Welch Allyn 6000 User Manual

Welch Allyn Connex Monitor 6000 Series™
®
Vital Signs
Directions for use
© 2014 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.
Welch Allyn, Connex, SureTemp, FlexiPort, and SureBP are registered trademarks of Welch Allyn.
Vital Signs Monitor 6000 Series and PartnerConnect are trademarks of Welch Allyn.
Integrated Pulmonary Index is a trademark of , and Oridion and Microstream are registered trademarks of, Oridion Medical 1987 Ltd. No implied license. Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized CO2 sampling products which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device and/or CO2 sampling products.
Radical-7R, Pulse CO-Oximeter, rainbow Acoustic Monitoring, RRa, and ReSposable are trademarks of, and SET, LNCS, SpHb, rainbow, and Masimo are registered trademarks of, Masimo Corporation. Possession or purchase of a Masimo­equipped device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device.
Nellcor and OxiMax are registered trademarks of Nellcor Puritan Bennett Inc.
Braun and ThermoScan are registered trademarks of Braun GmbH.
Health o meter is a registered trademark of Sunbeam Products, Inc., used under license.
EarlySense is a registered trademark of EarlySense Ltd.
Software in this product is Copyright 2014 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact Welch Allyn Technical Support: www.welchallyn.com/about/
company/locations.htm.
105853 (CD)
DIR 80019042 Ver. A
Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA
www.welchallyn.com
721953 (printed copy)
DIR 80019042 Ver. A
This manual applies to 901060 Vital Signs Monitor.
Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan, County Meath Republic of Ireland

