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SERVICE GUIDE
Release V6
English
Release V6
English
Important Information
Product Information
Product models: UT4000A/UT6000A Product name: Patient Monitor
Standard
The product is made under the ISO9001 and ISO13485 quality system certified by TUVPS. The product has passed the CE certification.
Manufacturer Information
Shenzhen Goldway Industrial Inc. Goldway Building, No. 3 Road, North Section, Shenzhen High-Tech Industrial Park, Shenzhen, P.R. China 518057 Tel: +86 755 26980999 Fax: +86 755 26980222
Version
First Edition: November 2009 Shenzhen Goldway Industrial Inc. All Rights Reserved.
Safety Conventions
The guide uses the following conventions for Notes, Cautions, and Warnings.
Note A Note calls attention to an important point in the text. Caution A Caution calls attention to a condition or possible situation that could damage or
destroy the product or the users work.
Warning A Warning calls attention to a condition or possible situation that could cause injury to
the user and/or patient.
Important Information
Explanation of Symbols
The following symbols appear on the monitor and its packaging. Table 1 Monitor Symbols
Symbol
0123
Description
CE mark
Symbol
Description
Fragile, handle with care
Recyclable
Keep upright
Recycle packaging
Maximum stacking
Humidity
Caution CF applied part: Connector has special protection against electric shocks and is defibrillator proof BF applied part: Connector has special protection against electric shocks and is defibrillator proof Waveform freeze key
Temperature
Atmospheric pressure
Keep dry
SpO2
ECG/RESP
ECG connector
NIBP cuff connector TEMP1 connector (UT6000A only) TEMP2 connector (UT6000A only)
NIBP key
On/off key
AC Power LED
Charging LED
ii
EU representatives
Dangerous Voltage
Date of manufacture
Serial number
Consult Instructions for Use 15V DC Power Input Port (UT4000A only) Compliance with WEEE standard
IPX1
Protective grade
USB port
Protective grounding
Catalog number
Fuse
Batch code
Ethernet port
Option number
The UT4000A/UT6000A monitors are Class IIb devices and comply with the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and carry CE-marking accordingly.
Authorized EU Representative
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175 Fax: 0049-40-255726
iii
Important Information
Goldway is not responsible for damage to the monitor when: Damage is caused by: Improper operation. Improper connection of the monitor to other devices. Accidental impact.
The monitor is altered without written authorization from Goldway. The serial number of the monitor is removed or becomes illegible.
iv
Important Information
Safety Standards
Table 2 Safety Standards
Parameter
Protection Class Degree of Protection
Specification
Class I, anti-shock, externally and internally powered equipment, per IEC 60601-1 Type CF and BF defibrillator-proof: per IEC 60601-1 Degree of noxious-liquid proof as IPX1 Anti-shock degree as combination of BF and CF applied part According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide As recommended by manufacturer Continuous
Table of contents
Table of Contents
Chapter 1 General Introduction
1.1 About the Guide ..........................................................................................................................1-2 1.1.1 Brief Introduction ...............................................................................................................1-2 1.2 Product Information ....................................................................................................................1-2 1.2.1 General ............................................................................................................................1-2
1.2.2 Main Components...............................................................................................................1-3 1.2.3 Intended Use ....................................................................................................................1-3 1.2.4 Audience ..........................................................................................................................1-4 1.2.5 Networking Capabilities .....................................................................................................1-4 1.3 Before You Begin ........................................................................................................................1-4 1.4 Monitor and Accessories Inspection............................................................................................1-5 1.5 Cleaning ......................................................................................................................................1-5 1.6 Returning the Monitor for Service ..............................................................................................1-6 1.7 Setting up the Monitor.................................................................................................................1-6 1.8 Before Powering On....................................................................................................................1-7 1.9 Setting Demo Mode.....................................................................................................................1-8 1.10 Setting the Network...................................................................................................................1-9 1.11 Updating the software..............................................................................................................1-13 1.11.1 New software.................................................................................................................1-13 1.11.2 Uport 1150 Adapter (Software Update tool)..................................................................1-13 1.11.3 Installing Uport 1150 Adapter .......................................................................................1-14 1.11.3 Creating a Hyper Terminal and connecting the monitor and PC ...................................1-16 1.11.4 Updating the Program File ............................................................................................1-19 1.11.5 Updating the Data File ..................................................................................................1-21 1.11.6 Updating the Language Resource File...........................................................................1-23 1.11.7 Language Setting...........................................................................................................1-25 1.12 Mounting Abilities...................................................................................................................1-26
Chapter 2 Maintenance
2.1 Testing and Inspecting Guidelines...............................................................................................2-2 2.1.1 Recommended Frequency ..................................................................................................2-3 2.1.2 Required Equipment...........................................................................................................2-3 2.1.3 Recording the Tests ............................................................................................................2-4 2.2 Planning Maintenance .................................................................................................................2-4 2.3 Performing Visual Inspection ......................................................................................................2-4 2.4 Cleaning and Disinfecting ...........................................................................................................2-5 2.4.1 General Guidelines .............................................................................................................2-5
TOC-1
Table of contents
2.4.2 Disinfecting Guidelines ......................................................................................................2-6 2.4.3 Cleaning the monitor ..........................................................................................................2-6 2.4.4 Cleaning the Cables............................................................................................................2-6 2.4.5 Cleaning the Accessories....................................................................................................2-7 2.4.6 Cleaning the Recorder ........................................................................................................2-9 2.5 Doing Performance Verification..................................................................................................2-9 2.5.1 Manufacturers Responsibility ...........................................................................................2-9 2.5.2 Performing Power Supply and Battery Test .......................................................................2-9 2.5.3 Performing ECG Test .......................................................................................................2-10 2.5.4 Performing Respiration Test (UT6000A only) ..................................................................2-10 2.5.5 Performing Temperature Test (UT6000A only)................................................................. 2-11 2.5.6 Performing Pulse SpO2 Test ............................................................................................. 2-11 2.5.7 Performing NIBP Test ...................................................................................................... 2-11 2.5.8 Performing NIBP Calibration ...........................................................................................2-14 2.5.9 Performing Speaker Test ..................................................................................................2-14 2.5.10 Performing Networking Test ..........................................................................................2-14 2.6 Performing Electrical Safety Test..............................................................................................2-15
Chapter 3 Troubleshooting
3.1 Power Problems...........................................................................................................................3-2 3.2 Display Problems ........................................................................................................................3-5 3.3 NIBP Problems............................................................................................................................3-6 3.4 Alarm Problems...........................................................................................................................3-7 3.5 SpO2 Problems ............................................................................................................................3-7 3.6 ECG Problems.............................................................................................................................3-8 3.7 Respiration Problems (UT6000A only)........................................................................................3-8 3.8 Temperature Problems (UT6000A only) ......................................................................................3-9 3.9 Recorder Problems (UT6000A only). ..........................................................................................3-9 3.10 Performance Verification.........................................................................................................3-10
Table of contents
4.2.8 AC/DC Power Module .......................................................................................................4-5 4.2.9 Recorder (UT6000A only) ..................................................................................................4-5 4.2.10 Processing the NIBP.........................................................................................................4-6 4.2.11 Processing the SpO2..........................................................................................................4-6 4.2.12 Processing the ECG..........................................................................................................4-7 4.2.12 Processing the Respiration (UT6000A only).....................................................................4-7 4.2.13 Processing the Temperature (UT6000A only) ...................................................................4-7
Table of contents
6.13 Removing the ECG Module ....................................................................................................6-15 6.14 Removing the NIBP Module ...................................................................................................6-16 6.15 Removing the AC/DC Power Module .....................................................................................6-17 6.16 Removing the Battery Connect Board.....................................................................................6-18 6.17 Removing the Inverter.............................................................................................................6-19 6.18 Removing the SpO2 module ....................................................................................................6-20 6.19 Removing the Main board Assembly ......................................................................................6-21 6.20 Removing the Front Case Assembly .......................................................................................6-22
TOC-4
General Introduction
1-1
General Introduction This chapter briefly introduces the monitor and related product support information.
