Body
Analyzer 1
Digital Scale &
Body Analyzer
Instruction Manual
mylifemyshop.com
1
Congratulations
on your My Life My Shop purchase.
The Body Analyzer 1 professional scale &
measurement system allows you to keep track
of your weight, body fat, muscle mass, water
weight, and bone density, helping you maintain
a healthy lifestyle.
To get the most out of your new digital body
analyzer and ensure your safety, read this
instruction manual prior to use.
Safety instuctions and symbols are located in
the back.
Please follow these instructions carefully, and
keep this manual for future reference.
For assistance,
call 1-888-870-2132 or visit us at:
mylifemyshop.com
Read this manual thoroughly before use
TABLE OF CONTENTS
Device Components ..............................................................................................................................................4
Getting Started ..........................................................................................................................................................5
Setting Up Users .......................................................................................................................................................6
Taking a Measurement ........................................................................................................................................7
Replacing the Batteries ........................................................................................................................................9
2 Year Warranty ..................................................................................................................................................... 10
How the Body Analyzer 1 Works ................................................................................................................. 11
Muscle Mass Percentage ..................................................................................................................................12
Body Fat Percentage ........................................................................................................................................... 13
Bone Density ..............................................................................................................................................................14
Water Weight Percentage ...............................................................................................................................15
Frequently Asked Questions.......................................................................................................................... 16
Care & Maintenance ............................................................................................................................................17
Caution ...........................................................................................................................................................................18
FCC Regulations ......................................................................................................................................................18
Safety Information ..............................................................................................................................................20
Warning Indicators ...............................................................................................................................................20
Device Specifications ...........................................................................................................................................21
Equipment Classification & General Use .............................................................................................. 22
mylifemyshop.com
DEVICE COMPONENTS
4
5
9
1
2
3
8
10
11
6
7
1
User Type
choose between male, female, & athlete
2
Weight
displays measurement of weight
3
Water Weight Percentage
displays the percentage of the weight reading that is
water weight
4
Units of Measure
allows you to display weight measurements in pounds,
kilograms, or stones
5
Body Fat Percentage
displays the percentage of the weight reading that is
body fat
6
Bone Density
displays the percentage of the weight reading that is
bone mass
4
mylifemyshop.com
7
Muscle Mass
displays the percentage of the weight reading that is
muscle mass
Contact Plates
8
these stainless steel plates allow a small electrical
current needed to perform the analysis to pass into
your body
Up Selection Indicator
9
allows you to navigate “up” when adjusting settings on
the scale
10
The Set Button
allows you to enter the scales “settings” mode and to
make selections
Down Selection Indicator
11
allows you to navigate “down” when adjusting settings
on the scale
GETTING STARTED
Preparing Your Body Analyzer
1. Open the battery compartment on the scale’s underside.
2. Insert batteries (4x AAA) observing the polarity signs (+ and -) inside
the battery compartment.
3. Close the battery compartment.
4. Select kg, st, or lb weight mode by pressing the tab on the back of the
scale.
6. Position scale on a hard, flat surface.
Initializing Your Scale
The first time you use your scale and anytime you move your scale it will
need to be initialized so that it weighs you properly. Follow these quick
steps to initialize your scale (after removing the insulating strip).
1. Place your scale on a hard, flat surface—not carpet.
2. Press down on the center of the platform with your foot, then lift your
foot off.
3. “0.0” will display on the screen.
4. Once the scale shuts down, it is ready to use; simply step on the scale
to take your measurements.
mylifemyshop.com
5
SETTING UP USERS
1. Press any button to activate the setup procedure.
2. Within 3 seconds, select a user number by pressing the Up or Down
buttons. Press Set to confirm.
3. The male or female symbol will begin to blink. Use the Up or Down button to
cycle through the icons and press the Set button to select the one that best
identifies you.
Male Female
Athlete Mode:
An athlete is defined as a person who is involved in intense physical activity for approximately 12
hours per week and who has a resting heart rate of approximately 60 beats per minute or less.
