elance Service Manaual - Rev H.pdf

Vital Signs Monitor 93300-05

Service Manual 070-1949-00 Rev. H

© 2014 Spacelabs Healthcare. All rights reserved. reserved. Contents Contents of this this publication publication may not be reproduced reproduced in in any form without without the the written permission permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending patents. Printed Printed in U.S.A. U.S.A. Specifications Specifications and price change privileges privileges are are reserved. Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if: •

• •

assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by Spacelabs Healthcare, and the electrical installation of the relevant room complies with the requirements of the standard in force, and the equipment is used in accordance with the operations manual.

Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist appropriately qualified technical personnel to repair those parts of the equipment which are classified by Spacelabs Healthcare as field repairable. Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Healthcare equipment.

CORPORATE CORPORATE OFFICES Corporate Headquarters Spacelabs Healthcare, Inc 35301 SE Center Street Snoqualmie, WA 98065 U.S.A Phone (1) 800-287-7108 Phone (1) 425-396-3300 Fax (1) 425-396-3301

Authorized EC Representative UNITED KINGDOM Spacelabs Healthcare, Ltd. 43 Moray Place Edinburgh, Lothian EH3 6BT Scotland 44(0)131 240 6481, Phone 44(0) 131 240 6459, Fax élance is a registered trademark of Spacelabs Healthcare, Inc.

Other brands and product names are trademarks of their respective owners.

Caution: Rx Only

US Federal law restricts the devices documented herein to sale by, or on the order of, a physician. Before use, carefully read the instructions, including all warnings and cautions.

© 2014 Spacelabs Healthcare. All rights reserved. reserved. Contents Contents of this this publication publication may not be reproduced reproduced in in any form without without the the written permission permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending patents. Printed Printed in U.S.A. U.S.A. Specifications Specifications and price change privileges privileges are are reserved. Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if: •

• •

assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by Spacelabs Healthcare, and the electrical installation of the relevant room complies with the requirements of the standard in force, and the equipment is used in accordance with the operations manual.

Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist appropriately qualified technical personnel to repair those parts of the equipment which are classified by Spacelabs Healthcare as field repairable. Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Healthcare equipment.

CORPORATE CORPORATE OFFICES Corporate Headquarters Spacelabs Healthcare, Inc 35301 SE Center Street Snoqualmie, WA 98065 U.S.A Phone (1) 800-287-7108 Phone (1) 425-396-3300 Fax (1) 425-396-3301

Authorized EC Representative UNITED KINGDOM Spacelabs Healthcare, Ltd. 43 Moray Place Edinburgh, Lothian EH3 6BT Scotland 44(0)131 240 6481, Phone 44(0) 131 240 6459, Fax élance is a registered trademark of Spacelabs Healthcare, Inc.

Other brands and product names are trademarks of their respective owners.

Caution: Rx Only

US Federal law restricts the devices documented herein to sale by, or on the order of, a physician. Before use, carefully read the instructions, including all warnings and cautions.

Table of Contents Contents Introduction Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 Physical Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 AC Line Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Environmental Requirements Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Monitor Options Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Setup Unpacking the monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Power Cable Connections Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2 Mounting the monitor monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Network Setup (Central System System only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3 Central Printer Setup . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . .2-9 Theory System Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 External Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Interconnection Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6 Maintenance Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Mechanical Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Electrical Safety Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4 Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5 Assembly/Disassembly Procedures Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Routing of Cables Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31 IBP Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32 NIBP Calibration. Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-33 EtCO2 Calibration. Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-35 Software Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-35 Service Due Date Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-35 Touch Screen Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 -36 Battery Maintenance Requirement. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-37 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38 Troubleshooting Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Power On Diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Diagnostic Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Information Required for Diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 System Troubleshooting Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 5-3 Parts Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Assembly Drawings and Schematics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Glossary

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

Appendix A – Electromagnetic Compatibility Appendix B – Symbols

i

Introduction Contents Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Physical Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Monitor Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Overview Spacelabs Healthcare’s products are designed and manufactured under good manufacturing practices and in compliance with all applicable regulatory requirements. To ensure proper operation in accordance with these guidelines, this product must be maintained by trained technicians, using Spacelabs Healthcare authorized replacement parts. Warnings, cautions, and notes are used throughout t his manual. They are identified b y the formats shown below. Be sure to read all warnings, cautions, and notes included in each section of this manual.

Warning: Alerts the user to potentially serious outcomes (death, injury, or serious adverse events) to the patient or user.

Caution: Alerts the user to actions to be taken to avoid non-serious injury to the patient or user, or to adverse effects to the device. Note: Failure to observe notifications may result in unexpected outcomes. The élance monitor is a lightweight, portable monitor designed for use as a compact bedside monitor or as a battery-operated monitor. The monitor features a resistive touch screen control and can be operated on either AC mains or battery power. Supported parameters including ECG, Resp, SpO 2, NIBP, Temperature, Invasive Pressure and EtCO2.

Figure 1-1: élance monitor 1-1

Introduction

Physical Dimensions Assembled Weight

2.4 kg (5.3 lbs) (for 10.2” display)

Dimensions (W×H×D)

252 × 193 × 75 (mm) 9.9 x 7.6 x 3.0 (in) (for 10.2” display)

Electrical Specifications Designed for continuous operation. Requires outlet with ground (Protective Earth) conductor. Designated Class I by applicable electrical safety standards.

AC Line Requirements AC input voltage range AC input current AC input frequency range

100-240 VAC 2.0 A - 1.0 A 50/60 Hz

Internally powered - automatic charging when line connected. Fully charged battery provides continuous monitoring for up to 5 hours. Requires 5 hours to fully charge internal battery.

Environmental Requirements Operating Temperature Humidity (operating)

0° to 40° C (32°F to 104°F) 15% to 95% relative humidity, non-condensing

1-2

Introduction

Available Configuration Configuration 93300-05

10.2" display, 4 trace, ECG, RESP, NIBP, SpO2 and 2 Temp

élance 5 93300-05I

10.2" display, 5 trace, ECG, RESP, NIBP, SpO2, 2 Temp and 2 IBP

élance 5i 93300-05IC

10.2" display, 5 trace, ECG, RESP, NIBP, SpO2, 2 Temp, 2 IBP and EtCO2

élance 5c 93300-05E

Black color 10.2" display, 4 trace, ECG, RESP, NIBP, SpO2, 2 Temp

élance 5 elite 93300-05IE

Black color 10.2" display, 5 trace, ECG, RESP, NIBP, SpO2, 2 Temp and 2 IBP

élance 5i elite 93300-05ICE

élance 5c elite

Black color 10.2" display, 5 trace, ECG, RESP, NIBP, SpO2, 2 Temp, 2 IBP and EtCO2

Monitor Options 93300-X -1 -2 -3 -4 -5 -7 -8 -9 -12 -16 -17 -18C -22 -05 -07 -A -C -E -I -M -N -P -S -T -U

English German French Italian Spanish Polish Portuguese Dutch Russian Turkish Czech Chinese (Simplified) Chinese (Traditional) 10.2" display with Base config. 12.1" display with Base config. (Refer to 93300-07 Service Manaul) Arrhythmia Analysis EtCO2 Elite Black Color (If this option is not selected, the unit is white in color) Dual Invasive Blood Pressure Masimo SpO2 Nellcor Oximax SpO2 Network enabled Spacelabs SpO2 ST Segment Analysis élance Recorder enabled (Recorder hardware should be ordered separately)

1-3

Introduction

External Recorder

1-4

Setup Contents Unpacking the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power Cable Connections .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mounting the monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Network Setup (Central System only) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Central Printer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-1 2-2 2-3 2-3 2-9

Unpacking the Monitor The élance monitor is shipped in one carton. Upon receiving the equipment, complete a detailed inventory to verify that the equipment you received matches your order. This inventory must include serial numbers, model numbers, and all options and cables received. Carefully inspect these items for shipping damage. If any damage is evident, immediately notify the shipping company and Spacelabs Healthcare. Please follow your hospital’s procedure regarding the disposal or recycling of packaging waste.

List of Components • • • • •

Spacelabs élance Monitor AC Power Cord Startup Kit Mounting Solution (Packed separately) Operations and Service Manual CD

Qty 1 Qty 1 Qty 1 Qty 1 Qty 1

Reusable Packing Materials The élance monitor’s packing material is designed to be reusable. Both the shipping box and inserts can be unfolded to minimize the storage place. We highly recommend you to keep a few for use during shipment. In case there is no servicing facility nearby you. You may consider sending the monitor back to Spacelabs Healthcare or our authorized di stributor for servicing. In order to provide maximum protection during shipment, it is recommended that the original packing materials be used for packing.

2-1

Setup

Power Cable Connections Warning: Do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally powered off. Do not use outlet switches not rated for load switching t o control power to the monitor .

AC Power Make sure that the AC outlet is properly grounded and supplies the specified voltage and frequency (100 to 240 VAC; 50 to 60 Hz, 1.0 A at 230VAC and 2.0A at 115VAC.