Contents

Introduction ............................................................................................. 1
Symbols ................................................................................................... 3
Screen elements ...................................................................................... 7
About warnings and cautions .............................................................. 13
iii
Indications for use ................................................................................................ 1
Contraindications ................................................................................................. 2
General warnings and cautions .......................................................................... 13
Physical design ...................................................................................... 19
Controls, indicators, and connectors .................................................................. 20
Setup ...................................................................................................... 23
Supplies and accessories ................................................................................... 23
Insert the battery ............................................................................................... 23
Mount the monitor ............................................................................................. 24
Attach the probe well ......................................................................................... 25
Attach the temperature probe ........................................................................... 26
Remove the temperature probe and well .......................................................... 26
Connect the NIBP hose ..................................................................................... 27
Disconnect the NIBP hose ................................................................................. 27
Connect the SpO2 cable or the SpO2/RRa dual cable ....................................... 27
Disconnect the SpO2 cable or the SpO2/RRa dual cable .................................. 29
Connect the patient movement cable ................................................................ 29
Disconnect the patient movement sensor and cable ........................................ 30
Attach a USB accessory ..................................................................................... 30
Detach a USB accessory .................................................................................... 31
Insert a new roll of paper ................................................................................... 31
Connect AC power ............................................................................................. 32
Disconnect AC power ........................................................................................ 32
Startup .................................................................................................... 33
Power ................................................................................................................. 33
Power up the monitor ........................................................................................ 34
Power down the monitor ................................................................................... 35
Reset the monitor .............................................................................................. 37
Set the date and time ........................................................................................ 37
Enter clinician information .................................................................................. 37
Set the default configuration .............................................................................. 38
Contents Welch Allyn Connex® Vital Signs Monitor 6000 Series™
iv
Navigation .............................................................................................. 39
Home tab ........................................................................................................... 39
Device Status area ............................................................................................. 39
Content area ...................................................................................................... 42
Navigation area .................................................................................................. 43
Using the keypad, keyboard, and barcode scanner ........................... 45
Open the numeric keypad .................................................................................. 45
Numeric keypad ................................................................................................. 45
Enter a number .................................................................................................. 46
Close the numeric keypad ................................................................................. 46
Open the keyboard ............................................................................................ 46
Keyboard ............................................................................................................ 46
Enter a letter or number ..................................................................................... 48
Enter a symbol or special character ................................................................... 48
Enter a diacritical mark ....................................................................................... 48
Close the keyboard ............................................................................................ 49
Use a barcode scanner ...................................................................................... 49
Connex CS ............................................................................................. 51
Overview ............................................................................................................ 51
Monitor tab ........................................................................................................ 52
Connect to the central station ........................................................................... 53
Disconnect from the central station .................................................................. 53
Continuous patient monitoring ........................................................................... 54
Activate the Continuous Monitoring profile ...................................................... 54
Pause continuous monitoring (Pause mode) ..................................................... 55
Resume continuous monitoring ........................................................................ 56
End continuous monitoring ............................................................................... 56
Assign a patient and location ............................................................................. 57
Profiles ................................................................................................... 59
Continuous Monitoring profile ........................................................................... 59
Continuous Monitoring profile ........................................................................... 61
Saving vital sign measurements (Continuous Monitoring profile) ...................... 63
Intervals Monitoring profile ................................................................................ 63
Spot Check profile .............................................................................................. 65
Triage profile ...................................................................................................... 65
Profile feature comparison ................................................................................. 66
Profile feature comparison ................................................................................. 67
Changing profiles ............................................................................................... 67
Patient data management .................................................................... 73
Add a patient to the patient list .......................................................................... 73
Load patient data with a barcode scanner ......................................................... 74
Select a patient .................................................................................................. 74
Manage patient records (Continuous Monitoring profile) .................................. 76
Manage patient records (Intervals Monitoring, Spot Check, and Triage
profiles) .............................................................................................................. 78
Printer ................................................................................................................ 79
Delete a patient from the list ............................................................................. 81
Directions for use Contents v
Alarms .................................................................................................... 83
Patient rest mode .............................................................................................. 85
Reset (pause or turn off) audio alarms ............................................................... 86
Cancel a paused alarm ....................................................................................... 88
Adjust vital sign alarm limits .............................................................................. 88
Modify audio alarm notification .......................................................................... 89
Alarm messages and priorities ........................................................................... 90
Nurse call ........................................................................................................... 97
Patient monitoring ................................................................................ 99
Standard and custom modifiers ......................................................................... 99
Custom scoring ................................................................................................ 100
Manual overrides ............................................................................................. 100
Patient movement ........................................................................................... 100
Capnography (CO2) .......................................................................................... 106
Respiration rate ................................................................................................ 111
IPI ..................................................................................................................... 113
Acoustic respiration rate (RRa) ......................................................................... 116
NIBP ................................................................................................................. 120
Temperature .................................................................................................... 131
SpO2 ................................................................................................................ 142
SpHb ................................................................................................................ 148
Pulse rate frame ............................................................................................... 152
Manual parameters frame ................................................................................ 154
Maintenance and service .................................................................... 157
Perform periodic checks .................................................................................. 157
Replace the printer paper ................................................................................. 157
Change the battery .......................................................................................... 158
Clean the monitor ............................................................................................ 160
Clean the accessories ...................................................................................... 161
Clean the stand ................................................................................................ 161
Advanced settings ............................................................................... 163
General ............................................................................................................. 163
Parameters ....................................................................................................... 168
Data management ........................................................................................... 173
Network ........................................................................................................... 176
Service ............................................................................................................. 179
Troubleshooting .................................................................................. 181
Patient movement messages .......................................................................... 181
CO2 messages ................................................................................................ 183
RRa messages ................................................................................................. 184
NIBP messages ............................................................................................... 185
SpO2 and SpHb messages .............................................................................. 186
Temperature messages ................................................................................... 187
Weight scale messages ................................................................................... 188
Patient data management messages .............................................................. 188
Communications module messages ................................................................ 189
Radio messages ............................................................................................... 189
Ethernet messages .......................................................................................... 189
USB and USB flash drive messages ................................................................ 190
Contents Welch Allyn Connex® Vital Signs Monitor 6000 Series™
vi
System messages ........................................................................................... 190
Battery power manager messages .................................................................. 191
Configuration Manager messages ................................................................... 191
Printer messages ............................................................................................. 191
Network messages .......................................................................................... 192
Problems and solutions .................................................................................... 192
Specifications ...................................................................................... 195
Physical specifications ..................................................................................... 195
Physical specifications ..................................................................................... 205
Environmental specifications ........................................................................... 217
Monitor radio .................................................................................................... 217
Configuration options ....................................................................................... 219
Standards and compliance ................................................................. 221
General compliance and standards .................................................................. 221
General radio compliance ................................................................................. 222
Guidance and manufacturer's declaration ........................................ 225
EMC compliance .............................................................................................. 225
Emissions and immunity information ............................................................... 225
Appendix .............................................................................................. 227
Approved accessories ...................................................................................... 227
Warranty .......................................................................................................... 238

Introduction

This directions for use describes the capabilities and operation of the monitor. The information, including the illustrations, covers all configuration options. If your monitor configuration lacks any of these options, some information in this manual might not apply.
Before using the monitor, you must familiarize yourself with all warnings and cautions, with the steps to power up the monitor, and with the sections of this directions for use that pertain to your use of the monitor. You must also familiarize yourself with all information that accompanies the accessories you use.
1
Note Some product features described in this publication might not be available
in your country. For the latest information about products and features, please call Welch Allyn Customer Care.

