Connex Integrated Wall System Directions for Use Software ver 1.5X to 1.7X. Ver H

© 2012 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 MasimoSpHb-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 2012 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 humanperceivable 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 7884 3329 Singapore +65 6419 8100 Spain +34 917 499 357 United Kingdom +44 207 365 6780

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

Software version 1.5X–1.7X 104066 (CD) 80016142 Ver. H

104069 (printed copy) Material Number 718745, 80016142 Ver. H

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

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

www.welchallyn.com

iii

Contents Introduction ... 1 Intended use ... 1 Contraindications ... 2

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

Controls, indicators, and connectors ... 13 Setup ... 17 Supplies and accessories ... 17 Unpack the wall system ... 17 Insert the battery ... 18 Prepare for mounting ... 19 Mounting location ... 20 Mount the wall system ... 21 Mount the accessory bin ... 25 Connect the blood pressure (NIBP) hose ... 26 Set up the physical assessment instrument handles and specula dispenser ... 27 Set up the SureTemp® Plus thermometer ... 27 Set up the Braun ThermoScan® PRO 4000 thermometer ... 28 Connect AC power ... 29 Attach an accessory ... 30

Startup ... 33 Power ... 33 Power up the monitor ... 34 Power down the monitor ... 35 Reset the wall system ... 35 Select a language ... 36 Set the date and time ... 36 Enter clinician information ... 36 Set the default configuration ... 37

Navigation ... 39 Home tab ... 39 Device Status area ... 39

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Contents

Welch Allyn Connex® Integrated Wall System

Content area ... 41 Navigation area ... 42

Profiles ... 45 Select a profile ... 48

Using the keypad, keyboard, and barcode scanner ... 49 Open the numeric keypad ... 49 Numeric keypad ... 49 Enter a number ... 50 Close the numeric keypad ... 50 Open the keyboard ... 50 Keyboard ... 50 Enter a letter or number ... 52 Enter a symbol or special character ... 52 Enter a diacritical mark ... 52 Close the keyboard ... 53 Use a barcode scanner ... 53

Patient data management ... 55 Add a patient to the patient list ... 55 Load patient data with the barcode scanner ... 55 Select a patient ... 56 Manage patient records ... 56 Delete a patient from the list ... 57 Modifiers ... 57 Set modifiers ... 58

Alarms ... 59 Reset (pause or turn off) audio alarms ... 62 Adjust vital sign alarm limits ... 63 Modify audio alarm notification ... 63 Alarm messages and priorities ... 64 Nurse call ... 67

Patient monitoring ... 69 NIBP ... 69 Temperature ... 77 SpO2 ... 87 SpHb ... 92 Pulse rate frame ... 95 Manual parameters frame ... 96

Physical assessment instrument handles ... 99 Use the physical assessment instrument handles ... 99

Maintenance and service ... 101 Perform periodic checks ... 101 Remove the wall system from the wall ... 101 Change the battery ... 103 Clean the wall system (excluding handle cradles and accessories) ... 104 Clean the handle cradles ... 105

Directions for use

Contents

v

Clean the wall system accessories ... 105

Specifications ... 107 Physical specifications ... 107 Environmental specifications ... 111 Monitor radio ... 112 Configuration options ... 113 Patents ... 113

Standards and compliance ... 115 General compliance and standards ... 115 General radio compliance ... 116

Guidance and manufacturer's declaration ... 119 EMC compliance ... 119 Emissions and immunity information ... 119

Advanced settings ... 123 General ... 123 Parameters ... 127 Data management ... 131 Network ... 134 Service ... 136

Troubleshooting ... 137 NIBP messages ... 137 SpO2 and SpHb messages ... 138 Temperature messages ... 139 Weight scale messages ... 140 Physical assessment instrument handles ... 140 Patient data management messages ... 141 Radio messages ... 141 Ethernet messages ... 142 USB messages ... 142 System messages ... 142 Battery power manager messages ... 143 Configuration Manager messages ... 143 Problems and solutions ... 144

Appendix ... 145 Approved accessories ... 145 Warranty ... 154

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Contents

Welch Allyn Connex® Integrated Wall System

1

Introduction The Welch Allyn Connex® Integrated Wall System combines the advanced, easy-to-use monitor capabilities of the Welch Allyn Connex® Vital Signs Monitor 6000 Series with the Welch Allyn 767 Power Handles. This manual (directions for use) is designed to help you understand the capabilities and operation of the wall system. The information in this manual, including the illustrations, is based on a wall system configured with non-invasive blood pressure (NIBP), body temperature, pulse oximetry (SpO2), total hemoglobin concentration (SpHb), pulse rate, weight scale, and two power handles. If your wall system configuration lacks any of these options, some information in this manual may not apply. Before using the wall system, read the sections of the manual that pertain to your use of the system. Note

Throughout this directions for use, the Integrated Wall System may be referred to as a wall system or monitor.

