I.E.M. klock User manual

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Blood pressure
measurement
from the wrist
9 Specifications
Blood pressure range: Systolic (SYS): 70 mmHg–260 mmHg
Diastolic (DIA): 45 mmHg–180 mmHg
Pulse (PULSE): 40–240 (1min)
Operating temperature: +10°C to +40°C / 50F to 104F
Operating humidity: 15% to 90%
Storage temperature: –20°C to +50°C / 4 F to 122F
Storage humidity: 15% to 95%
Display range: pressure: 0 mmHg–300 mmHg
pulse: 40–240 (1min)
Accuracy: Pressure: ±3 mmHg in range of display
Measuring method: Oscillometric
Cuff size: Circumference of wrist between 14 cm (5.5“) and 19.5 cm (7.7“)
Storage capacity: 50 measurements, up to 5 reminder times
Display: Liquid Crystal Display (LCD)
Controls: 2 buttons: »START/STOP« and »MENU«
Interface: Infrared, bidirectional
Power: 2x alkaline 1.5V micro batteries (AAA, LR03)
External dimensions: 74 mm x 55 mm x 27 mm (app. 2.9“ x 2.2“ x 1.1“) (W x L x H)
Weight: 110 gr (3.9 oz) incl. batteries
Subject to modification
(ENG)
Blood pressure measurement from the wrist
.
Instruction Manual
I.E.M. Industrielle Entwicklung Medizintechnik GmbH
Germany
Copyright ©Revision August 1999 (ENG) I.E.M. GmbH, all Rights reserved.
Do not publish or duplicate the contents of this manual without written authorization from I.E.M. GmbH.
8.1 Warranty
See Warranty Card attached
I.E.M GmbH, the Manufacturer, warrants this
product to be free of defects in material and
workmanship for a period of one (1 year) from
the date of original purchase. If the product
exhibits such a defect, I.E.M. will, at its option,
repair or replace it, provided the consumer:
1. Returns the product postpaid, insured and in
the original packaging to our service station.
2. Submits proof of date of original purchase.
This warranty does not cover finishes, nor does it
cover damage resulting from accident, misuse,
dirt, water, tampering, unreasonable use, servi-
cing performed or attempted by unauthorized
service agencies or units that have been modi-
fied or used for commercial purposes.
All implied warranties, including any implied
warranty of merchantibility or fitness for any
particular purpose, are limited in duration to
one year from the date of original purchase.
In no event will I.E.M GmbH be responsible for
consequential damages resulting from the use
of this product.
I.E.M. GmbH does not guarantee the batteries.
8.2 Repair
In case of repairs please fill out the warranty
card with correct sender address and
description of errors. Contact your local
supplier for details on the next service point.
8 Warranty And Repair Conditions
13
7 Maintenance And Care
12
Contents
7.1 Care
If necessary, please clean the plastic housing
and the cuff with a moist cotton cloth.
Important:
Do not wash or chemically clean the cuff
of the “Klock”!
Batteries do not belong in the household
waste!
Please dispose of empty batteries according
to your environmental regulations.
7.2 Calibration Of The “Klock”
The device has been calibrated by the
manufacturer for a period of 2 years. We
recommend the device should be checked and
recalibrated after 2 years of use. Please contact
our service department for instructions.
