ReliOn Premier VOICE User Manual

Para un solo usuario / uso domiciliario únicamente

Para el uso con tiras de prueba ReliOn™ Premier únicamente.

Las tiras de prueba se venden por separado.

Manual

del

Usuario

For single user / home use only For use with ReliOn™ Premier Test Strips only. Test strips sold separately.

User Manual

Servicio al cliente

1-855 -776-06 62

De 7 a.m. a 7 p.m., hora del centro,

los 7 días de la semana.

En caso de emergencia, póngase

en contacto con su profesional de

atención médica o con un servicio de

respuesta ante emergencias médicas.

DISTRIBUIDO POR:

Wal-Mart Stores, Inc.

Bentonville, AR 72716

www.ReliOnBGM.com

5404-00 Rev. 07/17

PGK7E1002 Rev0 07/2017

Customer Service

1-855-776 -0662

7a.m.–7p.m. Central time, 7 days a week

In case of emergency, please contact your healthcare professional or emergency medical response.

DISTRIBUTED BY:

Wal-Mart Stores, Inc. Bentonville, AR 72716 www.ReliOnBGM.com

Welcome to the ReliOn™ Premier Voice Blood Glucose Monitoring System

Thank you for choosing the ReliOn™ Premier Voice Blood Glucose Monitoring System. The system provides you with safe, fast and convenient blood glucose in vitro (i.e., outside the body) monitoring. The bilingual talking function of ReliOn™ Premier Voice Meter can be used as an aid for using the meter.

The ReliOn™ Premier Voice Meter is also designed to minimize code related errors in monitoring by using the auto coding function. You’ll receive an accurate result in five seconds with a small 0.5 μL blood sample.

This booklet contains important information about the ReliOn™ Premier Voice Glucose Monitoring System.

Please read it carefully before testing your blood glucose.

Bienvenido al Sistema de monitoreo de glucosa en sangre

ReliOn™ Premier Voice

Gracias por elegir el Sistema de monitoreo de glucosa en sangre

de voz ReliOn™ Premier. El sistema le proporciona un monitoreo

seguro, rápido y cómodo para el control de glucosa en sangre

invitro (es decir, externo). La función de voz bilingüe del medidor

de voz ReliOn™ Premier se puede usar como una ayuda para el

uso delmedidor.

El medidor de voz ReliOn™ Premier también está diseñado para

minimizar los errores relacionados con el código en el monitoreo

mediante el uso de la función con codificación automática.

Usted recibirá un resultado preciso en cinco segundos con una

pequeña muestra de sangre de 0.5 μL.

Este manual contiene información importante acerca del Sistema

de monitoreo de glucosa en sangre de voz ReliOn™ Premier.

Léalo atentamente antes de realizar la prueba de glucosa

en sangre.

Table of Contents

Information

Important Information: Read This First 4 Important Health-related Information 5 Specifications 7 ReliOn™ Premier Voice Blood Glucose Monitoring System (BGMS) 8 Inserting or Replacing the Batteries 9 ReliOn™ Premier Blood Glucose Test Strip 10 ReliOn™ Premier Voice Blood Glucose Meter 12 ReliOn™ Premier Voice Blood Glucose Meter Display 13

Preparation

Setting Up the ReliOn™ Premier Voice System 14 Adjusting Language, Date, Time and Sound 14 Setting the Hypoglycemia Indicator 17 Checking the System 19 Control Solution Testing 20 Comparing the Control Solution Test Results 23

Blood Glucose Testing

Using the Lancing Device 24 Preparing the Lancing Device 25 Preparing the Meter and Test Strip 27 Flagging Post-meal Test Results 28 Applying the Blood Sample 29 Discarding Used Lancets 31 Alternate Site Testing 32 ‘HI’ and ‘Lo’ Messages 35 Target Blood Glucose Ranges 36 Transferring Test Results 37

Additional Functions

Meter Memory 38 Viewing Past Test Averages 38 Viewing Test Results 40 Setting the Alarm Function 41 Setting the Post-meal Alarm (PP2 Alarm) 41 Setting the Time Alarms (Alarm 1–3) 42

Maintenance

Caring for the ReliOn™ Premier Voice System 44 Pre-cleaning and Disinfection 44 Pre-cleaning and Disinfection Procedures 46 Caution: Storage and Handling 49 Understanding Error Messages 50 General Troubleshooting 53 Performance Characteristics 54 Warranty Information 57

Notes 58

Important Information: Read This First

To receive safe and optimum system benefits, please read the entire manual contents before using the system. Please note the following information.