Indications for use

The Connex VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for
noninvasive blood pressure (NIBP)
pulse rate (PR)
noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2)
body temperature in normal and axillary modes
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments. Monitoring can be accomplished on the VSM 6000 series bedside monitor itself, and the VSM 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.g., at a central station). Secondary remote viewing and alarming features are intended to supplement and not replace any patient bedside monitoring procedures.
The optional Masimo rainbow® SET Pulse CO-Oximeter™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate (PR), total hemoglobin concentration (SpHb®), and/or respiration rate (RRa™). The Masimo rainbow SET Radical-7R™ Pulse CO-Oximeter and
accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion®module and accessories are intended for the continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired
Introduction Welch Allyn Connex® Vital Signs Monitor 6000 Series™
2
and inspired breath (etCO2 and FiCO2) and respiration rate (RR). It is intended for use with neonatal, pediatric, and adult patients in hospitals and hospital-type facilities.
The optional Oridion module also provides the clinician with an Integrated Pulmonary Index™ (IPI). The IPI is based on four parameters provided by the monitor: end-tidal
carbon dioxide (etCO2), respiration rate (RR), oxygen saturation (SpO2), and pulse rate (PR). The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1–10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital signs monitoring.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.
The optional EarlySense® (Everon) System is intended for continuous measurement of respiration rate, heart rate, and movement in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents, and adults. The operation of the EarlySense has been studied in children (weight 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.
This product is available for sale only upon the order of a physician or licensed healthcare professional.

Contraindications

This system (all configurations) is not intended to be used:
on patients connected to heart/lung machines
on patients being transported outside a healthcare facility
within the controlled access area of MRI equipment
in a hyperbaric chamber
in the presence of flammable anesthetics
in the presence of electrocauterization devices
Systems configured with EarlySense are not intended to be used:
on patients for whom proper positioning cannot be achieved or maintained
on patients who do not meet the weight limits tested or specified

Symbols

Documentation symbols

WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death.
3

Power symbols

CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. This definition applies to both yellow and black and white symbols.
WARNING Hot surface. Do not touch.
Follow the operating instructions/directions for use (DFU) — mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 days.
Power on/Display power-saving Equipotential terminal
(on the display) monitor is plugged into Alternating Current power
Battery absent or faulty
(on the monitor, green indicator) Alternating Current power present, battery fully charged
(on the monitor, amber indicator) Alternating Current power present, battery is charging
Battery charge level
Battery cover
4
Symbols Welch Allyn Connex® Vital Signs Monitor 6000 Series™
Alternating Current (AC) Rechargeable battery

Connectivity symbols

USB Ethernet RJ-45
Wireless signal strength
Best (4 bars)
Good (3 bars)
Fair (2 bars)
Weak (1 bar)
No signal (no bars)
No connection (blank)
Connected to central station Disconnected from central station

Miscellaneous symbols

CO2 sampling input CO2 sampling output/exhaust
Manufacturer Limited rotation/Turn completely to
Reorder number Serial number
Nurse call
right
Do not reuse China RoHS markings for control of
pollution caused by electronic information products. XX indicates Environmentally Friendly Use Period in years.
Nonionizing electromagnetic radiation
Restrictions for use of wireless device in Europe. European Community's Class 2 radio equipment.
Defibrillation-proof Type BF applied parts
Recycle the product separate from other disposables
Call for maintenance
Do not expose to open flame
Directions for use Symbols 5
Altitude range Not for injection
Transport and storage temperature range
Authorized Representative of the European Community
6
Symbols Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Screen elements

