Spot Vital Signs 4400 Instructions for Use Sw ver 1.X

© 2019 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. Legal Statement Welch Allyn, Inc. (“Welch Allyn”) assumes no responsibility for any injury to anyone that may result from (i) failure to properly use the product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual, or (ii) any illegal or improper use of the product. Welch Allyn, SureTemp, FlexiPort, and SureBP are registered trademarks of Welch Allyn. EcoCuff is a trademark of Welch Allyn. Nonin is a registered trademark of Nonin Medical, Inc. Software in this product is Copyright 2019 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). Hill-Rom 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 hillrom.com/opensource. Where required, a copy of FOSS source code is available on our FOSS website. PATENTS / PATENT hillrom.com/patents. May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. For information about any product, contact Hillrom Technical Support: hillrom.com/en-us/about-us/locations/. DIR 80024362 Ver. C Revision date: 2019-11

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA hillrom.com Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc.

This manual applies to

901057 Vital Signs Device.

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 ... 15

Supplies and accessories ... 15 Connect the battery ... 15 Mount the device ... 16 Attach the temperature probe ... 16 Connect the NIBP hose ... 17 Disconnect the NIBP hose ... 17 Connect the SpO2 cable ... 17 Disconnect AC power ... 18

Startup ... 19

Power ... 19 Common screen functionality ... 21 Primary screens ... 21 Pop-up screens ... 23 Navigation ... 23

Patient vitals ... 27 NIBP ... 27 Temperature ... 32 SpO2 ... 37 Enter vitals measurements manually ... 40 Additional parameters ... 40 Save patient data ... 41 Advanced settings ... 41

Maintenance and service ... 43

Perform periodic checks ... 43 Recommended service intervals ... 43 Replace the device battery ... 44 Cleaning requirements ... 45

iv

Contents

Welch Allyn® Spot Vital Signs 4400

Troubleshooting ... 49

NIBP messages ... 49 SpO2 messages ... 55 Temperature messages ... 56 Patient data messages ... 62 System messages ... 62 Power messages ... 64 Software update messages ... 64

Specifications ... 67

Physical specifications ... 67 Environmental specifications ... 71 Configuration options ... 71

Standards and compliance ... 73

General compliance and standards ... 73

Guidance and manufacturer's declaration ... 75

EMC compliance ... 75 Emissions and immunity information ... 76

Appendices ... 77

Approved accessories ... 77 Warranty ... 81

1

Introduction This manual describes the capabilities and operation of the Welch Allyn® Spot Vital Signs 4400 (device). The information, including the illustrations, pertains to a device configured with noninvasive blood pressure (NIBP), body temperature, pulse oximetry (SpO2), and pulse rate. If your device configuration lacks any of these options, some information in this manual might not apply. Before using the device, read the sections of the manual that pertain to your use of the device.

Intended use The Welch Allyn® Spot Vital Signs 4400 (device) is intended to be used by clinicians and medically qualified personnel for operator initiated spot-check/single measurement of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in oral, rectal and axillary modes of adult and pediatric patients down to 29 days of age. The intended use locations for patients to be measured are physician’s offices, general hospital and alternate care environments.

Contraindications This device is not intended to be used: •

for use on neonates.

•

for unattended monitoring.

•

for patient transport.

•

for use in the home healthcare environment.

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

2

Introduction

Welch Allyn® Spot Vital Signs 4400

3

Symbols and definitions Documentation symbols For information on the origin of these symbols, see the Welch Allyn symbols glossary: http://www.welchallyn.com/symbolsglossary. 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 (IFU) -- mandatory action. A copy of the IFU is available on this website. A printed copy of the IFU can be ordered from Welch Allyn for delivery within 7 calendar days.

Power symbols Stand-By

Direct current (DC)

Power plug

Battery absent or faulty

Alternating Current power present, battery fully charged

Battery charge level

Alternating Current power present, battery is charging

Battery

Alternating current (AC)

Rechargeable battery

4

Welch Allyn® Spot Vital Signs 4400

Symbols and definitions

Rated power input, DC

Rated power input, AC

Lithium-ion battery

Connectivity symbols USB

Miscellaneous symbols

IPX2

Manufacturer

Defibrillation-proof Type BF applied parts

Product Identifier

Serial Number

Reorder Number

Recyclable

Do not reuse, Single use device

Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

IP = International Protection Marking X = No object ingress rating

Call for maintenance

2 = Protected against vertically falling water drops when enclosure tilted up to 15° This way up

Fragile

Authorized Representative in the European Community

This device has no alarms.