AC Receptacle

Fuse Holder

Battery On/Off Switch Figure 2-1: AC power connection

Before connecting the élance to AC power: 1 Turn on the “Battery On/Off Switch” 2 Cover the battery On/Off switch with the warning sticker to prevent unintended access. Warning Label

To connect the élance monitor to AC power: 1 Connect the female connector end of the AC power cord to the mains connector on the élance monitor. Refer to Figure 2-1. 2 Plug the male connector end of the AC power cord into a properly grounded mains outlet. 3 Switch the “Battery On/Off switch” at the back of the monitor to “Battery” position. 4 The LED on the front panel should illuminate in yellow. 5 Charge the battery for 5 hours before the first use. 6 Turn on the monitor. The LED on the front panel should illuminate in green. 2-2

Setup

Mounting the monitor The élance monitor must be installed on a desktop mount or wall mount. The warranty will be void if damage is due to monitor not mounted. Follow the mounting instructions provided with the mounting solution to ensure it is properly installed.

Warning: Desktop and wall Mount that is not properly installed has pot ential danger of detaching from the mounting surface and cause severe injury. Monitor which is not securely mounted has the potential to fall when subject to external forces.

Caution: Check to ensure the wall mount or desktop mount is securely attached to the supporting surface. Check to ensure the mounting adaptor is securely attached to the monitor.

View Bedside Monitors at a Central Station (Central System only) Network Requirements: Creating a network of élance bedsides and an élance central station requires the following: 1. 2.

The bedside devices and the PC running the central station software should be physically connected using a regular Ethernet switch. Both bedside monitors and PC should be set to either static or automatic IP addressing mode. devices in the same dedicated network should be using the same mode.

All

2-3

Setup Bedside Monitor Network Setup Automatic IP Address Mode 1. The monitor is default to DHCP mode and will be assigned an IP address automatically when connected to a router or switch with DHCP server functionality.

2.

When the central notices a bedside monitor on the network, it displays a dialog box that allows the operator to select the physical location of the bedside monitor.

Static IP Address Mode 1. It is also possible to use static IP address for router and switch without DHCP server functionality. To use the mode, enter the biomed menu by touching / / to access the menu. Then select mode from the .

2.

The button will appear. menu.

Touch button to enter the

2-4

Setup 3.

Touch button then the button to enter the , and the .

4.

Enter the IP address in the following pop-up window.

5.

Enter the Subnet mask in the following pop-up window.

2-5

Setup 6.

Enter the Default gateway address in the following pop-up window. no gateway server is on the net work.

This should be left blank if

Set the Central name 1.

Set the Central name that is to be connected in the dedicated network This can be done in t he // as shown below

2-6

Setup Connect to Ethernet Network Caution: • Only qualified personnel should attempt to connect a monitor to an Ethernet LAN the first time. • Do not connect the monitor to an Ethernet local area network (LAN) prior to configuring the following settings. The monitor must be properly configured for LAN access before you operate the monitor. If you fail to correctly configure the monitor, you may interrupt other units also using the LAN. Note: Detailed installation instructions for the physical Ethernet LAN are beyond the scope of this document.

To connect a monitor onto an existing Ethernet LAN, complete the following steps at the Central: 1.

Click / menu, select the button, and double click on a monitor that will be used under the column. Enter the location/bed name to be displayed at the Central.

Double click one of the monitor

2.

Once set up this way, run the élance Central program on the Central PC.

3.

Ensure the bedside monitor network setup is completed. 2-7

Setup

4.

Attach a network cable to the RJ45 network connector on the monitor.

Figure 2-2: Network Connection

5.

Connect the other end of the network cable to the nearest network port.

6.

Power ON the monitor.

7.

When the central notices a bedside monitor on the network, it displays a dialog box that allows the operator to select the physical location of the bedside monitor.

8.

Confirm the connection.

9.

The monitor should start communicating. The bedside monitor ECG waveform and numeric will be displayed within the small view windows of the selected location.

2-8

Setup

Disconnect from Ethernet Network To remove a monitor from the LAN, disconnect the network cable from the 10/100BaseT network connection.

2-9

Theory Contents System Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 External Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6 Interconnection Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7 Boot Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

System Architecture CO2

ORIDION MINIMEDI CO2

EXH

SECOND SPEAKER

“Press”

UART

ATMEL ATMEGA640 MICROCONTROLLER

NIBP PUMP / VALVE

ALARM OUT

NIBP

BUFFER

ISOLATOR

EXTERNAL STRIP CHART RECORDER

BUFFER PATIENT ISOLATED FRONT END BP1 BP2

“Acquire” ATMEL ATMEGA162V MICROCONTROLLER

T1 T2 SpO2

“ECG ACQ” ATMEL ATMEGA162V MICROCONTROLLER

ECG RESP

MAIN SPEAKER I S O L A T O R

COMPACT FLASH CARD

“Z-Bitsy”

ETHERNET

BITSY-X PROCESSOR BOARD

USB

BATTERY

BACK LIGHT

LCD DISPLAY

+5V +14V

POWER SUPPLY

PATIENT ISOLATED FRONT END

TOUCH SCREEN

AC INPUT MODULE

AC INPUT

MONITOR BLOCK DIAGRAM

-

Patients ECG, RESP input signal is acquired, amplified and processed by the “ECG ACQ” ATMEL ATMEGA162V microcontroller. This part is electrically isolated from the other circuitry. Patient Invasive BP, Temperature and SpO 2 input signal is acquired, a mplified and processed by the “Acquire” ATMEL ATMEGA162V microcontroller. This part is electrically isolated from the other circuitry. Patient Non-Invasive BP and CO 2 input signal is acquired and processed by the AMTEL “Press” ATMEGA640 microcontroller. Monitor program is stored and run from the Zbitsy Board. Z-Bitsy processor Board processes the data from I/O connectors and internal compact flash card. The nurse alert output is controlled by the ATMEGA640 microcontroller. The main speaker is controlled by the Zbitsy Board. The second speaker is controlled by the ATMEGA640 microcontroller. Strip Chart Recorder is connected to the monitor externally. Signal send via a buffer to the processor board. Display signal is sent from the Z-bitsy to the LVDS driver board. The signal from the LVDS is subsequently sent to the LCD display. LCD backlight is controlled by the ATMEGA640 microcontroller. AC power cord is connected directly to the monitor via an AC input module. The internal power supply generates +5v and +14v for the boards and also responsible for charging the internal Lithium battery. 3-1

Theory

ECG Block Diagram ECG Input

MUX

PACER / LEADOFF

AMP

Detection

A/D Converter

-

ECG detection is by means of measuring the voltage of the QRS signal from the heart muscle.

-

Patient ECG is acquired via ECG lead wires.

-

Individual ECG lead signal is fed through a multiplexer for processing.

-

ECG signal from the multiplexer is fed to pacer detector to identify pacer spike for elimination subsequently.

It is also sense for leadoff condition by leadoff detector.

-

ECG signal is amplified by amplifiers.

-

Amplified ECG signal is then sent to the analog to digital converter for conversion.

-

Digitized ECG signal is sent to the microcontroller for processing.

Respiration Block Diagram RA RESP Input

28 KHz

LL

MUX

LEAD OFF

DEMOD

Detection

A/D Converter

-

Patient respiration detection is by means of impedance pneumography.

-

RESP signal is acquired via RA and LL of ECG lead wires.

-

Thoracic impedance is detected by passing a 28 kHz carrier to electrodes RA and LL.

-

Leadoff detection circuitry is used to detect lead off conditions.

-

The acquired signal is fed through a demodulator to recover the outline of the respiration pattern.

-

The signal is sent to A/D for digital conversion.

-

Digitized signal is sent to microcontroller for processing.

3-2

Theory

Invasive Blood Pressure Block Diagram +

-

Filter

IBP1 Input

AMP

A/D Converter

AMP

A/D Converter

Calibration MUX

IBP2 Input +

-

-

Filter

Patient blood pressure detection is b y pressure transducer connected to the patient blood vessel via catheter or tubing.

-

A +5v excitation voltage is applied to the pressure transducer.

The output of the pressure

transducer is at 5uv/mmHg/V.

-

Blood pressure signal is converted to voltage by the pressure transducer and sent through the filt er to the amplifier.

-

Calibration signal is control by a multiplexer for calibrating BP1 and BP2 channels.

-

Amplified signal is sent to the analog to digital converter for conversion.

-

Digitized signal is sent to the microcontroller for processing.

Temperature Block Diagram T1/T2 Input

-

Filter

Auto CAL 20°C /40°C

A/D Converter

AMP

Patient temperature detection is by using a temperature probe.

The thermistor inside the

temperature probes varies according to the temperature changes.

-

The thermistor signal is sent through a filter to the amplifier. conversion.

-

Then sent to the A/D for

Digitized signal is sent to the microcontroller for processing.

A 20°c and 40°c signal controlled by the ATMEGA162V is used for auto calibration of the temperature channels.

3-3

Theory

NIBP Block Diagram Pressure Transducer, P1

A/D Converter

Buffer

Pt. Cuff Bleed Valve

Pressure Transducer, P2

Vent Valve

Pump

Micro Controller ATMEGA64

-

Patient NIBP detection is by means of oscillometric method.

-

The ATMEGA64 microcontroller controls the pump, vent valve and bleed valve during NIBP measurement.

-

Cuff pressure is measure by P1 and sent t hrough buffer to A/D conversion.

-

The digitized signal will be sent to the ATMEGA162V microcontroller for processing.