Global navigation, controls, and indicators
Select option Process indicator for
7
activities like acquiring measurements and connecting to a central station
Select item from list Display lock/unlock
Increase or decrease value
Monitoring and connectivity
Connect to the central station and retain patient data (Monitor tab)
Connected to the central station (Device Status area)
Temporarily pause continuous monitoring but retain patient data
Disconnect from the central station but continue monitoring and retain patient data (Monitor tab)
Disconnected from the central station (Device Status area)
End continuous monitoring session for current patient and clear patient data
8
Screen elements Welch Allyn Connex® Vital Signs Monitor 6000 Series™
NIBP
NIBP start NIBP stop
Intervals status indicators NIBP view toggle
Temperature
Temperature site control Direct mode selector
SpO2 and Pulse rate
Pulse amplitude bar SatSeconds timer (Nellcor
SpO2 view toggle Response mode selector (Fast
Pulse rate (in beats per minute)
Total hemoglobin (SpHb)
SpHb view toggle Averaging mode selector
Capnography (CO2)
feature only)
mode selected)
(Long mode selected)
CO2 pump start CO2 pump stop
Directions for use Screen elements 9
Capnography (CO2)
etCO2 view toggle IPI view toggle
IPI graphic indicators
RRa
Respiration indicator Averaging mode selector
(Fast mode selected)
Patient movement
Manual parameters
Bed mode Bed exit
Patient turn indicator and timer
Patient turn indicator (Review tab)
Bed exit (Review tab)
Exit sensitivity indicator
Manual parameter selector
10
Screen elements Welch Allyn Connex® Vital Signs Monitor 6000 Series™
Alarm and information messages
Alarm limit control
Multiple alarms toggle Alarm audio paused
Alarm active Information message
Patient Rest Mode
Patient data management
Diacritical marks key (available for languages that use diacritical marks; appearance differs based on language)
Alarm On/Off toggle
Symbols key
Send patient data Print patient data/patient
trend data
Cancel action Add patient identifiers
Retrieve patient list from the network
Delete patient from List tab Clear patient context from
Forward or backward in Review tab
Select patient from List tab
Summary tab
Proceed to the next field to input patient information
Directions for use Screen elements 11
Settings
Save configuration settings
Save to USB flash drive
Restore factory default settings
Select state or view
Configure from USB flash drive
Close Advanced settings
12
Screen elements Welch Allyn Connex® Vital Signs Monitor 6000 Series™

About warnings and cautions

Warning and caution statements can appear on the monitor, on the packaging, on the shipping container, or in this document.
The monitor is safe for patients and clinicians when used in accordance with the instructions and the warning and caution statements presented in this manual.
Before using the monitor, you must familiarize yourself with all warnings and cautions, with the steps to power up the monitor, and with the sections of this directions for use that pertain to your use of the monitor. In addition to reviewing the general warnings and cautions presented in the next section, you must also review the more specific warnings and cautions appear throughout the manual in conjunction with setup/startup, device operation, patient monitoring, and maintenance tasks.
Failure to understand and observe any warning statement in this manual could lead to patient injury, illness, or death.
Failure to understand and observe any caution statement in this manual could lead to damage to the equipment or other property, or loss of patient data.
13