• Do not use the system for diagnosis or screening of diabetes.

• Use only fresh capillary whole blood samples for testing.

• Alternate site and fingertip test results may differ significantly due to rapid changes in the blood glucose level after eating, insulin injection or exercise.

Intended Use

• The ReliOn™ Premier Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh and calf.

• Alternate site testing should be used only during steady-state blood glucose conditions.

• The ReliOn™ Premier Voice Blood Glucose Monitoring System is intended for at-home in vitro (outside the body) self-testing by people with diabetes as an aid in monitoring the effectiveness of diabetes control.

• The system is intended to be used by a single person and should not be shared.

• The system is not intended for use on neonates, and is not for the diagnosis or screening of diabetes.

• ReliOn™ Premier Blood Glucose Test Strips are for use with the ReliOn™ Premier Voice Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites.

• ReliOn™ Premier Control Solutions are for use with the ReliOn™ Premier Voice Meter and ReliOn™ Premier Test Strips to check that the meter and test strips are working together properly, and that the test is performing correctly.

• The

ReliOn™ Premier

Voice Blood Glucose Monitoring System is intended for in vitro (outside the body) diagnostic use only and for the quantitative measurement of glucose in capillary whole blood.

• The

ReliOn™ Premier

Voice Blood Glucose Monitoring System is intended for use by a single user only. Do not share the meter and lancing device with another person.

• The

ReliOn™ Premier

Voice Blood Glucose Meter is designed to minimize code-related errors in monitoring by using the no-coding function.

• Glucose in blood samples reacts with the chemical in the test strip to produce a small electrical current. The

ReliOn™

Premier

Voice Meter converts this electrical current to

glucose concentration.

• The

ReliOn™ Premier

Voice Blood Glucose Meter should be

used only with the

ReliOn™ Premier

Test Strips.

• An abnormally high or low red blood cell count (hematocrit level over 60% or below 20%) may produce inaccurate results.

Important Health-related Information

• Inaccurate results may occur in severely hypotensive (having

low blood pressure) individuals or patients in shock.

• Inaccurate low results may occur for individuals experiencing a

hyperglycemic-hyperosmolar state, with or without ketosis.

• Inaccurate results may occur in patients undergoing

oxygen therapy.

• Critically ill patients should not be tested with blood

glucose meters.

• All parts of this kit are considered biohazardous and can

potentially transmit infectious diseases, even after you have performed pre-cleaning and disinfection.

• For questions or concerns, contact Customer Service:

1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week. At all other times or in case of emergency, please contact your healthcare professional or emergency medical response.

Specifications

Operating ranges

Temperature 50–104˚F (10–40˚C)

Relative humidity 10–90%

Hematocrit 20–60%

Product specifications

Measurement range 20–600 mg/dL Sample size Minimum 0.5 μL Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma-equivalent Assay method Electrochemical Battery life 1,000 tests Power Two alkaline AAA batteries Memory 500 test results

Size 3.90 x 2.21 x 0.75 inches (100 x 56 x 19 mm) Weight

2.47 oz (70 g) with batteries

ReliOn™ Premier Voice Blood Glucose Monitoring System

ReliOn™ Premier Voice Blood Glucose Monitoring System (BGMS) includes the following items:

➊

ReliOn™ Premier Voice Blood Glucose Meter

➋

User Manual

➌

Quick Reference Guide

➍

Batteries

➎

Logbook

➏

Carry Case

• Check all the components after opening the ReliOn™

Premier Voice Blood Glucose Monitoring System package.

• ReliOn™ Premier Control Solutions are necessary but

not included.

• ReliOn™ Premier Control Solutions and data cable for the

diabetes management system can be ordered separately by contacting Customer Service:

1-855-776-0662, 7 a.m. to 7 p.m.

Central time, 7 days a week.

CAUTION

• The meter and lancing device are for single-patient use.