Battery operation for portability 7 color TFT Big number for optimal visibility Two mounting abilities, including roll stand and wall mount
The monitor collects the physiological signals of ECG, RESP, TEMP, NIBP, SpO2 and converts the above into digital data which is analyzed and displayed. You may not have all of these functions, depending on the monitor configuration purchased.
1-2
General Introduction
1.2.2
Main Components
The monitor can contain the following components: Main unit ECG RESP NIBP SpO2 TEMP Recorder
The following table lists the models, including standard and optional features in each model. In the table, a solid circle indicates a standard feature and a hollow circle, an optional feature. Table 1-1 UT4000A/UT6000A Patient Monitors Configurations
Feature
ECG1 (3,5 Leads) ECG ST TEMP1, TEMP2 RESP NIBP SpO2 Recorder Display Screen Number of batteries Ethernet RJ45 port
1
UT4000A
None None None None 7 inches 1
UT6000A
7 inches 1
The UT4000A has one ECG channel. The UT6000A has two ECG channels.
1.2.3
Intended Use
For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations and for connectivity to clinical networks.
1-3
General Introduction
1.2.4
Audience
This guide is for biomedical engineers or technicians responsible for troubleshooting, repair and maintenance of Goldway patient monitors.
1.2.5
Networking Capabilities
You can use the UT4000A/UT6000A Patient Monitors along with other Goldway equipment to create a central monitoring system that allows remote monitoring. The monitor communicates with the UT4800 Central Monitoring System via an RJ45 port (optional) on the back of the monitor.
2. Keep the packaging for future transport or storage. If it is damaged, immediately contact the courier company.
3. Examine the monitor for cleanliness and general physical condition. Make sure that the: Housing is not cracked or broken. Power plug and cord are in good condition and plug prongs are not bent. External cables and accessories are in good condition and that the insulation is intact. Caution If the equipment or packaging show signs of damage, do not use the equipment.
1-4
General Introduction
Warning
Never attempt to open the monitor case. Only qualified personnel should service the monitor. Observe only the instructions in this guide to install and use the monitor. To maintain normal operation of the monitor, develop a good maintenance plan for periodic cleaning, maintenance and service. For more information, see Chapter 2 Maintenance.
Caution
1.5 Cleaning
Caution Do not immerse the monitor or its accessories in liquid or clean it with caustic or abrasive cleaners. Do not spray or pour any liquid on the monitor or its accessories. To clean the monitor: 1. Dampen a cloth with a commercial, nonabrasive cleaner, and wipe the exterior surfaces lightly. 2. Do not allow liquids to come in contact with the power connector or switches or to penetrate connectors or openings in the monitor. 3. For cables, sensors, and cuffs, follow the cleaning instructions in Cleaning and Disinfecting on Page 2-5. For more detailed information, see Chapter 2 Maintenance.
1-5
General Introduction
Before returning any equipment to Goldway, decontaminate it first. To pack the monitor for return, disconnect all cables. It is not necessary to return any sensor, temperature probe, NIBP tubing and cuff, or power cord. If possible, use the original packaging materials.
Ensure that the monitor transports in the environment within the following specifications: Table 1-2 Environmental Specifications Parameter Temperature - working Temperature - storage and transportation Relative humidity - operating Relative humidity - storage and transportation Barometric pressure - working Barometric pressure - storage and transportation Specification 10C 40C (50F 104F) -20C 55C (-4F 131F) 80% 95% 70 kPa 106 kPa 50 kPa 106 kPa
Locate the monitor in an area that: Is convenient for observation and operation Is free from movement, dust, corrosive or explosive gases Has a five centimeter space around to ensure good ventilation and smooth heat dissipation Caution Only install the monitor as outlined in this Service Guide. Never block the monitors air vent during operation. Always keep the monitor free from condensation and temperature changes when transporting it from one location to another. Never place the monitor in a location where the patient might inadvertently knock it off the bed.
Warning
1-6
General Introduction
Warning
Personnel connecting additional devices to input and output connectors are responsible for system compliance with the IEC 60601-1-1 standard. If you cannot determine the safety of the monitor when combining it with another medical device, contact Goldway to ensure that the combined devices are safe and will not cause electric shock or other hazards. When safety (for example an electrical shock caused by the sum of current leakage) cannot be determined from the specific combination of the monitor and other medical devices, contact the service representative, to ensure necessary safety.
1-7
General Introduction
1-8
General Introduction
Note This setting is only used on UT4000A (Version 6.* and higher) and UT6000A
(Version 6.* and higher) with network module. Default IP address of the monitor network module is 192.168.0.250.