-

The ATMEGA64 microcontroller will trigger to deflate the cuff if pressure is detected by P2 for more than 180 seconds.

Note: The NIBP algorithm is modeled on the Biotek NIBP simulator. Diastolic pressures may appear marginally low (no more than 6%) if the performance is checked with other patient simulators.

3-4

Theory

SpO2 Block Diagram SpO2 Input

Red AMP

IR

Ambient

S/H

AMP

LPF

S/H

AMP

LPF

S/H

AMP

Diff. AMP

Red

Diff. AMP

IR A D C

LPF

Diff. AMP

Red DC

Diff. AMP

IR DC

-

Patient SpO2 detection is by comparison of Red and IR light absorption by patient arterial blood.

-

The current for driving the LED is controlled by the ATMEGA162V microcontroller.

-

The signal detected at the SpO2 sensor is amplified and captured at by the sample and hold circuitry.

-

Then, the signal is further amplified and sent through a 7-8Hz LFP.

Each of dynamic RED and IR and static RED and IR signals are compare with the ambient signal at the Differential Amplified.

This is to derive the SpO2 IR, SpO2 IR DC, SpO2 RED, SpO2 RED

DC signals.

-

The SpO2 DC, SpO2 IR, SpO2 IR DC, SpO2 RED, SpO2 RED DC signals are sent to ATMEGA microcontroller for processing.

3-5

Theory

External Connectors The monitor’s external connectors are listed Reference J4

Connector

Description

Pin out 1 TD+ 2 TD3 RD+ 4 N.C. 5 N.C. 6 RD7 N.C. 8 N.C. 9 ETH LED1 + 10 ETH LED1 11 ETH LED2 12 ETH LED2 + 13 CHASSIS

RJ45

Ethernet – 10/ 100BaseT

J2

USB

USB Memory

1 2 3 4 5

VCC Data Data + GND CHASSIS

J5

RJ25

Alarm Relay Output

1 2 3 4 5 6

SW1 (Common) ALM OUT 1 (NC) ALM OUT 2 (NO) +14v DC N.C. GND

Contact Points

Strip Chart Recorder

1 2 3 4 5 6 7 8

TxD DTR RxD CTS +14v +14v GND GND

Caution: There is a delay of up to 0.2 seconds from alarm activation on the monitor until the signal changes state on the remote alarm connector J5.

External Controls The power ON/OFF switch located on the front bezel is the only external control for the monitor.

3-6

Theory

Interconnection Diagram Patient Input Connectors

LCD Driver Board

J8

LCD Display

Zbitsy Board

Touch Screen

ECG/ RESP J5

SpO2

T1

JB3

JB10

J23

J4

J7

Inverter Board

J1

J13 (B)

Side Board

J3 (B)

Main Speaker

LCD Backlight

External Strip Chart Recorder (Optional)

Main Board T2

J10

BP1

J12 J8(B) J16

BP2

J21 (B)

J18

J11

Nellcor Board (Optional)

Masimo Board (Optional)

J1

Battery Charger & I/O Board

J17

J4

CO2 Board (Optional)

J3

J4

J5

J2

RJ45

RJ25

USB

TB2

Power Supply

TB1

Batter

AC Socket

Monitor PCBs Interconnection Diagram

Boot Sequence 1. 2. 3.

After power-on, the SL and élance logo will be displayed during the boot up period. Monitor will perform internal self test during this period. The Normal screen will be displayed when no error is detected during the self test.

3-7

Maintenance Contents Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Mechanical Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Electrical Safety Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2 Preventive Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Functional Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5 Assembly/Disassembly Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Routing of Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29 IBP Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 NIBP Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31 EtCO2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33 Software Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34 Service Due Date Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

Overview The following information describes the requirements and tests necessary for safety and performance verification of the monitor. It is recommended that the preventive maintenance check be done annually.

Caution: Observe precautions for handling electrostatic-sensitive devices! Note: • Never touch electrostatic-sensitive electronic components without following proper anti-static procedures, including the use of an ESD wrist band and mat. An electrostatic discharge from your fingers can permanently damage electronic components and cause latent failures. • All static-sensitive electronic components are packaged in static-shielding bags. Retain the bag for repackaging the component should you need to store it or return it to Spacelabs Healthcare for any reason. • Cleaning, preventive maintenance, and safety checks should be performed annually and following any product di sassembly/assembly. Preventive maintenance and safety checks must be performed by trained personnel only.

Required Test Equipment • Electrical Safety Analyzer — D ynatech Nevada 232C or equivalent • Patient Simulator — Dynatech Nevada 300B or equivalent Note: • Before testing, ensure that the module housing(s) and its DC po wer supply(s) have their associated cables attached, but are not interconnected. • Ensure that the Ethernet cabl e and AC power sources are removed. • The AC line is auto detected; no user selection is necessary. • Ensure that the leakage test equipment is calibrated.

4-1

Maintenance

Mechanical Inspection Verify that: • The monitor and all optional equipment are clean. • All screws are tight. • The case and connector pins are not damaged. • There are no frayed or pinched wires or cables.

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

Definitions Classification — IEC/EN/UL 60601-1 Safety standard designation for the class of equipment and type of patient applied parts that indicate the degree of protection provided against electrical shock. Leakage Current — Current that is not functional. It includes patient leakage, ground leakage, and enclosure (or chassis) leakage. Patient Lead Leakage — Current that flows from the applied part of the patient lead to ground. Chassis Leakage — Current flowing from the enclosure (or from conductive parts accessible to the operator) through the ground conductor. Normal Condition — Condition in which all means provided for protection are intact. Includes, ground connections, insulation, creepage and clearance distances. Single Fault Condition — Open ground, open neutral, line voltage on a patient connection, or any single state other than normal condition that could compromise patient safety. UUT — Unit Under Test. Spacelabs Healthcare does not endorse standards to the excl usion of others. Therefore: BE SURE TO CHECK YOUR LOCAL REQUIREMENTS TO ENSURE YOUR EQUIPMENT SAFETY TESTS COMPLY WITH LOCAL STANDARDS . Generally accepted standards for medical monitoring equipment, such as the Underwriters Laboratory (UL) and the National Fire Protection Association (NFPA) standards, are summarized in Table 1.

4-2

Maintenance

Table 1: Summary of Standards for Medical Monitoring Equipment

International Mains to Chassis U.S. (120 V) Mains to Chassis Mains Resistance Leakage Leakage 100 µA - normal condition, ground 300 µA - normal condition, ground 500 milliohms* attached (AC connector to chassis) attached (AC connector to chassis) 500 µA - single fault condition, open 300 µA - single fault condition, 500 milliohms* ground or reverse polarity open ground or reverse polarity * Measured from the AC Power cord third wire ground to the most distant ground attachment

Equipment Required Electrical Safety Analyzer, Fluke model 232D or equivalent. These tests should be performed according to t he hospital’s scheduling requirements, at least annually or after repair or modification. Note: All tests must be performed according to the safety analyzer’s operations manual, and any local requirements.

Warning Before starting safety tests, ensure that no patient is connected to the device under test. If safety tests must be performed on equipment currently monitoring a patient, obtain permission to disconnect the cables from the monitor and patient.

Ground Resistance 1

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

2

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

Chassis Leakage Current Tests 1

Plug the leakage analyzers into mains power.

2

Plug the equipment into the analyzer’s AC receptacle.

3

Verify that the leakage current from the chassis to ground is less t han the values in Table 2.

4-3

Maintenance Table 2: Enclosure Leakage Test Conditions and Limits Neutral

Ground

Condition

Condition

Polarity

International

U.S.

Limit

Limit

Closed neutral

Closed ground

Normal polarity

100 µA

300 µA

Open neutral

Open ground

Normal polarity

500 µA

300 µA

Closed neutral

Open ground

Normal polarity

500 µA

300 µA

Patient Lead Leakage Current Tests (Patient Modules) Before you can perform the Patient Lead Leakage Current Test, verify that the monitor passes the ground resistance and chassis current leakage tests. It is recommended that the equipment be operating for 30 minutes prior to the test to allow thermal stabilization. 1

Patient Leads Current Leakage — measure the leakage current between each of the patient lead wires and the ground lug on the monitor back panel. Also, measure the leakage current between all combinations of ECG leads and ground. The current must be less than 10 uA with the ground connected, and 50 uA with the ground open.

2

Leakage Current to Ground with 50/60 Hz — AC mains voltage applied to leads. Apply AC mains voltage and measure the leakage current between each of the ECG lead wires and the ground. The current must be less than 50 uA at any line voltage.

Preventive Maintenance A Spacelabs Healthcare Field Service Engineer or qualified hospital biomedical technician should check the monitor and optional equipment for acceptable performance and electrical safety to

ensure they operate according to current requirements.