General warnings and cautions

WARNING Many environmental variables, including patient physiology and clinical application, can affect the accuracy and performance of the monitor. Therefore, you must verify all vital signs information before treating the patient. If there is any question about the accuracy of a measurement, verify the measurement using another clinically accepted method.
WARNING Alarm limits are patient-specific. For alarms to function properly, you must set or verify alarm limits appropriate for each patient. Each time the monitor is powered on, you must check that the alarm settings are appropriate for your patient before you start monitoring.
WARNING The monitor is not intended for use during patient transport outside of the medical facility. Do not use the monitor to take measurements on any patient in transit.
WARNING Do not use the monitor as an apnea monitor. Neither the VSM 6000 series monitors, nor any of the integrated or accessory sensor systems used in conjunction with the VSM 6000 series monitors, are intended for use in apnea monitoring.
14
About warnings and cautions Welch Allyn Connex® Vital Signs Monitor 6000 Series™
WARNING Use only Welch Allyn approved accessories, and use them according to the manufacturer’s directions for use. Using unapproved accessories with the monitor can affect patient and operator safety and can compromise product performance and accuracy.
WARNING Inaccurate measurement risk. Do not connect more than one patient to a monitor.
WARNING Inaccurate measurement risk. Dust and particle ingress can affect the accuracy of blood pressure measurements. Use the monitor in clean environments to ensure measurement accuracy. If you notice dust or lint build-up on the monitor's vent openings, have the monitor inspected and cleaned by a qualified service technician.
WARNING Inaccurate measurement risk. Liquids and excessive moisture can damage patient sensors and cause them to perform inaccurately or fail.
WARNING Patient harm risk. Always remove sensors from patients and disconnect them completely from monitors before bathing.
WARNING Liquids can damage electronics inside the monitor. Prevent liquids from spilling on the monitor. If liquids are spilled on the monitor:
1. Power down the monitor.
2. Disconnect the power plug.
3. Remove battery pack from the monitor.
4. Dry off excess liquid from the monitor.
Note If liquids possibly entered the monitor, remove the monitor
from use until it has been properly dried, inspected, and tested by qualified service personnel.
5. Reinstall battery pack.
6. Power on the monitor and verify that the monitor functions normally before using it.
If liquids enter the printer housing:
1. Power down the monitor.
2. Disconnect the power plug.
3. Remove battery pack from the monitor.
4. Remove and discard the paper roll.
5. Clean and dry the inside of the printer housing.
Note The printer housing has a drain tube that directs liquids down
and out the bottom of the monitor. If liquids possibly entered other openings in the monitor, remove the monitor from use until it has been properly dried, inspected, and tested by qualified service personnel.
6. Install a new roll of paper.
7. Power on the monitor and verify that the monitor functions normally before using it.
Directions for use About warnings and cautions 15
WARNING Safety risk and potential shock hazard. Cords, cables, and accessories damaged from prior misuse can affect patient and operator safety. Inspect all cords, cables, and accessories for strain relief wear, fraying, or other damage according to the recommendations presented in the Maintenance and service section of this manual. Replace as necessary. Inspect the AC cord for exposed copper before touching the cord. Unplug the AC cord only by pulling on the plug, never the cord. Never lift the monitor by the power cord or patient connections.
WARNING Fire and explosion hazard. Do not operate the monitor in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched environments; or in any other potentially explosive environment.
WARNING Fire and shock hazard. Only connect LAN cables contained within the perimeter of a single building. Conductive LAN cables spanning multiple buildings may introduce fire or shock hazards unless they are fitted with fiber optic cables, lightning arrestors, or other applicable safety features.
WARNING The monitor may not function properly if dropped or damaged. Protect it from severe impact and shock. Do not use the monitor if you notice any signs of damage. Qualified service personnel must check any monitor that is dropped or damaged for proper operation before putting the monitor back into use.
WARNING Defective batteries can damage the monitor. If the battery shows any signs of damage or cracking, it must be replaced immediately and only with a battery approved by Welch Allyn.
WARNING Improper disposal of batteries may create an explosion or contamination hazard. Never dispose of batteries in refuse containers. Always recycle batteries according to local regulations.
WARNING Electric shock hazard. Do not open the monitor or attempt repairs. The monitor has no user-serviceable internal parts. Only perform routine cleaning and maintenance procedures specifically described in this manual. Inspection and servicing of internal parts shall only be performed by qualified service personnel.
WARNING Inaccurate measurement risk. Do not expose to temperatures higher than 122º F (50º C).
WARNING Inaccurate measurement risk. Do not use the monitor on patients who are on heart-lung machines.
WARNING Inaccurate measurement risk. If using patient sensors during full body irradiation, keep the sensor out of the irradiation field. If the sensor is exposed to the irradiation, the reading might be inaccurate or the monitor might read zero during the active irradiation period.
WARNING Inaccurate measurement risk. Do not use the monitor on patients who are experiencing convulsions or tremors.
