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.

3
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

8
SpO
2
Accessory Disposal .................................................................................................. 77
ECG Accessory Disposal ................................................................................................... 77
Technical Assistance.......................................................................................................... 77
ERROR MESSAGES................................................................................................................... 79
Blood Pressure Measurement Error Messages ............................................................... 79
SpO
2
Measurement Error Messages ................................................................................. 79
Blood Glucose Measurement Error Messages................................................................. 79
Ear Temperature Measurement Error Messages.............................................................. 80
SPECIFICATIONS ....................................................................................................................... 82
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC).. 86

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INTRODUCTION
Intended Use
The Vital Signs Monitor is intended for the monitoring of parameters such as ECG,
non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate,
body temperature, blood glucose, and oxygen saturation of arterial hemoglobin (SpO2) of
adult patient. The monitor is intended to be used by clinicians and medically qualified
personnel and trained users.
Main measurement function
- NIBP (Non-Invasive Blood Pressure)
- SpO
2
- Infrared thermometer
- Blood glucose Meter
- ECG
Contents of System
1. Main monitor
2. Infrared thermometer
3. Probe cover of infrared thermometer
4. Blood glucose meter
5. Blood glucose test strip (10 strips)
6. Safety lancet (10 pieces)
7. SpO
2
sensor and extension cable
8. ECG cable
9. NIBP upper arm cuff and extension hose
10. AC power cord
11. Warranty card
12. ECG electrode pads (5 pieces)
13. SD memory card
14. Probe cover cassette (16 pcs)

10
Monitor Overview
1. Blood glucose meter
2. Smart card reader
3. Non-invasive blood pressure (NIBP) measurement button
(When PUMP indicator lights up, press the button to start a NIBP measurement. For
emergency stop during the measurement, press this button again)
4. Silence button (When the alarm sounds, press this button to temporarily mute the
audio. Refer to page 73 for more information.)
5. SpO
2
sensor connection port
6. ECG cable connection port
7. NIBP pressure hose connection port
8. Infrared thermometer
9. Power On/Off button
10. Power display LED
11. RF LED
12. USB LED
13. Alarm LED

11
Before Measurement - Connecting Accessories
Start with the monitor off, and connect all accessories to the monitor. The following figures
show the accessary ports on the front and back panels. (For reference only, some of the
accessories show may differ from actual products).
Accessary ports on the front panel
1. SpO
2
sensor connection port
2. ECG cable connection port
3. NIBP pressure hose connection
port
Accessary ports on the back panel
1. Printer port
2. SIM/SD memory card slot
3. Barcode
4. Power switch
5. USB connector
6. AC power cord

12
Accessories of VSM100 Pro include:
1. SpO
2
finger sensor and extension cable
Note:
If you are going to change the sensor, make sure you choose the corresponding brand
to your model.
In case you have to use a different brand, please consult your agent firstly.
2. NIBP pressure cuff and hose
3. ECG cable
Note:
Color code: the colors shown here are according to IEC requirements.

13
4. Barcode scanner (Optional)
5. AC power cord
Note:
Without this item, the monitor can still work until the battery run out.
Different specifications of AC power cord are for different countries. Make sure you
use the correct one in your country.
Use this AC power cord to recharge the battery. It takes approximately 5 hours for the
battery to get fully recharged.
6. Rolling stand (Optional)
This stand is for moving the monitor conveniently. The monitor can work well without
this stand. Refer to the rolling stand manual.

14
CAUTION!
Make sure that all accessories are securely connected to monitor before
performing any test, or it may cause inaccurate results.
Note:
Before taking measurements, please pair up the glucose meter (please refer to page
32) and infrared thermometer (please refer to page 34) with the monitor and
the cuff is completely evacuated.
Use only recommended accessories with the monitor.
The monitor is equipped with a Lithium-ion rechargeable battery. When using the
monitor for the first time or the battery is low, connect the monitor to a power source
and charge the battery. It takes approximately 5 hours to fully charge the battery.

15
Monitor Main Display Area
Area
Description
1
ECG display area
Display ECG-related info
2
SpO
2
display area
Display SpO
2
-related info
3
>> button
Display ECG- different channel
4
Print button
Touch this button to print out the readings
5
Print button (ECG)
Touch this button to save the ECG data and to print
out the ECG waveforms
6
Menu button
Touch this button to change settings
7
STAT button
Touch this button for a 5-min consecutive
measurement
8
Temperature display area
Display temperature-related info
9
Blood glucose display area
Display blood-glucose-related info
10
SpO
2
display area
Display SpO
2
-related info
11
NIBP display area
Display NIBP-related info
12
Heart rate display area Display heart-rate-related info
13
Status indicator display area
Display status indicators
14
Date / Time
Display date and time
You may key in the date and time
15
Patient’s info
Display the patient’s ID

16
For details, please refer to the following sections.
Note:
To view or change related settings, directly touch SpO
2
, BG, Temp, HR, NIBP areas.
When a reading exceeds the set alarm limit, the reading turns red.
If the time and date display on the main screen shows red, which indicates an error
appeared. Please switch off the power switch in the back of monitor. After waiting for 2
minutes, re-switch it on.
ECG Display Area
SpO
2
display area
Note:
When the sensor is disconnected, the waveform disappears; the SpO
2
reading remains
for 30 seconds and then disappears.
>> button
Display ECG-different channel.
Print button
Touch this button to print out the readings. Please refer to page 20.
Note:
When you touch this button, the monitor beeps. However, the monitor does not detect
whether a printer is connected. Please make sure the printer is well connected.
Lead II signal
Lead I signal
Pulse waveform Pulse signal amplitude and
signal quality display
SpO
2
reading
A
larm lower limit
Alarm upper limit

17
Print button (ECG)
Touch this button to save the ECG data and to print out the ECG waveforms.
Note:
When you touch this button, the monitor beeps. However, the monitor does not detect
whether a printer is connected. Please make sure the printer is well connected.
Menu button
Touch this button to enter setup menu. Please refer to page 21.
STAT
Touch this button for a 5-min consecutive measurement.
Temperature display area
Blood glucose display area
SpO
2
display area
Measurement unit
Temperature reading
Measurement unit
Blood glucose reading
Pulse waveform Pulse signal amplitude
SpO
2
reading
Alarm lower limit
Alarm upper limit