Nellcor Intouch Service Manual sw ver 2.4.6 or lower

Windows and Windows CE are registered trademarks of the Microsoft Corporation. To obtain information about a warranty, if any, contact Nellcor Technical Services Department, 1.800.635.5267, or your local Nellcor representative. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor and Intouch are trademarks of Nellcor Puritan Bennett Inc.

TABLE OF CONTENTS List of Figures List of Tables List of Figures ... List of Tables ... Section 1: Introduction ... 1.1 Manual Overview... 1.2 Description of Intouch Remote Oximetry Notification System... 1.3 Related Documents ... Section 2: Routine Maintenance ... 2.1 Cleaning... 2.2 Periodic Safety and Functional Checks... 2.3 Battery ... Section 3: Performance Verification... 3.1 Introduction ... 3.2 Equipment Needed... 3.3 Performance Verification ... 3.4 Safety Test... Section 4: Installation ... 4.1 Introduction ... 4.2 Intouch Transmitter Installation ... 4.3 Turning on the Intouch Transmitter ... 4.4 Pager and Bed Number Assignments ... 4.5 Testing Transmitter Range ... Section 5: Troubleshooting ... 5.1 Introduction ... 5.2 How to Use This Section ... 5.3 Who Should Perform Repairs... 5.4 Replacement Level Supported ... 5.5 Returning the Intouch Remote Oximetry Notification System ... 5.6 Obtaining Replacement Parts... 5.7 Troubleshooting Guide ... 5.8 Restoring the Intouch Software on the Compaq Programmer ... 5.9 Error Messages ... 5.10 EMI (Electromagnetic Interference)... Section 6: Site Survey And Installation Program... 6.1 Introduction ... 6.2 Initial Installation Procedure ... 6.3 Intouch Install Program... Section 7: Spare Parts ... 7.1 Introduction ... Section 8: Packing For Shipment ... 8.1 Introduction ... 8.2 General Instructions ... Section 9: Specifications ... 9.1 System Specifications ... 9.2 Electrical ... 9.3 Environmental... 9.4 Physical ... Section 10: Technical Supplement ... 10.1 Introduction ... 10.2 Block Diagram ... Section 11: Index ...

ii iii 1-1 1-1 1-1 1-5 2-1 2-1 2-1 2-2 3-1 3-1 3-1 3-1 3-3 4-1 4-1 4-1 4-5 4-7 4-13 5-1 5-1 5-1 5-1 5-1 5-1 5-2 5-2 5-2 5-6 5-7 6-1 6-1 6-2 6-5 7-1 7-1 8-1 8-1 8-1 9-1 9-1 9-1 9-3 9-3 10-1 10-1 10-1 11-1