Before setting the network features, connect the monitor to the central monitoring system via a network cable and a network switch. You can set the network features of the monitor either through the central monitoring system PC or via another networked PC connected to the LAN. Then, power on the monitor.
1. From the Central Monitoring System, Open Internet Protocol (TCP/IP) Properties, and mark down the IP address and Subnet mask of central monitoring system, For example, the central monitoring system IP address is 192.168.2.98, Subnet mask is 255.255.255.0. Caution If you use another networked PC, also mark down its IP address and Subnet mask in order to restore itafter setting the monitor network features. 2. Set the PC and monitor to be in the same network. Open the Internet Protocol (TCP/IP) Properties of the central monitoring system PC (or another PC), set PC IP address as 192.168.0.* (Range of * is 1-100) and ensure that the IP address 192.168.0.* is not used in other device on the LAN. Set the Subnet mask as the same as the central monitoring system. For example (Figure 1-2) set PC IP address to 192.168.0.88, and set the Subnet mask to 255.255.255.0.
General Introduction 3. Open a browser and type in the address bar: 192.168.0.250. Enter to link NePort-R module. Both the default user name and the password are admin.
Figure 1-3 Linking Interface 4. Click OK and entered NePort Web Console interface.
1-10
General Introduction 5. Click Network, enter Network Settings interface. Set the Subnet as same as central monitoring system. If the Subnet is 255.255.255.0, set the IP address to 192.168.*.** (192.168.* must be the same to the front 3 segments IP address of the central monitoring system. Range of ** is 1-249 and except the address has used in this LAN). Keep other parameters as the original. After that, click OK. For example, change the IP address here to 192.168.2.50 and Subnet mask to 255.255.255.0. (Figure 1-5) If the Subnet is not 255.255.255.0, contact Goldway to confirm the network settings.
Caution
1-11
General Introduction 6. Click Serial1 Settings, enter the serial settings. Make sure that parameters are set as the same as Figure 1-6. Other parameters remain the original. Click OK after setting.
7. Click connection1, and enter the connection settings. Set the parameters according to Figure 1-7. Other parameters remain the original. Set the Remost Host the actual Central monitoring system IP address. Click OK to exit. For example, change the Remost Host here to 192.168.2.98. (Figure 1-7.)
8. Click Apply / Reset. 9. Click the Submit in Apply / Reset Interface to save the settings.
1-12
General Introduction 10. Restore the network setting of central monitoring system PC (or another PC) 11. Restart the monitor.
Before you perform a software update, you need the following equipment and material: One PC with CD-ROM One Network Cable New Software One Uport 1150 Adapter (Software Update tool) Note This process is only used on UT4000A (Version 6.* and higher) and UT6000A (Version 6.* and higher).
Table 1-3 The software File Name 6A_Flash_V*.**.bin1 6A_Eeprom_V*.**.bin1 6A_Language_V*.**.bin1 Description UT4000A/UT6000A M128 program file UT4000A/UT6000A M128 data file UT4000A/UT6000A Language resource file
It includes: IFU for Uport 1150 Adapter Connect cable DB9-RS422 200mm USB-RS232/RS422 Uport1150 Adapter Uport 1150 Adapter installation CD
1-13
General Introduction
2.
Assemble the USB-RS232/RS422 Uport1150 Adapter and Connect cable DB9-RS422 200mm as described in Table 1-4 and shown in Figure 1-8.
Table 1-4 Uport1150 Adapter bond holes connection Line Color of Connect cable DB9-RS422 200mm 1 2 3 4 5 Yellow Green Black Blue (None) Bond hole names of USB-RS232/RS422 Uport1150 Adapter T+ TR+(D+) R- (D- ) GND
Note Select the corresponding folder (bolded in the above path) according to your actual windows system.
1-14
General Introduction 2. Plug USB-RS232/RS422 Uport1150 Adapter into an USB port of the PC. The system displays a pop-up window alerting that new hardware is found. Select automatic installation and complete the driver installation. 3. 4. Restart the PC. Click following options step by step to find Device Manager as shown in Figure 1-9: Start Control Panel System Hardware Device Manager.
5.
Double click Uport 1150 and click Ports Configurations (Figure 1-10).
1-15
General Introduction 6. Double click the item inside (Circle in Figure 1-10). The Port 1 window appears (Figure 1-11).
7.
Set the Interface to RS-422 (Circle in Figure 1-11) and keep others the default settings.
8.
Make down the Port Number name ( Rectangle in Figure 1-11). For example, there is COM3 (current).
9.
1-16
General Introduction 2. 3. 4. 5. Connect the monitor to AC power. Click start at the lower left quarter of the computer screen. Click the following options step by step to create a Windows HyperTerminal. All Programs Accessories Communications Hyper Terminal New Windows Hyper Terminal. The Connection Description pop up is displayed (Figure 1-13). 6. Enter a name and choose an icon for the connection and click ok. For example, enter COM3 115200 here.
7.
Set the Connect using area in the Connect to window according to the Port number of Uport1150. (Figure 1-14). For example, set it to COM3. (See Figure 1-11 in Page 1-16)
1-17
General Introduction 8. Setting COM Properties as shown following Figure 1-15: Bits per second: 115200 Data bits: 8 Parity: None Stop bit: 1 Flow control: None
9.
After the Hyper Terminal window appears, hold down the CTRL + C and power on the monitor. Figure 1-16 describes the right messages on the terminal window.
Note If the messages are not intact as shown, press Enter to refresh.
1-18
General Introduction
2. 3.
Click Transfer in the Menu of Hyper Terminal window. Click Send File to open the dialogue window appears as Figure 1-18.
4.
Click Browse to find File 6A_Flash_V*.**. Bin and set Protocol to Xmodem.
5.
1-19
General Introduction 6. Wait until the sending is completed. The progress bar and data are displayed here. (circle in Figure 1-19)
Figure 1-19 Xmodem file send window-1 Note If error message appears or the sending is interrupted, retry until the file is send successfully. 7. After the sending completed. There is a word done in Hyper Terminal window. (Circle in Figure 1-20)
1-20
General Introduction
2. 3.
Click Transfer in the Menu of Hyper Terminal window: Click Send File to open the dialogue window appears as Figure 1-22.