Male
Athlete
Female
Athlete
4. The height display will now begin to blink. Press the Up and Down buttons
to adjust to your height then press the Set button to confirm.
5. The age display will now begin to blink. Press the Up and Down buttons to
adjust to your age then press the Set button to confirm.
6. The display will show “0.0” before turning off. The user settings are
now saved.
Repeat procedure to configure up to 8 unique users (ex: P1) or to change
specific user details. Once a user has been created it can me modified but
not deleted.
6
mylifemyshop.com
TAKING A MEASUREMENT
Your First Measurement
1. If you have not taken a measurement before, use the Up and Down
arrows to select the user profile that identifies you.
2. Make sure your scale is on a hard, flat surface (not carpet) and has
been initialized.
3. When the screen displays “0.0,” step onto the scale with your bare
feet and ensure your feet are in good contact with the 4 stainless steel
contact pads on the platform.
• The condition of your skin on the bottom of your feet can affect
the reading. To get the most accurate and consistent reading, wipe
your feet with a damp cloth, leaving them slightly moist before
stepping on the scale.
4. Stand still, and remain on your Body Analyzer 1 until the complete
readout is displayed.
5. Your weight will display, followed by a series of moving measurement
indicators.
6. After 2-3 seconds, your weight will be joined by your body fat %, body
water %, muscle mass %, and bone density measurements.
7. You may step off of the scale; the measurements will continue to be
displayed for 10 seconds, after which time the scale will turn off.
mylifemyshop.com
7
TAKING A MEASUREMENT
Every Other Measurement
1. Make sure your scale is on a hard flat surface (not carpet) and has been
initialized.
2. The Body Analyzer 1 uses “Sense-On Technology” and automatic user
detection, so simply step onto the platform to take your measurement.
2. If you are taking a complete measurement, be sure to remove your shoes
and socks. You must have bare feet to obtain body fat and total body water
measurements.
• The condition of your skin on the bottom of your feet can affect the
reading. To get the most accurate and consistent reading, wipe your
feet with a damp cloth, leaving them slightly moist before stepping on
the scale.
3. Step onto the platform and ensure that your feet are in good contact with
the 4 stainless steel contact pads on the platform.
4. Stand still, and remain on your Body Analyzer 1 until the complete readout
is displayed.
5. Your weight will display followed by moving measurement indicators.
6. After 2-3 seconds, your weight will be joined by your body fat %, body
water %, muscle mass %, and bone density measurements.
7. You may step off of the scale; the measurements will continue to be
displayed for 10 seconds, after which time the scale will turn off.
Note:
When the body fat reading displays, a horizontal bar will appear below the
body fat reading. This corresponds to the Low, Normal, Moderate, and High
ranges.
8
mylifemyshop.com
REPLACING THE BATTERIES
When the “ “ symbol appears, it is time to replace your batteries. Remember,
Do Not dispose of the old batteries with regular household waste. Please
refer to your local ordinances and recycling instructions regarding disposal
of worn batteries.
Replacing the Batteries
1. Open the Battery Compartment on the bottom of the Body Analyzer 1 .
2. Remove the old batteries and dispose of them appropriately.
3. Insert the new batteries (4 X AAA) into the battery compartment according
to the polarity indicators visible inside the compartment.
4. Once the new batteries are installed, all the digits on the front LCD will
light up.
5. Close the battery compartment and wait for the display to show “0.0.”
Unit Selector
Battery
Compartment
mylifemyshop.com
9
TWO-YEAR WARRANTY
This My Life My Shop product is warranted to be free of
manufacturer’s defects in materials or workmanship for two years
from the date of purchase. Damage or wear resulting from an
accident, misuse, abuse, commercial use, or unauthorized adjustment
and/or repair are not covered under this warranty.
Should this product require warranty service (or replacement
at our discretion) please contact client service to obtain a
Return Merchandise Authorization number (RMA) and return
instructions. Proof of purchase is required. Products returned
without a My Life My Shop generated RMA number will not be
accepted and the sender will not receive a refund, replacement,
or repaired product.
info@mylifemyshop.com
1.888.870.2132
There are no express warranties except as listed to the right. This warranty gives you specific legal
rights and you may have other rights which will vary from state to state.
