Welch Allyn, Connex, SureTemp, FlexiPort, and SureBP are registered trademarks of Welch Allyn.
Vital Signs Monitor 6000 Series and PartnerConnect are trademarks of Welch Allyn.
Integrated Pulmonary Index is a trademark of , and Oridion and Microstream are registered trademarks of, Oridion Medical
1987 Ltd. No implied license. Possession or purchase of this device does not convey any express or implied license to use
the device with unauthorized CO2 sampling products which would, alone, or in combination with this device, fall within the
scope of one or more of the patents relating to this device and/or CO2 sampling products.
Radical-7R, Pulse CO-Oximeter, rainbow Acoustic Monitoring, RRa, and ReSposable are trademarks of, and SET, LNCS,
SpHb, rainbow, and Masimo are registered trademarks of, Masimo Corporation. Possession or purchase of a Masimoequipped device does not convey any express or implied license to use the device with unauthorized sensors or cables
which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this
device.
Nellcor and OxiMax are registered trademarks of Nellcor Puritan Bennett Inc.
Braun and ThermoScan are registered trademarks of Braun GmbH.
Health o meter is a registered trademark of Sunbeam Products, Inc., used under license.
EarlySense is a registered trademark of EarlySense Ltd.
Software in this product is Copyright 2014 Welch Allyn or its vendors. All rights are reserved. The software is protected by
United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the
licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the
product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or
otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title,
and ownership of the software remain with Welch Allyn or its vendors.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact Welch Allyn Technical Support: www.welchallyn.com/about/
company/locations.htm.
105853 (CD)
DIR 80019042 Ver. A
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 USA
www.welchallyn.com
721953 (printed copy)
DIR 80019042 Ver. A
This manual applies to 901060 Vital Signs Monitor.
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland
This directions for use describes the capabilities and operation of the monitor. The
information, including the illustrations, covers all configuration options. If your monitor
configuration lacks any of these options, some information in this manual might not
apply.
Before using the monitor, you must familiarize yourself with all warnings and cautions,
with the steps to power up the monitor, and with the sections of this directions for use
that pertain to your use of the monitor. You must also familiarize yourself with all
information that accompanies the accessories you use.
1
NoteSome product features described in this publication might not be available
in your country. For the latest information about products and features,
please call Welch Allyn Customer Care.
Indications for use
The Connex VSM 6000 series of monitors is intended to be used by clinicians and
medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for
•noninvasive blood pressure (NIBP)
•pulse rate (PR)
•noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2)
•body temperature in normal and axillary modes
The most likely locations for patients to be monitored are general medical and surgical
floors, general hospital, and alternate care environments. Monitoring can be
accomplished on the VSM 6000 series bedside monitor itself, and the VSM 6000 series
bedside monitor also can transmit data continuously for secondary remote viewing and
alarming (e.g., at a central station). Secondary remote viewing and alarming features are
intended to supplement and not replace any patient bedside monitoring procedures.
The optional Masimo rainbow® SET Pulse CO-Oximeter™ and accessories are indicated
for the continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate (PR), total hemoglobin concentration (SpHb®), and/or
respiration rate (RRa™). The Masimo rainbow SET Radical-7R™ Pulse CO-Oximeter and
accessories are indicated for use with adult, pediatric, and neonatal patients during both
motion and no-motion conditions, and for patients who are well or poorly perfused in
hospitals and hospital-type facilities.
The optional Oridion®module and accessories are intended for the continuous
noninvasive measurement and monitoring of carbon dioxide concentration of the expired
and inspired breath (etCO2 and FiCO2) and respiration rate (RR). It is intended for use
with neonatal, pediatric, and adult patients in hospitals and hospital-type facilities.
The optional Oridion module also provides the clinician with an Integrated Pulmonary
Index™ (IPI). The IPI is based on four parameters provided by the monitor: end-tidal
carbon dioxide (etCO2), respiration rate (RR), oxygen saturation (SpO2), and pulse rate
(PR). The IPI is a single index of an adult or pediatric patient's ventilatory status displayed
on a scale of 1–10, where 10 indicates optimal pulmonary status. IPI monitoring displays
a single value that represents the patient's pulmonary parameters and alerts clinicians to
changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital signs monitoring.
Optional compatible weight scales (e.g., Health o meter®) can be used for height,
weight, and BMI input.
The optional EarlySense® (Everon) System is intended for continuous measurement of
respiration rate, heart rate, and movement in an automatic contact-less manner, in a
hospital or clinic setting. The system is indicated for use in children, adolescents, and
adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg)
and adults (weight <111 Kg) during sleep and resting condition.
This product is available for sale only upon the order of a physician or licensed healthcare
professional.