• DO NOT share them with anyone including other

family members.

• DO NOT use on multiple patients.

Inserting or Replacing the Batteries

Step 1

Make sure the meter is turned off. Press firmly on the battery cover and slide in the direction of the arrow. Then swing it open.

Step 2

Remove the used batteries and insert the two new batteries. Close the battery cover firmly.

• The ReliOn™ Premier Voice Meter uses two AAA alkaline

batteries.

• Before using the meter, check the battery compartment and

insert batteries if empty.

• When the

symbol appears on the display while the meter

is in use, the batteries should be replaced as soon as possible.

• Test results may not be saved if the batteries run out completely.

NOTE

• Removing the meter batteries will not

affect your stored results. However, meter setting may need to be reset, see page 14.

ReliOn™ Premier Blood Glucose Test Strip

The ReliOn™ Premier Voice Blood Glucose Monitoring System measures blood glucose quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the strip.

Important Safety Instructions

• All components that come into contact with blood samples should be considered to be biohazardous and capable of transmitting viral diseases, even after disinfection.

• Do not share the meter or lancing device with another person.

• The ReliOn™ Premier Test Strips should be used only with fresh

capillary whole blood samples.

• Do not reuse test strips.

Insert

Contact bars

Gently push the test strip, with its contact bars facing up, into the test strip port of meter

Confirmation window

Check here to see whether sufficient blood sample has been applied

Edge to apply blood sample

Apply blood sample here for testing

• Do not use ReliOn™ Premier Test Strips beyond the expiration

date. This may cause inaccurate results.

• When test strips are used and stored according to correct storage and handling methods, both new, unopened vials and vials that have been opened can be used until the expiration date printed on the test strip box and vial label.

• Store test strips in a cool and dry place at a temperature between 34–86˚F (1–30˚C).

• Keep test strips away from direct sunlight or heat, and do not freeze.

• Store test strips only in their original vial.

• Close the vial tightly after taking out a test strip for testing and use the test strip immediately.

• Handle test strips only with clean, dry hands.

• Do not bend, cut or alter test strips in any way.

• For detailed storage and usage information, refer to the ReliOn™ Premier Test Strips package insert.

• Keep meter and testing supplies away from young children.

NOTE

• You can get more safety information at FDA Public

Health Notification (www.fda.gov/medicaldevices/safety/ alertsandnotices/ucm234889.htm) or at CDC Clinical Reminder (www.cdc.gov/injectionsafety/FingerstickDevicesBGM.html).

ReliOn™ Premier Voice Blood Glucose Meter

Data Port

Used to transfer data from the meter to a computer with a data cable

Button

Turns the meter on/off, confirms menu selections

< Button

Selects or changes information

Display

Shows results and messages

Test Strip Port

Insert test strip here

> Button

Selects or changes information

Speaker

Announces each step

Test Strip Ejector

Slide down to discard used strips

NOTE

• The data cable for the data management software can be

ordered separately. Please contact Customer Service: 1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week.

ReliOn™ Premier Voice Blood Glucose Meter Display

alarm:

appears when the time alarm

has been set

mem: appears when test results

stored in the memory are displayed

ctl: appears when the control

solution test results are displayed

Test results Blood insertion symbol: indicates

meter is ready for the application of a drop of blood or control solution

Temperature symbol

Post-meal test flag: appears during post-meal testing and

when post-meal test results are displayed

Hypoglycemia symbol: appears when the test result is

below the hypoglycemic level

Post-meal alarm symbol: appears when the post-meal

alarm has been set

Mute symbol: appears only when the sound is set to ‘OFF’

Battery symbol: indicates meter batteries are running low

and need to be replaced

mg/dL: unit for measuring blood glucose Date / temperature Time

13 14

NOTE

• It is recommended to check if the display screen on the meter matches the illustration above every time the meter turns on.

• Do not use the meter if the display screen does not exactly match the illustration as the meter may show incorrect results.

07 08 09

02 03

06 11

Setting Up the ReliOn™ Premier Voice System

Meter settings, such as time and date, should be checked and updated before using the meter or after changing the meter batteries.