DO NOT RETURN TO RETAILER, PLEASE CONTACT US DIRECTLY FOR WARRANTY SERVICE
OR REPAIR, THANK YOU.
HOW IT WORKS
The Body Analyzer 1 Digital Scale & Body Analzyer uses BIA (Bio Impedance
Analysis) technology which passes an electrical current through the body
to estimate body fat mass, lean mass, total body water, and bone mass. The
electrical current is small and will not be felt. Contact with the body is made via
stainless steel pads on the platform of the scale.
The scale simultaneously calculates your body fat percentage, total body water
percentage, bone mass, and muscle mass while measuring your body weight,
offering you a more accurate reading of your overall health and fitness.
This scale stores the personal data of up to 8 users. In addition to being a body
analyzer, it also can be used as a conventional scale.
Note: This scale is designed for at-home use and ease of measurement.
The Body Fat percentage may not be 100% accurate because this scale does
not include handholds that measure electrical currents through the hands.
However, it is very consistent. To get the best results from your Body
Analyzer 1 , we recommend getting professionally measured first. Then
compare this measurement to your Body Analyzer 1 reading to track your
progress over time.
mylifemyshop.com
11
MUSCLE MASS PERCENTAGE
According to the American College of Sports Medicine, lean muscle mass
may decrease by nearly 50 percent between the age of 20 and 90. If you do
nothing to maintain muscle mass, you could be losing muscle and increasing
fat. It is also important to know your muscle mass percentage during weight
reduction. At rest, the body burns approximately 110 additional calories for
each kilo of muscle gained. Benefits of gaining muscle mass include:
• Reversing the decline in strength, bone density, and muscle mass
associated with aging
• Maintenance of flexible joints
• Guided weight reduction when combined with a healthy diet
Muscle Mass Percentage Chart
Gender Age Low (-) Normal (0) High (+) Very High
18-40 <24.4 24.4 - 30.2 30.3 - 35.2 ≥35.3
Female
Male
12
41-60 <24.2 24.2 - 30.3 30.4 - 35.3 ≥35.4
61-80 <24.0 24.0 - 29.8 29.9 - 34.8 ≥34.9
18-40 <33.4 33.4 - 39.4 39.5 - 44.1 ≥44.2
41-60 <33.2 33.2 - 39.2 39.3 - 43.9 ≥44.0
61-80 <33.0 33.0 - 38.7 38.8 - 43.4 ≥43.5
mylifemyshop.com
BODY FAT PERCENTAGE
One of the things the human body is made up of is a percentage of fat. Body
fat is vital for a healthy, functioning body; however, too much or too little body
fat can be unhealthy.
That’s why it is important to measure and monitor your body fat
percentage. Body fat percentage gives you a better measure of fitness,
rather than weight alone. The composition of your weight loss could mean
you are losing muscle mass rather than fat. You could still have a high
percentage of fat even when a scale indicates you are at a “normal weight.”
Normal healthy range of Body Fat percentage:
Standard for Men:
Source: University of Illinois Department of Food Science and Human Nutrition. Body Fat Percentage Calculator.
Rating 20-29 30-39 40-49 50-59 60 Plus
Low <13 <14 <16 <17 <18
Normal 14-20 15-21 17-23 18-24 19-25
Mod. High 21-23 22-24 24-26 25-27 26-28
High >23 >24 >26 >27 >28
Standard for Women:
Source: University of Illinois Department of Food Science and Human Nutrition. Body Fat Percentage Calculator.
Rating 20-29 30-39 40-49 50-59 60 Plus
Low <19 <20 <21 <22 <23
Normal 20-28 21-29 22-30 23-31 24-31
Mod. High 26-31 30-32 31-33 32-33 33-35
High >31 >32 >33 >34 >35
mylifemyshop.com
13
BONE DENSITY
Regular exercise and a balanced diet can help maintain healthy bones. Like
muscle, bone is a living tissue that can respond to exercise by becoming stronger,
and it can become weaker from lack of excercise. For most people, bone density
peaks in their thirties and then begins to decline, but regular exercise can help
prevent the decline.