1 Overview 2
2 Introduction 3
2.1 Preliminary 3
2.2 Contents 3
2.3 CE-Marking 3
2.4 Manufacturers Declaration 3
3 Application Information 4
3.1 General Information On Blood Pressure 4
3.2 Purpose Of Use 4
4 Use Of The Device 5
4.1 Start Of Operation 5
4.2 How To Apply
The „Klock“ To Your Wrist 5
4.3 Blood Pressure Measurement
And Storing Results 6
4.4 Evaluation By The Doctor 6
4.5 Display Previous Measurements 6
4.6 Deleting Stored Measurements 7
4.7 Setting Time And Date 7
4.8 Reminder Function 7
4.9 Description Of Symbols 8
5 Important Instructions 9
5.1 Important Safety Instructions 9
6 Description Of Errors
And How To Correct Them 10
6.1 Error Messages 10
6.2 Trouble Shooting 11
7 Maintenance And Care 12
7.1 Care 12
7.2 Calibration Of The „Klock“ 12
8 Warranty And Repair Conditions 13
8.1 Warranty 13
8.2 Repair 13
9 Specifications Cover
1 Overview
2
!Start/Stop-button, described in text
as left button
@Menu-button, described in text
as right botton
#Infrared-eye to transmit the
stored measured data to the
doctor’s computer
$Cuff
%Battery compartment on the back
^Display
!!@@
##
$$
%%
^^
11
6 Descriptions Of Errors And How To Correct Them
6.2 Trouble Shooting
Description of error
The measurement cannot be stopped and the
cuff does not deflate instantly when pushing
the left button once
Left button has been pushed but the measure-
ment does not start (pumping stops early)
Display shows no symbols
Display shows battery symbol
Time and/or date wrong
Frequent error messages
Correction of error
Open cuff, remove batteries, stop using
the device. Contact Service!
Check batteries, change if necessary
Check batteries, change if necessary
Change both batteries
see Setting Time And Date
a) put on cuff correctly (see 4.2)
b) wrist too small or big 14 cm (5.5“)
to 19.5 cm (7.7“) circumference
c) hold arm and fingers still during
measurement
2 Introduction
2.4 Manufacturers Declaration
Manufacturer:
I.E.M. GmbH
Germany
I.E.M. GmbH declares that the product “Klock”
corresponds to the guidelines according to
93/42/ECC of June, regarding Medical Products.
Stolberg, August 1999
I.E.M. GmbH
2.1 Preliminary
With this home blood pressure measurement
device you have purchased a first-class system
of newest technology, simplest handling and
greatest reliability. We thank you for your trust
and are always available to answer questions
about service and the product.
2.2 Contents
1. “Klock” - home blood pressure measurement
device to be used on the wrist
2. Instruction manual
3. Short guide
4. Two batteries
5. Warranty Card
2.3 CE-Marking
“Klock” corresponds to the European
regulations, which are based on the Medical-
Devices-Directives (MDD). The quality of the
device was inspected according to the
EC-guideline 93/42/EEC and carries
CE-mark 0434.310
6 Descriptions Of Errors And How To Correct Them
Error number
Err 01
Err 02
Err 03
Err 04
Cause
Motion detected
or Arrhythmia
Cuff
System error or
Pneumatic defect
battery error
Correction
Keep arm, hand and fingers still and at the
level of the heart
repeat measurement
a) put cuff on correctly (see 4.2)
b) the circumference of the wrist should be
between 14 cm (5.5“) and 19.5 cm (7.7“)
do not take any more measurements
change battery (see 4.1)
6.1 Error Messages
4
3 Application Information
3.2 Purpose Of Use
“Klock” is intended to automatically measure
your blood pressure and pulse.
In order to achieve exact measurement results,
the device must only be placed against the
naked wrist. It is necessary to hold it up to
the level of your heart during measurement!
The device is suitable for wrists with a
circumference of 14 cm (5.5“) to 19.5 cm
(7.7“). The device is only suitable for blood
pressure-measurements on adults.
Never alter your medication on the basis of
the self measured values. The evaluation
of the measurements and the basis of the
therapy lies exclusively with your doctor.
3.1 General Information On Blood Pressure
The blood pressure fluctuates in the course of
the day. The threshold value for hypertension
in adults is defined by the World Health
Organisation (WHO) as 140/90 mmHg.
If you measure your blood pressure regularly,
you will become more aware about the
reactions of your body to different influences
(e.g. stress or physical activity) and can
consciously adjust to a healthier lifestyle.
Please take your “Klock” with you on each
visit to the doctor. If your doctor is equipped
with our special software, he/ she can
evaluate the data stored by you and receives
an even better overview about your blood
pressure-values.
9
Heavy arteriosclerosis and other circulatory
problems, such as spasms in the lower arm,
may result in erroneous readings.
The pulse rate display of the device cannot
be used to control the heart frequency of a
pace maker.
Never use the device when in a shower or
a bath. However, should liquid come into
the device, the batteries should be taken
out instantly and further use of the device
should be avoided. Please contact your local
service point.