i

Table of Contents

LIST OF FIGURES Figure 1-1: Intouch Remote Oximetry Notification System...1-3 Figure 1-2: Transmitter Top View ...1-3 Figure 1-3: Transmitter Front View ...1-4 Figure 1-4: Transmitter Rear View...1-4 Figure 1-5: Pager Front View...1-4 Figure 1-6: Programmer Front View ...1-5 Figure 1-7: Programmer Side View ...1-5 Figure 3-1: Intouch Transmitter ...3-2 Figure 3-2: Communication OK Page...3-3 Figure 3-3: Test Page ...3-3 Figure 4-1: Intouch Transmitter Front View ...4-2 Figure 4-2: Intouch Components ...4-3 Figure 4-3: Transmitter Placement – N-395/595 ...4-4 Figure 4-4: Transmitter Rear View...4-4 Figure 4-5: Transmitter Top View ...4-5 Figure 4-6: Transmitter Front View ...4-6 Figure 4-7: Test Page ...4-7 Figure 4-8: Programmer ...4-8 Figure 4-9: 3-button Screen...4-8 Figure 4-10: Assignment Program Main Screen ...4-9 Figure 4-11: Transmitter Data Loaded...4-9 Figure 4-12: Programming Successful ...4-11 Figure 4-13: Start Button ...4-11 Figure 4-14: Transmitter Program Main Screen ...4-12 Figure 4-15: Transmitter Program Main Screen ...4-12 Figure 4-16: Transmitter Programming Successful ...4-13 Figure 4-17: Programmer On/Off Button ...4-14 Figure 4-18: 3-button Screen...4-15 Figure 4-19: Transmitter Program Main Screen ...4-15 Figure 4-20: Survey Page Display ...4-16 Figure 5-1: Removing the Flash Card Slot Cover...5-2 Figure 5-2: Inserting the Flash Card ...5-3 Figure 6-1: Programmer Power Switch...6-5 Figure 6-2: Start Button ...6-6 Figure 6-3: Password Screen ...6-6 Figure 6-4: Installation Program Alarms Screen...6-7 Figure 6-5: Transmitter Data Loaded Status Message...6-8 Figure 6-6: Pagers Selection Page Display...6-9 Figure 6-7: Alarms Screen...6-10 Figure 6-8: Pagers Configuration Screen ...6-11 Figure 6-9: Monitor Configuration Screen...6-12 Figure 6-10: Sending Program Data Status Screen ...6-13 Figure 6-11: Programming Successful Status Screen...6-13 Figure 6-12: Survey Paging Started Status Screen...6-14 Figure 6-13: Transmitter Top View ...6-15 Figure 6-14: Programmer Power On/Off Button ...6-16 Figure 6-15: Password Screen ...6-16 Figure 6-16: Enter Current Password Screen ...6-17 Figure 6-17: Installation Program Password Screen ...6-17 Figure 7-1: Intouch Remote Oximetry Notification System...7-2 Figure 10-1: Intouch Block Diagram ...10-1

ii

Table of Contents

LIST OF TABLES Table 3-1: Table 4-1: Table 5-1: Table 6-1: Table 6-2: Table 7-1:

Enclosure Leakage Current Limits... 3-4 POST Light Sequence ... 4-6 Transmitter Error Messages ... 5-6 Survey Pages Intervals... 6-12 Number of Survey Pages... 6-12 Parts List ... 7-1

iii

Blank Page

SECTION 1: INTRODUCTION 1.1 1.2 1.3

1.1

Manual Overview... page 1-1 Description of Intouch Remote Oximetry Notification System ... page 1-1 Related Documents... page 1-5

MANUAL OVERVIEW The most recent revision of the Intouch manuals is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html This manual contains information for servicing the Intouch remote oximetry notification system. Only qualified service personnel should service this product. Before servicing the Intouch remote oximetry notification system, read the operator’s manual carefully for a thorough understanding of operation. WARNING: Explosion hazard. Do not use the Intouch remote oximetry notification system in the presence of flammable anesthetics.

1.2

DESCRIPTION OF INTOUCH REMOTE OXIMETRY NOTIFICATION SYSTEM Caution: When connecting the Intouch remote oximetry notification system to any monitor, verify proper operation before clinical use. Both the Intouch remote oximetry notification system transmitter and the monitor connected to it must be connected to a grounded outlet. Accessory equipment connected to the monitor’s data interface must be certified according to IEC Standard 950 for data-processing equipment or IEC Standard 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects additional equipment to the oximeter signal input port or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. Caution: Whenever an Intouch remote oximetry notification system transmitter is moved, perform the performance verification procedures in paragraph 3.3 to ensure there are no interference problems. Whenever transmitting equipment is installed near an Intouch remote oximetry notification system transmitter, perform the performance verification procedures in paragraph 3.3 while the other transmitter is transmitting to ensure there are no interference problems.