Press and hold the

button for 3 seconds to enter the ‘SET’ mode. While setting up the meter, current settings will appear on the display. The meter will also announce each function when the talking function is on. Press and hold the < or > button to scroll faster. To complete the settings and exit from the ‘SET’ mode, press and hold the

button for 3 seconds again.

Adjusting Language, Date, Time and Sound

Step 1 Entering the ‘SET’ Mode

Press and hold the button for 3 seconds. After all the segments flash across the screen, ‘SET’ is displayed on the screen. If the talking function is on, the meter will say “Set meter.” Press the button again to progress to the next step.

Step 2 Selecting a Language

The meter has a bilingual, talking function that can be used as a verbal aid for using the meter and hearing test results.

When entering the language selection mode for the first time, ‘L1’ will be blinking and the meter will announce “Language Selection” in the default language, English.

To select another language (L2, Spanish), press the < or > button. Press the

button to confirm the language and

progress to the next step.

Step 4 Setting the Month

A number indicating the month will blink on the bottom left corner of the screen. If the talking function is on, the meter will say “Set month.” Press

the < or > button

until the

correct month appears. Press the

button to confirm the selection and progress to the next step.

Step 5 Setting the Date

The meter will say “Set date” when the talking function is on. Press

the < or > button

until blinking number shows the correct date. Press the

button to confirm the date and progress

to the next step.

Step 3 Setting the Year

The meter will say “Set year” if the talking function is on. Press

the < or > button

until correct year appears. Press and hold the

> button to scroll faster. After setting the year, press the button to confirm the selection and progress to the next step.

Step 6 Setting the Time Format

The meter can be set in the 12-hour (AM/PM) or the 24-hour clock format.

If the talking function is on, the meter will say “Set time 12-hour / 24-hour.” Press

the < or >

button

to select a format. The AM/PM is not displayed in the 24-hour format. After selecting the format, press the

button to progress to the

next step.

Step 8 Setting the Minute

If the talking function is on, the meter will say “Set minute.” Press

the < or > button

until the correct minute appears. After setting the minute, press the

button to progress to the next step.

Step 7 Setting the Hour

If the talking function is on, the meter will say “Set hour.” Press

the < or > button

until the correct

hour appears. Press the

button to confirm the

hour and progress to the next step.

Step 9 Turning the Sound On/Off

A number showing the sound volume will blink and the meter will say “Set volume.” Press

the < or >

button to adjust the volume from 1 (lowest) to 3 (highest), or to turn the beep sound ‘OFF’ or ‘On’.

When ‘beep On’ is selected, the meter will beep instead of announcing messages. To turn off the sound, press the

button

when ‘OFF’ blinks on the display. Then the

symbol will appear

on the display and the meter will be muted. Press the

button

to save the setting and progress to the next step.

NOTE

•

symbol is displayed only when the sound is set to ‘OFF.’

Setting the Hypoglycemia Indicator

The meter can indicate a possible low blood glucose test result (hypoglycemia). The hypoglycemia level can be selected from a level of 60 to 20 mg/dL.

Step 10 Turning on the Hypoglycemia Indicator

When entering the hypoglycemia indicator setting mode, the symbol and ‘HYPo’ will blink. If the talking function is on, the meter will say “Set hypoglycemia indicator.” On pressing the

< or >

button, the screen will

display ‘On’ or ‘OFF.’ Press

button to set the hypoglycemia level if ‘On’ is selected. The screen will return to step 2, language selection mode, if ‘OFF’ is selected.

CAUTION

• Ask your healthcare professional to help you decide what your

hypoglycemia level is before setting your hypoglycemic level.

Step 12 Exiting from Set Mode

After completing the meter settings, press and hold the button for 3 seconds to confirm all settings and exit the ‘SET’ mode. If the talking function is on, the meter will announce the set date and time for confirmation.

Step 11 Setting Your Hypoglycemic Level

The hypoglycemic level can be set from 60 to 20 mg/dL. To set your hypoglycemic level, press the

< or > button until the level you want appears. Press the

button to confirm. Then the screen will return to step 2, language selection mode (See page 14).

Checking the System

ReliOn™ Premier Voice Meter and Test Strips should be checked using ReliOn™ Premier Control Solutions, available in two levels (Level 1 and 2). ReliOn™ Premier Control Solutions contain known amounts of glucose and are used to check that the meter and test strips are working properly.