Temperature limit

Global Trade Item Number

Instructions for use

Symbols and definitions

Stacking limit by number

Keep dry

Humidity limitation

Mass in kilograms (kg)

Maximum safe working load limits

Non-ionizing electromagnetic radiation

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

5

6

Symbols and definitions

Welch Allyn® Spot Vital Signs 4400

7

About warnings and cautions Warning and caution statements can appear on the device, on the packaging, on the shipping container, or in this document. The device 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 device, familiarize yourself with the sections of this instructions for use that pertain to your use of the device. 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 device. Therefore, you must verify all vital signs information, especially NIBP and SpO2, before treating the patient. If there is any question about the accuracy of a measurement, verify the measurement using another clinically accepted method. WARNING Personal injury risk. The power cord plug is the disconnect device used to isolate this equipment from supply mains. Position the equipment so that it is not difficult to reach or disconnect the plug. WARNING Patient injury risk. Damaged cords, cables, and accessories can affect patient and operator safety. Never lift the device 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 device sensors and other conductive parts in contact with the patient. WARNING Patient injury risk. Any external compression of the blood pressure hose or cuff or kinked tubing may cause patient injury, system errors, or inaccurate measurements.

8

About warnings and cautions

Welch Allyn® Spot Vital Signs 4400

WARNING Patient injury risk. Wash hands to reduce the risk of crosscontamination and nosocomial infection. WARNING Patient injury risk. Do not place the device in any position that might cause it to fall on the patient. WARNING Patient injury risk. Do not place the cuff on the arm on the same side of a mastectomy or lymph node clearance. If necessary, use the femoral artery in the thigh to take a measurement. WARNING Patient injury risk. Inaccurate measurement risk. Do not place the cuff where it can disturb proper circulation. Do not place the cuff on any area where circulation is compromised or on any extremity used for intravenous infusions. Do not place the cuff on any limb where intravascular access or therapy, or an arterio-vascular (A-V) shunt is present. Observe the limb concerned to ensure that operation of the device does not result in prolonged impairment of circulation. WARNING Patient injury risk. Inaccurate measurement risk. Do not use an SpO2 finger clip sensor and a blood pressure cuff simultaneously on the same limb. Doing so may cause a temporary loss of pulsatile flow, resulting in either no reading or an inaccurate SpO2 or pulse rate until the flow returns. WARNING Do not apply cuff to areas on patient where skin is delicate or damaged, as this can cause further injury. Check cuff site frequently for irritation. WARNING Equipment failure and patient injury risk. Do not cover the air intake or exhaust vents on the rear and base of the device. Covering these vents could cause overheating of the device. 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 device 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 device are allowed by anyone other than a qualified Welch Allyn service representative. Modification of the device could be hazardous to patients and personnel. WARNING Fire and explosion hazard. Do not operate the device 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 Electric shock hazard. This equipment must only be connected to a supply mains with protective earth.

Instructions for use

About warnings and cautions 9

WARNING Electric shock hazard. Do not open the device or attempt repairs. The device has no user-serviceable internal parts. Only perform routine cleaning and maintenance procedures specifically described in this manual while the device is not in use on a patient. Inspection and servicing of internal parts shall only be performed by qualified service personnel. 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 device. Connecting additional devices to the device may increase chassis or patient leakage currents. 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 according to local regulations. WARNING Use the device only as described in this instructions for use. Do not use the device on patients as described in the Contraindications. WARNING Inaccurate measurement risk. The device is not intended for use during patient transport outside of the medical facility. Do not use the device to take measurements on any patient in transit. WARNING Inaccurate measurement risk. Do not connect more than one patient to a device. WARNING Inaccurate measurement risk. Dust and particle ingress can affect the accuracy of blood pressure measurements. Use the device in clean environments to ensure measurement accuracy. If you notice dust or lint build-up on the device's vent openings, have the device 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 device on patients who are on heart-lung machines. WARNING Inaccurate measurement risk. Do not use the device on patients who are experiencing convulsions or tremors.

10

Welch Allyn® Spot Vital Signs 4400

About warnings and cautions

WARNING Liquids can damage electronics inside the device. Prevent liquids from spilling on the device. If liquids are spilled on the device: 1. 2. 3. 4.

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

If liquids possibly entered the device, remove the device 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 device and verify that the device functions normally before using it. WARNING The device may not function properly if dropped or damaged. Protect it from severe impact and shock. Do not use the device if you notice any signs of damage. Qualified service personnel must check any device that is dropped or damaged for proper operation before putting the device back into use. WARNING Defective batteries can damage the device. 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 device can affect patient and operator safety and can compromise product performance and accuracy, and void the product warranty. 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 device on battery power alone when it is attached to a patient. WARNING Safety risk. Make frequent electrical and visual checks on cables, sensors, and electrode wires. All cables, sensors, and electrode wires must be inspected and properly maintained and in proper working order to allow the equipment to function properly and to protect patients. WARNING The use of the Spot Vital Signs 4400 device adjacent to or stacked with other equipment or medical electrical systems should be avoided because it could result in improper operation. If such use is necessary, the Spot Vital Signs 4400 and other equipment should be observed to verify that they are operating normally.