4-4

Maintenance

Function Test Setup • Apply Shake Test to the monitor to confirm no loose parts inside the unit. • Connect élance to ECG, SpO2 and Temperature Simulators • Leave NIBP unconnected. Power Up • Connect élance to mains power • Check: The yellow LED is lit. • Power-up the élance. • Check: Green LED in front panel is lit. • Check: Battery Charging icon is d isplayed (mains power) • Disconnect AC power from élance. • Check: Battery icon is displayed S/N and SW Version Check • Touch -> -> -> Configuration> to bring up élance’s Configuration Menu. • Check: serial number is correct • Check: ACQUIRE, PRESS, ECGACQ, CF displayed • Check: Main software version is correct NIBP Safety and Pneumatic Checks • Start NIBP Measurement with hose disconnected • Listen for 2 NIBP pump speeds during the 1st 5 seconds of the measurement. • Stop NIBP Measurement. • Connect élance to NIBP Cuff wrapped around mandrel. • Start the NIBP measurement and observe the time. Squeeze the cuff every 5 seconds and then release. Until message “NIBP measurement time exceeded” is displayed. • Check: NIBP measurement timeout in 135 seconds. Main Physiological Parameters ECG: • Setup monitor to displa y Leads III, II, V(for 5-Lead cable) or Lead II(for 3-Lead cable) • Verify that the selected ECG Leads are displayed correctly • Check parameters (HR, RR, SpO2, PR) Set HR Low Alarm Limit to 60. Set HR to 40. Verify that the ECG numeric zone turn yellow, alarm activated and message HR<60 is displayed. Set HR High Alarm Limit to 80. Set HR to 120. Verify that the ECG numeric zone turn yellow, alarm activated and message HR>80 is displayed. Respiration: • Setup monitor to display RESP (in channel 2 only). • Check RESP waveform quality (clean signal), • Turn on the RR alarms, • Set RESP Lower Limit to 25. • Set simulator Resp Rate to 20. • Verify that the RESP numeric zone turns yellow, alarm activated and RR<25 message is displayed. • Set RESP High Alarm Limit to 35. • Set simulator Resp Rate to 40 • Verify that the RESP numeric zone turns yellow, alarm activated and RR>35 message is displayed 4-5

Maintenance SpO2 • Setup monitor to display SpO2 (in channel 3 only). • Check SpO2 waveform quality (clean signal) • Turn on the SpO2 alarms, • Set SpO2 High Alarm Limit to 95. • Connect a SpO2 finger sensor to your finger and observe the reading, • If the reading is above 95%. Verify that SpO2 numeric zone turn yellow, alarm activated and message “SpO2 >95” is displayed. • Set SpO2 High Alarm Limit to 100 and Low Limit to 99. • Connect a SpO2 finger sensor to your finger and observe the reading, • If the reading is below 99%. Verify that the SpO2 numeric zone turn yellow, alarm activated and message “SpO2 <99” is displayed. • Record Results ECG – Arrythmia & ST (For option A & T only) • Set simulator to generate PVC. Observe PVC per minute counter increases by 1 in every occurance of PVC waveform. Observe that the monitor generate PVC alarm when the PVC per minute counter reaches 10. • Set simulator to generate Couplet.Observe that the monitor generates Couplet alarm. • Set simulator to generate V-tach waveform. Observe that the monitor generates V-tach alarm. • Set simulator to generate Pause waveform. Observe that the monitor generates Pause alarm. • Set the ST alarm ON and ST setting to 1mm. • Set the simulator to generate ST value 1 mm above the baseline. Observe that the monitor generates ST alarm.. • Set the simulator to generate ST value 1 mm below the baseline. Observe that the monitor generates ST alarm • Repeat the above steps above with ST settings of 2, 3, 4, 5, 6, 7, 8mm. ECG/Respiration Lead-off Check Attach ECG cables to the ECG simulator – White, Black, Green, Red, Brown (for AAMI 5-lead cable) – White, Black, Red (for AAMI 3-lead cable) Setup ECG II,I, V(for 5-lead ECG cable only) in Channels 1, 2, 4 – Disconnect RL (Green) (for 5-lead ECG cable only) – Observe that all waveforms are still displayed Reconnect RL, Disconnect LL (Red) – Observe that all waveforms except for Lead I disappear “Check ECG Lead” message is displayed. Reconnect LL, Disconnect RA (White) – Observe that all waveforms disappear, and “ECG Lead off” message is displayed. Reconnect RA, Disconnect LA (Black) – Observe that all waveforms except Lead II disappear. Reconnect LA, Disconnect V (Brown) (for 5-lead ECG cable only) – Observe that Lead V waveform disappear – Reconnect V Record results •

•

•

•

•

•

•

4-6

Maintenance • •

•

•

Select Respiration Lead in Channel 2 Disconnect LL (Red) – Observe that the RESP waveform disappears Reconnect LL, Disconnect RA (White) – Observe that the RESP disappear – Reconnect RA Record results

Temperature • Connect a temp probe to the monitor. • Leave the temp probe in room temp for 3 min. • Observe that the monitor displays the room temp. • Hold the temperature probe and wait for 3 min. • Observe that the monitor displa ys approx. 36.5 degrees Celsius or your body surface temperature. IBP •

•

•

•

•

•

•

•

Set P1 IBP Systolic alarm limit to 110(L) and 130(H), Diastolic alarm limit to 70(L) and 90(H), Mean alarm limit to 85(L) 105(H). Set the simulator to generate Systolic pressure below 110mmHg. Observe that the monitor generates P1 IBP Systolic low limit alarm. Set the simulator to generate Systolic pressure above 130mmHg. Observe that the monitor generates P1 IBP Systolic high limit alarm. Set the simulator to generate Diastolic pressure below 70mmHg. Observe that the monitor generates P1 IBP Diastolic low limit alarm. Set the simulator to generate Diastolic pressure above 90mmHg. Observe that the monitor generates P1 IBP Diastolic high limit alarm. Set the simulator to generate Mean pressure below 85mmHg. Observe that the monitor generates P1 IBP Mean low limit alarm. Set the simulator to generate Mean pressure above 105mmHg. Observe that the monitor generates P1 IBP Mean high limit alarm. Same setting and test apply to P2.

EtCO2 Connect the EtCO2 sampling line to a 5% CO2 gas cylinder output port. Verify that the EtCO2 reading on the monitor is 38mmHg±2mmHg. • Set the EtCO2 alarm high limit to 30mmHg. Verify that the monitor generates EtCO2 high limit alarm. Set the EtCO2 alarm low limit to 45mmHg. Verify that the monitor generates EtCO2 low limit alarm. •

•

Network • Check: Central Waveforms match monitor • Check: Central Parameters match monitor • Record results

4-7

Maintenance Alarm Annunciation • Set ECG simulator to Asystole. Verify that the ECG numeric zone turn red and displayed “ASY”, alarm is triggered with message “ECG asystole” displayed. • Set ECG simulator to VFib. Verify that the ECG numeric zone turn red and displayed “VF”, alarm is triggered with message “ECG ventricular fibrillation” displayed. • Check: Life-threatening alarm tone is annunciated (in groups of ten at eight second intervals) • Record results

2nd Speaker • Check: 2nd speaker is activated if alarm is not attended in the preset period of time (0-3 minutes). • Check: Alarm Silence key (silences both speakers) • Set ECG simulator to normal sinus rhythm • Record results

Speaker Volume • Select “Speaker Volume” in -> < Clinical> -> • Check: speaker volume sounds at all 10 settings (note, only main speaker will sound) Recorder Option • (Skip this page if Recorder not installed) • Connect Recorder • Check: élance reports ”Recorder connected”. • Open the recorder door • Check: élance reports “Recorder door is open” • Remove paper then close the recorder door • Check: élance reports “Recorder out of paper” • Insert a roll of paper and cl ose door. • In élance -> -> Menu, run < Recorder Diagnostics> • Check: test pattern at end of recording for missing print head dots.

Power Cycle and Check Time • Power cycle monitor • Check: élance logo seen during start-up • Check: correct time on monitor display

Electrical Leakage Current Tests • Connect the monitor power cord and the patient leads to the safety analyzer. • Power up the Safety Analyzer • Power up the monitor • Test the monitor for normal and single fault conditions • Compare the results with Table 1 & 2 in the Electrical Safety Testing section above to insure safe operation. • Power off the monitor • Equipment failing this test should be repaired before returning to service.

4-8

Maintenance

Assembly/Disassembly Procedures Caution: Before beginning any disassembly procedures, power OFF the monitor, disconnect the AC cord from the AC power receptacle, remove the battery switch label and disconnect the battery by moving the battery switch to position. Observe precautions for handling electrostatic-sensitive devices! Replace the battery switch label when the monitor is re-assembled. Proper torque 6.0±0.5 lb-in is recommended to secure the enclosure with screws at assembly.

Required Tools and Parts • Anti-static mat with wrist strap • #1 and #2 Phillips-head screwdriver • 5/16-inch nut driver • 3/16-inch nut driver

Installing or Replacing the Optional Recorder 1.

Align the top and bottom locking pins with the keyholes on the monitor side panel.

Latch Release Latch

2.

Side the recorder downward until the latch locks the recorder in position.

3.

To uninstall, release the latch and slide the recorder upward until it reach the top of the keyhole. Then, gently detach it from the monitor side panel.

4-9

Maintenance

Replacing the Front Panel / LCD 1.

Remove label covering battery on/off switch. position.

Disconnect battery power by moving the switch to off

Battery ON/OFF Switch

2.

Remove two screws from the top and three screws from the bottom that is hidden under the rubber plugs.