1-1

Section 1: Introduction

The Intouch remote oximetry notification system is an alarm notification system intended for use in real-time monitoring of routine patient status and alarm events from the Nellcor NPB-290, NPB-295, N-395, and N-5951 pulse oximetry monitors. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to supplement and not to replace any part of the current device monitoring procedures. The intended patient population comprises adult, pediatric, and neonatal patients. The intended environments of use are hospitals and hospital-type facilities. Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities such as surgicenters, sub-acute centers, special nursing facilities, and sleep labs, outside of the hospital. The Intouch is for prescription use only. The Intouch remote oximetry notification system is not considered to be diagnostic without skilled interpretation and does not replace physician's care. The Intouch remote oximetry notification system (Figure 1-1) is comprised of three basic components: • Intouch Transmitter, Figure 1-2 through Figure 1-4 • Intouch Pager, Figure 1-5 • Intouch Programmer, Figure 1-6 and Figure 1-7 The Intouch transmitter connects to an NPB-290, NPB-295, N-395, or N-5951 pulse oximeter with the appropriate cable. When the pulse oximeter goes into alarm, the transmitter transmits that alarm to a designated pager or pagers. WARNING: An Intouch system must always consist of at least two pagers, so that if one pager is temporarily not receiving messages (for example, because batteries are exhausted or the user is out of range) and no one silences the alarm at the monitor, the second pager will be notified via a reminder page. The Intouch pager is worn by a caregiver. When the pager receives an alarm page it beeps or vibrates and displays the patient bed number, alarm type, and patient monitored parameters. Pagers must be separated from each other, by at least 4 inches, to eliminate interference between pagers. The Intouch programmer is used to set up the Intouch remote oximetry notification system. Note:

1

Your programmer (see Figure 1-6) may look somewhat different than the one illustrated here. However, the only buttons you will need when using it with the Intouch transmitter are the Power button, the far left Application button, and the Q button on the side (see Figure 1-7). The other three application buttons are not used with the Intouch system.

The N-595 must have software version 2.4.6 or lower to work with the Intouch system.

1-2

Section 1: Introduction

Figure 1-1: Intouch Remote Oximetry Notification System

Figure 1-2: Transmitter Top View

1-3

Section 1: Introduction

Figure 1-3: Transmitter Front View

Figure 1-4: Transmitter Rear View

Figure 1-5: Pager Front View

1-4

Section 1: Introduction

Figure 1-6: Programmer Front View

Figure 1-7: Programmer Side View 1.3

RELATED DOCUMENTS To perform test and troubleshooting procedures, and to understand the principles of operation and circuit analysis sections of this manual, you must know how to operate the Intouch remote oximetry notification system. Refer to the Intouch remote oximetry notification system operator’s manual. The most recent copy of the operator’s manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

1-5

Blank Page

SECTION 2: ROUTINE MAINTENANCE 2.1 Cleaning ... page 2-1 2.2 Periodic Safety and Functional Checks ... page 2-1 2.3 Battery ... page 2-2

2.1

CLEANING Caution: Do not spray, pour, or spill any liquid on any of the Intouch components, its accessories, connectors, switches, or openings in the chassis. Caution: Do not immerse the components of the Intouch remote oximetry notification system in liquid or clean with caustic or abrasive cleaners. Do not spray or pour any liquid on the components of the Intouch remote oximetry notification system.

2.1.1

Transmitter

For surface-cleaning and disinfecting follow your institution’s procedures or:

2.1.2

•

The transmitter may be surface-cleaned by using a soft cloth dampened with either a commercial, nonabrasive cleaner or a solution of 70% alcohol in water, and lightly wiping the surfaces of the transmitter.

•

The transmitter may be disinfected using a soft cloth saturated with 10% chlorine bleach in tap water solution.

Programmer

To clean the programmer screen, use a clean cloth designed for use on lenses or touch-sensitive screens. To clean the casing, use a clean damp cloth. Wipe dry with a dry cloth. 2.1.3

Pager

To clean the pager screen, use a clean cloth designed for use on lenses or touchsensitive screens. To clean the casing, use a clean damp cloth. Wipe dry with a dry cloth. 2.2

PERIODIC SAFETY AND FUNCTIONAL CHECKS The following checks should be performed at least every 2 years by qualified service technicians. 1.

Inspect the exterior of the Intouch equipment for damage.

2.

Inspect the safety labels for legibility. If the labels are not legible, contact Nellcor Technical Services Department or your local Nellcor representative.

3.