The device should not be operated within
the area of a Nuclear Spintomograph or
other highly sensitive electronic equipment.
The use of components other than delivered
with the device can lead to measurement
errors.
(Exception: change of batteries)
5.1 Important Safety Instructions
Caution:
Should unpleasantness occur during a
measurement
Counter measures:
Push the left button for instant cuff
deflation. Open the cuff and take the device
off. Please contact your local service point.
If you are suffering from any heart problems,
such as arrythmia etc. or if you are pregnant,
always consult with your physician to deter-
mine if the “Klock” Blood Pressure Watch is
safe for you to use.
5 Important Instructions
4.1 Start Of Operation
Open the battery compartment on the back
side of the device. Insert the batteries as shown
below. Check that the polarity is correct - see
label - and that the strip is under the batteries.
Always use high quality 1.5 V batteries.
Now you should set time and date (see Setting
Time And Date).
“Klock” is now ready for use.
4 Use Of The Device
4.2 How To Apply The “Klock” To Your Wrist
The blood pressure measurement device is
put on like a normal wrist watch. Fix the cuff
on your wrist. In order to get correct measure-
ment results and to avoid unneccessary error
measurements, arm, hand and fingers should
be held still during measurement, and you
should not talk. You should be seated. Always
hold the device at the level of the heart.
8 5
4 Use Of The Device
4.9 Description of Symbols
SYS [mm Hg]
DIA [mm ⁄ Hg]
PULSE [1min]
HOUR
MIN
DAY
MON
Err 01
No
Clr
Co
Operation / Situation
Pulse detected
Display systolic value
Display diastolic value
Display pulse
Time of event
Display of hour
Display of minute
Display of day
Display of month
displayed when battery is empty
Error message
Number of measurement
Delete stored measurements
Infrared communication mode
Meaning
upper value
lower value
number of pulses / minute
sound / blinking as a reminder
change batteries (see 4.1)
see 6.1
if the left button is pushed 5 more
seconds, all stored data will be deleted
Bidirectional or data download option
and reminder function programming
4.6 Deleting Stored Measurements
If the left button is held down more than 5
seconds, a signal will be heard and the display
shows „Clr“. If the left button is held down
another five seconds, all stored measurements
up to this date will be deleted and the time
modus will appear again.
Please Note:
Measurements should be taken whilst seated
after 3–5 minutes of relaxation.
6
4 Use Of The Device
4.4 Evaluation By The Doctor
Blood pressure values stored in the “Klock” can
be downloaded to a computer by your doctor
using an evaluation software. The doctor can
obtain further details on this by contacting the
local supplier. Consult your doctor.
4.5 Display Previous Measurements
First press and hold the right button until the dis-
play begins to flash. Then press the left button.
The previous blood pressure value is displayed fol-
lowed by the recording time and date. You can
page backwards to other measurements by repea-
tedly pressing the left button. Press the right but-
ton or wait 30 seconds without pressing any but-
tons to exit this mode.
The above is only available if measurements have
been stored in the “Klock”. If not the display will
go directly to setting the time after pressing the
right button (see: Setting Time And Date).
4.3 Blood Pressure Measurement
And Storing Results
Push the left button briefly once. As long as
the button is held down, you should see the
following in the display:
“Klock” will inflate and deflate in steps. After
the measurement the display will show the
following:
The measurement number will blink (here No.:
27). After 10 seconds this
measurement will be stored under this number
If the left button is pushed once during blinking,
the measurement will not be stored.
4 Use Of The Device
4.7 Setting Time And Date
Repeatedly press and hold the right button
until MON, DAY, HOUR and MIN start to flash.
Then press the left button several times until
the minute (MIN) setting is correct. Now press
the right button to select hour (HOUR) and
then afterwards date (year, MON, DAY). You can
again set the correct numbers with the left but-
ton. You can exit this mode, by waiting 30
seconds without pressing any buttons or by
pressing the right button until the year disap-
pears.
4.8 Reminder Function
“Klock” is able to remind you, for instance,
to take your medication. An audible signal
will be heard. The setting of the different times
(up to 5) can only be done at your doctor’s
office if equipped with special computer
software.