Calcium and Vitamin D (good sources of which are dairy products, green leafy
vegetables, and fish) contribute to healthy bones.
The bone mass readings given by this product are an estimation of the amount
of bone in your body. Those with osteoporosis or low bone densities may not
get accurate estimations. If you have any concerns regarding your bones you
should consult your doctor.
Rating 20-29 30-39 40-49 50-59 60 Plus
Low <7.6 <7.4 <7.0 <6.6 <6.3
Normal 7.6-8.4 7.4-8.2 7-7.8 6.6-7.4 6.3-7.1
High >8.5 >8.3 >7.9 >7.5 >7.2
14
mylifemyshop.com
BODY WATER
Body water is the single most important factor of body weight. It
represents over half of your total weight and almost two-thirds of your
lean body mass. Body weight also a key contributor to cellular functions
and plays a vital role in regulating body temperature, mostly though
perspiration.
The combination of your weight and fat measurements could appear to be
“normal” but your body hydration level could be insufficient for healthy living.
Body water measurement results are influenced by the proportion of body fat and
muscle. If the proportion of body fat is high, or the proportion of muscle is low, then the
body water results will tend to be low.
Short term fluctuations of body weight, body fat, and body water are normal;
we suggest you chart your progress over time, rather than focus on a single
day’s reading.
Normal healthy range of water weight percentage:
Body Fat & Range Optimal Total Body Water & Range
4-14% 70-63%
15-21% 63-57%
Men
Women
Total Body Water Percentage
Source: Derived from Wang & Deurenberg: “Hydration of fat-free body mass.”
American Journal. Clin Nutr 1999,69833-841
22-24% 55-37%
25 and Over 70-58%
4-20% 70-58%
21-29% 58-52%
30-32% 52-49%
33 and Over 49-37%
mylifemyshop.com
15
FREQUENTLY ASKED QUESTIONS
?
How exactly is my body fat and water being measured?
The Body Analyzer 1 uses a measurement method known as Bio-electrical Impedance Analysis
(BIA). A minute current is sent through your body, via your feet and legs. This current flows easily
through the lean muscular tissue, which has a high fluid content, but not easily through fat. By
measuring your body’s impedance (its resistance to the current), the quantity of muscle can be
determined, and the quantity of fat and water can then be estimated.
What is the value of the current passing through me when the measurement is
taken? Is it safe?
The current is less than 1mA. You may not be able to feel it, but please note that this device should
not be used by anyone with an internal electronic medical device, such as a pacemaker, as a
precaution against disruption to that device.
If I measure my body fat and water at different times during a day, it can vary quite
considerably. Which value is correct?
Your body fat percentage reading varies with body water content, and the latter changes
throughout the course of the day. There is no right or wrong time of the day to take a
reading, but aiming to take measurements at a regular time when you consider your body to
be normally hydrated. It is not recommended to take readings after having a bath or sauna,
following intensive exercise, or within 1-2 hours of drinking in quantity or eating a meal.
Is it possible to get a different reading when using a body analyzer from another
manufacturer?
Different body analyzers take measurements around different parts of the body and use
different mathematic algorithms to calculate the percentage of body fat. The best advice is
not to make comparisons from one device to another, but to use the same device each time to
monitor any change.
What should I do if my body fat reading is very ‘high’?
A sensible diet, fluid intake, and exercise program can reduce your body fat percentage.
Professional medical guidance should be sought before embarking on such a program.
Why are the body fat percentage ranges for men and women so different?
Women naturally carry a higher percentage of fat than men, because the make-up of the
body is different.
How do I use my Body Analyzer 1 while pregnant?
During pregnancy, a woman’s body composition changes considerably in order to support the
developing child. Under the circumstances, body fat percentage readings could be inaccurate
and misleading.
16
mylifemyshop.com
CARE & MAINTAINANCE
• Clean exposed parts with a soft, slightly damp cloth.