The test strip vials have ReliOn™ Premier Control Solution ranges printed on their labels. Compare the result displayed on the meter to the control solution range printed on the test strip vial.

Before using a new meter or a new vial of test strips, you should conduct a control solution test following the procedure on pages 20-22 with ReliOn™ Premier Control Solutions.

NOTE

• Use ReliOn™ Premier Control Solutions only.

• Check the expiration dates printed on the bottle. When the control solution bottle is first opened, record the discard date (date opened plus three (3) months) in the space provided on the label.

• Make sure the meter, test strips and control solutions are at room temperature before testing. Control solution tests must be done at room temperature (68–77˚F, 20–25˚C).

• Before using the control solution, shake the bottle, discard the first 1 or 2 drops and wipe the tip clean.

• Close the control solution bottle tightly and store at a temperature between 46–86˚F (8–30˚C).

Use ReliOn™ Premier Control Solution when:

• You want to practice the test procedure, instead of using blood

• You use the meter for the first time

• You begin using a new vial of test strips

• You suspect that the meter or the strips are not working properly

• You think your test results are inaccurate or they do not reflect how you feel

• The meter is dropped or damaged

Step 1

Insert a test strip into the meter’s test strip port, with the contact bars facing upwards. Gently push the test strip into the port until the meter automatically turns on and the symbol appears. If the talking function is on, the meter will say “Blood glucose test. Please apply blood onto the test strip.”

Control Solution Testing

Step 2

While the symbol blinks, press and hold the <

button for 3 seconds until ‘ctl’ appears on the display. If the talking function is on, the meter will say “Control solution test. Please apply control solution onto the test strip.”

Step 3

Shake the ReliOn™ Premier Control Solution bottle well before each test. Remove the cap and squeeze the bottle to discard the first 1 or 2 drops.

Then wipe the tip with a clean tissue or cloth. While the

symbol blinks, apply the control solution to the narrow edge of the test strip until the meter beeps. Make sure the confirmation window of test strip fills completely.

NOTE

• The meter may switch off if the control solution is not applied

within 2 minutes of the

symbol appearing on

the screen.

• If the meter turns off, remove the strip, reinsert and start

from step 2.

CAUTION

• The ranges printed on the test strip vial are for ReliOn™

Premier Control Solutions only.

• They do not have any connection to your blood glucose level.

Step 5

Compare the result displayed on the meter to the range printed on the test strip vial. The result should fall within that range.

Step 6

Slide the test strip ejector button to discard the used test strip safely in a disposable container.

Step 4

A test result will appear after the meter counts down from 5 to 1. If the talking function is on, test result will be announced.

If step 2 is missed, the test result can be marked as a control solution test result by pressing and holding the

button for 3 seconds until ‘ctl’

appears on the display. When ‘ctl’ is displayed, the result is stored in the meter’s

memory but is not included in the averages.

Comparing the Control Solution Test Results

The test result of each control solution should be within the range printed on the label of test strip vial. Repeat the control solution test if the test result falls outside of this range.

Out of range results may occur due to the following factors.

Situations Actions

• When the control solution bottle was not shaken well

• When the meter, test strip or the control solution were exposed to high or low temperatures

• When the first one or two drops of the control solution were not discarded or the tip of the vial was not wiped clean

•

When the meter is not functioning properly

Repeat the control solution test by referring to the ‘NOTE’ on page 19.

• When the control solution is past the expiration date printed on the bottle

• When the control solution is past its discard date (the date the bottle was opened plus three (3) months)

• When the control solution is contaminated

Discard the used control solution and repeat the test using a new bottle of control solution.

If results continue to fall outside the range printed on the test strip vial, the ReliOn™ Premier Voice Meter and ReliOn™ Premier Test Strips may NOT be working properly. Do not use your system and contact Customer Service:

1-855-776-0662, 7 a.m. to

7 p.m. Central time, 7 days a week.

NOTE

• The ReliOn™ Premier Control Solutions can be purchased separately. Contact Customer Service: 1-855-776-0662.

Using the Lancing Device (sold separately)

A lancing device, such as the ReliOn™ Lancing Device (sold separately), is needed in order to collect a blood sample.