7
4.6 Deleting Stored Measurements
If the left button is held down more than 5
seconds, a signal will be heard and the display
shows „Clr“. If the left button is held down
another five seconds, all stored measurements
up to this date will be deleted and the time
modus will appear again.
Please Note:
Measurements should be taken whilst seated
after 3–5 minutes of relaxation.
6
4 Use Of The Device
4.4 Evaluation By The Doctor
Blood pressure values stored in the “Klock” can
be downloaded to a computer by your doctor
using an evaluation software. The doctor can
obtain further details on this by contacting the
local supplier. Consult your doctor.
4.5 Display Previous Measurements
First press and hold the right button until the dis-
play begins to flash. Then press the left button.
The previous blood pressure value is displayed fol-
lowed by the recording time and date. You can
page backwards to other measurements by repea-
tedly pressing the left button. Press the right but-
ton or wait 30 seconds without pressing any but-
tons to exit this mode.
The above is only available if measurements have
been stored in the “Klock”. If not the display will
go directly to setting the time after pressing the
right button (see: Setting Time And Date).
4.3 Blood Pressure Measurement
And Storing Results
Push the left button briefly once. As long as
the button is held down, you should see the
following in the display:
“Klock” will inflate and deflate in steps. After
the measurement the display will show the
following:
The measurement number will blink (here No.:
27). After 10 seconds this
measurement will be stored under this number
If the left button is pushed once during blinking,
the measurement will not be stored.
4 Use Of The Device
4.7 Setting Time And Date
Repeatedly press and hold the right button
until MON, DAY, HOUR and MIN start to flash.
Then press the left button several times until
the minute (MIN) setting is correct. Now press
the right button to select hour (HOUR) and
then afterwards date (year, MON, DAY). You can
again set the correct numbers with the left but-
ton. You can exit this mode, by waiting 30
seconds without pressing any buttons or by
pressing the right button until the year disap-
pears.
4.8 Reminder Function
“Klock” is able to remind you, for instance,
to take your medication. An audible signal
will be heard. The setting of the different times
(up to 5) can only be done at your doctor’s
office if equipped with special computer
software.
7
4.1 Start Of Operation
Open the battery compartment on the back
side of the device. Insert the batteries as shown
below. Check that the polarity is correct - see
label - and that the strip is under the batteries.
Always use high quality 1.5 V batteries.
Now you should set time and date (see Setting
Time And Date).
“Klock” is now ready for use.
4 Use Of The Device
4.2 How To Apply The “Klock” To Your Wrist
The blood pressure measurement device is
put on like a normal wrist watch. Fix the cuff
on your wrist. In order to get correct measure-
ment results and to avoid unneccessary error
measurements, arm, hand and fingers should
be held still during measurement, and you
should not talk. You should be seated. Always
hold the device at the level of the heart.
8 5
4 Use Of The Device
4.9 Description of Symbols
SYS [mm Hg]
DIA [mm ⁄ Hg]
PULSE [1min]
HOUR
MIN
DAY
MON
Err 01
No
Clr
Co
Operation / Situation
Pulse detected
Display systolic value
Display diastolic value
Display pulse
Time of event
Display of hour
Display of minute
Display of day
Display of month
displayed when battery is empty
Error message
Number of measurement
Delete stored measurements
Infrared communication mode
Meaning
upper value
lower value
number of pulses / minute
sound / blinking as a reminder
change batteries (see 4.1)
see 6.1
if the left button is pushed 5 more
seconds, all stored data will be deleted
Bidirectional or data download option
and reminder function programming
4
3 Application Information
3.2 Purpose Of Use
“Klock” is intended to automatically measure
your blood pressure and pulse.
In order to achieve exact measurement results,
the device must only be placed against the
naked wrist. It is necessary to hold it up to
the level of your heart during measurement!
The device is suitable for wrists with a
circumference of 14 cm (5.5“) to 19.5 cm
(7.7“). The device is only suitable for blood
pressure-measurements on adults.
Never alter your medication on the basis of
the self measured values. The evaluation
of the measurements and the basis of the
therapy lies exclusively with your doctor.