Remove Rubber Plug & Screw





4-10

Maintenance 3. Place the monitor upright in front of you with the screen facing you. 4. Gently create a small gap at the top right corner at the junction of the front and rear enclosure with your finger nail or non-metallic tools to prevent scratching the enclosures. Gradually widen the gap so that it is enough to insert the finger tip. (Note 1: There are latches along the left and right sides of the front and rear enclosure. Therefore, it is easier to start separating the front and rear enclosure from the top right corner as shown.

It is easier to start separating the front and rear enclosures from this area.

There are three latches along each side of the monitor.

4-11

Maintenance

5. Insert the finger tip into the gap created in step 4. Use the thumb to push the rear enclosure and the index finger to pull the front enclosure. Gradually apply force until the latches on the right hand side of the monitor are unlocked. Crack sound may be heard when the latches are unlocked. The right hand side of the monitor has been opened now. Maintain the gap in about 1cm wide. Use the index finger to pull the front enclosure in the direction of arrows.

DO NOT flip the front panel to open. The latches on the left hand side of the monitor will be broken.

Use the thumb to push the rear enclosure in the direction of arrows.

6. Continue to separate the front and rear enclosures by moving the finger tips along the gap from right to left. Maintain the gap on the right hand side of the monitor in about 1cm while unlocking the latches on the left hand side of the monitor. Again, crack sound may be heard while unlocking the latch. Support the front enclosure with your left hand to prevent it from tipping forward.

Keep the gap on the right at about 1cm wide while uplocking the latches on the left.

Further separate the enclosures gently along the top by moving the finger tips towards the left of the monitor in the direction of arrows.

4-12

Maintenance 7.

Maintain the opening on the top to about 5cm. Disconnect the LCD Backlight cable.

Keep the gap on the top at about 5cm.

Disconnect the LCD Backlight cable.

8.

Move the front enclosure towards the left and lean against the rear enclosure to get access to the touchscreen cable connector on the Main Board.

Touch-screen cable connector.

4-13

Maintenance

9.

Flip the latch of the touch-screen cable connector (J23) downwards and remove the touch-screen cable carefully. (Warning: DO NOT flip the latch down more that 90 degrees or the connector will be damaged permanently.)

Touch-screen cable.

Touch-screen cable connector latch.

Flip the latch down to unlock.

10. The picture below shows the touch-screen cable connector J23 in its unlocked position.

Touch-screen cable connector latch in its unlocked position.

4-14

Maintenance

11. The picture below shows the touch-screen cable connector J23 in its locked position.

Touch-screen cable connector latch in its locked position.

interconnection cables. 12.

Place the LCD front panel flat in front of the rear enclosure before disconnecting the LCD and Backlight Inverter cables.

LCD Cable

Touch Screen Cable

Backlight Inverter Cable

13. Gently disconnect the LCD cable from the Zbitsy Board.

4-15

Maintenance 14. Gently disconnect the Backlight Inverter cable from the Main Board.

LCD Backlight Cable

Touch Screen Cable

LCD Cable

15. Replace the LCD Assembly. 16. Reconnect the LCD cable, Touch Screen cable, LCD Backlight cable and reassemble the monitor.

Caution: • Never pull on the flex cable. This may damage the cable end or the connector. • Take care when handling cables and connectors. They are fragile and can be damaged if not handle carefully. Note: Proper operation of the monitor depends upon correct cable re-insertion following disassembly. Ensure that the flex cable is aligned properly and fully inserted into the connector prior to locking the connector tab down.

Replacing the Zbitsy Board 1.

Disconnect battery power by moving the rear switch to off position.

2.

Remove the Front Panel.

4-16

Maintenance 3.

Gently separate the two connectors between the Zbitsy Board and the Main Board. Separate this connector between the Zbitsy and Main Board

Mylar sheet placed between Zbitsy Board and Main Board

Zbitsy Board

Main Board

Separate this connector between the Zbitsy and Main Board

4.

Replace the Zbitsy Board and reassemble the monitor. Make sure the mylar sheet is placed between the Zbitsy and Main Board during reassembly.

Replacing the Main Board 1.


2.

Remove the front panel.

3.

Remove four screws that hold t he Main Board to the rear enclosure. Remove Screw (under the mylar sheet)

Remove Screw

Remove Screw Remove Screw (under the mylar sheet)

4-17

Maintenance 4.

Gently disconnect all the interconnection cables from the Main Board and Zbitsy Board. the interconnection from the Patient Input Panel are under the mylar sheet.

Please note

These connections from Patient Input Panel are under the mylar sheet.

5.

Separate the connector that connects the Main Board and I/O Board.

Separate connection between Main Board and I/O Board

(View from bottom)

The connector can be seen from the left after lifting up the Main Board slightly

(View from Patient Input Panel side) 4-18

Maintenance 6.

Disconnect the NIBP hose from the Tee joint near the top right of the Main Board.

Disconnect the hose from the Tee Joint

7.

Gently lift the Main Board up from the left. Make sure the top right corner near the alarm LED by moving the Main Board to the left when removing the Main Board from the rear enclosure.

Move Main Board to the left to near the alarm LED

4-19

Maintenance 8.

Place the monitor in upright position. Gently remove the Main Board partially from the rear enclosure. Disconnect the interconnection cables before completely separate the Main Board from the rear enclosure.

9.

Disconnect the EtCO2 cable (if installed), Side PCB cable, Power Supply cable and Speaker cable from the Main Board.

Speaker cable

Side PCB cable Power Supply cable

EtCO2 cable (if installed)

10. Remove the Zbitsy Board from the Main Board. 11. Replace the Main Board and reassemble the monitor.

4-20

Maintenance

Replacing the Inverter board Assembly 1.


2.


3.

Remove the Main Board and Zbitsy Board from the rear enclosure.

4.

Remove the Mylar sheet covering the battery.

5.

Remove two screws that hold the Inverter Board on the rear enclosure. Remove Screw

Remove Screw

Replacing the Power Supply Assembly 1.


2.


3.


4.

Remove the Mylar sheet covering the battery.

5.

Remove four screws that hold the Power Supply Board on the rear enclosure.

Remove Screw

Remove Screw

Remove Screw

Remove Screw

4-21

Maintenance 6.

Flip the Power Supply Board to the right and remove the cables from the AC input module.

Disconnect AC Input Cable

Power Supply cable

7.

Replace Power Supply Board and reassemble the monitor. Power Supply during reassembly.

Ensure the mylar sheet is installed on the

4-22

Maintenance

Replacing the CO2 Board 1.


2.


3.


4.

Remove four screws that hold the CO2 Board on the rear enclosure.

Remove Screw

Remove Screw

5.

Remove Screw

Remove Screw

Replace EtCO2 Board and reassemble the monitor.

4-23

Maintenance

Replacing the Battery 1.


2.


3.


4.

Remove the mylar sheet which covering the battery.

5.

Remove the screws that is holding the patient input panel. Remove Screw

Remove Screw

6.

Remove four screws that secure the t wo metal braces to the rear enclosure.

Remove Screw

Remove Screw

Remove Screw

Remove Screw

4-24

Maintenance 7.

Flip the patient input panel sideway so that the Temperature connector is clear from the battery. Remove the battery by pulling the strap on the top, and then remove the battery from its contact.

Pull this strap to lift the battery up

8.

Replace battery and reassemble the monitor.

4-25

Maintenance

Replacing the Masimo SpO2 PCBA 1.


2.


3.


4.

Remove the Mylar sheet and Battery.

5.

Remove the Masimo SpO2 PCBA by removing four screws holding the Board to the rear enclosure.

Remove Screw

Remove Screw

6.

Remove Screw

Remove Screw

Replace the Masimo SpO2 PCBA and reassemble the monitor.

4-26

Maintenance

Replacing the Nellcor SpO2 PCBA 1.


2.


3.


4.


5.

Remove the Nellcor PCBA by removing two screws holding the board to the rear enclosure. Remove Screw

Remove Screw

6.

Replace the Nellcor Board and reassemble the monitor.

4-27

Maintenance

Replacing the I/O PCBA 1.


2.


3.


4.


5.

Remove the screw on the Ground Plate that is holding the grounding wire from the I/O Board.

6.

Remove the screw that holds the I/O Board to the rear enclosure.

Remove Screw

Remove Screw

7.

Gently slide the I/O Board out of the slots on both sides.

Battery Connector

8.

Main board Connector

Reinstall the replacement I/O Board in reverse order.

4-28

Maintenance

Replacing the Patient Input Panel 1.


2.


3.

Remove two screws that hold the patient input panel to the rear enclosure.

Remove Screw T1

T2 SpO2 IBP 1

IBP 2

ECG

Remove Screw

4.

Gently remove all the interconnection cables from the Main Board.

5.

Remove the patient input panel from the rear enclosure.

6.

Replace the patient input panel board and reassemble the monitor.

4-29

Maintenance

Replacing the Recorder Side PCBA 1.


2.


3.


4.

Remove the CO2 PCBA if installed.

5.

Remove two screws from the middle that hold the Recorder Side PCBA to rear enclosure.

Alarm LED connector

Remove Screw

Remove Screw

Connect to Main board

6.

Remove the recorder Side PCBA.

7.

Replace the Side Board and reassemble the monitor in reverse order.

