely (preventing proper inflation) may result in errors. WARNING Do not change the connector(s) on the blood pressure cuff tubing of this device to luer type. Luer type connectors are commonly used in intravenous infusion systems. Using the luer connectors on blood pressure cuff tubing creates the risk that the blood pressure tubing could be mistakenly connected to a patient's intravenous line, resulting in the introduction of air into the patient's circulatory system.

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Safety Summary

Welch Allyn Spot Vital Signs LXi

Temperature Warnings These warnings pertain to the Spot Vital Signs LXi temperature feature.

SureTemp® Plus These warnings are specific to the SureTemp Plus thermometer option. WARNING Use only Welch Allyn probe covers. Using other manufacturers’ probe covers or no probe cover may produce temperature measurement errors and/or inaccuracy. WARNING Always use a probe cover whenever coming into contact with a patient. WARNING Long-term continuous monitoring beyond three to five minutes is not recommended in any mode. WARNING Oral/axillary probes (blue ejection button at top of probe) and blue removable probe wells are used for taking oral and axillary temperatures only. Rectal probes (red ejection button) and red removable probe wells are used for taking rectal temperatures only. Use of the probe at the wrong site will result in temperature errors. Use of the incorrect removable probe well could result in patient cross-contamination. WARNING The thermometer connectors and probe are not waterproof. Do not immerse or drip fluids on these items. Should this occur, dry the connectors and probe with warm air. Check all functions for proper operation and accuracy. WARNING Do not take an axillary temperature through patient’s clothing. Direct probe cover to skin contact is required. WARNING Do not autoclave. WARNING Use Welch Allyn single-use disposable probe covers to limit patient cross-contamination. WARNING Incorrect insertion of probe can cause bowel perforation. WARNING Washing hands greatly reduces the risk of cross-contamination and nosocomial infection. WARNING To ensure optimal accuracy, always confirm that the correct mode is selected.

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Safety Summary

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Braun Thermoscan PRO 4000 These warnings are specific to the Braun ThermoScan PRO 4000 thermometer option. WARNING Keep the probe window clean, dry, and undamaged at all times to ensure accurate measurements. To protect the probe window, always keep the thermometer in the storage cover while transporting or when not in use. WARNING Only use Braun ThermoScan probe covers with this thermometer. Using other manufacturer’s probe covers or no probe cover may produce temperature measurement errors and/or inaccuracies. If the thermometer is used without a probe cover attached, clean the lens (see “Braun ThermoScan PRO 4000 Thermometer” on page 44). WARNING Do not autoclave. WARNING The thermometer is not waterproof. Do not immerse or drip fluids on it. Should this occur, dry the thermometer with warm air. Check for proper operation and accuracy.

SpO2 Warnings These warnings pertain to the Spot Vital Signs LXi SpO2 feature. WARNING Only use Spot Vital Signs LXi with Masimo or Nellcor SpO2 option with Masimo or Nellcor brand sensors and accessories, respectively. Using the wrong or unapproved sensors or cables may cause improper performance. WARNING The SpO2 sensor and extension cables are intended for use only for pulse oximetry measurements. Do not attempt to connect these cables to a PC or any similar device. WARNING Before using, carefully read the sensor Directions for Use, including all warnings, cautions, and instructions. WARNING Do not use a damaged sensor or pulse oximetry cable or a sensor with exposed optical components. WARNING Incorrect application or a long duration of use of an SpO2 sensor may cause tissue damage. Inspect the sensor site periodically as directed in the sensor’s Directions for Use. WARNING Certain ambient environmental conditions, sensor application errors, and certain patient conditions may affect SpO2 readings and pulse signal. WARNING Do not immerse the sensor or patient cables in water, solvents, or cleaning solutions (the sensors and connections are not waterproof). Do not use irradiation, steam, or ethylene oxide for sterilization. WARNING The SpO2 in the Spot Vital Signs LXi device is not intended for use as an apnea monitor. WARNING Consider the SpO2 an early warning device. As a trend toward patient deoxygenation is indicated, use laboratory instruments to analyze blood samples to completely understand the patient’s condition.