4.
Click Browse to find File 6A_ Eeprom_V*.**. Bin and set Protocol to Xmodem.
5.
1-21
General Introduction 6. Wait until the sending is completed (Figure 1-23). The progress bar and data are displayed here. (Circle in Figure 1-23)
7.
After the sending is completed, the word done appears in the Hyper Terminal window. (Circle in Figure 1-24)
1-22
General Introduction
2. 3.
Click Transfer in the Menu of Hyper Terminal window: Click Send File to open the dialogue window in Figure 1-26.
4.
Click Browse to find File 6A_Language_V*.**. Bin and set Protocol to Xmodem.
5.
1-23
General Introduction 6. Wait until the sending is completed. The progress bar and data are displayed here. (circle in Figure 1-27)
7.
After the sending is completed, the word done appears in the Hyper Terminal window. (Dark red circle in Figure 1-28)
1-24
General Introduction
Figure 1-29 Hyper Terminal windows-8 2. Type the number Four (4) and press Enter to enter the load language progress. (Figure 1-30) 3. Type the id number (the id number of language which you want to install) and press enter. The information load language success means the software updating is completed. For example, when setting the UT4000A for English enter 2. (Circle in Figure 1-30)
General Introduction 4. 5. 6. Power off the monitor. Disconnect the Uport 1150 adapter from the monitor and PC. Repower the monitor and check the software version.
2. Attach the Mounting adapter that comes with the mounting solution.
For information on mounting the monitor on the roll stand or the wall mount, see Goldway Roll Stand Installation Guide and Goldway Wall Mount Installation Guide.
1-26
General Introduction To mount the patch board to UT6000A: 1. Screw up and mount the Adapter Plate on the bottom of monitor.
2. Attach the Mounting Adapter that comes with the mounting solution.
For information on mounting the monitor on the roll stand or the wall mount, see Goldway Roll Stand Installation Guide and Goldway Wall Mount Installation Guide.
1-27
Maintenance
Chapter 2 Maintenance
2-1
Maintenance
This chapter describes how to inspect and maintain the UT4000A/UT6000A Patient Monitors.
After
Installing or software updating
Complete
Visual inspection Power supply and battery test
Speaker Test Power Supply and Battery Test NIBP Test All safety tests
Replacing any internal parts (except the SpO2 and ECG module)
Power Supply and Battery Test NIBP Test Temperature Test Speaker Test All safety tests
Power Supply and Battery Test ECG test Speaker Test Respiration Test All safety tests
Power Supply and Battery Test Pulse SpO2 Test All safety tests
2-2
Maintenance
Table 2-2 Recommended Frequency Tests Preventive Maintenance NIBP Calibration Performance NIBP Accuracy Test Pulse SpO2 Test Once a year, or if you suspect the measurement is incorrect. Once a year, or more often if specified by local laws. Frequency
Safety (In accordance with IEC 60601-1) System Enclosure Leakage Current Ground Integrity Patient Leakage Current Once every two years, and after repairs where the unit has been opened (front and back separated) or the monitor has been damaged by impact.
Table 2-3 Required Test Equipment Performing Visual inspection Power Supply and Battery Test Speaker Test Pulse SpO2 Test ECG/Respiration Performance Test NIBP Test None None None Adult SpO2 sensor Patient simulator ECG trunk cable and lead set Reference manometer (includes hand pump and valve), accuracy 0.2% of reading Expansion chamber (volume 500 ml 10%) Piece of appropriate tubing None Patient simulator (with 0.1Cor 0.2F ) Electrical Safety Tester
2-3
You Need
Maintenance
Tests
Visual inspection Power Supply and Battery Test NIBP Test VI:P or V:F PB:P or PO:F
Recording
NT:P/X1/X2/X3 or NT:F/X1/X2/X3
Safety Tests
S(1):P/X1/X2 or S(1):F/X1/X2 S(2): P/X1 or S(2): F/X1 S(3): P/X1 or S(3): F/X1
Maintenance there is any apparent physical damage. If yes, do not use the monitor. Contact the authorized service personnel and report the damage until problems are settled before connecting the monitor to patients. 2. Inspect all cables, connecting wires and external connectors. Do not use for any show signs of damage. Contact authorized service personnel and reports the damage until problems are settled before connecting the monitor to patients. 3.
Check and make sure the safety marks on the equipment are legible.
Follow the following general precautions: Always dilute cleaning agents according to the instructions in this chapter or use the lowest possible concentration. Never let liquid enter the monitor case. Never immerse any part of the equipment in liquid or allow any liquid to enter electrical contacts. Never use abrasive material (such as steel wool or silver polish). Never use bleach, strong solvents, or acetone on any part of the monitor Never autoclave, steam sterilize, or ultrasonically clean the monitor or cables Never use alcohol on the patient cables. Alcohol can cause the plastic to become brittle and fail prematurely.
2-5
Maintenance
Caution
If you see any signs of deterioration or damage on any accessory, do not use it, and replace it with a new one. Use the equipment according to instructions accompanied with the sensors. The manufacturer information might be more current. If you spill liquid on the exterior of the monitor, use a clean cloth to dry the monitor. If you believe the liquid may be inside the monitor, power off the monitor and contact your service representative.
Do not use strong solvents for disinfection. Always dilute cleaning agents according to the manufacturers instructions or use the lowest possible concentration. Disinfect the equipment with a cloth moistened with these materials. 70% ethanol, 70% isopropyl alcohol Acetaldehyde: Cidex
Caution
When disinfecting any accessories, follow the manufacturers instructions; otherwise, use the disinfection agents listed in this chapter.
Maintenance
Warning
Use only the validated cleaning agents and disinfectants listed below. Using other agents may damage the sensor or its connecting wires, shorten product lifetime, or cause safety hazards. Select disinfectants carefully as some have very similar names but very different compositions. Never immerse the sensor connector in any of the cleaning solutions, disinfectants, or other liquids. The sensor and cable housing may be immersed, however. Never soak sensors in disinfectants longer than specified by the disinfectant manufacturer. Never sterilize or autoclave the sensors.
