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1.1

 

Intended use 

 

The tenso-comfort BPM 105 / BPM 205 is a  
non-invasive wrist blood pressure device 
intended for use in measuring blood pressure 
and pulse rate by adults 
 
The measuring method is an oscillometric blood 
pressure measurement with automatic sequence 
and refers to the auscultatory method as the 
reference standard. 
 
The model version BPM 105 is equipped with a 
radio module to transmit the measurement data 
to a PC or PDA. 
 
 
 
 
 
 
 
 
 
 
 

1.2

 

Warnings  

 
The symbols below identify and alert the 
user to the presence of important safety, 
operating, and service instructions. 
 
WARNING: 
Indicates that non-compliance with the 
safety instructions may lead to health 
injury or bodily harm of the user or other 
persons. 
 
CAUTION: 
Indicates that non-compliance with the 
safety instructions may lead to damage to 
the product or other property and/or to 
bodily harm of the user or other persons. 
 

General Warnings:  

 

WARNING:

Please read these safety and operations 
instructions in their entirety for this 
device and any of its accompanying 
accessories and software and all other 
literature provided in the box prior to 
using or allowing another person to use 

this device or any of its accompanying 
accessories or software.   
When using this Biocomfort device, 
compliance with these basic safety 
instructions is essential to reducing the 
risk of personal injury or damage to 
property.  Retain all of these instructions
for future reference. 

 

WARNING:

  

This device is only intended for use as 
described in this manual. Do not use 
this device for any other purpose.  This 
device is intended only for measuring 
blood pressure and pulse rate. 

 

WARNING:

  

Contact you physician for specific 
information about your blood pressure.  
Contact your doctor immediately about 
any unusually results measured by the 
device, such as, for example, high or 
low blood pressure or irregular pulse 
rate. Self-diagnosis and treatment using 
measured results may be dangerous.  

This device is not intended to provide 
any diagnosis or treatment. Always 
follow the instructions of your physician 
or licensed healthcare provider.     

 

WARNING:

The values measured on this Biocomfort 
device should only be interpreted by a 
physician. 

 

WARNING:

Do not take any new medication, cease 
taking any medication that you are 
currently taking, or modify or varify the 
dosage of medication you are currently 
taking without consulting your 
physician.   

 

WARNING:

This device will not 

properly measure blood pressure in 
individuals with severe 
arteriosclerosis, severe hypertension, 
severe diabetes, severe kidney disease 
or cascular disease or other conditions 
that may compromise circulation.  
Consult your physician before using 

Summary of Contents for BPM105

Page 1: ...ed States Biocomfort Inc 23 Third Avenue Burlington MA 01803 Distributor in Canada Biocomfort Inc 5300 Explorer Dr Mississauga ON L4W 5G4 Manufacturer Biocomfort Diagnostics GmbH Co KG Bernhaeuser Str...

Page 2: ...ntries Windows is a trademark or registered trademark of Microsoft Corporation in the United States and or other countries All other brands and marks referenced herin are the properties of their respe...

Page 3: ...How to start up your blood pressure 3 Control elements Display MEM button 1 Switch on device memory mode 2 Select user 3 Change values SET button 1 Switch on device setting mode 2 Selection button nex...

Page 4: ...stolic blood pressure indication 9 Blood pressure unit indication 10 Error indication 11 User no indication 12 Diastolic blood pressure indication 13 Blood pressure unit indication 14 Indication that...

Page 5: ...ny other person to use this product you must ensure that the person has received and read and understands this user manual including in particular the safety instructions herin Keep this user manual i...

Page 6: ...s Biocomfort device compliance with these basic safety instructions is essential to reducing the risk of personal injury or damage to property Retain all of these instructions for future reference WAR...

Page 7: ...cer birth defects or other reproductive harm WARNING Take three or more consecutive measurements to determine blood pressure with the device If you experience variations in the measurements contact yo...

Page 8: ...ned only with a soft clean cloth and if necessary a mild cleaning solution CAUTION Only use AAA LR03 1 5V batteries in this device Replace batteries periodically If the blood pressure monitor is left...