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Safety Summary

Welch Allyn Spot Vital Signs LXi

WARNING Tissue damage can be caused by incorrect application or duration of use of a Nellcor OxiMax sensor. Inspect the sensor site as directed in the sensor Directions for Use. WARNING Do not use the sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The MS board pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. WARNING Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING Failure to cover the Nellcor OxiMax sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.

General Cautions A caution statement in this manual identifies a condition or practice, which if not corrected or discontinued immediately, could lead to equipment failure, equipment damage, or data loss. These cautions pertain to the entire Spot Vital Signs LXi device. Caution If the accuracy of any measurement is in question, check the patient’s vital sign(s) with an alternate method and then check to verify the device is functioning properly. Caution Place the device on a secure surface or use one of the optional mounting accessories. Caution Do not place fluids on or near the device. Caution It is recommended that the device is used within stated operating temperature ranges (see “Environmental” on page 67). The device will not meet its performance specifications if used outside these temperatures ranges. Caution Always unplug the AC power transformer from the outlet before moving the mobile stand to a new location. Caution The basket has a three-pound weight limit. Take care not to exceed this limit. Caution Only use a 9V battery with the Healthometer scale. Remove and discard the wall mounted power supply. Caution When using the Healthometer scale, remove the two hex nuts on the RS-232 cable, as supplied, before screwing the cable into the scale base.

Service Manual

Safety Summary

Blood Pressure Cautions These cautions pertain to the Spot Vital Signs LXi blood pressure feature. Caution Minimize extremity and cuff motion during blood pressure readings. Caution If the blood pressure cuff is not at heart level, note the difference in reading due to the hydrostatic effect. Add the value of 1.80 mmHg (.2 kPa) to the displayed reading for every inch (2.5 cm) above heart level. Subtract the value of 1.80 mmHg (.2 kPa) from the displayed reading for every inch (2.5 cm) below heart level. Caution Proper blood pressure cuff size and placement is essential to the accuracy of the blood pressure determination. See Reusable Two-Piece Cuff Measurements or Durable One-Piece Cuff Measurements of the Directions for Use for sizing information. Caution The position and physiologic condition of the subject can affect a blood pressure reading.

Temperature Cautions These cautions pertain to the Spot Vital Signs LXi temperature feature. Caution The SureTemp Plus feature only operates with the probe well in place. Caution Do not use alkaline batteries in the Braun ThermoScan PRO 4000. Caution Biting the probe tip may result in damage to the probe.

SpO2 Cautions These cautions pertain to the Spot Vital Signs LXi SpO2 feature. Caution The pulse oximeter is calibrated to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin may affect the accuracy of the measurement. Caution Some sensors may not be appropriate for a particular patient. If at least 10 seconds of perfusion pulses cannot be observed for a given sensor, change sensor location or sensor type for perfusion to resume. Caution Physiological conditions, medical procedures, or external agents that may interfere with the pulse oximeter’s ability to detect and display measurements include dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents such as nail polish, dye, or pigmented cream. Caution When selecting a sensor, consider the patient’s weight and activity level, the adequacy of perfusion, the available sensor sites, the need for sterility, and the anticipated duration of monitoring.

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Safety Summary

Welch Allyn Spot Vital Signs LXi

Electrostatic Discharge (ESD)

Electrostatic discharge is a sudden current flowing from a charged object to another object or to ground. Electrostatic charges can accomulate on common items such as foam drinking cups, cellophane tape, synthetic clothing, untreated foam packaging material, and untreated plastic bags and work folders, to name only a few. Electronic components and assemblies, if not properly protected against ESD, can be permanently damaged or destroyed when near or in contact with electrostatically charged objects. When you handle components or assemblies that are not in protective bags and you are not sure whether they are static-sensitive, assum that they are static-sensitive and handle them accordingly. •

Perform all service procedures in a static-protected environment. Always use techniques and equipment designed to protect personnel and equipment from electrostatic discharge.