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.

Intended use Handle module assembly Handles supply power to Welch Allyn 3.5V instruments.

Connex® Vital Signs Monitor patient monitor 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

2

Welch Allyn Connex® Integrated Wall System

Introduction

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

•

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. 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

Li-ion battery

AC input power

4

Welch Allyn Connex® Integrated Wall System

Symbols

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

Authorized Representative in the European Community

Call for maintenance

Defibrillation-proof Type BF applied parts

Manufacturer

Recycle

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.

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® Integrated Wall System

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 (Not available)

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® Integrated Wall System

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 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.

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Welch Allyn Connex® Integrated Wall System

About warnings and cautions

WARNING Liquids can damage electronics inside the Connex IWS. Prevent liquids from spilling on the wall system. If liquids are spilled on the wall system: 1. 2. 3. 4. 5.

Power down the wall system. Disconnect the power plug. Remove the wall system from the wall. Remove battery pack from the wall system. Dry off excess liquid from the wall system. Note

6. 7. 8.

If liquids possibly entered the wall system, remove the wall system from use until it has been properly dried, inspected, and tested by qualified service personnel.

Reinstall battery pack. Mount the wall system on the wall. Power on the wall system and verify that it functions normally before using it.

WARNING Safety risk. Damaged cords, cables, and accessories can affect patient and operator safety. 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 oxygenenriched 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 Use the monitor only as described in this directions for use. Do not use the monitor on patients as described in the Contraindications.

Directions for use

About warnings and cautions

11

WARNING Inaccurate measurement risk. Do not use the monitor on patients who are experiencing convulsions or tremors. 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 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 vents on the right or exhaust vents on the front of the Connex IWS. Covering these vents could cause overheating or muffling of alarms. WARNING This equipment is not suitable for use in the presence of electrosurgery. 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 The physical assessment instruments (handles) are designed for intermittent use. On-time should not exceed 2 minutes. Allow at least 10 minutes offtime between patients. 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 Welch Allyn is not responsible for the integrity of any wall mounting interface. Welch Allyn recommends that you contact your Biomedical Engineering Department or maintenance service to ensure professional installation, safety, and reliability of any mounting accessory. 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.

12

Welch Allyn Connex® Integrated Wall System

About warnings and cautions

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 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. 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.

13

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

Note Front view

No. Feature

Description

1

Physical assessment instruments Handles and handle cradles

Handles will accept any 3.5V Welch Allyn instrument head. The handle cradles support using one handle at a time. A handle turns on automatically when you remove it from a cradle and turns off when you return it.

2

Rheostat

Located on each handle. Turn clockwise to increase light output; turn counterclockwise to decrease light output.

3

Exhaust vents

Exhaust vents cool the monitor.

4

LCD screen

1024 x 600 color touchscreen provides a graphical user interface.

5

Storage compartment

Provides covered storage for additional probe covers and other small accessories.

6

Expansion slots

Provide space to add modules.

7

SureTemp® Plus thermometer probe covers

Support temperature measurements from oral, axillary, and rectal sites.

8

SureTemp® Plus thermometer probe

Supports temperature measurements from oral, axillary, and rectal sites.

14

Controls, indicators, and connectors

No. Feature

Welch Allyn Connex® Integrated Wall System

Description

9

Braun ThermoScan® PRO 4000 thermometer and dock

Support temperature measurements from the ear. Dock charges the thermometer battery.

10

SureTemp® Plus thermometer connector

Secures the probe connection to the wall system.

11

Blood pressure and pulse oximetry

See front underside view for more detail.

12

Power switch and LED

Power-on/Standby switch. The LED indicates the charging status when connected to AC power: • Green: The battery is charged. • Amber: The battery is charging.

13

USB/Comms cover

Houses light bar. Provides access to host USB connections for optional accessories and some routing for cords and cables.

14

Light bar

Provides a visual alarm with red and amber LEDs.

15

Speaker

Provides tones. A piezo beeper inside the monitor provides backup.

16

Specula dispenser

Dispenses KleenSpec® disposable specula in pediatric (2.75 mm) and adult (4.25 mm) sizes.

Front underside views (Left: USB/Comms cover attached; Right: USB/Comms cover removed)

1

Retention screws

Supports removing and attaching USB/Comms cover.

2

Blood pressure

Self-contained module for easy replacement. Supports dual-lumen or single-lumen hoses.

3

Pulse oximetry

Optional Nellcor (SpO2) or Masimo Rainbow SET (SpO2 or combined SpO2/SpHb) in a self-contained module for easy replacement.

4

USB-to-computer connector

Provides a connection to an external computer for testing, data transfer, and software upgrades.

5

Power connection

Provides an external AC power connection.