FOR-A D40 Pro Guía de referencia

BLOOD GLUCOSE PLUS BLOOD PRESSURE

MONITORING SYSTEM

Operations & Procedures Manual

Long-Term Care

D40 Pro

Thank you for purchasing the FORA D40 Pro Blood Glucose Plus Blood Pressure

Monitoring System. This manual provides important information to help you use

the system properly. Before using this product, please read the following contents

thoroughly and carefully.

If you have other questions regarding this product, please contact the place of purchase

or call Customer Service at 1-888-307-8188.

The FORA D40 Pro is intended for multi-patient use in a long-term care or home health

care setting. Please note that the following procedures are provided only as a model

to help your facility establish its own policy and procedures. Your own policy may differ

depending upon the existing procedures. Please consult with the Director of Nursing for

further guidance.

CAUTION: Please carefully read the User’s Manual and all product instructions before

using this Long-Term Care and Home Health Care Manual and administering blood

glucose and blood pressure tests.

TABLE OF CONTENTS

IMPORTANT SAFETY PRECAUTIONS 06

Interfering Substances 07

BEFORE YOU BEGIN 08

INTENDED USE 08

TEST PRINCIPLE 08

METER OVERVIEW 09

Display Screen 10

Test Strip 10

Setting the Meter 11

THE FOUR MEASURING MODES 12

BEFORE TESTING 13

Control Solution Testing 13

Performing a Control Solution Test 13

BLOOD GLUCOSE TESTING 15

Preparing the Puncture Site 15

Alternative Site Testing 16

Performing a Blood Glucose Test 17

TESTING THE BLOOD PRESSURE 18

Before Measurement 18

Fitting the Cuff Correctly 19

Proper Measurement Position 19

Taking Measurements 20

METER MEMORY 21

Reviewing Test Results 21

Reviewing Day Average Results 22

MAINTENANCE 22

Battery 22

Replacing the Battery 23

Recharging the Battery 24

CLEANING AND DISINFECTING PROCEDURES 24

Caring for Your Meter 24

Disinfecting Procedures 25

Cleaning 26

Meter Storage 26

Important Test Strip Information 27

Important Control Solution Information 27

SYSTEM TROUBLESHOOTING 28

Result Readings 28

Error Messages 28

Troubleshooting 29

SPECIFICATIONS 30

TRAINING TOOLS 31

Attachment 1: FORA D40 Pro Blood Glucose Plus Blood Pressure Monitoring System Training Checklist 31

Attachment 2: FORA D40 Pro Blood Glucose Plus Blood Pressure Monitoring System Training Quiz 32

Attachment 3: FORA D40 Pro Blood Glucose Plus Blood Pressure Monitoring System Quality Control 33

Results Record

Notes 34

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

Users should 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

bloodborne 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system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.

1. Use this device ONLY for the intended use described in this manual.

2. DO NOTuseaccessorieswhicharenotspeciedbythemanufacturer.

3. DO NOT use the device if it is not working properly or if it is damaged.

4. DO NOT under any circumstances use the device on newborns or infants.

5. This device does NOT serve as a cure for any symptoms or diseases. The data measured is for

reference only.

6. Before using this device to test blood glucose, read all instructions thoroughly and practice the test.

Carry out all the quality control checks as directed.

7. Keep the device and testing equipment away from young children. Small items such as the battery

cover, batteries, test strips, lancets and vial caps are choking hazards.

8.Keepthedeviceanditsexiblecordawayfromhotsurfaces.

9. DO NOT apply the cuff to areas other than the place directed.

10. Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic

clothing, carpets, etc.) may cause damaging static discharges that may cause erroneous results.

11. DO NOT use this instrument in close proximity to sources of strong electromagnetic radiation, as

these may interfere with the accurate operation.

12. Proper maintenance and periodic control solution tests are essential to the longevity of your

device. If you are concerned about your accuracy of measurement, please contact customer

service or place of purchase for help.

Interfering Substances

Interfering substances depend on concentration. The interfering substances listed below will have no

effect up to the limiting concentration level noted.

Substance Limiting Concentration

(mg/dL)

Therapeutic /

Physiological Concentration Range

(or Upper Limit) (mg/dL)

Acetaminophen 6.25 0.45 - 3

Ascorbic Acid 5 2

Dopamine 1.25 0.03

Levodopa 1.4 0.02 - 0.28

Methyldopa 1.25 0.1 - 0.5

Tolazamide 12.5 1.6

Galactose 250 < 5

Mannose 250 1.15

Glutathione Reduced 23 47 - 100 (Intracellular)

Hemoglobin

(Hemolysis Method) 100 2.5

Pralidoxime Iodide 5 ~ 10 (IV Dose 500 mg)

BEFORE YOU BEGIN

Severe dehydration and excessive water loss

may cause readings which are lower than actual

values. If the patient is suffering from severe

dehydration, consult a healthcare professional

immediately.