3.1 General Information On Blood Pressure
The blood pressure fluctuates in the course of
the day. The threshold value for hypertension
in adults is defined by the World Health
Organisation (WHO) as 140/90 mmHg.
If you measure your blood pressure regularly,
you will become more aware about the
reactions of your body to different influences
(e.g. stress or physical activity) and can
consciously adjust to a healthier lifestyle.
Please take your “Klock” with you on each
visit to the doctor. If your doctor is equipped
with our special software, he/ she can
evaluate the data stored by you and receives
an even better overview about your blood
pressure-values.
9
Heavy arteriosclerosis and other circulatory
problems, such as spasms in the lower arm,
may result in erroneous readings.
The pulse rate display of the device cannot
be used to control the heart frequency of a
pace maker.
Never use the device when in a shower or
a bath. However, should liquid come into
the device, the batteries should be taken
out instantly and further use of the device
should be avoided. Please contact your local
service point.
The device should not be operated within
the area of a Nuclear Spintomograph or
other highly sensitive electronic equipment.
The use of components other than delivered
with the device can lead to measurement
errors.
(Exception: change of batteries)
5.1 Important Safety Instructions
Caution:
Should unpleasantness occur during a
measurement
Counter measures:
Push the left button for instant cuff
deflation. Open the cuff and take the device
off. Please contact your local service point.
If you are suffering from any heart problems,
such as arrythmia etc. or if you are pregnant,
always consult with your physician to deter-
mine if the “Klock” Blood Pressure Watch is
safe for you to use.
5 Important Instructions
2 Introduction
2.4 Manufacturers Declaration
Manufacturer:
I.E.M. GmbH
Germany
I.E.M. GmbH declares that the product “Klock”
corresponds to the guidelines according to
93/42/ECC of June, regarding Medical Products.
Stolberg, August 1999
I.E.M. GmbH
2.1 Preliminary
With this home blood pressure measurement
device you have purchased a first-class system
of newest technology, simplest handling and
greatest reliability. We thank you for your trust
and are always available to answer questions
about service and the product.
2.2 Contents
1. “Klock” - home blood pressure measurement
device to be used on the wrist
2. Instruction manual
3. Short guide
4. Two batteries
5. Warranty Card
2.3 CE-Marking
“Klock” corresponds to the European
regulations, which are based on the Medical-
Devices-Directives (MDD). The quality of the
device was inspected according to the
EC-guideline 93/42/EEC and carries
CE-mark 0434.310
6 Descriptions Of Errors And How To Correct Them
Error number
Err 01
Err 02
Err 03
Err 04
Cause
Motion detected
or Arrhythmia
Cuff
System error or
Pneumatic defect
battery error
Correction
Keep arm, hand and fingers still and at the
level of the heart
repeat measurement
a) put cuff on correctly (see 4.2)
b) the circumference of the wrist should be
between 14 cm (5.5“) and 19.5 cm (7.7“)
do not take any more measurements
change battery (see 4.1)
6.1 Error Messages
1 Overview
2
!Start/Stop-button, described in text
as left button
@Menu-button, described in text
as right botton
#Infrared-eye to transmit the
stored measured data to the
doctor’s computer
$Cuff
%Battery compartment on the back
^Display
!!@@
##
$$
%%
^^
11
6 Descriptions Of Errors And How To Correct Them
6.2 Trouble Shooting
Description of error
The measurement cannot be stopped and the
cuff does not deflate instantly when pushing
the left button once
Left button has been pushed but the measure-
ment does not start (pumping stops early)
Display shows no symbols
Display shows battery symbol
Time and/or date wrong
Frequent error messages
Correction of error
Open cuff, remove batteries, stop using
the device. Contact Service!
Check batteries, change if necessary
Check batteries, change if necessary
Change both batteries
see Setting Time And Date
a) put on cuff correctly (see 4.2)
b) wrist too small or big 14 cm (5.5“)
to 19.5 cm (7.7“) circumference
c) hold arm and fingers still during
measurement
7 Maintenance And Care
12
Contents
7.1 Care
If necessary, please clean the plastic housing
and the cuff with a moist cotton cloth.
Important:
Do not wash or chemically clean the cuff
of the “Klock”!