4-30

Maintenance

Routing of Cables It is important to route the Speaker cable, Jumper cable and EtCO2 cable and hose (For option C only) according to the diagram below.

4-31

Maintenance

IBP Calibration Required tools and parts: 1. 2. 3.

Patient Simulator (Dynatech Nevada 300B or equivalent) with Invasion BP cable, or Reusable pressure transducer, or Disposable pressure transducer

IBP calibration procedure 1.

Perform IBP calibrations only on units with option ‘I’ whenever the Zbitsy Board or Main Board is replaced.

2.

Plug the two pressure cables (BP1/BP2) from the patient simulator into the IBP1/IBP2 connectors of the Patient Input Panel of the monitor. Set the simulator to a static pressure of 0mmHg for both BP1 and BP2. Or connect pressure transducer to the IBP1/IBP2 connectors.

3.

Power on the monitor.

4.

Select / / keys.

5.

Select . The message “P1 calibrating” will be displayed at the bottom of the screen. Waiting briefly. Verify message “P1 calibration OK” followed by 2 beep tones.

6.

Select . The message “P2 calibrating” will be displayed at the bottom of the screen. Waiting briefly. Verify message “P2 calibration OK” followed by 2 beep tones.

4-32

Maintenance

NIBP Calibration Required tools and parts: 1. 2. 3. 4. 5. 6.

Sphygmomanometer Pressure generator (e.g. squeeze bulb) Trimmer driver Two T-piece connector and 3 short hoses (approx. 15cm each) Adult cuff wrap on cylinder Stopwatch or equivalent (e.g. watch with second hand)

NIBP calibration procedure 1.

2.

Disassemble the monitor so that the NIBP calibration potentiometer R267 is accessible. This can be done by removing the I/O Board from the rear enclosure and connect directly to the Main Board. The position of R267 on the Main Board is shown below. NIBP calibration potentiometer : R267

3. 4.

Make sure the monitor can be powered on and can perform NIBP measurement. Setup the calibration system as show below. Pressure of Sphygmomanometer NIBP reading on display

4-33

Maintenance 5. 6.

7. 8. 9.

Set monitor’s to “ON “ under // menu. Pressurize the sphygmomanometer to 50mmHg. Observe the NIBP pressure reading on the monitor display. Adjust the NIBP calibration potentiometer R267 until the reading is within 1mmHg of the sphygmomanometer pressure. Repeat step 6 by pressurizing the sphygmomanometer to 100mmHg and 200mmHg respectively. Release pressure and wait for NIBP reading to return to 0mmHg. Reassemble the monitor.

NIBP leakage test procedure 1.

Setup the calibration system as show below.

= Clamping position

2. 3. 4. 5.

Pressurize the sphygmomanometer to 50mmHg. Then, clamp the hose as shown above. Observe the pressure leakage during 1 minute by using a stop watch or equivalent. The leakage rate should be within 6mmHg per minute. Repeat step 3 by pressurizing the sphygmomanometer to 100 mmHg, 150mmHg, 200mmHg and 250 mmHg respectively. If the leakage rate exceeded 6mmHg/min, t hen check the pneumatic system.

4-34

Maintenance

EtCO2 Calibration Required tools and parts: 1. 2.

Oridion FilterLine sampling line 5% CO2 calibration gas cylinder.

EtCO2 calibration procedure 1.

2. 3. 4.

Connect an Oridion FilterLine sampling line to the élance monitor. Enable EtCO2 monitoring in the / menu. The EtCO2 waveform will replace RESP waveform and display in the second waveform zone. Attach the output of the 5% CO2 calibration gas canister to the sampling line. Enter the // menu and press the button. “CO2 calibrating” message will be displayed while calibration gas is supplied to the sampling line. “CO2 calibration OK” message will be displayed if the calibration completes successfully after 12 minutes. The will be an alert tone after the calibration. The EtCO2, FiCO2 and RR numeric values will return to 0.

Caution: Dispose calibration gases in accordance with local and federal laws.

Software Update Refer to PSN for detailed upgrade instructions.

Service Due Date Setting Set Service Due date under // menu, There are three preconfigured settings (3/6/12 months) are available.

4-35

Maintenance When “On” is selected, the Service Due Time can be set by clicking at the “Set” button.

Touchscreen Calibration Touchscreen calibration can be done under // menu. Follow the steps stated below to perform the touch screen calibration.

4-36

Maintenance

Battery Maintenance Requirement The following are the required discharge/charge cycle and int erval: i) Fully charge the battery every 6 months if the monitor is kept in storage most of the time as backup. ii) Complete a full discharge/charge cycle of the battery every 6 months if the monitor is in regular use and is connected to AC power most of the time.

Procedures : For monitor kept in store room as backup 1. Fully charge the battery by connecting the monitor to AC power for at least 5 hours. Disconnect the AC power and verify that the batte ry gauge at the lower right hand corner of the display represents a full y charged battery icon as shown below.

2. Record of the battery discharge/charge cycle shall be maintained for future reference. For monitor that is connected to AC most of the time 1. Disconnect the monitor from AC power. 2. Leave the monitor ON for a few hours until “Battery Low” alarm message is triggered. 3. Re-connect the monitor to AC power for at least 5 hours. 4. Disconnect AC power and observe that the battery gauge at lower right hand corner of the display represents a fully charged battery icon. This indicates the completion of a discharge/charge cycle. 5. Re-connect AC power to resume normal use. 6. Record of the battery discharge/charge cycle shall be maintained for future reference.

4-37

Maintenance

Cleaning Clean the case by washing it with mild soap and water. Use TF solvent for cleaning the electronic connectors and contacts as necessary.

Warning: Accelerated Hydrogen Peroxide (AHP) and quaternary ammonia-based products ARE NOT RECOMMENDED for cleaning monitors and cables. These chemicals attack the plastics used in patient monitors and cables, and will cause serious safety hazards as the electrical insulating properties and structural integrity of the equipment break down. Cavicide, Virex, Virex 256, SaniCloth, and Sanicloth Plus are common quaternary ammonia germicidal products. The manufacturers of these solutions advertise that these germicidal products are safe for use on hard, non-porous surfaces, such as linoleum floors, formica countertops, and stainless steel. The manufacturers discourage the use of quaternary ammonia germicidal products on computer-grade plastics and on data, patient, and power cables, which are classified as porous materials.

Caution: • Do not autoclave. • Never use solvents, acetone, abrasive cleaning agents, or abrasive cleaning pads. • Use only approved cleaning agents including 70% alcohol, soap and water, green soap, or 10% bleach solution. Note: •

Refer to the operations manual for detailed cleaning instructions.

4-38

Troubleshooting Contents Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Power On Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Diagnostic Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Information Required for Diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 System Troubleshooting Flow chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Overview The first several sections describe the available di agnostics features and how to use them. This is followed by a section which lists diagnostics failure messages and the suggested corrective actions. The troubleshooting procedures in this chapter isolate equipment problems to a Field Replaceable Unit (FRU).

Caution: Observe precautions for handling electrostatic-sensitive devices! Note: • Never touch electrostatic-sensitive electronic components without following proper anti-static procedures, including the use of an ESD wrist band and mat. An electrostatic discharge from your fingers can permanently damage electronic components and cause latent failures. • All static-sensitive electronic components are packaged in static-shielding bags. Retain the bag should you need to repackage the component for storage or need to return it to Spacelabs for any reason.

Required Tools and Parts The following items are necessary for troubleshooting: •Anti-static mat with wrist strap •#1 and #2 Phillips-head screwdriver •5/16-inch nut driver •3/16-inch nut driver •Patient simulator •Multimeter

Problem Solving Before starting the troubleshooting procedures, first establish that there is a fault by performing the monitor functional tests. Refer to the Operations Manual for specific information on operation.

5-1

Troubleshooting

System Startup When the monitor is powered ON, observe the following sequence: 1. The LED on the front panel should illuminate in green after the On/Off button is depressed and the monitor will beep once. 2. A boot screen will be displayed for a while. 3. Normal screen will be displayed and the monitor will beep twice. 4. NIBP zeroing and EtCO 2 warning up (if EtCO2 is installed) message will be displayed after the two beeps.

Power-ON Diagnostics Power-ON diagnostic tests verify system hardware integrity during power-ON and can often help isolate and troubleshoot a problem. The normal screen will be displayed after the completion of the Power-On diagnostics.

Diagnostic Menus Recorder diagnostic diagnostic is available for testing the recorder. It can be accessed accessed through / / / . Diagnostics>. Diagnostic result will be printed from the recorder.

Error Log For troubleshooting intermittent problems, the monitor maintains an error log for both recoverable and nonrecoverable errors in its battery-backed, non-volatile memory. All diagnostics failures are logged in t he error log. Most errors relate to the Zbitsy Board. Event log can be access through / / / .

5-2

Troubleshooting

Information Required for Diagnostic Please provide the following information before contacting EMO GTS for assistance.. -

Spacelabs Healthcare Field Complaint Analysis Requirement

Submitter/Contact Bedside Serial Number Bedside Software Version Bedside Options String Central Software Version (if connected)

Bedside Event Log Issue Pictures Issue Video

Required Required Optional

Issue Description

Issue Reproduction Steps

5-3

Troubleshooting

System Troubleshooting Flowchart This section describes troubleshooting procedures which can be used i n conjunction with, or separately from, the diagnostics to isolate a failure. ECG/RESP

Re-analyze problem. No

Display ECG/RESP waveform?