●Ifthepatient’sbloodglucoseresultsarelower

or higher than usual, and does not have any

 symptomsofillness,rstrepeatthetest.Ifthe

patient has symptoms or continues to get

results which are higher or lower than usual,

follow the treatment advice of a healthcare

professional.

●Useonlyfreshwholebloodsamplestotest

patient’s blood glucose. Using other substances

will lead to incorrect results.

●Ifthepatienthassymptomsthatare  

inconsistent with the blood glucose test results

and you have followed all the instructions given

in this owner’s manual, contact a healthcare

professional.

●Wedonotrecommendusingthisproducton

severely hypotensive individuals or patients in

shock. Readings which are lower than actual

values may occur for individuals experiencing

a hyperglycemic-hyperosmolar state, with or

without ketosis. Please consult a healthcare

professional before use.

●Criticallyillpatientsshouldnotbetestedwitha

blood glucose monitoring system.

freshcapillarywholebloodfromthengerand

the following alternative sites: palm, forearm or

upperarm. This system is intended for

multiple-patient use in professional healthcare

settings as an aid to monitor the effectiveness of

diabetes control. This system is only used with

single-use auto-disabling lancing devices.

The system should not be used for the diagnosis

of or screening for diabetes, nor for neonatal use.

Alternative site testing such as the palm, forearm,

and upper arm should be done only during

steady state times (when glucose is not changing

rapidly).

This system is also intended to be used to

non-invasively measure the systolic and diastolic

blood pressure and pulse rate of an adult

individual. The blood pressure is measured by

usinganinatablecuffwrappedaroundthearm.

INTENDED USE

The FORA D40 Pro Blood Glucose Plus Blood

Pressure Monitoring System is intended for use in

the quantitative measurement of glucose in

TEST PRINCIPLE

Your system measures the amount of sugar

(glucose) in whole blood. The glucose testing is

based on the measurement of electrical current

generated by the reaction of glucose with the

reagent of the strip. The meter measures the

current, calculates the blood glucose level, and

displays the result. The strength of the current

produced by the reaction depends on the amount

of glucose in the blood sample.

The blood pressure is measured non-invasively at

the arm based on the Oscillometric method. This

device is NOT able to take measurements in the

presence of common arrhythmia, such as atrial or

ventricularprematurebeatsoratrialbrillation;it

may produce reading errors.

METER OVERVIEW Display Screen

RF Button

Assists you with wireless data transmission.

S Button

Enterandconrmthemetersettings.

M Button

Enter the meter memory.

AVERAGE Button

Assists you with blood pressure average

mode.

ON/OFF Button

Starts a single non-invasive blood pressure

measurement.

Power Indicator

Indicates the power status of the device.

RF Indicator

Indicates a wireless data transmission.

Test Slot

Insert test strip here to turn the meter on for

testing.

Battery Compartment

Strip Ejector

Eject the used strip by pushing this button

up.

AC/DC Adapter Port

Connects to a power supply.

Pressure Cuff

Air Tube

Air Plug

Connects to air jack.

Air Jack

89 7

Absorbent Hole

Touch a drop of blood here, blood will

be automatically drawn in.

Test Strip Handle

Hold this part to insert the test strip into the

slot.

Contact Bars

Insert this end of the test strip into the meter.

Pushitinrmlyuntilitwillgonofurther.

Conrmation Window

Thisiswhereyouconrmifenoughblood

has been applied to the absorbent hole in the

strip.

Test Strip

ATTENTION:

The front side of the test strip should

face up when inserting test strip.

Test results might be wrong if the contact

bar is not fully inserted into the test slot.

NOTE:

The FORA D40 Pro meter should only be used with FORA

D40 Pro Test Strips. Using other test strips with this meter can

produce inaccurate results.

Date

Systolic Pressure Symbol

Measuring Mode

Systolic Pressure Value

Diastolic Pressure Symbol

Diastolic Pressure Value

Volume Symbol

Ketone Warning

Heart Symbol for IHB Detection

(Irregular Heart Beat)

Pulse Rate

Day Average Result

Battery Symbol

Memory Mode Symbol

Unit for Blood Pressure

Unit for Blood Glucose

Time

Test Strip Symbol

Blood Drop Symbol

Display Screen

1718

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