Validated Disinfectants Metricide 28 Cidex Formula 7 Kohrsolin (2%) Metricide Plus 30 Cidex OPA Mucapur-CD (1%) Terralin Liquid Cidex Plus Isopropanol (70%) or Isopropanol Wipes (70%) Incidin Liquid Omnicide 28 To clean and disinfect the sensor: 1. Clean the sensor according to the instructions supplied with the cleaning agent. 2. Disinfect the sensor according to the instructions supplied with the disinfectant. 3. Wipe the exterior surfaces lightly. Do not allow liquids to come in contact with the power connector or switches or to penetrate connectors or openings in the
2-7
Maintenance
monitor. 4. Dispose of any sensor showing signs of deterioration or damage. 2.4.5.2 Cleaning the NIBP Cuffs To clean the cuff: 1. Remove the bag from inside the cuff. 2. Clean the cuff in detergent (mild soap water) and air dry it. 3. Check the cuff and tube. To sterilize the cuff to avoid cross-infection: 4. Disinfect the cuff in an autoclave or immerse it into one of the following detergents: 70% isopropanol or 70% ethanol To put the rubber inflation bag back into the cuff: 1. Roll the bag from both ends in the direction of the tube. 2. Insert the rolled bag from the tube side into the opening on the short side of the cuff. 3. Push the tube through to the other side of the cuff. 4. Hold the tube together with the cuff and shake the whole cuff until it reaches the bag.
2.4.5.3 Cleaning the Temperature Accessories Clean the temperature sensor after each use. To clean the temperature sensor: 1. Hold the probe with one hand and clean the sensor from the top with a wet lint- free cloth dampened with isopropanol. 2. In addition, regularly disinfect the sensor with ethylene oxide. 3. Use a dry cloth to clean the surface of the temperature sensor. 4. Check the temperature sensor and do not use it if you see any signs of damage or deterioration.
Caution
Never heat the sensor to over 100 (212). Only heat it to 80 (176) - 100 (212) for a short time.
2-8
Maintenance
2.4.6 Cleaning the Recorder After extended use, deposits of paper debris may collect on the print head making recordings uneven and faint, shortening the life of the print head and the roll shaft.
To clean the print head: 1. Apply an anti-static agent to the recorder door, and open the door. 2. Remove the paper roll from the recorder. 3. Thread a cloth cleaning strip around the roller until the strip comes out of the top of the roller. 4. Pull the strip through the roller. 5. Clean the roller housing gently with a soft cloth. 6. Soak a cotton swab in alcohol and gently wipe the surface of the thermal printer head. 7. Reload the paper roller after the alcohol is dried and close the recorder door. Caution Always apply an anti-static agent to protect against ESD damage.
2-9
Maintenance
3.
Check if the power led is on and in either color of the following: Green: The monitor is powered on and in normal working status. Yellow: The monitor is connected to AC power but not turned on. It is under internal battery charging status.
4.
Press the On/Off key of the monitor to turn on the monitor and unplug the power cable. Inspect if the power LED is green and if a battery icon displaying in the status box on the screen, showing that the monitor is powered by batteries.
To test the ECG: 1. Connect one end of the ECG cable to the ECG connector of the monitor and the other end to the simulator. 2. 3. Confirm that the patient simulator has been properly connected to the monitor. Confirm and make sure the ECG lead II is displayed on the ECG channel, without noise and the heart rate displays 802bpm. When the R wave appears you should hear a beep. 4. Confirm every ECG lead and make sure there is an ECG waveform and no noise interference. 5. 6. 7. 8. Adjusting the ECG gain to 2mV, and confirm the change in the ECG waveform. Unplug the RA from the simulator, and confirm that a lead off message pops-up. Reconnect RA lead. Set the 1mV calibration in the ECG menu, and confirm that a 1mV calibration square wave is overlapped on the ECG waveform. 9. The ECG test is complete.
Maintenance 4. Confirm that the respiration rate displays 302rpm and the waveform channel displays the respiration waveform. 5. Change monitor respiration lead and confirm that the parameter and waveform remain the same. 6. Unplug the ECG cable and the respiration test is completed.
If the pressure reading is compared with a precise blood pressure meter, and the difference is more than 3mmHg, the monitor needs pressure calibration. Authorized
personnel can perform the required calibration. Before you start, see Required Equipment on Page 2-3. The following tests verify the performance of the non-invasive blood pressure measurement. NIBP accuracy NIBP overpressure valve NIBP calibration procedure (if required)
2-11
Maintenance
Testing the NIBP accuracy: 1. Connect the manometer and the pump with tubing to the NIBP connector on the UT4000A/UT6000A Patient monitor. (Figure 2-1 and Figure 2-2)
2. Connect the tubing to the expansion chamber (500ml cylinder). 3. Press on the front panel of the monitor to freeze the waveform of the screen. , and press the wheel to enter the
5. Rotate the wheel to NIBP and press to enter the menu. 6. Rotate the wheel to Work mode and set it to Test. 7. Squeeze the manometer pump with the air chamber to apply a pressure of 50mmHg.
2-12
Note the pressure displayed in the NIBP numeric pane and record this result as X1 (see Recording the Tests on Page 2-4). It should be 50mmHg 3mmHg. 9. Press the to stop the test.
10. Squeeze the manometer pump with the air chamber to apply a pressure of 50mmHg. 11. Press .
Note the pressure displayed in the NIBP Numeric Pane and record the result as X2. 250mmHg 3mmHg is a proper result. 12. Press the to stop the test.
If the difference between the manometer and displayed values is greater than 3mmHg, calculate the difference by the following formula, and then calibrate the monitor (See Performing NIBP Calibration on Page 2-14). Vadj = [(X1 50) + (X2 250)] / 2 If the difference between the manometer and displayed values is not greater than 3mmHg, go to the Testing the Overpressure.
Testing the Overpressure: 1. Press on the front panel of the monitor to freeze the waveform of the screen. , and press the wheel to enter the
3. Rotate the wheel to NIBP and press to enter the menu. 4. Rotate the wheel to Work mode and set it to Test. 5. Rotate the wheel to Patient Type and set it to Adult. 6. Squeeze the manometer pump with the air chamber to apply a pressure of 290mmHg. 7. Press and verify the valves are opened
8. Release the pressure on the manometer. 9. Rotate the wheel to Patient Type and set it to Neo. 10. Squeeze the manometer pump with the air chamber to apply a pressure of 150mmHg. 11. Verify the valves are opened 12. Release the pressure on the manometer.