WARNING Use the monitor only as described in this directions for use. Do not use the monitor on patients as described in the Contraindications.
16
About warnings and cautions Welch Allyn Connex® Vital Signs Monitor 6000 Series™
WARNING Personal/patient injury risk. Wall-mounted equipment and accessories must be installed in accordance with accompanying instructions. Improper installation can result in the monitor falling off the wall and injuring someone. Welch Allyn is not responsible for the integrity of any installation not performed by authorized Welch Allyn service personnel. Contact an authorized Welch Allyn service representative or other qualified service personnel to ensure professional installation for safety and reliability of any mounting accessory.
WARNING Do not place the monitor in any position that might cause it to fall on the patient.
WARNING Welch Allyn is not responsible for the integrity of a facility's power. If the integrity of a facility's power or protective earth conductor is in doubt, always operate the monitor on battery power alone when it is attached to a patient.
WARNING Avoid continuously monitoring a patient when the device is operating on battery power. If only battery power is available, you must remain in the room with any patient whose vital signs are being monitored continuously. Actively monitor both patient and battery status to ensure patient safety.
WARNING Patient harm and equipment damage risk. Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. When transporting the monitor on a mobile stand, properly secure all patient cables and cords to keep them clear of the wheels and to minimize trip hazards.
WARNING For operator and patient safety, peripheral equipment and accessories that can come in direct patient contact must comply with all applicable safety, EMC, and regulatory requirements.
WARNING All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (for example, IEC 60950), as applicable to the monitor. Connecting additional devices to the monitor may increase chassis or patient leakage currents. To maintain operator and patient safety, consider the requirements of IEC 60601-1-1. Measure the leakage currents to confirm that no electric shock hazard exists.
WARNING Equipment failure and patient harm risk. Do not cover the air intake or exhaust vents on the rear and base of the monitor. Covering these vents could cause overheating of the monitor or muffling of alarms.
WARNING This equipment is not suitable for use in the presence of electro-surgery.
WARNING Cross-contamination or nosocomial infection risk. Clean and disinfect the monitor on a routine basis according to your facility's protocols and standards or local regulations. Thorough hand-washing before and after contact with patients greatly reduces the risk of cross-contamination and nosocomial infection.
WARNING For patient safety, do not use the monitor or any accessory during MRI scanning. Induced current could cause burns.
Directions for use About warnings and cautions 17
WARNING When the monitor is not conected to a secondary alarm system during continuous monitoring, check the monitor regularly to receive patient data, alarms, and alerts.
WARNING Patient safety risk. The EarlySense system is not intended for high-risk patients in coronary or respiratory distress who require continuous monitoring of heart function or CO2. For these patients, the most reliable method of patient monitoring involves close personal surveillance and/or equipment suited to that type of monitoring.
CAUTION United States Federal law restricts this monitor to sale, distribution, or use by or on the order of a physician or licensed healthcare professional.
CAUTION Electromagnetic interference risk. The monitor complies with applicable domestic and international standards for electromagnetic interference. These standards are intended to minimize medical equipment electromagnetic interference. Although this monitor is not expected to present problems to other compliant equipment or be affected by other compliant devices, interference issues still may occur. As a precaution, avoid using the monitor in close proximity to other equipment. In the event that equipment interference is observed, relocate the equipment as necessary or consult manufacturer's directions for use.
CAUTION Use only a Class I (grounded) AC power supply cord for powering this monitor.
CAUTION Do not use a long press of to power down the monitor
when it is functioning normally. You will lose patient data and configuration settings.
CAUTION Never move the monitor or mobile stand by pulling on any of the cords as this may cause the monitor to tip over or may damage the cord. Never pull on the power cord when removing it from the power outlet. When disconnecting the power cord, always grasp the attachment plug and not the cord. Keep the cord away from liquids, heat, and sharp edges. Replace the power cord if the strain relief or cord insulation is damaged or begins to separate from the attachment plug.
CAUTION Use only the Welch Allyn USB client cable to connect a laptop computer to the USB client port. Any laptop connected to the monitor must be running on a battery, a 60601-1-compliant power supply, or a 60601-1­compliant isolation transformer. While monitoring a patient, you can only charge the laptop battery if it is connected to 60601-1-compliant, isolated AC power.
CAUTION If the touchscreen is not responding properly, refer to the troubleshooting section. If the problem cannot be resolved, discontinue use of the monitor and contact an authorized Welch Allyn service center or qualified service personnel.
CAUTION Verify patient identity on the monitor after manual or barcode entry and before printing or transferring patient records.
CAUTION Keep the monitor outside of MRI suites and any areas marked for high magnetic or electric field strength.
18
About warnings and cautions Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Physical design