Contraindications
This system (all configurations) is not intended to be used:
•on patients connected to heart/lung machines
•on patients being transported outside a healthcare facility
•within the controlled access area of MRI equipment
•in a hyperbaric chamber
•in the presence of flammable anesthetics
•in the presence of electrocauterization devices
Systems configured with EarlySense are not intended to be used:
•on patients for whom proper positioning cannot be achieved or maintained
•on patients who do not meet the weight limits tested or specified
Symbols
Documentation symbols
WARNING The warning statements in this manual identify conditions or practices that could
lead to illness, injury, or death.
3
Power symbols
CAUTION The caution statements in this manual identify conditions or practices that could
result in damage to the equipment or other property, or loss of data. This definition applies to
both yellow and black and white symbols.
WARNING Hot surface. Do not touch.
Follow the operating instructions/directions for use (DFU) — mandatory action.
A copy of the DFU is available on this website.
A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 days.
Power on/Display power-savingEquipotential 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
(on the monitor, amber indicator)
Alternating Current power present,
battery is charging
Warning and caution statements can appear on the monitor, on the packaging, on the
shipping container, or in this document.
The monitor is safe for patients and clinicians when used in accordance with the
instructions and the warning and caution statements presented in this manual.
Before using the monitor, you must familiarize yourself with all warnings and cautions,
with the steps to power up the monitor, and with the sections of this directions for use
that pertain to your use of the monitor. In addition to reviewing the general warnings and
cautions presented in the next section, you must also review the more specific warnings
and cautions appear throughout the manual in conjunction with setup/startup, device
operation, patient monitoring, and maintenance tasks.
•Failure to understand and observe any warning statement in this manual could lead
to patient injury, illness, or death.
•Failure to understand and observe any caution statement in this manual could lead to
damage to the equipment or other property, or loss of patient data.
13
General warnings and cautions
WARNING Many environmental variables, including patient physiology and
clinical application, can affect the accuracy and performance of the monitor.
Therefore, you must verify all vital signs information before treating the
patient. If there is any question about the accuracy of a measurement,
verify the measurement using another clinically accepted method.
WARNING Alarm limits are patient-specific. For alarms to function
properly, you must set or verify alarm limits appropriate for each patient.
Each time the monitor is powered on, you must check that the alarm
settings are appropriate for your patient before you start monitoring.
WARNING The monitor is not intended for use during patient transport
outside of the medical facility. Do not use the monitor to take
measurements on any patient in transit.
WARNING Do not use the monitor as an apnea monitor. Neither the VSM
6000 series monitors, nor any of the integrated or accessory sensor
systems used in conjunction with the VSM 6000 series monitors, are
intended for use in apnea monitoring.
14
About warnings and cautionsWelch Allyn Connex® Vital Signs Monitor 6000 Series™
WARNING Use only Welch Allyn approved accessories, and use them
according to the manufacturer’s directions for use. Using unapproved
accessories with the monitor can affect patient and operator safety and can
compromise product performance and accuracy.
WARNING Inaccurate measurement risk. Do not connect more than one
patient to a monitor.
WARNING Inaccurate measurement risk. Dust and particle ingress can
affect the accuracy of blood pressure measurements. Use the monitor in
clean environments to ensure measurement accuracy. If you notice dust or
lint build-up on the monitor's vent openings, have the monitor inspected
and cleaned by a qualified service technician.
WARNING Inaccurate measurement risk. Liquids and excessive moisture
can damage patient sensors and cause them to perform inaccurately or fail.
WARNING Patient harm risk. Always remove sensors from patients and
disconnect them completely from monitors before bathing.
WARNING Liquids can damage electronics inside the monitor. Prevent
liquids from spilling on the monitor.
If liquids are spilled on the monitor:
1. Power down the monitor.
2. Disconnect the power plug.
3. Remove battery pack from the monitor.
4. Dry off excess liquid from the monitor.
NoteIf 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. Power down the monitor.
2. Disconnect the power plug.
3. Remove battery pack from the monitor.
4. Remove and discard the paper roll.
5. Clean and dry the inside of the printer housing.
NoteThe printer housing has a drain tube that directs liquids down
and out the bottom of the monitor. If liquids possibly entered
other openings in the monitor, remove the monitor from use
until it has been properly dried, inspected, and tested by
qualified service personnel.
6. Install a new roll of paper.
7. Power on the monitor and verify that the monitor functions normally before
using it.
Directions for useAbout warnings and cautions 15
WARNING Safety risk and potential shock hazard. Cords, cables, and
accessories damaged from prior misuse can affect patient and operator
safety. Inspect all cords, cables, and accessories for strain relief wear,
fraying, or other damage according to the recommendations presented in
the Maintenance and service section of this manual. Replace as necessary.
Inspect the AC cord for exposed copper before touching the cord. Unplug
the AC cord only by pulling on the plug, never the cord. Never lift the
monitor by the power cord or patient connections.
WARNING Fire and explosion hazard. Do not operate the monitor in the
presence of a flammable anesthetic mixture with air, oxygen, or nitrous
oxide; in oxygen-enriched environments; or in any other potentially
explosive environment.