• Never use detergents, excess water, treated cloths, harsh cleaning agents, or
sprays.
• Do not immerse the scale in water.
• Treat your scale with care. It contains sensitive electronic parts. Avoid rough
treatment.
• Do not jump on, drop, or kick the scale. Treat it with care to ensure the best
performance.
• Do not store the scale where you store cleaning chemicals. The vapors from
some household products may affect the electronic components of your scale.
• Do not attempt to lubricate, disassemble, or open the scale casing as this will
void your warranty.
• Always weigh yourself on the same scale placed on the same floor
surface.
• Do not compare weight readings from one scale to another, as some
differences will exist due to manufacturing tolerances.
• Placing your scale on a hard, even floor will ensure the greatest accuracy and
consistency.
• It is recommended that you measure at the same time of the day, preferably
early evening before a meal for the most consistent results.
• Your scale rounds up or down to the nearest increment.
• If you weigh yourself twice and get two different readings, your weight lies
between the two.
• Do not dispose of batteries in fire. Batteries may explode or leak. Remove the
batteries if the scale will not be used for a long period.
mylifemyshop.com
17
CAUTION
BIA (Bio-electrical Impedance Analysis) method determines your body fat
percentage by sending a harmless signal through the body.
This device should not be used by anyone with an internal electronic medical
device, such as a pacemaker, as a precaution against disruption to that device.
If in doubt, contact your physician.
This product is for domestic use only.
Professional medical guidance should always be sought before embarking on diet
and exercise programs.
Pregnant women should consult their doctor before use.
FCC REGULATIONS
The device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1)
this device may not cause harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Warning: Changes or modifications to this unit not expressly approved by the party responsible for compliance
could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that interference will not occur in
a particular installation. If this equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.
18
mylifemyshop.com
SAFETY INFORMATION
The Body Analyzer 1 Digital Scale & Body Analyzer allows you to track and
analyze several key components of your weight. It is intended for use by adults and
it is not intended for use on infants and children. This device is designed for home
use only.
CAUTION
As instructed on page 1, read this user manual thoroughly before use. This device is
designed and manufactured to operate within defined limits. Misuse may result in
harm. The following should be observed for best use and to maintain your device:
• This device is intended solely to monitor and determine weight.
• Its sole function is measurement.
• Monitoring weight with this device does not equate to a medical diagnosis.
• Keep the unit out of reach of infants or children.
• Use only accessories and detachable parts specified and authorized by the
manufacturer. Not doing so may cause damage to the unit or danger to you.
• Avoid using this device on slippery or wet floors, or while you are still wet from
the bath or shower.
• Do not store this device where it can be exposed to extreme temperatures,
humidity, moister, sunlight, dust or where you store chemicals and cleaners.
PREGNANT WOMEN SHOULD CONSULT THEIR DOCTOR BEFORE USE.
mylifemyshop.com
19
SAFETY INFORMATION
Symbol Description
The Operation Guide Must be Read
Serial Number
Manufacturer
Direct Current
Complies with EU Requirments
Indoor Use Only
ENVIRONMENT PROTECTION - Waste electrical
products should not be disposed of with household waste.
Please recycle where facilities exist. Check with your local
authority or retailer for recycling advice
WARNING INDICATORS
Symbol Description
20
Overload Warning. The maximum weighing capacity of the
scale has been exceeded. Remove the weight immediately;
otherwise, permanent damage to the scale will occur.
Low battery warning. Replace the batteries. Always replace
all the worn batteries at the same time; do not combine old
and new batteries.