The monitor is available in two sizes: standard and extended. The primary difference between these models is the number of parameters they support.
Note Your monitor, based on size or configuration, might not contain all
parameters or features illustrated in this section.
In a standard monitor, up to two parameter modules are installed on the left side. You can tell which modules are installed based on the connectors visible on the outside of the device. The following image shows a standard monitor with pulse-oximetry and blood-pressure modules.
19
Standard monitor left side
20
Physical design Welch Allyn Connex® Vital Signs Monitor 6000 Series™
The extended version can have a maximum of three modules (such as CO2, pulse oximetry, and blood pressure) on the left side.
Extended monitor left side
Equipment setup and basic monitor functions are the same for both models, unless otherwise noted in the directions for use.

Controls, indicators, and connectors

The following diagrams show a full-featured monitor. Your monitor, based on size or configuration, might not contain all of these features.
No. Feature Description
1 Printer Printer provides a printout of patient and device information.
Directions for use Physical design 21
No. Feature Description
2 Light bar Provides a visual alarm with red and amber LEDs.
3 Thermometry Temperature probe cover box.
4 Thermometry Temperature probe.
5 Thermometry (connector behind cover) Secures the probe connection to the monitor.
6 LCD screen 1024 x 600 pixels color touchscreen provides a graphical user
interface.
7 Battery compartment (behind cover) Houses the lithium-ion battery.
8 Blood pressure Supports dual-lumen or single-lumen hoses.
9 Pulse oximetry
10 CO2 CO2 sampling exhaust port.
11 CO2 CO2 sampling input connector (behind cover).
Nellcor or Masimo rainbow SET module. The Nellcor module measures SpO2 and pulse rate. The Masimo module measures SpO2, pulse rate, SpHb, and RRa.
Note
Note
SpHb and RRa are optional parameters.
Monitors configured with RRa cannot be configured with CO2.
No. Feature Description
1 Power switch and LED Power-on/Display power-saving button.
The LED indicates the charging status when the monitor is connected to AC power:
22
Physical design Welch Allyn Connex® Vital Signs Monitor 6000 Series™
No. Feature Description
Green: The battery is charged.
Amber: The battery is charging.
2 Ethernet RJ-45 Provides a hardwired connection to the computer network.
3 USB client Provides a connection to an external computer for testing and
software upgrades.
4 Nurse call Provides a connection to the hospital nurse call system. (Not
available on the 6300 model.)
5 Fan exhaust
6 Ground lug (equipotential terminal) Provided for electrical safety testing and as a means for
connection of a potential-equalization conductor.
7 Power connection Provides an external AC power connection.
8 Mobile stand mounting hardware Secures the mounting plate to the monitor.
9 Recess for mounting plate Secures the monitor when the monitor is mounted on the mobile
stand or wall.
10 USB connector door Provides access to host USB connections for optional
accessories.
11 Fan intake
12 Speaker Provides tones. A piezo beeper inside the monitor provides
backup.

Setup

Supplies and accessories

For a list of all approved supplies and accessories, see Approved accessories in the Appendix.

Insert the battery

23
This procedure applies to first-time setup of the monitor.
WARNING Risk of fire, explosion, and burns. Do not short-circuit, crush, incinerate, or disassemble the battery pack.
1. Turn the monitor upside down to access the battery cover.
2. Locate the battery cover, indicated by
3. Insert a coin into the slot and push to open. Choose a coin that fits comfortably into the slot.
4. Slide in the battery.
.
24
Setup Welch Allyn Connex® Vital Signs Monitor 6000 Series™
Note Do not remove the tab label from the battery. This tab helps
you remove the battery from the compartment when you need to replace it.
5. Replace the battery cover by inserting one end into the notched access and then pressing firmly on the opposite end.
Note New batteries are only 30 percent charged. Therefore, connect the monitor
to AC power immediately after inserting a new battery.

Mount the monitor

You can install the monitor on a mobile stand or on an interior wall equipped with a Welch Allyn-approved wall-mount fixture.

Check the mounting bracket

Before you mount the monitor, make sure the stand or wall-mount fixture has the mounting bracket designed for your monitor. Monitors with a standard housing require a small bracket. Monitors with an extended housing require a large bracket.
Small bracket for standard housing Large bracket for extended housing
Note If your monitor has an extended housing but the small bracket is installed
on your stand or wall-mount fixture, you must replace the small bracket with the large bracket. Follow the steps presented in the Mounting Bracket Replacement Install Guide shipped with the large bracket, and then proceed to mount the monitor.
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