WelchAllyn Vital Signs Monitor Series 6000 Directions for use Software Version 1.0X - 1.7X Ver C

© 2013 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 is a trademark of Welch Allyn. LNCS, SpHb, ReSposable , and Rainbow are trademarks of, and SET, LNOP, and Masimo are registered trademarks of, Masimo Corporation. Possession or purchase of a Masimo SpO2- or Masimo SpHb-equipped 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. Software in this product is Copyright 2013 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, reverseengineered, 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 information about any Welch Allyn product, call Welch Allyn Technical Support: USA +1 800 535 6663 +1 315 685 4560 Canada +1 800 561 8797 European Call Center +353 46 90 67790 Germany +49 695 098 5132 Japan +81 42 703 6084 Malaysia +603 7875 3341 Singapore +65 6419 8100 Spain +34 917 499 357 United Kingdom +44 207 365 6780

103730 (CD) DIR 80016590 Ver. C

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

Australia +61 2 9638 3000 China +86 21 6327 9631 France +33 155 69 58 49 Italy +39 026 968 2425 Latin America +1 305 669 9003 Netherlands +31 202 061 360 South Africa +27 11 777 7555 Sweden +46 85 853 6551

103501 (printed copy) Material Number 720276, 80016590 Ver. C

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

iii

Contents Introduction ... 1

Intended use ... 1 Contraindications ... 1

Symbols ... 3 Screen elements ... 5 About warnings and cautions ... 9

General warnings and cautions ... 9

Controls, indicators, and connectors ... 15 Setup ... 19

Supplies and accessories ... 19 Insert the battery ... 19 Mount the monitor on a stand ... 20 Mount the monitor on the wall ... 20 Attach the probe well ... 20 Attach the temperature probe ... 21 Remove the temperature probe and well ... 22 Connect the NIBP hose ... 22 Disconnect the NIBP hose ... 23 Connect the SpO2 cable ... 23 Disconnect the SpO2 cable ... 24 Attach an accessory ... 24 Detach an accessory ... 25 Insert a new roll of paper ... 25 Connect AC power ... 26 Disconnect AC power ... 26

Startup ... 27

Power ... 27 Power up the monitor ... 28 Power down the monitor ... 29 Reset the monitor ... 29 Set the date and time ... 29 Enter clinician information ... 30 Set the default configuration ... 30

Navigation ... 31 Home tab ... 31

iv Contents

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Device Status area ... 31 Content area ... 33 Navigation area ... 34

Profiles ... 37

Select a profile ... 40

Using the keypad, keyboard, and barcode scanner ... 41 Open the numeric keypad ... 41 Numeric keypad ... 41 Enter a number ... 42 Close the numeric keypad ... 42 Open the keyboard ... 42 Keyboard ... 42 Enter a letter or number ... 44 Enter a symbol or special character ... 44 Enter a diacritical mark ... 44 Close the keyboard ... 45 Use a barcode scanner ... 45

Patient data management ... 47

Add a patient to the patient list ... 47 Load patient data with the barcode scanner ... 47 Select a patient ... 48 Manage patient records ... 48 Print patient data ... 49 Printer ... 49 Delete a patient from the list ... 50 Modifiers ... 50 Set modifiers ... 50

Alarms ... 53 Reset (pause or turn off) audio alarms ... 56 Adjust vital sign alarm limits ... 57 Modify audio alarm notification ... 57 Alarm messages and priorities ... 58 Nurse call ... 61

Patient monitoring ... 63

NIBP ... 63 Temperature ... 72 SpO2 ... 84 SpHb ... 89 Pulse rate frame ... 92 Manual parameters frame ... 93

Maintenance and service ... 95

Perform periodic checks ... 95 Replace the printer paper ... 95 Change the battery ... 97 Clean the monitor ... 98 Clean the accessories ... 99

Directions for use

Contents

v

Clean the stand ... 99

Specifications ... 101 Physical specifications ... 101 Environmental specifications ... 105 Monitor radio ... 105 Configuration options ... 106 Patents ... 107

Standards and compliance ... 109

General compliance and standards ... 109 General radio compliance ... 110

Guidance and manufacturer's declaration ... 113 EMC compliance ... 113 Emissions and immunity information ... 113

Advanced settings ... 117

General ... 117 Parameters ... 121 Data management ... 125 Network ... 127 Service ... 130