2-13
Maintenance
3. Rotate the wheel to NIBP and press to enter the menu. 4. Rotate the wheel to Calibration and press. 5. Rotate the wheel to select one appropriate value most close to Vadj. 6. The NIBP Calibration is completed.
2-14
Maintenance
In order to establish a systematic maintenance plan, we recommend all safety tests and records shall be made under the following circumstances: Upon reception of the monitor, every year, and the monitor is opened for repair.
Use the following safety test procedures for verifying safe installation or service of the monitor. The setups used for these tests and the acceptable ranges of values are derived from local and international standards but may not be equivalent. These tests are not a substitute for local safety testing where it is required for an installation or a service event. If using the Metron Safety tester, perform the tests in accordance with your local regulations, for example in Europe use IEC60601-1/IEC60601-1-1. The Metron Report should print results with the names listed below, together with other data.
The monitor safety tests include: System Enclosure Leakage Ground integrity Patient leakage current with mains voltage
Figure 2-3 S(1) Part 1: System Enclosure Leakage Current - NC (normal condition)
2-15
Maintenance
Expected Test Results Normal condition maximum leakage current x1 100A. This measures leakage current of exposed metal parts of Instrument under Test (IUT) and between parts of the system within the patient environment; normal and reversed polarity using S2. Safety test according IEC 60601-1 / UL2601-1.
Figure 2-4 S(1) Part 2: System Enclosure Leakage current - Single Fault (open earth)
Expected Test Results Single Fault maximum leakage current x2 500A (IEC 60601-1) 300A (UL2601-1). This measures leakage current of exposed metal parts of Instrument under Test (IUT) with Protective Earth (PE) open circuit (S4 = open) and between parts of the system within the patient environment; normal and reversed polarity using S2.
2-16
Maintenance
Expected Test Results With mains cable, maximum impedance x = 100 mOhms (IEC 60601-1 and UL2601-1). This measures impedance of Protective Earth (PE) terminal to all exposed metal parts of Instrument under Test (IUT), which are for safety reasons connected to the Protective Earth (PE). Test current 25 Amp applied for 5 to 10 seconds.
Figure 2-6 S(3) Patient Leakage current - Single Fault Condition (S.F.C.) mains on applied part
Expected Test Results Maximum leakage current, x = 50A @ 250V (IEC60601-1 and UL2601-1). Measures patient leakage current from applied Part to earth caused by external main voltage on applied Part with switch S5 open and closed. Each polarity combination possible is tested using S2 and S6. This test is applicable for every measurement input.
2-17
Troubleshooting
Chapter 3 Troubleshooting
3-1
Troubleshooting
Possible cause
The cord is unplugged or broken. The fuse is blown. (UT6000A only) The AC power adapter has malfunctioned. (UT4000A only) The AC/DC power cable has malfunctioned.
Action
Ensure that the AC power cord is plugged into an outlet. Replace the fuse. See Removing Power Fuses on page 6-4. Replace the Adapter. See Removing the Power Adapter on page 5-3. Replace the battery connect Board or DC Connector. See Removing the Battery Connect Board/DC Connector on page 5-17. (UT4000A) See Removing the Battery Connect Board on page 6-18. (UT6000A) Check output voltage on AC/DC Power Module. If you do not capture 15 V, replace the AC/DC power module. See Removing the AC/DC Power Module on page 6-17.(UT6000A) Replace the front case assembly. See Removing the Front case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Charge the battery or replace it, see Removing the Battery on page 5-4 (UT4000A) or 6-3 (UT6000A). Reseat both the battery and battery cable. Replace the battery connect Board or DC Connector. See Removing the Battery Connect Board/DC Connector on Page 5-17. (UT4000A) See Removing the Battery Connect Board on Page 6-18. (UT6000A) Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Follow the steps in the decision trees in the following power problem processing.
I can turn on the monitor with AC Power, but not battery power.
The battery or connector is loose. The battery does not have a connection to the Main board module.
The LCD, cables, battery, AC/DC Power Module or main PCB has malfunction
3-2
Troubleshooting
Prepare the following before troubleshooting: 1. 2. 3. 4. One good battery with enough charge (not fully charged) and a good fuse. Batterys voltage is above 11V Standard tools Verify that supply mains is OK (measure by an multi-meter)
3-3
Troubleshooting
Table 3-1 J160 Pin Definition Pin1 GND Pin2 GND Pin3 (Signal) Pin4 (Signal) Pin5 15V Pin6 15V
3-4
Troubleshooting
Possible Cause
There is a bad connection between the backlight LCD to others There is a bad inverter.
Action
Ensure that there is a proper connection between the cable, LCD, backlight and main board module. Replace the inverter. Removing the Inverter on page 5-10 (UT4000A) or 6-19 (UT6000A). Replace the front case assembly. See Removing the Front Case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Open the monitor and reseat the LCD signal cable. Replace the front case assembly. See Removing the Front Case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Ensure that all connectors to the Main board module are seated correctly. Replace the front case assembly. See Removing the Front Case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A).
The LCD cable is not connected correctly. The LCD has malfunction.
There is a bad connection to the Main board module. The monitor keypad or navigation wheel is broken.
3-5
Troubleshooting
Possible Cause
The tube or cuff is kinked. There is an air leak in the air tube or cuff. The NIBP module has malfunctioned.
Action
Straighten the tube or cuff. Replace the cuff and ensure that there is no air leakage in the tube. Replace the NIBP module. See Removing the NIBP Module on page 5-15 (UT4000A) or 6-16 (UT6000A). Ensure that all external blood pressure reading requirements are met and that the patient is not moving excessively. Use proper cuff size, ensure proper cuff placement. Ensure that the tube is straight and not kinked. Replace the cuff and ensure that there is no air leakage in tube. Replace the NIBP module. See Removing the NIBP Module on page 5-15 (UT4000A) or 6-16 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Use proper cuff size, ensure proper cuff placement. Ensure that all external blood pressure reading requirements are met and that the patient is not moving excessively.
Wrong cuff size or incorrect cuff placement. The tube is kinked or there is air leakage in the air tube or cuff.
Wrong cuff size or incorrect cuff placement. There have been some external problems.
3-6
Troubleshooting
Possible Cause
There is a bad connection to the speaker. The speaker has malfunction.
