FOR-A VSM100 Pro User manual

VSM100 Pro
Vital Signs Monitor
(Blood Glucose, Blood Pressure, Temperature,
SpO2 and ECG Measurement)
Operator’s Manual

FORA Vital Signs Monitor VSM100 Pro
About the Manual
The precautions, warnings and notes throughout this manual are very important.
Please read this manual carefully before using VSM100 Pro Vital Signs Monitor.
Version 2.0 2021/05
311-2300200-004

1
SAFETY INFORMATION
WARNING!
A warning statement in this manual identifies hazards that could lead to patient injury,
illness or death. These warnings pertain to the entire VSM100 Pro Vital Signs
Monitor.
CAUTION!
A caution statement in this manual identifies hazards that could lead to minor
personal injury, product damage or property damage.
General Warnings and Cautions
The information in this manual is a comprehensive guide to the operation of the monitor. For the
best results, read this manual thoroughly before using the monitor.
WARNING!
Use this monitor only for the intended use described in this manual.
The monitor is not intended for use without healthcare practitioner's supervision.
If the monitor cannot take a measurement or the measurement readings seem
dubious, check the condition of the patient first.
If any abnormality is found in the patient or the monitor, take appropriate measures,
such as stopping the monitor, to ensure the safety of the patient.
This monitor is not suitable to use around flammable anesthetic mixture with air or
oxygen or nitrous oxide. An explosion may occur.
Do not let the monitor or its flexible cord come into contact with surfaces which are too
hot to touch.
To ensure patient safety, use only the accessories and supplies (i.e., cuffs, hoses,
temperature probes, SpO
2
probe, test strips, etc.) recommended for or supplied with
this monitor. Using unapproved accessories with this monitor can affect patient and/or
operator safety.
Avoid water or any fluid from leaking the connectors (especially AC power input
socket). Should this occur, dry the connectors with a clean cloth immediately. For the
monitor, remove the battery right away and do NOT turn on the monitor, then contact
the customer service for assistance.
Use with the specified AC voltage and frequency.
Do not plug/unplug the AC adapter cable into an AC outlet with wet hands.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
Do not obstruct the mains power switch or position the equipment where the
connection to the mains line can be accidentally disconnected.
No modification of this equipment is allowed.

2
MR UNSAFE!
Do not use the VSM100 Pro during a magnetic resonance imaging (MRI) scanning,
computed tomography (CT) screening, diathermy, radio-frequency identification
(RFID), and electromagnetic security systems.
CAUTION!
Every three months, inspect the blood pressure cuff, SpO
2
cable, and other
accessories for fraying or other damage. Replace if necessary.
Electric shock hazard: An operator may only perform maintenance procedures
specifically described in this manual. For service, contact the customer service.
This monitor complies with the current applicable standards for electromagnetic
interference. As a precaution, avoid using this monitor close to other equipment.
This monitor is composed of high-quality precision parts. Protect it from severe impact
and shock. If it is dropped or damaged, it should be checked by a qualified service
technician for proper operation prior to further use. Do not use this monitor if you
notice any signs of damage. Contact the customer service for assistance.
Do not use the SpO
2
probe with the blood pressure cuff simultaneously on the same
limb. Doing so may result in inaccurate pulse rate and perfusion readings.
Do not use the SpO2 probe during a magnetic resonance imaging (MRI) scanning.
The monitor is waterproof IPX2 degree. However, do not immerse it in water or drip
fluids on heat exhale holes on the rear panel.
When storage space is less than 20 records, the VSM100 Pro will display the
reminder information.
The use of this device is restricted to one patient at a time.
Blood Pressure Warnings and Cautions
These warnings and cautions pertain to the blood pressure feature of this monitor.
WARNING!
Do not wrap the cuff around any of the following locations. Doing so can cause an
accident. Anywhere on the four limbs that a venous pulse is secured, such as where
there is an IV or blood transfusion. Any limb with an artificial dialysis shunt.
When the cuff hose is bent or blocked, there could still be air in the cuff even though
the pressure display reads 0mmHg. This may block the blood flow in the arm, which
may in turn cause peripheral function disorders. In addition, make sure the cuff is
deflated before use.
Avoid compression of the blood pressure hose or cuff tubing. This may cause system
errors to occur in the monitor.
This monitor does not operate effectively on patients who are experiencing
convulsions or tremors.

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CAUTION!
When several blood pressure measurements are taken on the same patient, regularly
check the cuff site and extremity for possible ischemia, purpura, and/or neuropathy.
Wrapping the cuff too loosely may lead to inaccurate results.
ECG Warnings and Cautions
These warnings and cautions pertain to the ECG warnings and cautions.
WARNING!
In order to minimize interference and the danger of burns to the patient, only use
FORA ECG cables. Keep the ECG cable as far away as possible from any
electrosurgical cables. Make sure that the electrosurgical return conductor (neutral) is
properly attached to the patient.
Danger of destroying the monitor during defibrillation! The monitor is type CF
protected only when the original FORA patient cables are used.
Patients with a pacemaker must be observed continuously because the heart rate
from the pacemaker might still be registered in case of a cardiac arrest or some
arrhythmias. Do not rely entirely upon heart rate meter alarm signals. Keep
pacemaker patients under close surveillance.
Pacemaker monitoring is not possible with ECG cables that have unshielded lead
wires. Ensure that only shielded lead wire ECG cables are used when monitoring
patients that have a pacemaker.
FORA recommends to apply a SpO
2
sensor in addition to the ECG measurement and
to set the alarm range for the peripheral pulse (PP) in the range of the heart rate (HR),
or to set the HR source in the SpO
2
menu to SpO
2
.
Caution!
The guidelines in this section are for overview only. They are not a substitute for, nor
do they overrule manufacturers’ documentation and instructions or departmental
procedures.
SpO2Warnings
These warnings and cautions pertain to the SpO
2
feature of this monitor.
WARNING!
The SpO
2
probe and extension cables are intended for use only for pulse oximeter
measurements. Do not attempt to connect these cables to a PC or any other monitor.
Do not use a damaged probe or extension cables.
Incorrect application or extended use of a SpO
2
probe on the same sensor site may
cause incorrect readings. Inspect the sensor site periodically as directed in the