Troubleshooting ... 131

NIBP messages ... 131 SpO2 and SpHb messages ... 132 Temperature messages ... 133 Weight scale messages ... 134 Patient data management messages ... 134 Radio messages ... 135 Ethernet messages ... 135 USB messages ... 135 System messages ... 136 Battery power manager messages ... 136 Configuration Manager messages ... 137 Printer messages ... 137 Problems and solutions ... 138

Appendix ... 139

Approved accessories ... 139 Warranty ... 146

1

Introduction This manual describes the capabilities and operation of the monitor. The information, including the illustrations, pertains to a monitor configured with noninvasive blood pressure (NIBP), body temperature, pulse oximetry (SpO2), total hemoglobin concentration (SpHb), pulse rate, and weight scale options. If your monitor configuration lacks any of these options, some information in this manual might not apply. Before using the monitor, read the sections of the manual that pertain to your use of the monitor.

Intended use The 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,

•

pulse rate,

•

noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and

•

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. The optional Masimo Rainbow SET® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of 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. Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input. This product is available for sale only upon the order of a physician or licensed health care professional.

Contraindications This system is not intended to be used: •

on patients connected to heart/lung machines

•

on patients being transported outside a healthcare facility

•

near an MRI machine

•

in a hyperbaric chamber

2

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Introduction

•

near flammable anesthetics

•

near electro-cauterization devices

For contraindications of SpO2 and SpHb sensors, consult the sensor manufacturer's directions for use.

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.

Consult operating instructions.

Power symbols Power on/standby

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

Alternating Current (AC)

Rechargeable battery

4

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Symbols

Li-ion battery

AC input power

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

Miscellaneous symbols Meets essential requirements of European Medical Device Directive 93/42/EEC

European Community Representative

Manufacturer

Defibrillation-proof Type BF applied parts

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

5

Screen elements Global navigation

Select option

NIBP NIBP start

NIBP stop

Intervals status indicators

NIBP view toggle

Temperature site control

Process indicator

Temperature

Direct mode selector

6

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Screen elements

SpO2 and Pulse rate Pulse amplitude bar

SatSeconds timer (Nellcor feature only)

SpO2 view toggle

Response mode selector (touch for Fast mode)

Heart rate (in beats per minute)

Total hemoglobin (SpHb) SpHb view toggle

Averaging selector

Manual parameters Manual parameter selector

Alarm and information messages Alarm limit button

Alarm On/Off toggle

Multiple alarms toggle

Alarm audio paused

Alarm active

Directions for use

Screen elements

Patients list and review

Diacritical marks key (available for languages that use diacritical marks; appearance differs based on language)

Symbols key

Send patient test reports

Print patient test reports

Cancel print request

Add patient identifiers

Retrieve the patient list from the network

Settings Save configuration settings

Advanced settings

Save to USB flash drive

Restore factory default settings

Configure from USB flash drive

7

8

Screen elements

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

9

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, familiarize yourself with the sections of this directions for use that pertain to your use of the monitor. •

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. The clinician 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- or facility-specific. The clinician 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 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.

10

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

About warnings and cautions

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 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. WARNING Safety risk. Damaged cords, cables, and accessories can affect patient and operator safety. Never lift the monitor by the power supply cord or patient connections. Routinely inspect the AC power cord, blood pressure cuff, SpO2 cable, and other accessories for strain relief wear, fraying, or other damage. Replace as necessary. 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.

Directions for use

About warnings and cautions

11

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 Use the monitor only as described in this directions for use. Do not use the monitor on patients as described in the Contraindications. WARNING Inaccurate measurement risk. Do not use the monitor on patients who are experiencing convulsions or tremors. WARNING Wall mounted equipment and accessories must be installed in accordance with accompanying instructions. 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 Equipment damage and personal injury risk. 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.

12

About warnings and cautions

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

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. 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 60601-1 compliant isolation transformer.

Directions for use

About warnings and cautions

13

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.

14

About warnings and cautions

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

15

Controls, indicators, and connectors Your model might not contain all of these features.

Note

No. Feature

Description

1

Printer

Optional. Printer provides a printout of patient and device information.

2

Light bar

Provides a visual alarm with red and amber LEDs.

3

Thermometry

Optional. Temperature probe cover box.

4

Thermometry

Optional. 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 Li-ion battery.