Action
Ensure that the connection to speaker is correct. Replace the speaker. See Removing the Speaker Assembly on page 5-13 (UT4000A) or 6-12 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A).
Possible Cause
The SpO2 sensor has malfunctioned. The SpO2 module has malfunctioned.
Action
Replace the SpO2 sensor. Replace the SpO2 board. See Removing the SpO2 module on page 5-6 (UT4000A) or 6-20 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Ensure that all external SpO2 reading requirements are met and that the patient is not moving excessively.
3-7
Troubleshooting
Possible Cause
The ECG leads are off. The ECG cable is broken. The ECG 3/5 lead set is not configured correctly. The main board module has malfunctioned.
Action
Ensure that the leads are connected. Ensure that the cable is in good working order. Correct the ECG configuration. Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Replace the ECG module. See Removing the ECG Module on page 5-7 (UT4000A) or 6-15 (UT6000A). Ensure that the ECG leads are connected. Ensure that all external ECG reading requirements are met and that the patient is not moving excessively. Ensure proper skin preparation has been performed.
The ECG leads are off. There has been some external problem.
3-8
Troubleshooting
Possible Cause
The probe lead is off. The temperature is over range. The probe has malfunctioned. The main board has malfunction.
Action
Ensure that the temperature probe is connected. Ensure that temperature readings are in the range of 0oC-50oC. Replace the temperature probe. Replace the main board. See Removing the Main board Assembly on page 6-21 (UT6000A). Replace the temperature probe. Replace the main board. See Removing the Main board Assembly on page 6-21 (UT6000A).
Possible Cause
The paper is not installed correctly. The recorder is using improper paper. The recorder has a mechanical problem. The paper is out and/or the recorder door is open. The system does not recognize the recorder.
Action
Remove paper and reinstall correctly. Use only the recommend recorder paper. Replace the recorder. See Removing the Recorder on page 6-5 (UT6000A). Install a new paper supply. Open the recorder door, and then close it again. Check the recorders physical connections. See Removing the Recorder on page 6-5 (UT6000A). Replace the recorder module. See Removing the Recorder on page 6-5 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 6-21 (UT6000A).
3-9
Troubleshooting
3-10
Theory of Operation
4-1
Theory of Operation This chapter overviews the operation theory of several major functional components of the UT4000A/UT6000A Patient Monitors.
Speaker assembly
NIBP Module SPO2 Module AC/DC power module AC power assembly AC socket Supply mains
Recorder
Main Board assembly Speaker Driver Charge control Inverter control Keys control Power supply to other modules Signals interface Temperature
Display assembly
Inverter
Battery LED
4-2
Theory of Operation
Monitoring patient ECG, heart rate and respiration rate (UT6000A only) Non-invasive blood pressure Blood oxygen saturation Temperature (UT6000A only)
In addition to monitoring and displaying the status of physiological parameters, the monitor performs various microprocessor-programmed analytical functions, including:
Providing both visual and audible alarm signals as necessary. Providing warning messages when harmful conditions are detected that would degrade or prevent valid measurements. Providing trend waveforms or tabular data. Recording current waveforms or tabular data. (UT6000A only).
UT4000A/UT6000A Patient Monitors operate from either an AC power source or on battery power. The monitor charges the internal battery when powered by supply mains.
Front case assembly Main Board assembly I/O Module assembly Display assembly
In addition, the UT6000A Patient Monitor contains an optional recorder module. The following sections briefly describe the functional units in block diagrams.
4-3
Theory of Operation
Microprocessor Flash memory Power management control - Voltage regulator - Battery charger that monitor status of battery LCD drivers Power distribution and monitoring Speaker driver Connectors - DC input (wire to AC/DC module) - LCD - LCD backlight - Alarm LED - SpO2 - Temp (Temperature)
LAN connector and isolation transformer RS422 Port (SW updates only) Speaker ECG connector NIBP connector Recorder
4.2.6 Speaker
The speaker is driven by an amplifier connected to the microprocessor. The speaker provides an audio for alarm conditions and HP/RP sounds. The microprocessor generates different audio tones for different alarm priorities and conditions.
4-4
Theory of Operation
The power management circuitry charges a lead-acid battery through a battery charger. The battery can power the system through several DC/DC converters that provide various voltage outputs required by various chips. And the isolated transformers (external power adapter of the UT4000A patient monitor and the AC/DC power module of the UT6000A patient monitor) provide the power to the monitor. Note The UT6000A patient monitor has a built-in AC/DC power module and the UT4000A an external power adapter. The UT6000A patient monitor can directly connect to the supply mains. However for the UT4000A monitor, a power adapter is needed connection..
Main components: - Digital thermal head array assembly Printing width (48mm on 58mm paper) Motor (paper drive) and driver circuitry Dectector for running out of paper or opened recorder door Selectable print speed (12.5mm/s, 25 mm/s)
Print head control is implemented on the Main Board. The microprocessor sends data to the recorder via a local BUS.
4-5
Theory of Operation
Pressure data is converted to digital format and conveyed to the processor. The NIBP pump uses an oscillometric method that drives stepwise pressure deflation. Pump software eliminates most ambient noise and motion interference. It can be applied to neonatal, pediatric and adult patients. The blood pressure range for Systolic is 30-254 mmHg and Diastolic 10-220 mmHg. Accuracy is Maximum Mean Error 5 mmHg, with Maximum Standard Deviation no greater than 8 mmHg. NIBP processing uses an oscillometric technique to provide needed measurements at selected intervals. This technique uses an inflatable sphygmomanometer cuff similar to those used by clinicians in routine measurements. A motorized pump inflates the cuff to approximately 170 mmHg (adult mode) initially, at which point the pressure effectively stops the flow of blood. Then, under monitor control, the pressure in the cuff is gradually reduced, while a pressure transducer detects the pressure and transmits the parameter signal to the NIBP input circuitry. As the pressure is reduced, blood flows in the previously occluded artery, and changes the measurements made by the transducer. The point at which oscillation increases sharply is defined as systolic pressure. As the cuff continues to deflate, the oscillation amplitude increases to a maximum, and then decreases. The peak oscillation amplitude is defined as the mean arterial pressure. The point at which the system detects a rapid decrease in oscillation is defined as the diastolic pressure.