Instructions for use

About warnings and cautions

11

WARNING Use only accessories and cables Welch Allyn recommends for use with the Spot Vital Signs 4400 device. Accessories and cables not recommended by Welch Allyn may affect the EMC emissions or immunity. WARNING Maintain minimum separation distance of 12 inches (30 cm) between any part of the Spot Vital Signs 4400 device and portable RF communication equipment (including peripherals such as antenna cables and external antennas). Performance of the Spot Vital Signs 4400 device might degrade if proper distance is not maintained. WARNING Use of accessories, transducers, and cables other than those specified may result in degraded electromagnetic compatibility performance of this device. WARNING Use of accessories, transducers, and cables other than those specified may result in increased emissions or decreased immunity of the device. CAUTION This device is not intended for use in the home healthcare environment. CAUTION Before disassembling the device or installing options, disconnect the patient from the device, power down the device, and disconnect the AC power cord and any attached accessories (for example, SpO2 sensors, blood pressure hoses and cuffs, and temperature probes) from the device. CAUTION To ensure that the device meets its performance specifications, store and use the device in an environment that maintains the specified temperature and humidity ranges. CAUTION Do not operate the device in the presence of magnetic resonance imaging (MRI) or hyperbaric chambers. CAUTION Electric shock hazard. Do not sterilize the device. Sterilizing the device could damage the device. CAUTION United States Federal law restricts this device to sale, distribution, or use by or on the order of a physician or licensed healthcare professional. CAUTION Electromagnetic interference risk. The device complies with applicable domestic and international standards for electromagnetic interference. These standards are intended to minimize medical equipment electromagnetic interference. Although this device 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 device 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 device. Sterilizing the device could harm the device.

12

About warnings and cautions

Welch Allyn® Spot Vital Signs 4400

CAUTION Use only a Class I (grounded) AC power cord to charge the power source for the device. CAUTION Never move the device or mobile stand by pulling on any of the cords. This may cause the device 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 device 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 device and contact an authorized Welch Allyn service center or qualified service personnel. CAUTION If the device stops operating within its design specifications, remove it from service and have it inspected by a qualified service person.

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 probe well

Houses the SureTemp probe on the device

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 device is powering up.

14

Welch Allyn® Spot Vital Signs 4400

Controls, indicators, and connectors

No. Feature

Description

4

Blue button on lower-left corner of the device. • Powers on the device • Provides power options for the device • Wakes up the device from Sleep mode

Power button

Back-Bottom-Left view

No. Feature

Description

1

Battery compartment (behind cover)

Houses the battery (captive screw secures cover to device)

2

NIBP

Connects the NIBP hose to the device

3

USB client port

Provides a connection to an external computer for testing, software upgrades, and connectivity

4

Power connection

Connects the power adapter to the device

5

USB port

Connects a USB drive to the device for saving log files

6

Thermometry

Connects the SureTemp probe to the device

7

SpO2

Connects the SpO2 sensor to the device

15

Setup Supplies and accessories For a list of all approved supplies and accessories, see Approved Accessories in the Appendices. WARNING Patient injury risk. Clean all accessories, including cables and tubes, before storing the accessories on the device or cart. This helps reduce the risk of cross contamination and nosocomial infection. Refer to 'Clean the equipment' in "Maintenance and service" for directions.

Connect the battery This procedure applies to first-time setup of the device. The battery is inserted in the battery compartment when you receive a new device. However, it is not connected. 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 device can affect patient and operator safety and can compromise product performance and accuracy, and void the product warranty. 1. Set the device on a flat surface with the screen facing downward to access the battery cover.

16

Welch Allyn® Spot Vital Signs 4400

Setup

2. Locate the battery cover, indicated by

on the back of the device.

3. Using a double-slotted screwdriver, loosen the captive screw at the base of the battery cover, and then remove the cover. 4. Remove the battery to access the battery connection port on the device. 5. Insert the battery connector into the battery connection port on the device. 6. Insert the battery into the battery compartment. 7. Replace the battery cover, and then tighten the captive screw at the bottom of the battery cover. Do not over-tighten the screw.

Note

Mount the device The Spot Vital Signs 4400 device can be mounted on either the mobile stand, desk stand, or wall mount. Follow the assembly instructions or instructions for use included with your device.

Connect AC power to a power source You can use the device with power from the mains outlet. Battery power can be used after charging the battery. Note

The Spot 4400 device includes a separate power supply unit as part of the Medical Electrical (ME) Equipment.

Attach the temperature probe 1. Insert the probe well into the front of the device. 2. Insert the SureTemp probe into the probe well. 3. Attach the SureTemp probe connector to the bottom of the device.