mylifemyshop.com
DEVICE SPECIFICATIONS
Product Name
Dimensions 12.63 in x 12.88 in x .94 in (Approx. 321mm x 327mm x 24mm)
Net Weight 4.2 lbs (Approx 1.91 kg)
Display Digital LCD, 4.9375 in (W) x 1.875 in (H)
Measurement Units (lb/in), (kg/cm) or (st/in)
Measurement Range 5kg to150kg / 0st:11lb to 23st: 8lb / 11lb to 397lb
Weight Capacity 180 kg; 397 lb; 28 st 5 lb
Weight Graduation kg: 0.1 kg / lb: 0.2 lb / st: 0.2 lb (<20 st); 1 lb (≥ 20st)
Height Range 3’ 3.5” - 8’ 2.5” (100cm - 250cm)
Body Fat % Range 5 - 60% in graduations of 0.1%
Total Body Water % Range 20 - 80% in graduations of 0.1%
Muscle Mass % Range 10 - 80% in graduations of 0.1%
Body Analyzer 1 Digital Scale & Body Analyzer - MM42114-0000
Bone Mass % Range 0.5 - 10 kg in graduations of 0.1kg
Normal Mode Age Range 18 years of age or older
Number of Users 8
Power Source 4 AAA Batteries
Auto-On SENSE ON Technology
Auto-O Automatic Shut-o
Accessories (1) Instruction Manual + (1) Insert Card
mylifemyshop.com
21
EQUIPMENT CLASSIFICATION &
EQUIPMENT and its APPLIED PARTS shall be classified by marking and /or identification as described in Clause 6.
This includes:
5.1 According to the type of protection against electric shock:
a) EQUIPMENT energized from an external electrical power source:
— CLASS I EQUIPMENT;
— CLASS II EQUIPMENT.
b) INTERNALLY POWERED EQUIPMENT.
5.2 According to the degree of protection against electric shock:
— TYPE B APPLIED PART;
— TYPE BF APPLIED PART;
— TYPE CF APPLIED PART.
5.3 According to the degree of protection against ingress of water as detailed in the current edition of IEC 529[see 6.1
5.4 According to the method(s) of sterilization or disinfection recommended by the manufacturer.
5.5 According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE
5.5 According to the mode of operation:
— CONTINUOUS OPERATION;
— SHORT-TIME OPERATION;
— INTERMITTENT OPERATION;
— CONTINUOUS OPERATION WITH SHORT-TIME LOADING;
— CONTINUOUS OPERATION WITH INTERMITTENT LOADING.
6.8 ACCOMPANYING DOCUMENTS
6.8.1* General EQUIPMENT shall be accompanied by documents containing at least instructions for use, a technical
All applicable classifications specified in Clause 5 shall be included in both the instructions for use and the technical
6.8.2 Instructions for use
a) *General information
1)].
WITH AIR or WITH OXYGEN OR NITROUS OXIDE:
— EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH
AIR or WITH OXYGEN OR NITROUS OXIDE;
— CATEGORY AP EQUIPMENT;
— CATEGORY APG EQUIPMENT.
description and an address to which the USER can refer. The ACCOMPANYING DOCUMENTS shall be regarded
as a component part of EQUIPMENT.
description, if separable. All markings specified in Sub-clause 6.1 shall be included in full in the ACCOMPANYING
DOCUMENTS if they have not been permanently affixed to EQUIPMENT by the manufacturer. See also Subclause 6.1 d). Warning statements and the explanation of warning symbols (marked on the EQUIPMENT) shall be
provided in the ACCOMPANYING DOCUMENTS.
— Instructions for use shall state the function and intended application of the EQUIPMENT.
— Instructions for use shall contain all information necessary to operate the EQUIPMENT in accordance with
its specification. This shall include explanation of the function of controls, displays and signals, the sequence
of operation, connection and disconnection of detachable parts and ACCESSORIES, replacement of material
which is consumed during operation.
— Instructions for use shall provide the USER or OPERATOR with information regarding potential
electromagnetic or other interference between the EQUIPMENT and other devices together with advice
regarding avoidance of such interference.
— Instructions for use shall include indications on recognized ACCESSORIES, detachable parts and materials, if
the use of other parts or materials can degrade minimum safety.
— Instructions for use shall instruct the USER or OPERATOR in sufficient detail concerning cleaning,
preventive inspection and maintenance to be performed by him, including the frequency of such
maintenance. Such instructions shall provide information for the safe performance of routine maintenance.
Additionally, instructions for use shall identify the parts on which preventive inspection and maintenance shall
be performed by other persons, including the periods to be applied, but not necessarily including details about
the actual performance of such maintenance.