4-6
Theory of Operation diodes (LEDs). A photo diode provides detection. To identify the oxygen saturation of arterial hemoglobin, the patient monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vacuolar bed, and both blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The measurement is based on the differences between maximum and the minimum absorption. In addition to the oximetry function, the measurement can also provide the heart rate.
Display the ECG data Compute the heart rate Detect a lead-off condition if one of the electrode connections is disrupted Detect the presence of pacemaker signals within the QRS complex of the ECG waveform
5-1
UT4000A System Disassembly This chapter describes the procedures for disassembling and assembling the UT4000A monitor in order to replace or repair defective assemblies/components. Warning After any monitor repair, you must perform the recommended Performance and Safety tests before putting the monitor into operation. Failure to perform those tests might result in incorrect monitor readings. For more information on performing Performance and Safety tests, see Chapter 2 Maintenance.
One Phillips-head screw driver 5mm (at least 100mm long) One Phillips-head screw driver 3mm One flat-head screw driver 5mm One wire cutter One long flat nose plier One hexagon nut driver 5.5mm One Uport 1150 transducer (purchased from Goldway) ESD mat and wrist strap
5.2 Disassembly
You can disassemble the monitor down to all major component parts, including:
Warning Before attempting to open or disassemble the monitor, disconnect the power supply from
the monitor and remove the battery. High voltage is made by the LCD backlight driver.
Caution Observe ESD (electrostatic discharge) precautions when working inside the unit.
5-2
p/n 83801041000
5-3
2. With one thumb pushing the battery and the other rotating the battery holder as shown, the battery will pop out automatically.
5-4
Back top 4. Separate the front and rear case by pulling the upper and lower edge of the front case.
5-5
p/n 83801002000
5-6
4. Remove the ECG module gently. p/n 83801005000 Description ECG Module
5-7
p/n 83801050000
5-8
p/n 83801044000
5-9
p/n 83801027000
5-10
p/n 83801046000
5-11
5-12
p/n 83801054000
5-13
p/n 83801052000
5-14
p/n 83801006000
5-15
4. Remove the I/O module assembly 4A (or I/O module assembly 4A (with RJ45)).
5-16
4. Cut the tie wraps.(Circles) 5. Remove the plastic nut from connector with long flat nose plier.
p/n
83801042000
Description
Battery connect Board/DC Connector 4A
5-17
6-1
UT6000A System Disassembly This chapter describes the procedures for disassembling and assembling the UT6000A monitor in order to replace or repair defective assemblies/components. Warning After any monitor repair, you must perform the recommended Performance and Safety tests before putting the monitor into operation. Failure to perform those tests might result in incorrect monitor readings. For more information on performing Performance and Safety tests, see Chapter 2 Maintenance.
One Phillips-head screw driver 5mm (at least 100mm long) One Phillips-head screw driver 3mm One flat-head screw driver 5mm One wire cutter One long flat nose plier One hexagon nut driver 5.5mm One Uport 1150 transducer (purchased from Goldway) ESD mat and wrist strap
6.2 Disassembly
You can disassemble the monitor down to all major component parts, including:
Warning Before attempting to open or disassemble the monitor, disconnect the power supply from
the monitor and remove the battery. High voltage is made by the LCD backlight driver.
Caution Observe ESD (electrostatic discharge) precautions when working inside the unit.
6-2
2. With one thumb pushing the battery and the other rotating the battery holder as shown, the battery will pop out automatically.
6-3
6-4
3. Pull the recorder straight out of the monitor and disconnect the connector.
4. Removed recorder.
p/n 83801015000
Description Recorder
6-5
Underside
5. Separate the front and rear case by pulling the upper and lower edge of the front case. Carefully move the alarm LED cover and keep it be with the front case. Carefully move the connectors panel
6-6
p/n 83801053000
6-7
p/n 83801045000
6-9
6-10
6-11
p/n 83801054000
6-12
6-13
p/n 83801040000
6-14
6-15
4. Remove screws. (Circles) 5. Remove the NIBP module. p/n 83801006000 Description NIBP Module
6-16
5. Remove the AC/DC Power Module. p/n 83801008000 Description AC/DC Power Module
6-17
p/n 83801043000
6-18
p/n 83801027000
6-19
3. Remove the SpO2 module. 4. Disconnect the connector board (Rectangle) and connect it back to the main board.
p/n 83801002000
6-20
p/n 83801051000
6-21
p/n 83801047000
6-22
Electromagnetic Compatibility
A-1
Electromagnetic Compatibility
Caution
Provide ESD training to all users. Users should understand what electrostatic discharge is, how damage can occur, and how to prevent ESD.
A-2
Electromagnetic Compatibility
A.2.1
Emission test
RF emissions CISPR 11
Compliance
Group 1
Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3
Class A
The UT4000A/UT6000A Patient Monitors are suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Class A
Complies
A.2.2
Immunity test
Electrostatic discharge (ESD) IEC 61000-4-2
Compliance level
6 kV contact 8 kV air
A-3
Electromagnetic Compatibility Table A-2 Electromagnetic immunity for all Equipment and Systems(Continuous)
Immunity test
Electrical fast transient/burst IEC 61000-4-4
Compliance level
1kV for power supply 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 sec 3A/m
Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the UT4000A/UT6000A Patient Monitors requires continued operation during power mains interruptions. It is recommended that the UT4000A/UT6000A Patient Monitors be powered from an uninterruptible power supply or a battery.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5% UT1 (>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 sec
3A/m
Power frequency magnetic fields Should be at levels characteristic of a typical location in a typical commercial or hospital environment.
A-4
Electromagnetic Compatibility
A.2.3
Immunity test
3 Vrms
3.5 d = P V1 3.5 d = P E1 7 d = P E1
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
3 V/m
a.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the UT4000A/UT6000A A-5
Electromagnetic Compatibility Patient Monitors are used exceeds the applicable RF compliance level above, the UT4000A/UT6000A Patient Monitors should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the UT4000A/UT6000A Patient Monitors. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
A.2.4
3.5 d = P V1
3.5 d = P E1
7 d = P E1
0.23 0.74 2.33 7.38 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
A-6
Electromagnetic Compatibility The following interference test results do not affect patient diagnoses. Table A-5 Interference phenomena
A-7
13304005000
13304005000
1.0
1.0