Page 9: ...ent Blood pressure should be measured at least twice daily morning and evening when you are relaxed Since physical exertion eating smoking and drinking especially alcohol and caffeine affects blood pr...

Page 10: ...e minimum residual pressure in the vascular system The unit for blood pressure is mmHg millimeters of mercury Blood pressure does not remain constant It changes constantly In the morning it is lower t...

Page 11: ...without regard to age have been established by the U S National Institutes of Health in 2003 Category Systolic mmHg Diastolic mmHg Normal Self Check 120 80 Pre Hypertension 120 139 80 89 Stage 1 Hyper...

Page 12: ...nging the batteries Step 2 Pull the battery compartment cover on the back side of the device in the direction of the arrow and remove Step 3 Remove any used batteries To make it easier to remove the u...

Page 13: ...pplied and the measuring process can begin 3 3 Con guring the device Before using the blood pressure meter for the rst time or if you would like to adapt the device to your needs you must make a few s...

Page 14: ...e and time The correct setting of the date and time makes it easier for you to make a correct time allocation of your measurements In order to set the correct date and time in your measuring device pl...

Page 15: ...herwise continue with the settings by pressing the SET button 3 5 Con guring the measured value memory applies only for the BPM205 device without wireless interface Note The blood pressure meter store...

Page 16: ...ty number has been selected see Section 4 2 Carrying out the blood pressure measurement steps 3 to 5 The procedure for clearing the measured value memory is described in Section 3 7 3 6 Resetting the...

Page 17: ...ns that the wireless connection is reset Step 1 In order to clear the stored blood pressure values from the measured value memory press the SET button until the word mem starts blinking on the right s...

Page 18: ...rrying out the blood pressure measurement 4 and should not be too tight or too loose away from the heel of your hand see gure The device should sit about 0 4 0 8 inch The cuff is suitable for a wrist...

Page 19: ...4 If the user identity number doesn t agree with your measured value memory press the MEM button until the identity number of your measured value memory appears Step 5 Con rm the measured value memory...

Page 20: ...e con gured so that the measured blood pressure measurements can be allo cated to up to 8 different users based on the user identity number 1 to 8 In this case the measured value memory for the indi v...

Page 21: ...Step 2 The user identity number blinks on the dis play in the measured value memory of which the result of the last blood pressure measure ment was stored Step 3 In order to look at the contents of th...

Page 22: ...loth if neces sary with a mild cleaning solution Stains on the cuff can be carefully removed with a moist cloth and soapsuds Do not wash Never submerge the measuring device in Do not clean the device...

Page 23: ...sure that the cuff is not damaged by sharp objects needles scissors etc and do not fold the cuff tightly Handle the device carefully and store it in the storage bag when not in use The storage bag is...

Page 24: ...he cuff and repeat the measurement If this error message appears re peatedly have the device checked by the manufacturer Error messages Causes Measures Remarks 5 error Air released too quickly Switch...

Page 25: ...he Health Manager software Con gure the device with the Health Manager soft ware and enable at least one user The rst time the device is put into operation at least one user must be registered Error m...

Page 26: ...values 7 14 21 and 28 day average Pressure build up Automatic by means of electric pump 8 Technical data Measuring accuracy Pressure 3 mmHg Pulse 5 of the displayed value Air release Automatic fast ai...

Page 27: ...adio spectrum FCC Class B Part 15 9 EMC Information Electromagnetic Compatibility This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device...

Page 28: ...rformance please refer to section 1 1 Intended Use Guidance and manufacturer s declaration electromagnetic immunity The BPM105 BPM205 is intended for use in the electromagnetic environment specified b...

Page 29: ...as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symb...

Page 30: ...aration distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8...

Page 31: ...low with the following meanings The serial number of the device is composed as follows and can be found under the bar code Please follow the operating manual SN Serial number REF Article or order numb...

Page 32: ...OR THEIR RESPECTIVE LICENSORS SPECIFICALLY DISCLAIM ALL WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE TILTLE AND NON...

Page 33: ...ched to or furnished with the product or from breach of warranty breach of contract negligence tort liability strict liability or any other legal or equitable theory and you hereby irrevocably waive a...

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