Verify that the units perform properly as described in paragraph 3.3.

4.

Perform the electrical safety tests detailed in paragraph 3.4. If the unit fails these electrical safety tests, do not attempt to repair the unit. Contact Nellcor Technical Services Department or your local Nellcor representative.

2-1

Section 2: Routine Maintenance

2.3

BATTERY

2.3.1

Transmitter

The transmitter needs to be returned to Nellcor for battery replacement. Refer to Returning the Intouch Remote Oximetry Notification System, paragraph 5.5. The transmitter batteries should be replaced every 24 months. 2.3.2

Pager

Refer to the Intouch remote oximetry notification system operator's manual for battery replacement procedures. The most recent copy of the operator’s manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html 2.3.3

Programmer

Refer to the Intouch remote oximetry notification system operator's manual for battery charging and replacement procedures.

2-2

SECTION 3: PERFORMANCE VERIFICATION 3.1 3.2 3.3 3.4

3.1

Introduction... page 3-1 Equipment Needed... page 3-1 Performance Verification ... page 3-1 Safety Tests ... page 3-3

INTRODUCTION Caution: Whenever an Intouch remote oximetry notification system transmitter is moved, perform the performance verification procedures in paragraph 3.3 to ensure there are no interference problems. Whenever transmitting equipment is installed near an Intouch remote oximetry notification system transmitter, perform the performance verification procedures in paragraph 3.3 while the other transmitter is transmitting to ensure there are no interference problems. This section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without disassembling the units of the Intouch remote oximetry notification system. All tests must be performed as the last operation before the Intouch remote oximetry notification system is returned to use. If the Intouch remote oximetry notification system fails to perform as specified in any test, repairs must be made to correct the problem before the Intouch remote oximetry notification system is returned to use.

3.2

EQUIPMENT NEEDED Equipment

Safety Analyzer

Description

Must meet CAN/CSA C22.2 No. 60601.1, and UL 2601-1 specifications. Bio-Tek Instruments, Inc. or compatible.

3.3

PERFORMANCE TESTS

3.3.1

Intouch Transmitter Communicating with Monitor

This procedure verifies that the Intouch transmitter is communicating with the patient monitoring equipment (NPB-290, NPB-295, N-395, and N-5951) and the applicable pager(s).

1

The N-595 must have software version 2.4.6 or lower to work with the Intouch system. 3-1

Section 3: Performance Verification

Figure 3-1: Intouch Transmitter 1.

Connect the monitor to AC power and turn on the monitor.

Caution: The antenna must be connected to the transmitter before the transmitter is turned on. Turning on the transmitter without the antenna connected may damage the transmitter.

1

2.

Connect the transmitter power supply cable to the transmitter.

3.

Connect the transmitter power supply AC power cable to the power supply and to AC power.

4.

Connect the transmitter to the monitor with the applicable interface cable.

5.

Press On/Off button to turn on the transmitter.

6.

The Communications indicator will be amber while the transmitter is turned on, but not communicating with the NPB-290, NPB-295, N-395, or N-5951 oximeter.

The N-595 must have software version 2.4.6 or lower to work with the Intouch system.

3-2

Section 3: Performance Verification

7.

The Communications indicator turns green when communication is established with the monitor.

8.

The transmitter will transmit a page to the associated pager(s) when communication is established. See Figure 3-2.

Figure 3-2: Communication OK Page 3.3.2

Test Page

This procedure verifies that the transmitter is communicating with the monitor and the applicable pager(s). This procedure also verifies that patient data is being transmitted. 1.

Complete Intouch Transmitter Communicating with Monitor in paragraph 3.3.1.

2.

Press transmitter On/Off button. See Figure 3-1.

3.

The transmitter should transmit a test page to the assigned pager(s). See Figure 3-3.

Figure 3-3: Test Page Note:

Refer to the Intouch operator's manual for a complete description of alarm notification messages. The most recent copy of the operator’s manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

3.4

SAFETY TEST Intouch safety tests meet the standards of, and are performed in accordance with, CAN/CSA-C22.2 No. 601.1 and UL 2601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety, for instruments classified as Class 1 and Type "Not Classified."