— the meaning of figures, symbols, warning statements and abbreviations on EQUIPMENT shall be explained in
the instructions for use.
b) *Responsibility of the manufacturer Not used (see Appendix A).
c) SIGNAL OUTPUT and SIGNAL INPUT PARTS If a SIGNAL OUTPUT or SIGNAL INPUT PART is intended
only for connection to specified EQUIPMENT complying with the requirements of this Standard, this shall be
stated in the instructions for use
d) Cleaning, disinfection and sterilization of parts in contact with the PATIENT For EQUIPMENT parts which
come into contact with the PATIENT during NORMAL USE, instructions for use shall contain details about
cleaning or disinfection or sterilization methods that may be used (see also Sub-clause 44.7) or, where
22
mylifemyshop.com
necessary, identify suitable sterilization agents, and list the temperature, pressure, humidity and time limits
which such EQUIPMENT parts can tolerate.
e) Mains operated EQUIPMENT with additional power source Instructions for use of mains operated
EQUIPMENT containing an additional power source not automatically maintained in a fully usable condition
shall contain a warning statement referring to the necessity for periodical checking or replacement of such
an additional power source. If CLASS I EQUIPMENT is specified for operation connected to a SUPPLY
MAINS and alternatively using an INTERNAL ELECTRICAL POWER SOURCE, instructions for use shall
contain a statement saying that where the integrity of the external protective conductor in the installation
or its arrangement is in doubt, EQUIPMENT shall be operated from its INTERNAL ELECTRICAL POWER
SOURCE.
f ) Removal of primary batteries
Instructions for use of EQUIPMENT containing primary batteries shall contain a warning to remove
these batteries if EQUIPMENT is not likely to be used for some time, unless there is no risk of a SAFETY
HAZARD arising.
g) Rechargeable batteries
Instructions for use of EQUIPMENT containing rechargeable batteries shall contain instructions to ensure
safe use and adequate maintenance.
h) EQUIPMENT with a specified power supply or battery charger Instructions for use shall identify power
supplies or battery chargers necessary to ensure compliance with the requirements of this Standard.
j ) Environmental protection Instructions for use shall:
— identify any risks associated with the disposal of waste products, residues, etc. and of the EQUIPMENT and
ACCESSORIES at the end of their useful lives;
6.8.3 Technical description
— provide advice on minimizing these risks.
a) *General
The technical description shall provide all data, which is essential for safe operation.
This shall include:
— data mentioned in sub-clause 6.1;
— all characteristics of the EQUIPMENT, including range(s), accuracy, and precision of the displayed values or
an indication where they can be found. In addition to details required to be included in instructions for use, the
technical description shall state whether particular measures or particular conditions are to be observed for
installing EQUIPMENT and bringing EQUIPMENT into use.
b) Replacement of fuses and other parts
— If the type and rating of fuses utilized in the mains supply circuit external to PERMANENTLY INSTALLED
EQUIPMENT is not apparent from the information concerning RATED current and mode of operation of
EQUIPMENT, the required type and rating of fuses shall be indicated in at least the technical description.
— The technical description shall contain instructions for replacement of interchangeable and/or detachable
parts which are subject to deterioration during
NORMAL USE.
c) Circuit diagrams, component part lists, etc. The technical description shall contain a statement that the
supplier will make available on request circuit diagrams, component part lists, descriptions, calibration
instructions, or other information which will assist the USER’s appropriately qualified technical personnel to
repair those parts of EQUIPMENT which are designated by the manufacturer as repairable.
d) Environmental conditions for transport and storage The technical description shall contain a specification of
the permissible environmental conditions for transport and storage which shall be repeated on the outside of
the packaging of the EQUIPMENT [see Sub-clause 6.1 v)]
6.8.4 Not used.
6.8.5 Not used.
Compliance with the requirements of Sub-clause 6.8 is checked by inspection of the ACCOMPANYING
DOCUMENTS.
GENERAL USE
mylifemyshop.com
23
mylifemyshop.com
Loading...