No

Problem resolved from previous stage?

Replace ECG cable

Replace ECG input board

No


YES YES

YES

YES

Correct ECG and RESP waveforms appear on screen?

Noisy ECG Signal? No

End No

YES

ECG lead selection functions?

Replace Main board No

YES

Lead fault circuit functions?


YES

ECG and RESP alarms OK?


YES



YES

End

For optimal cardiac monitoring, it is necessary to recognize problems that can interfere with getting a reliable ECG signal. Causes of interference include artifact from patient movement and poorly placed or poorly functioning equipment and electrical i nterference from AC or other bedside devices. An artifact, also refer to as waveform interference, may be seen with excessive movement (somatic tremor). It makes the baseline of the ECG appear wavy, bumpy, or tremulous. Dry electrodes may also cause this problem because of poor contact. Intermittent artifact may also be due to intermittent lead wires and ECG cable. Electrical interference, also refer to as AC i nterference or 50/60-cycle interference, is caused by electrical power leakage. It may also result from interference from other room equipment or i mproperly grounded equipment. As a result, t he lost current pulses at a rate of 50/60 cycles/second. This interference appears on the ECG as a baseline t hat’s thick and unreadable. In some case, the waveform baseline can be severely affected and may cover the whole ECG waveform channel. Refer to the table below for the most commonly encountered ECG problems, the possible causes, and interventions. 5-4

Troubleshooting Artifact (Waveform Interference) Dirty or corroded connections. Improper electrode application

•

•

Dry electrode gel

•

•

Intermittently short circuit in lead wires or cable

•

Replace intermittent or broken lead wires or cable

•

Electrical interference from other medical devices in the room.

•

Make sure all medical devices associate with the same patient are attached to a common ground. Use a ground wire adaptor if necessary.

•

Improper electrode application Defective ECG lead wires and/or cable.

•

Re-apply electrodes.

•

Replace any faulty lead wires and cable.

Electrical interference from other medical devices associated with the patient.

•

Make sure all medical devices being used, such as IV pump, ventilator, electrical bed, are attached to a common ground. Use a ground wire adaptor if necessary. Check all three-pronged plugs to ensure no prong is loose. Notify biomed department if poor grounding has been observed at wall socket or power strip being used.

•

•

•

Replace dirty or corroded wires Check the electrodes and reapply if necessary. Clean the patient’s skin well to remove skin oil and dead skin cells. Skin oils and dead skin cells inhibit ECG electrical signal conduction. Check the electrode gel. If it is dry, do not use and replace with new electrodes.

Weak ECG Signal

•

Fuzzy Baseline (Electrical Interference) •

•

•

5-5

Troubleshooting SpO2 Connect SpO2 cable to simulator and monitor

SpO2 waveform appears on display?

Replace sensor / cable No


No

Replace Main Board (Option S) or Masimo Board (Option M) or Nellcor Board (Option N)

YES

YES

SpO2 alarms OK? No

Replace Main board or Masimo Board (Option M) or Nellcor Board (Option N)


No

Re-analyze problem.

YES

YES

End

5-6

Troubleshooting

NIBP

Connect NIBP cuff to monitor and simulator

Press Start NIBP and wait for the cuff to inflate

Replace leak


YES

Cuff fully inflate?

No

Check air leak in pneumatic system.

Air leak found?



YES

YES

Was reading successful?



YES


YES

Press Start NIBP and wait for the cuff to inflate

Press Stop NIBP while cuff is inflating

Pump stops and cuff deflates?




YES

YES

NIBP alarms ok?




YES

YES

End

5-7

Troubleshooting

TEMP

Connect temperature cable to simulator and module

Temperature numeric appears on display?

No

Replace Temperature probe



YES

YES

Temperature alarms OK?



No

Re-analyze problem.

YES

YES

All Temperature channels tested? No

YES

End

5-8

Troubleshooting

Invasive BP

Connect pressure cable to simulator and monitor

Pressure waveform appears on display?

No

Replace pressure transducer / cable



YES

YES

Pressure numeric appears on display?

Zero BP channel

Pressure waveform appears on display?

No


YES

YES

BP alarms OK?




YES

YES

All pressure channels tested? No

YES

End

5-9

Troubleshooting

EtCO2

Turn on the “EtCO2 Enabled” in Clinical menu.

Does EtCO2 replace RESP on display?

No

Replace Main board



YES

YES Connect a sampling line

Does pump start running?

No

Ensure sampling line is compatible. Replace sampling line.


No

Replace EtCO2 module

YES YES

Does EtCO2 waveform appear on display?

No

Check for occlusion. Replace sampling line.



No

YES YES

Does EtCO2 numeric appear correctly on display?

Perform CO2 Calibration No


No


YES

YES

EtCO2 alarms OK?

Replace Main board



No

YES

YES

End

5-10

Parts Contents Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Assembly Drawings and Schematics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Parts List Part Number

Description Electronic PCBA

670-1401-02 670-1401-04 670-1402-00 670-1402-04 670-1402-05 017-0102-00 010-1732-00 010-1636-01 010-1979-01 150-0352-00-x 150-0408-00 050-0660-00 010-1734-01 010-1958-00 010-1733-00 670-1407-01 670-1406-00 670-1397-02 670-1496-00 010-1635-01 670-1435-00 146-0130-00

PCBA,93300 Main Board PCBA,93300 Main Board PCBA, Zbitsy Board PCBA,ZBITSY BOARD PCBA,ZBITSY BOARD Power Supply Assy PCBA, Oridion CO2 PCBA, Masimo SpO2 (MS-2011) PCBA,LVDS,T5 BOARD (For use with 150-0408-00) DISPLAY,10.2",W/REPLACED CCFL TUBE,EXCHANGE DISPLAY,LCD,10.2 IN TFT-LCD W/TOUCHSCREEN KIT,SERVICE,CMI LCD REPLACE AUO,10.2" 10.2" Backlight Inverter PCBA,LED DRIVER (For use with CMI LCD 150-0408-00) LVDS Board (For AUO LCD 150-0352-00 only) PCBA, Charger I/O PCBA, Printer Interface PCBA, ECG-DB9 (For use with option M & S) PCBA, ECG-DB9 (For use with option N) Nellcor SpO2 Board PCB ASSY, LED, 93300 Battery,15V Lithium

Enclosure ASSEMBLY SERVICE KIT

650-1579-00 650-1579-01 650-1579-02 650-1579-03 650-1579-04 650-1579-05 650-1585-00 650-1585-01 650-1585-02 650-1585-03 650-1585-04 650-1585-05 348-0726-01 348-0726-03 348-0726-04

ASSY,PANEL PATIENT,93300-M ASSY,PANEL PATIENT,93300-IM ASSY,PANEL PATIENT,93300-CIM ASSY,PANEL PATIENT,93300-EM ASSY,PANEL PATIENT,93300-EIM ASSY,PANEL PATIENT,93300-CEIM ASSY,PANEL PATIENT,93300-N ASSY,PANEL PATIENT,93300-IN ASSY,PANEL PATIENT,93300-CIN ASSY,PANEL PATIENT,93300-EN ASSY,PANEL PATIENT,93300-EIN ASSY,PANEL PATIENT,93300-CEIN Gasket, Horizontal Gasket, Side Gasket, Up

6-1

Parts Elance 5i and c - Patient Input Panel hardware (White) 614-0421-00 PANEL ASSY,PATIENT INTERFACE,GREY 175-1628-00 CABLE ASSY,FOR IBP 175-1627-00 CABLE ASSY,TEMPERATURE,SHORT 334-4714-01 LABEL,PRINTER INSTRUCTION,GRAY 334-4715-01 LABEL,93300,SL SPO2,GRAY 334-4715-02 LABEL,93300,SL SPO2,IBP,GRAY 334-4715-03 LABEL,93300,SL SPO2,IBP,CO2,GRAY Elance 5 Elite i and c - Patient Input Panel hardware (Black) 175-1628-00 CABLE ASSY,FOR IBP 175-1627-00 CABLE ASSY,TEMPERATURE,SHORT 614-0421-03 PANEL ASSY,PATIENT INTERFACE,SILVER 334-4715-04 LABEL,93300,SL SPO2,SILVER 334-4715-05 LABEL,93300,SL SPO2,IBP,SILVER 334-4715-06 LABEL,93300,SL SPO2,IBP,CO2,SILVER 334-4714-02 LABEL,PRINTER INSTRUCTION,Silver st

For e5 (White) - 1 Generation Enclosure Replaceable Parts 050-0551-00 KIT,SERVICE,ENCLOSURE,10.2 INCH,WHITE 614-0421-00 Panel Assy, Patient interface, SL SpO2, Grey 614-0421-01 Panel Assy, Patient interface, Masimo SpO2, Grey 614-0421-02 Panel Assy, Patient interface, Nellcor SpO2, Grey st