Batteries do not belong in the household
waste!
Please dispose of empty batteries according
to your environmental regulations.
7.2 Calibration Of The “Klock”
The device has been calibrated by the
manufacturer for a period of 2 years. We
recommend the device should be checked and
recalibrated after 2 years of use. Please contact
our service department for instructions.
1 Overview 2
2 Introduction 3
2.1 Preliminary 3
2.2 Contents 3
2.3 CE-Marking 3
2.4 Manufacturers Declaration 3
3 Application Information 4
3.1 General Information On Blood Pressure 4
3.2 Purpose Of Use 4
4 Use Of The Device 5
4.1 Start Of Operation 5
4.2 How To Apply
The „Klock“ To Your Wrist 5
4.3 Blood Pressure Measurement
And Storing Results 6
4.4 Evaluation By The Doctor 6
4.5 Display Previous Measurements 6
4.6 Deleting Stored Measurements 7
4.7 Setting Time And Date 7
4.8 Reminder Function 7
4.9 Description Of Symbols 8
5 Important Instructions 9
5.1 Important Safety Instructions 9
6 Description Of Errors
And How To Correct Them 10
6.1 Error Messages 10
6.2 Trouble Shooting 11
7 Maintenance And Care 12
7.1 Care 12
7.2 Calibration Of The „Klock“ 12
8 Warranty And Repair Conditions 13
8.1 Warranty 13
8.2 Repair 13
9 Specifications Cover
Blood pressure measurement from the wrist
.
Instruction Manual
I.E.M. Industrielle Entwicklung Medizintechnik GmbH
Germany
Copyright ©Revision August 1999 (ENG) I.E.M. GmbH, all Rights reserved.
Do not publish or duplicate the contents of this manual without written authorization from I.E.M. GmbH.
8.1 Warranty
See Warranty Card attached
I.E.M GmbH, the Manufacturer, warrants this
product to be free of defects in material and
workmanship for a period of one (1 year) from
the date of original purchase. If the product
exhibits such a defect, I.E.M. will, at its option,
repair or replace it, provided the consumer:
1. Returns the product postpaid, insured and in
the original packaging to our service station.
2. Submits proof of date of original purchase.
This warranty does not cover finishes, nor does it
cover damage resulting from accident, misuse,
dirt, water, tampering, unreasonable use, servi-
cing performed or attempted by unauthorized
service agencies or units that have been modi-
fied or used for commercial purposes.
All implied warranties, including any implied
warranty of merchantibility or fitness for any
particular purpose, are limited in duration to
one year from the date of original purchase.
In no event will I.E.M GmbH be responsible for
consequential damages resulting from the use
of this product.
I.E.M. GmbH does not guarantee the batteries.
8.2 Repair
In case of repairs please fill out the warranty
card with correct sender address and
description of errors. Contact your local
supplier for details on the next service point.
8 Warranty And Repair Conditions
13
Blood pressure
measurement
from the wrist
9 Specifications
Blood pressure range: Systolic (SYS): 70 mmHg–260 mmHg
Diastolic (DIA): 45 mmHg–180 mmHg
Pulse (PULSE): 40–240 (1min)
Operating temperature: +10°C to +40°C / 50F to 104F
Operating humidity: 15% to 90%
Storage temperature: –20°C to +50°C / 4 F to 122 F
Storage humidity: 15% to 95%
Display range: pressure: 0 mmHg–300 mmHg
pulse: 40–240 (1min)
Accuracy: Pressure: ±3 mmHg in range of display
Measuring method: Oscillometric
Cuff size: Circumference of wrist between 14 cm (5.5“) and 19.5 cm (7.7“)
Storage capacity: 50 measurements, up to 5 reminder times
Display: Liquid Crystal Display (LCD)
Controls: 2 buttons: »START/STOP« and »MENU«
Interface: Infrared, bidirectional
Power: 2x alkaline 1.5V micro batteries (AAA, LR03)
External dimensions: 74 mm x 55 mm x 27 mm (app. 2.9“ x 2.2“ x 1.1“) (W x L x H)
Weight: 110 gr (3.9 oz) incl. batteries
Subject to modification
(ENG)
/