WARNING Fire and shock hazard. Only connect LAN cables contained
within the perimeter of a single building. Conductive LAN cables spanning
multiple buildings may introduce fire or shock hazards unless they are fitted
with fiber optic cables, lightning arrestors, or other applicable safety
features.
WARNING The monitor may not function properly if dropped or damaged.
Protect it from severe impact and shock. Do not use the monitor if you
notice any signs of damage. Qualified service personnel must check any
monitor that is dropped or damaged for proper operation before putting the
monitor back into use.
WARNING Defective batteries can damage the monitor. If the battery
shows any signs of damage or cracking, it must be replaced immediately
and only with a battery approved by Welch Allyn.
WARNING Improper disposal of batteries may create an explosion or
contamination hazard. Never dispose of batteries in refuse containers.
Always recycle batteries according to local regulations.
WARNING Electric shock hazard. Do not open the monitor or attempt
repairs. The monitor has no user-serviceable internal parts. Only perform
routine cleaning and maintenance procedures specifically described in this
manual. Inspection and servicing of internal parts shall only be performed
by qualified service personnel.
WARNING Inaccurate measurement risk. Do not expose to temperatures
higher than 122º F (50º C).
WARNING Inaccurate measurement risk. Do not use the monitor on
patients who are on heart-lung machines.
WARNING Inaccurate measurement risk. If using patient sensors during
full body irradiation, keep the sensor out of the irradiation field. If the
sensor is exposed to the irradiation, the reading might be inaccurate or the
monitor might read zero during the active irradiation period.
WARNING Inaccurate measurement risk. Do not use the monitor on
patients who are experiencing convulsions or tremors.
WARNING Use the monitor only as described in this directions for use. Do
not use the monitor on patients as described in the Contraindications.
16
About warnings and cautionsWelch Allyn Connex® Vital Signs Monitor 6000 Series™
WARNING Personal/patient injury risk. Wall-mounted equipment and
accessories must be installed in accordance with accompanying
instructions. Improper installation can result in the monitor falling off the
wall and injuring someone. 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 Avoid continuously monitoring a patient when the device is
operating on battery power. If only battery power is available, you must
remain in the room with any patient whose vital signs are being monitored
continuously. Actively monitor both patient and battery status to ensure
patient safety.
WARNING Patient harm and equipment damage risk. Carefully route
patient cabling to reduce the possibility of patient entanglement or
strangulation. 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.
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.
WARNING For patient safety, do not use the monitor or any accessory
during MRI scanning. Induced current could cause burns.
Directions for useAbout warnings and cautions 17
WARNING When the monitor is not conected to a secondary alarm
system during continuous monitoring, check the monitor regularly to
receive patient data, alarms, and alerts.
WARNING Patient safety risk. The EarlySense system is not intended for
high-risk patients in coronary or respiratory distress who require continuous
monitoring of heart function or CO2. For these patients, the most reliable
method of patient monitoring involves close personal surveillance and/or
equipment suited to that type of monitoring.
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 60601-1compliant isolation transformer. While monitoring a patient, you can only
charge the laptop battery if it is connected to 60601-1-compliant, isolated
AC power.
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.
CAUTION Keep the monitor outside of MRI suites and any areas marked
for high magnetic or electric field strength.
18
About warnings and cautionsWelch Allyn Connex® Vital Signs Monitor 6000 Series™
Physical design
The monitor is available in two sizes: standard and extended. The primary difference
between these models is the number of parameters they support.
NoteYour monitor, based on size or configuration, might not contain all
parameters or features illustrated in this section.
In a standard monitor, up to two parameter modules are installed on the left side. You
can tell which modules are installed based on the connectors visible on the outside of
the device. The following image shows a standard monitor with pulse-oximetry and
blood-pressure modules.
NoteDo not remove the tab label from the battery. This tab helps
you remove the battery from the compartment when you
need to replace it.
5. Replace the battery cover by inserting one end into the notched access and then
pressing firmly on the opposite end.
NoteNew batteries are only 30 percent charged. Therefore, connect the monitor
to AC power immediately after inserting a new battery.
Mount the monitor
You can install the monitor on a mobile stand or on an interior wall equipped with a
Welch Allyn-approved wall-mount fixture.
Check the mounting bracket
Before you mount the monitor, make sure the stand or wall-mount fixture has the
mounting bracket designed for your monitor. Monitors with a standard housing require a
small bracket. Monitors with an extended housing require a large bracket.
Small bracket for standard housingLarge bracket for extended housing
NoteIf your monitor has an extended housing but the small bracket is installed
on your stand or wall-mount fixture, you must replace the small bracket
with the large bracket. Follow the steps presented in the Mounting BracketReplacement Install Guide shipped with the large bracket, and then
proceed to mount the monitor.
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