Adjustable Cap Charger

Release Button

Lancet

• The lancing device is for use by a single user only and should not be shared with anyone including other family members.

Lancet Holder

CAUTION

To reduce the chance of infection

• All components that come into contact with blood samples should be considered to be biohazardous and capable of transmitting viral diseases, even after disinfection.

• Do not use a lancet that has been used by another person and never share your meter and lancing device with anyone.

• Wash your hands thoroughly with soap and water after handling your meter, lancing device or test strips.

• Keep your meter and lancing device clean. See the pre-cleaning and disinfection section on page 44.

NOTE

• Repeated puncturing at the same sample site may cause

pain or skin calluses (thick hard skin).

• Choose a different site each time you test.

Step 1

Wash hands and the sample site with soap and warm water. Rinse and dry thoroughly.

Preparing the Lancing Device

Step 2

Pull the adjustable cap sideways to remove.

Step 3

Insert a new disposable lancet firmly into the lancet holder. Twist off the protective cover of the lancet and set it aside, then replace the adjustable tip. Keep the protective cover to replace on top of the used lancet after testing.

Step 4

The lancing device has five puncture depth settings. The shorter lines are for a shallower puncture and the longer lines are for a deeper puncture. Adjust the depth of puncture as necessary.

Step 5

Cock the lancing device by holding the body in one hand and pulling on the charger. A click may be heard.

NOTE

• The skin depth to retrieve samples will vary for various people

at different sample sites.

• The lancing device’s adjustable tip allows the best depth of

skin penetration for an adequate sample size.

• A beginning setting of three (3) is recommended.

Step 6

Insert a test strip with the contact bars facing up into the meter’s test strip port.

Push the test strip gently into the test strip port until the meter automatically turns on and the

symbol appears.

If the talking function is on, the meter will say “Blood glucose test. Please apply blood onto the test strip.”

Preparing the Meter and Test Strip

Step 7

To attach a post-meal flag ( ) to a test result, press and hold the

button for 3 seconds

after inserting the test strip. The post-meal flag (

) and the symbol will

appear on the screen. If the talking function is on, the meter will say

“Post-meal test. Please apply blood onto the test strip.”

The test result will also be displayed with the post-meal flag (

If you do not want to save the result as a post-meal test, move on to Step 8 after Step 6. If you want to delete the post-meal flag ( ) that has been attached, press and hold the > button for 3 seconds again before applying the blood sample or when the test result is displayed just after testing.

Flagging Post-meal Test Results

ReliOn™ Premier Voice Meter allows post-meal test to be flagged with

symbol.

The post-meal flag (

) can be attached and deleted just before applying the blood sample or when the test result is displayed just after testing.

Once the test result is saved with the post-meal flag (

), it

cannot be deleted.

Step 9

After the symbol appears on the screen, apply the blood sample to the narrow end of the test strip until the meter beeps.

If the blood sample does not fill the confirmation window completely, an ‘Er4’ message may appear because of abnormal viscosity or insufficient volume.

If the talking function is on, the meter will say “Error four. The sample was not enough or too thick.”

Then discard the test strip, insert a new one and apply the blood sample again after

symbol appears on the screen.

Step 8

Obtain a blood sample using the lancing device. Place the device against the pad of the finger. The best puncture sites are on the middle or ring fingers.

Press the release button. Remove the lancing device from the finger. Wait a few seconds for a blood drop to form.

A minimum volume of 0.5 microliter is needed to fill the confirmation window.

Applying the Blood Sample

Good

Sample

Insufficient

Sample

Approximate size

Step 10

The test result will appear after the meter counts down from 5 to 1.

If the talking function is on, the result will be announced.

The result will be automatically stored in the meter memory.

Step 11

Discard the used test strip safely in a disposable container by pushing up the test strip ejector.

If the test strip is removed after the test result is displayed, the meter will automatically turn off after 3 seconds.

NOTE

• The meter may switch off if the blood sample is not applied within 2 minutes of the

symbol appearing on the screen.

• If the meter turns off, remove the strip, reinsert and start from step 7.

+ 84 hidden pages

ReliOn Premier VOICE User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual