WelchAllyn Vital Signs Monitor Series 6000 Directions for use Software Version 2.0X - 2.2X

© 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

721953 (printed copy) DIR 80019042 Ver. A

This manual applies to

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA www.welchallyn.com

901060 Vital Signs Monitor.

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan, County Meath Republic of Ireland

iii

Contents Introduction ... 1

Indications for use ... 1 Contraindications ... 2

Symbols ... 3 Screen elements ... 7 About warnings and cautions ... 13

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

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

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

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Contents

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

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

1

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. 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

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

2 Introduction

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

3

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

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 symbols 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

Battery charge level

(on the monitor, amber indicator) Alternating Current power present, battery is charging

Battery cover

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Symbols

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)

Nurse call

Connected to central station

Disconnected from central station

Miscellaneous symbols CO2 sampling input

CO2 sampling output/exhaust

Manufacturer

Limited rotation/Turn completely to right

Reorder number

Serial number

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

Recycle the product separate from other disposables

Restrictions for use of wireless device in Europe. European Community's Class 2 radio equipment.

Call for maintenance

Defibrillation-proof Type BF applied parts

Do not expose to open flame

Directions for use

Symbols

Altitude range

Not for injection

Transport and storage temperature range

Authorized Representative of the European Community

5

7

Screen elements Global navigation, controls, and indicators Select option

Process indicator for 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)

Disconnect from the central station but continue monitoring and retain patient data (Monitor tab)

Connected to the central station (Device Status area)

Disconnected from the central station (Device Status area)

Temporarily pause continuous monitoring but retain patient data

End continuous monitoring session for current patient and clear patient data

8

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Screen elements

NIBP NIBP start

NIBP stop

Intervals status indicators

NIBP view toggle

Temperature site control

Direct mode selector

Temperature

SpO2 and Pulse rate Pulse amplitude bar

SatSeconds timer (Nellcor feature only)

SpO2 view toggle

Response mode selector (Fast mode selected)

Pulse rate (in beats per minute)

Total hemoglobin (SpHb) SpHb view toggle

Averaging mode selector (Long mode selected)

CO2 pump start

CO2 pump stop

Capnography (CO2)

Directions for use

Screen elements

Capnography (CO2) etCO2 view toggle

IPI view toggle

IPI graphic indicators

RRa Respiration indicator

Averaging mode selector (Fast mode selected)

Bed mode

Bed exit

Patient turn indicator and timer

Bed exit (Review tab)

Patient movement

Patient turn indicator (Review tab)

Exit sensitivity indicator

Manual parameters Manual parameter selector

9

10

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Screen elements

Alarm and information messages Alarm limit control

Alarm On/Off toggle

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)

Symbols key

Send patient data

Print patient data/patient trend data

Cancel action

Add patient identifiers

Retrieve patient list from the network

Select patient from List tab

Delete patient from List tab

Clear patient context from Summary tab

Forward or backward in Review tab

Proceed to the next field to input patient information

Directions for use

Screen elements

11

Settings Save configuration settings

Select state or view

Save to USB flash drive

Configure from USB flash drive

Restore factory default settings

Close Advanced settings

12

Screen elements

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

13

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.

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.

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

About warnings and cautions

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. 2. 3. 4.

Power down the monitor. Disconnect the power plug. Remove battery pack from the monitor. 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. 2. 3. 4. 5.

Power down the monitor. Disconnect the power plug. Remove battery pack from the monitor. Remove and discard the paper roll. 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.