Connex Spot Monitor Directions for use sw 1.X Ver L May 2015

© 2015 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. EcoCuff is a trademark of Welch Allyn. LNCS, ReSposable , SET, LNOP, and Masimo are registered trademarks of Masimo Corporation. Possession or purchase of a Masimo SpO2-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. For Masimo patent information, please visit www.masimo.com/patents.htm. NellcorTM SpO2 Patient Monitoring System with OxiMaxTM Technology and NellcorTM SpO2 OxiMaxTM Technology are registered trademarks of COVIDIEN LP Covidien Holdings Inc. Braun and ThermoScan are registered trademarks of Braun GmbH. Nonin is a registered trademark of Nonin Medical, Inc. The Bluetooth® word mark and logos are registered trademarks owned by BluetoothSIG, Inc. and any use of such marks by Welch Allyn is under license. Software in this product is Copyright 2015 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. This product may contain software known as “free” or “open source” software (FOSS). Welch Allyn uses and supports the use of FOSS. We believe that FOSS makes our products more robust and secure, and gives us and our customers greater flexibility. To learn more about FOSS that may be used in this product, please visit our FOSS website at www.welchallyn.com/opensource. Where required, a copy of FOSS source code is available on our FOSS website. For patent information, please visit www.welchallyn.com/patents. For information about any Welch Allyn product, contact your local Welch Allyn representative: www.welchallyn.com/ about/company/locations.htm. DIR 80019224 Ver. L Revised 2015-05

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

This manual applies to

901058 Vital Signs Monitor Core.

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 and definitions ... 3 About warnings and cautions ... 7 General warnings and cautions ... 7

Controls, indicators, and connectors ... 13 Setup ... 19

Supplies and accessories ... 19 Connect the battery ... 19 Mount the monitor ... 20 Attach the probe well and temperature probe ... 21 Remove the temperature probe and probe well ... 22 Connect the NIBP hose ... 22 Disconnect the NIBP hose ... 22 Connect the SpO2 cable ... 22 Disconnect the SpO2 cable ... 22 Attach an accessory ... 22 Detach an accessory ... 23 Disconnect AC power ... 23

Startup ... 25

Power ... 25 Login methods ... 30 Profiles ... 31 Common screen functionality ... 35 Primary screens ... 36 Pop-up screens ... 39 Navigation ... 39

Patient data management ... 43

Load patient data with the barcode scanner ... 43 Add a patient ... 44 Manage patient records ... 44 Modifiers ... 45

Alarms ... 47 Vital sign summary view ... 47

iv Contents

Connex® Spot Monitor

Alarm limits ... 47 Alarm reminder signal ... 47 Alarm types ... 47 Alarm notification locations ... 48 Icons on the Home tab ... 48 Reset (pause or turn off) audio alarms ... 50 Adjust vital sign alarm limits ... 51 Modify audio alarm notification ... 51 Alarm messages and priorities ... 52 Nurse Call ... 53

Patient monitoring ... 55

Required parameters ... 55 Intervals ... 56 NIBP ... 59 Temperature ... 62 SpO2 ... 71 Modifiers and manual parameters ... 76 Configuration tool ... 77 Custom scoring ... 77 Advanced settings ... 77

Maintenance and service ... 79

Perform periodic checks ... 79 Replace the monitor battery ... 79 Replace the APM work surface battery ... 80 Cleaning requirements ... 81

Troubleshooting ... 87 NIBP messages ... 87 SpO2 messages ... 93 Temperature messages ... 104 Patient and clinician data messages ... 112 Radio messages ... 114 Connectivity messages ... 120 System messages ... 121 Software update messages ... 123 Bluetooth® messages ... 124 APM messages ... 125

Specifications ... 127

Physical specifications ... 127 Environmental specifications ... 134 Monitor radio ... 134 Bluetooth® module ... 135 Configuration options ... 136

Standards and compliance ... 137 General compliance and standards ... 137 General radio compliance ... 138

Directions for use

Contents

v

Guidance and manufacturer's declaration ... 143

EMC compliance ... 143 Emissions and immunity information ... 143

Appendices ... 147

Approved accessories ... 147 Warranty ... 155

vi

Contents

Connex® Spot Monitor

1

Introduction This manual describes the capabilities and operation of the Connex Spot Monitor (monitor). The information, including the illustrations, pertains to a monitor configured with noninvasive blood pressure (NIBP), body temperature, pulse oximetry (SpO2), and pulse rate. 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 Connex Spot Monitors (monitor) are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments. 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 sensors, consult the sensor manufacturer's directions for use.

2

Introduction

Connex® Spot Monitor

3

Symbols and definitions Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning statements appear with a grey background in a black and white document. 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. Follow 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 calendar days.