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probe’s directions for use.
Certain ambient environmental conditions, probe application errors, and certain
patient conditions may affect SpO
2
readings and pulse signal.
CAUTION!
The SpO
2
probe is not intended for use as an apnea monitor.
Do not immerse the probe or patient cables in water, solvents, or cleaning solutions
(the sensors and connections are not waterproof).
Do not use irradiation, steam, or ethylene oxide for sterilization.
Consider the SpO
2
as an early warning monitor. As a trend toward patient
deoxygenation is indicated, use laboratory instruments to analyze blood samples to
completely understand the patient’s condition.
The Following Factors May Lead to Inaccurate Results:
►Excessive ambient light
►Excessive motion
►Anemia or low hemoglobin concentrations
►Fingernail polish
►Arterial catheters, blood and infusion lines, etc.
►Cardiovascular dyes
►Improper sensor use
►Incorrect sensor
►Electrosurgical interference
►Venous pulsations
Infrared Thermometer Warnings
CAUTION!
Always store the thermometer in a cool and dry place: temperatures between -4°F to
140°F (-20°C to 60°C), relative humidity 10% to 85%, non-condensing. Avoid direct
sunlight.
Avoid dropping the thermometer from a height or strongly hitting it with a hard object.
Only use the probe covers provided by the manufacturer. For proper hygiene, do not
share probe cover. Damaged probe cover may result in error display.
Do not disassemble the thermometer.
Basic safety precautions should always be observed, especially when the
thermometer is used on or near children and disabled persons.
This thermometer is not intended to be a substitution for consultation with your
physician.
Keep probe covers out of reach of children.
Temperature of left and right ear may differ. Always measure the same ear.

5
Blood Glucose Warnings
WARNING!
Carefully read the owner’s manual of the blood glucose monitoring system before
use.

6
IMPORTANT SAFETY PRECAUTIONS
Read Before Use
Users need to adhere to Standard Precautions when handling or using this device. All parts of
the glucose monitoring system should be considered potentially infectious and are capable of
transmitting blood-borne pathogens between patients and healthcare professionals. For more
information, refer to “Guideline for Isolation Precautions: Preventing Transmission of Infectious
Agents in Healthcare Settings 2007”
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html
The meter should be disinfected after use on each patient. This Blood Glucose Monitoring
System may only be used for testing multiple patients when Standard Precautions and the
manufacturer’s disinfection procedures are followed.
Only auto-disabling, single use lancing devices may be used with this device.
For more information on the risk of blood-borne pathogen transmission from blood glucose meter
and lancing devices, please refer to:
“FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk
for Transmitting Bloodborne Pathogens: Initial Communication” (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

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Table of Contents
INTRODUCTION ........................................................................................................................... 9
Intended Use ......................................................................................................................... 9
Main measurement function ................................................................................................ 9
Contents of System .............................................................................................................. 9
Monitor Overview................................................................................................................ 10
Before Measurement - Connecting Accessories.............................................................. 11
Monitor Main Display Area ................................................................................................. 15
Monitor Functions............................................................................................................... 20
Print ............................................................................................................................... 20
Print ........................................................................................................................... 21
Menu.............................................................................................................................. 21
PERFORM MEASUREMENTS.................................................................................................... 44
SpO
2
Measurement ............................................................................................................. 44
Blood Pressure Measurement ........................................................................................... 46
STAT .............................................................................................................................. 47
ECG Measurement.............................................................................................................. 48
Glucose Measurement........................................................................................................ 52
Before You Begin ........................................................................................................... 52
The Four Measuring Modes........................................................................................... 56
Before Testing................................................................................................................ 56
Testing With Blood Sample............................................................................................ 58
Maintenance .................................................................................................................. 61
System Troubleshooting ................................................................................................ 65
Detailed Information....................................................................................................... 66
Temperature Measurement ................................................................................................ 67
Before You Begin ........................................................................................................... 67
Replacing the Battery .................................................................................................... 69
Using the Device............................................................................................................ 70
Recalling the Memory .................................................................................................... 71
Care & Cleaning ............................................................................................................ 71
ALARM AND MESSAGE ............................................................................................................ 73
TAKING CARE OF THE MONITOR ............................................................................................ 76
Cleaning/ Disinfection ........................................................................................................ 76
Vital-sign Monitor ........................................................................................................... 76
Blood Pressure Cuff....................................................................................................... 76
Cables and Pressure Hose............................................................................................ 76
Temperature Sensor ...................................................................................................... 76
SpO
2
Sensor.................................................................................................................. 77
Battery Removal and Replacement ................................................................................... 77