•

Remove static-sensitive components and assemblies from their static-shielding bags only at static-safe workstations - a properly grounded table and grounded floor mat and only when you are wearing a grounded wrist strap (with a resistor of at least 1 megohm in series) or other grounding device.

•

Use only grounded tools when inserting, adjusting, or removing static-sensitive components and assemblies.

•

Remove or insert static-sensitive components and assemblies only with monitor power turned off.

•

Insert and seal static-sensitive components and assemblies into their original staticshielding bags before removing them from static-protected areas.

Always test your ground strap, bench mat, conductive work surface, and ground cord before removing components and assemblies fromtheir protective bags and before beginning any disassembly or assembly procedures.

Service Manual

Safety Summary

Symbols The following symbols are associated with the Spot Vital Signs LXi.

Safety Symbols Identifies information within the manual to avoid injury. Caution: consult accompanying documents

Identifies information within the manual to avoid equipment failure. Pb

Internally Powered, Lead Acid Battery

Handle with Care

Transport Temperature

Storage Humidity

Recycle

Class II Equipment

IPXØ

Equipment is not protected against the ingress of liquid.

Type BF Equipment

On/Off

Recycle the product separate from other disposables, see “Product Disposal” on page 48.

Non-ionizing radiation (RF transmitter)

Mode of Operation: Continuous

DC Power In

Navigation Buttons

Select

Button Symbols

Blood Pressure

MEM

Memory

Power On/Off

Connection Symbols USB Connection

Serial Port Connection

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Safety Summary

Welch Allyn Spot Vital Signs LXi

Agency Symbols CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1 C

US

166292

CONFORMS TO: UL STD 60601-1 IEC 60601-1 The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93/42/EEC Medical Device Directive.

0297 EC

REP

European Regulatory Manager Welch Allyn Ltd. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: +353 46 90 67700 Fax: +353 46 90 67755

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2 Overview Purpose and Scope The Spot Vital Signs LXi Service Manual is intended as a reference for maintenance and repair to the field replaceable unit (FRU) level and are listed on page 95. Note

If you crack the case some of these parts will need to be calibrated using the repair tool. Internal replacement parts require the Welch Allyn Spot LXi repair software.

This manual provides the technical qualified service person with troubleshooting information, repair procedures, and calibration and performance verification instructions. A technical overview of the Spot Vital Signs LXi subsystems is provided as an introduction to the device’s circuitry and pneumatics. This manual is intended for the technical qualified service personnel. Service training classes on Welch Allyn’s products are available. Contact Welch Allyn Technical Service for information.

Other Applicable Documents The Spot Vital Signs LXi Directions for Use manual is also available. Refer to this document for information other than maintenance and repair. Welch Allyn 9600 Plus Calibration Tester Directions for Use - for all models. Braun ThermoScan PRO 4000 User’s Guide - for models 450E0, 45NE0, 45ME0. Masimo Directions for Use - for models 45MT0, 45ME0. Nellcor Directions for Use - for models 45NT0, 45NE0.

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Overview

Welch Allyn Spot Vital Signs LXi

Miscellaneous Mounting Accessories Wall Mount Kit WALL MOUNT KIT EF: 4701-62

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aterial #: 711890 Rev. B

Attach bracket to wall before assembling basket.

1

3

} 5

4

Welch Allyn is NOT responsible for the integrity of any wall mounting interface. Ensure you are using the appropriate hardware to mount the device to a surface. Welch Allyn recommends that the customer contact their Biomedical Engineering Department or maintenance service to ensure professional installation, safety, and reliability of any mounting accessory.

Service Manual

Overview

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Overview

Mobile Stand Kit

Welch Allyn Spot Vital Signs LXi

Service Manual

Overview

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