Power symbols Power button

Equipotential ground

(on the display) Power plug

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

Alternating Current (AC)

Rechargeable battery

4

Connex® Spot Monitor

Symbols and definitions

Rated power input, DC

Rated power input, AC

Lithium-ion battery

Direct current (DC)

Connectivity symbols Bluetooth®

Ethernet RJ-45

USB

Nurse call

Wireless signal strength • Best (4 bars) • Good (3 bars) • Fair (2 bars) • Weak (1 bar) • No signal (no bars) • No connection (blank)

Miscellaneous symbols Manufacturer

Defibrillation-proof Type BF applied parts

Product Identifier

Serial number

Reorder number

China RoHS markings for control of pollution caused by electronic information products. XX indicates Environmentally Friendly Use Period in years.

Do not reuse

Recycle the product separate from other disposables

Nonionizing electromagnetic radiation

Call for maintenance

Directions for use

Symbols and definitions 5

Light below

FCC ID

IPX1

Prescription only

The identification number assigned by the Federal Trade Commission

IC ID

Industry Canada identification number. The equivalent governing body to the FCC in the United States

This end up

Fragile

European Community Representative

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

IP = International Protection Marking X = No object ingress rating

Australian Regulatory Compliance Mark

1 = Protected against vertically dripping water Intertek ETL Listed Mark indicating successful independent safety testing

Recycle

Temperature range

Global Trade Identification Number

Stacking limit by number

Keep dry

Humidity range

Screen symbol Process indicator for activities like acquiring measurements and connecting to a laptop

6

Symbols and definitions

Connex® Spot Monitor

7

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. 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 patient data.

General warnings and cautions WARNING Patient injury risk. 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 Patient injury risk. To ensure data integrity and patient confidentiality, save readings and clear the monitor's display between patients. WARNING Personal injury risk. The power cord is the disconnect device to isolate this equipment from supply mains. Position the equipment so that it is not difficult to reach or disconnect the cord. WARNING Patient injury 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 Patient injury risk. During defibrillation, keep discharge paddles away from the monitor ECG lead wires, electrodes, any other monitor sensors, and other conductive parts in contact with the patient.

8

About warnings and cautions

Connex® Spot Monitor

WARNING Patient injury risk. Any external compression of the blood pressure hose or cuff may cause patient injury, system errors, or inaccurate measurements. WARNING Patient injury risk. Wash hands to reduce the risk of crosscontamination and nosocomial infection. WARNING Patient injury risk. Do not place the monitor in any position that might cause it to fall on the patient. WARNING Patient injury risk. Verify patient identity on the monitor after manual or barcode entry and before printing or transferring patient records. Failure to identify the correct patient can result in patient injury. WARNING Equipment failure and patient injury 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 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 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 Equipment damage and personal injury risk. No modifications to the monitor are allowed by anyone other than a qualified Welch Allyn service representative. Modification of the monitor could be hazardous to patients and personnel. 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 arresters, or other applicable safety features. WARNING Electric shock hazard. This equipment must only be connected to a supply mains with protective earth. 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.

Directions for use

About warnings and cautions

9

WARNING Electric shock hazard. 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 Explosion or contamination hazard. Improper disposal of batteries may create an explosion or contamination hazard. Never dispose of batteries in refuse containers. Always recycle batteries accord ing to local regulations. 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 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 Inaccurate measurement risk. 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 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. 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. Do not use the monitor on patients who are experiencing convulsions or tremors.

10

Connex® Spot Monitor

About warnings and cautions

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. Reconnect the power plug. 7. Power on the monitor and verify that the monitor functions normally before using it. 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 Personal injury risk. Improper handling of the battery can lead to heat generation, smoke, explosion or fire. Do not short-circuit, crush, incinerate, or disassemble the battery. Never dispose of batteries in refuse containers. Always recycle batteries according to national or local regulations. 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, and void the product warranty. 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 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. CAUTION Electric shock hazard. Do not sterilize the monitor. Sterlizing the monitor could damage the device.

Directions for use

About warnings and cautions

11

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 Do not move the stand while the power source is plugged into the mains outlet. CAUTION Do not sterilize the monitor. Sterilizing the monitor could harm the device. CAUTION Use only a Class I (grounded) AC power cord to charge the power source for the 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. This may cause the monitor to tip over or damage the cord. Never pull on the power cord when disconnecting the cord from the mains outlet. When disconnecting the power cord, always grasp the attachment plug. Keep the cord away from liquids, heat, and sharp edges. Replace the power cord if the strain relief, cord insulation, or metal prongs are damaged or begin 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.

12

About warnings and cautions

Connex® Spot Monitor

13

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

Note

Front-Left view

No. Feature

Description

1

LCD screen

7" color touchscreen provides a graphical user interface.

2

Thermometry

Secures the SureTemp unit to the monitor

3

Battery charge and power-up status indicator The LED indicates the charging and power-up status when connected to AC power: • Green: The battery is charged. • Amber: The battery is charging. • Flashing: the monitor is powering up.

4

Power button

Blue button on lower-left corner of the monitor. • Powers on the monitor • Places into Sleep mode, except when an alarm condition is active (brief press)

14

Connex® Spot Monitor

Controls, indicators, and connectors

No. Feature

Description •

Wakes up the monitor from Sleep mode