For e5 Elite (Black) - 1 Generation Enclosure Replaceable Parts 050-0551-01 KIT,SERVICE,ENCLOSURE,10.2 INCH,BLACK 614-0421-03 Panel ASSY, Patient interface, SL SpO2, Silver 614-0421-04 Panel Assy, Patient interface, Masimo SpO2, Silver 614-0421-05 Panel Assy, Patient interface, Nellcor SpO2, Silver For e5 (White) – 2 050-0616-00 367-0848-00 367-0849-00 650-1552-04 200-0402-04 333-0908-04 614-0421-00 614-0421-01 614-0421-02

nd

Generation Enclosure Replaceable Parts KIT,SERVICE,ENCLOSURE REAR,WHITE,10.2" HANDLE,FRONT,WHITE,10.2" HANDLE,REAR,WHITE,10.2" ASSY,ENCLOSURE FRONT,WHITE,10.2 INCH COVER,ALARM LENS,10.2 INCH PANEL,PRINTER SIDE,10.2 INCH PANEL ASSY,PATIENT INTERFACE,GREY Panel Assy, Patient interface, Masimo SpO2, Grey Panel Assy, Patient interface, Nellcor SpO2, Grey

6-2

Parts nd

For e5 Elite (Black) – 2 Generation Enclosure Replaceable Parts 050-0616-01 KIT,SERVICE,ENCLOSURE REAR, BLACK ,10.2" 367-0848-01 HANDLE,FRONT, BLACK ,10.2" 367-0849-01 HANDLE,REAR, BLACK ,10.2" 650-1552-05 ASSY,ENCLOSURE FRONT, BLACK ,10.2 INCH 200-0402-05 COVER,ALARM LENS,10.2 INCH 333-0908-05 PANEL,PRINTER SIDE,10.2 INCH 614-0421-03 PANEL ASSY,PATIENT INTERFACE,SILVER 614-0421-04 Panel Assy, Patient interface, Masimo SpO2, Silver 614-0421-05 Panel Assy, Patient interface, Nellcor SpO2, Silver For e5 (White) – 3rd 050-0634-00 650-1576-02 367-0848-00 367-0849-00 650-1552-04 200-0402-04 333-0908-04 614-0421-00 614-0421-01 614-0421-02 386-0609-00 175-1632-00 107-0104-00 348-0825-00 107-0103-00 348-0734-00 214-1104-00

Generation Enclosure Replaceable Parts KIT,SERVICE,ENCLOSURE REAR,WHITE,10.2" ASSY,ENCLOSURE REAR,WHITE,10.2" HANDLE,FRONT,WHITE,10.2" HANDLE,REAR,WHITE,10.2" ASSY,ENCLOSURE FRONT,WHITE,10.2 INCH COVER,ALARM LENS,10.2 INCH PANEL,PRINTER SIDE,10.2 INCH PANEL ASSY,PATIENT INTERFACE,GREY PANEL ASSY,PATIENT INTERFACE,MASSIMO SPO2,GREY PANEL ASSY,PATIENT INTERFACE,NELLCOR SPO2,GREY PLATE, MOUNTING CABLE ASSY,AC IN INSULATOR,POWER SUPPLY THERMAL PAD INSULATOR,PLATE MOUNTING GASKET,HEAT SINK HEAT SINK

For e5 Elite (Black) – 3rd G eneration Enclosure Replaceable Parts 050-0634-01 KIT,SERVICE,ENCLOSURE REAR,BLACK,10.2" 650-1576-03 ASSY,ENCLOSURE REAR,BLACK,10.2" 367-0848-01 HANDLE,FRONT,BLACK ,10.2" 367-0849-01 HANDLE,REAR,BLACK,10.2" 650-1552-05 ASSY,ENCLOSURE FRONT,BLACK,10.2 INCH 200-0402-05 COVER,ALARM LENS,10.2 INCH 333-0908-05 PANEL,PRINTER SIDE,10.2 INCH 614-0421-03 PANEL ASSY,PATIENT INTERFACE, SILVER 614-0421-04 PANEL ASSY,PATIENT INTERFACE,MASSIMO SPO2, SILVER 614-0421-05 PANEL ASSY,PATIENT INTERFACE,NELLCOR SPO2, SILVER 386-0609-00 PLATE, MOUNTING 175-1632-00 CABLE ASSY,AC IN 107-0104-00 INSULATOR,POWER SUPPLY 348-0825-00 THERMAL PAD 107-0103-00 INSULATOR,PLATE MOUNTING 348-0734-00 GASKET,HEAT SINK 214-1104-00 HEAT SINK

6-3

Parts Interconnection Cable 175-1629-00 175-1630-00 175-1634-00 175-1637-00 175-1637-01 175-1644-00 175-1635-00 175-1656-01 175-1663-01 175-1663-02 175-1674-00 175-1854-00 175-1872-00

Cable ASSY, High Voltage (For use with AUO LCD 150-0352-00) Cable ASSY, Power Supply Cable ASSY, Printer Interface Cable ASSY, ECG Rev A Cable ASSY, ECG Rev B Cable ASSY, LVDS Cable, Oridion EtCO2 to Main Board CABLE ASSY,MS SPO2 CABLE ASSY,INNER,MASIMO SPO2 CABLE ASSY,INNER,NELLCOR SPO2 CABLE ASSY,INNER,NELLCOR SPO2,10PINS CABLE ASSY,LED DRIVER (For use with CMI LCD 150-0408-00) CABLE ASSY,INVERTER ADAPTER (For use with CMI LCD 1500408-00)

Others 119-0509-00 010-1735-00 019-0537-00 019-0537-01

ASSY LTPA245, Printer Header & Roller ASSY, Paper Drive PCBA,MAIN CONTROLLER,PRINTER STYLUS KIT,93300,WHITE STYLUS KIT,93300,BLACK

6-4

Parts

Assembly Drawings and Schematics The following assembly drawings and schematics are included as part of this manual. Description PCBA, 93300 M/B

P/N 670-1401-04

Drawing No.

6-5

Glossary The following terms may appear in this manual:

7-1

Glossary

7-2

Glossary

7-3

Appendix A — Electromagnetic Compatibility Contents Electromagnetic Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 Electromagnetic Immunity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Electromagnetic Emissions Emission Test RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker IEC 61000-3-3

Compliance

Electromagnetic Environment

Group 1

The monitor emits electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Evaluate on site before use.

Class A

Suitable for use in all environments other that domestic and those directly connected to a low voltage supply network used for domestic purposes.

Complies

The monitor causes less that 0.06% maximum voltage change during worse-case operation.

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Appendix A - Electromagnetic Compatibility

Electromagnetic Immunity Note: The monitor is intended for use in the electromagnetic environment specified below. The customer, or user, of the monitor should ensure that it is used in such an environment. Immunity Test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

IEC 60601 Test Level ±6 kV contact ±8 kV air ±2 kV for power supply lines ±1 kV for input/output data lines ±1 kV differential mode ±2 kV common mode <5% UT (>95% dip in UT for 0.5 cycle) 40% UT (60% dip in UT for 5 cycles) 70% UT (30% dip in UT for 25 cycles) <5% UT (>95% dip in UT for 5 seconds)

Compliance Level

Electromagnetic Environment

6 kV contact 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

0.5 kV for power, test levels >0.5kV 1 kV Transient on data lines had no affect

Mains power quality should be that of a typical commercial or hospital environment.

1 kV differential mode 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% UT (>95% dip in UT for 0.5 cycle) 40% UT (60% dip in UT for 5 cycles) 70% UT (30% dip in UT for 25 cycles) <5% UT (>95% dip in UT for 5 seconds)

Mains power quality should be that of a typical commercial or hospital environment. The monitor automatically switches to internal battery operation during mains power interruptions.

Power frequency magnetic fields should be at levels characteristic 3 A/m 3 A/m of a typical location in a typical commercial or hospital environment. Note: UT is the AC mains voltage prior to application of the test level. All power line immunity tests were performed at 120 VAC/60 Hz and 230 VAC/50 Hz. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

A-2


Frequency Separation Distances Note: This equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this equipment, as recommended in the table below, according to the maximum output power of the communications equipment.

3Vrms, 2Hz sine 80% AM

3Vrms, 2Hz sine 80% AM

A-3


Interference RF fields pulsating at a sustained rate within the physiological pass band of this equipment may be detected and then displayed as a valid waveform, or the fields may al ter a valid waveform and cause an erroneous parameter value. AC line transients may disrupt displayed ECG, RESP and SpO2 waveforms causing noise and erroneous parameter data; may also affect video d isplay synchronization. Self recovers when line transients are removed.

Mitigation Evaluate RF fields on site. Troubleshoot with patient simulators and then determine the source of the interference. Separate the sensitive receivers from the causes of the i nterference (refer to the following table).

Investigate sources of AC line transients in the facility power system; inspect facility ground network; review equipment operating on the same lo w voltage circuit; separate suspect sources. Use a Hospital Grade isolation transformer to protect the monitor from the line transients.

A-4

Appendix B — Symbols The following list of international and safety symbols describes all symbols used on Spacelabs Healthcare products. No one product contains every symbol.

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

XXX

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

B-1

Appendix B - Symbols

B-2


B-3


B-4


B-5


B-6


B-7


B-8


B-9


Oridion Microsteam CO2

Not for use on Neonates or Infants

Read the instructions before use

Abbreviations used as symbols are shown below.

B-10

elance Service Manaual - Rev H.pdf

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