3.4.1

Ground Integrity

Caution: Do not perform a ground integrity test. Disable the ground integrity test on your automatic tester. The ground integrity test is not required for the Intouch system and may damage the equipment.

3-3

Section 3: Performance Verification

3.4.2

Enclosure Leakage Current

This test is in compliance with UL 2601-1 (earth leakage current). The applied voltage for UL 2601-1, CSA 601.1, and UL 2601-1 is 120 volts AC, 60 Hz. All measurements shall be made with the power both "On" and "Off". 1.

Connect the Intouch transmitter power supply AC plug to the electrical analyzer as recommended by the analyzer operating instructions.

2.

Connect the Intouch transmitter power supply DC plug to the Intouch transmitter DC input connector.

3.

The equipotential terminal on the analyzer is not connected to any metal on the Intouch transmitter.

4.

The analyzer leakage indication must not exceed the values listed in Table 3-1. Table 3-1: Enclosure Leakage Current Limits AC Polarity

Neutral Wire (L2)

Leakage Current

Normal

Closed

300 µA

Reversed

Closed

300 µA

* Reversed

Open

1000 µA

Normal

Open

1000 µA

* = With AC polarity reversed and neutral wire (L2) open, the line wire (L1) is actually open

3-4

SECTION 4: INSTALLATION 4.1 Introduction... page 4-1 4.2 Intouch Transmitter Installation ... page 4-1 4.3 Turning On the Intouch Transmitter ... page 4-5 4.4 Pager and Bed Number Assignments... page 4-7 4.5 Testing Transmitter Range... page 4-13

4.1

INTRODUCTION This section discusses how to configure the components of the Intouch remote oximetry notification system. Caution: When connecting the Intouch remote oximetry notification system to any monitor, verify proper operation before clinical use. Both the Intouch remote oximetry notification system transmitter and the monitor connected to it must be connected to a grounded outlet. Accessory equipment connected to the monitor’s data interface must be certified according to IEC Standard 950 for data-processing equipment or IEC Standard 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects additional equipment to the oximeter signal input port or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. Caution: Whenever an Intouch remote oximetry notification system transmitter is moved, perform the performance verification procedures in paragraph 3.3 to ensure there are no interference problems. Whenever transmitting equipment is installed near an Intouch remote oximetry notification system transmitter, perform the performance verification procedures in paragraph 3.3 while the other transmitter is transmitting to ensure there are no interference problems.

4.2

INTOUCH TRANSMITTER INSTALLATION To minimize the likelihood of the transmitter creating interference with the monitor, place the transmitter on top of the monitor towards the rear. For best results with the N-395 and N-5951, place the transmitter on top of the monitor towards the right rear. WARNING: In the USA, do not connect the Intouch transmitter to an electrical outlet controlled by a wall switch because the AC power may be accidentally turned off. WARNING: To ensure patient safety, do not place the Intouch transmitter in any position that might cause it to fall on the patient. WARNING: Do not lift the monitor by the sensor cable or power cord because the cable or cord could disconnect from the monitor, causing the monitor to drop on the patient.

1

The N-595 must have software version 2.4.6 or lower to work with the Intouch system. 4-1

Section 4: Installation

Caution: The antenna must be connected to the transmitter before the transmitter is turned on. Turning on the transmitter without the antenna connected may damage the transmitter.

Figure 4-1: Intouch Transmitter Front View 1.

Connect antenna to transmitter. See Figure 4-1.

2.

Place transmitter on top of the NPB-290, NPB-295, N-395, or N-5951 pulse oximeter. See Figure 4-3, Transmitter placement.

Note:

1

To minimize the likelihood of the transmitter creating interference with the monitor, place the transmitter at the rear of the monitor. For best results with the N-395 or N-5951 monitor, place the transmitter at the right rear of the monitor, as indicated in Figure 4-3.

The N-595 must have software version 2.4.6 or lower to work with the Intouch system.

4-2