Final version – No artwork master Tenso-comfort Blood pressure monitor BPM 105/ BPM 205 User manual Distributor in the United 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 Strasse 17 73765 Neuhausen a.d.F.
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Table of Contents 1 Introduction; Safety Information 1.1 Intended use 1.2 Warnings General information for selfmeasurement of blood pressure 2.1 Before taking a measurement 2.2 Blood pressure information .2 .3 3.1 3.2 3.3 3.4 3.5 3.6 3.
Display elements 1 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 3 4 5 6 7 8 9 10 11 12 13 4 Number eld for systolic blood pressure, user no.
Contents of Package 1 Introduction; Safety Information - Blood pressure monitor - Storage bag - 2 x 1.5 V alkaline batteries (type AAA / LR03) - User manual and important safety information - Biocomfort Limited Product Warranty Dear Customer, Info at www.biocomfort.com For help getting started or any questions you may have, please do not hesistate to give us a call at 1-866-294-8267 (available from 9 a.m. to 5 p.m.
1.1 Intended use 1.2 Warnings 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 symbols below identify and alert the user to the presence of important safety, operating, and service instructions. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard.
this device if you suffer from any of these conditions. WARNING: If you suffer from arrhythmia, you must consult with your physician prior to using this device. WARNING: This device has been designed for and is intended for use on persons with normal sinus rhythms only. Consult your physician before using this device if you do not have a normal sinus rhythm WARNING: If you have a cardiac pacemaker, this device will indicate your actual pulse rate.
CAUTION: Use only with Biocomfort parts and accessories with this device. Parts and accessories not approved by Biocomfort for use with this device may damage the unit. CAUTION: Measurements can be affected by physical exertion, stress. Avoid taking measurements under these conditions. CAUTION: The cuff contains a sensitive air-tight bubble. Handle the cuff carefully and avoid all types of stress through twisting or buckling.
2 WARNING: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. Operation of Device with Wireless Capability (BPM105): CAUTION: Do not activate or use the wireless device where the use of wireless devices (e.g. phones) is prohibited or when it may cause interference or danger.
increase the wait time depending on your individual physiological characteristics. It is important that you document your blood pressure and pulse measurements for your physician. Keep a record of your blood pressure and pulse readings for your physician.
A blood pressure which is too low (hypotension) (i.e., systolic values under 105 mmHg and/or diastolic values under 60 mmHg) can cause unpleasant discomfort, such as dizziness and fatigue. Please consult your physician. A regular self check with the Biocomfort blood pressure monitor will be necessary if your blood pressure lies outside these normal ranges. Regular self checks are strongly recommended even with normal blood pressure values.
Preliminary note: This operating manual refers to the blood pressure monitor model BPM105 with a wireless interface and model BPM205 without a wireless interface. The measured value memory for the BPM105 device with a wireless interface is directly congured via the Health Manager software. Chapter 3.5 does not apply to the BPM105 model 3.1 Inserting / exchanging batteries The Biocomfort blood pressure meter is delivered with two 1.
When batteries are removed, the internal clock of the measuring device doesn’t continue to run, so when the device is used again after exchanging the batteries or after storing the device without batteries, the date and time may have to be reset (see Section 3.4). 3.2 Switching on 3.3 Conguring the device Switch on your blood pressure meter by pressing the On/Off button. Every time you turn it on, all display elements appear for about 2 seconds as a function test.
Note: If you keep the MEM button pressed, you can change the currently active parameter faster. On/Off button: By pressing the On/Off button, you exit the settings menu and the set parameters are saved. 3.4 Setting the date and time Note: The measured blood pressure and pulse values are stored with the date and time. The correct setting of the date and time makes it easier for you to make a correct time allocation of your measurements.
Step 5: Press the SET button again: Now the display for the day starts blinking. Step 11: If you do not wish to make any further settings, exit the settings menu by pressing the On/Off button. Otherwise, continue with the settings by pressing the SET button. Step 9: Press the SET button again: Now the display for the minutes starts blinking. 3.
“on” means: The measured value memory is enabled for user “1”. “off” means: The measured value memory is blocked for user “1”. Step 2: To change the measured value memory state for user “1” from “off” to “on” or vice versa, press the MEM button. Step 3: After you have set the measured value memory to the status you wish, you can set the status of the measured value memory for user “2” by pressing the SET button again.
Step 1: To reset the wireless interface, press the SET button until the radio symbol (= fat black dot in double parentheses) appears in the bottom left-hand corner of the display. To the right of the radio symbol appear two “0”s. – If there is a dash between the two “0”s, this means that the wireless connection is being maintained. – If there is no dash between the two “0”s, this means that the wireless connection is reset.
“ CLr” disappear. If you now carry out step 3, the contents in memory will be retained. 4 Carrying out the blood pressure measurement Step 3: If you do not wish to make any further settings, exit the settings menu by pressing the On/Off button. Otherwise, continue with the settings by pressing the SET button. 4.1 Applying the cuff Attention: There is no possibility to clear the memory for only one or two users.
The wrist circumference at the point of measurement must be at least 5.31inch. 4.2 Carrying out the blood pressure measurement Please note the following when carrying out blood pressure measurements: – Make sure there is at least a 3-minute interval between two consecutive measurements. – Set comfortably and up straight. Place both feet rmly on the oor and relax. – When the device is held above or below the heart, this leads to faulty measurements.
Step 8: Press the On/Off button to switch off the device. If the measurements do not change, consult your physician immediately! Note: The device switches off automatically no later than 2 minutes after the end of the measurement. 4.3 Use by multiple persons WARNING: Hypertension warning According to the World Health Organization (WHO), normal values for blood pressure are 140 mmHg for the systolic pressure and 90 mgHg for the diastolic pressure.
5.1 Storing the measured values For every user identity number (1 to 8), the blood pressure meter automatically stores the last 110 measured blood pressure measurements together with the date and time of the measurement. If the memory is full, the oldest result is overwritten by the result of the next measurement. The measured values are retained in the measured value memory even when the batteries are removed. 5.
Once the end of the measured value memory has been reached, or if there are no other measured values available, the following is displayed: 6.1 Function control of the display Every time you turn on the blood pressure meter, all display elements appear for about 2 seconds. This gives you the oppurtunity to determine whether all display elements are working properly, since a faulty display can lead to false interpretations of the measured values.
Caution: Use only Biocomfort parts and accessories with this device. Parts and accessories not approved by Biocomfort for use with this device may damage the unit. Caution: Do not attempt to open or repair the device yourself. This may damage the device or cause personal injury. The monitor does not contain any user serviceable components. Operating and Storage Temperatures and Environmental Conditions Make sure that the cuff is not damaged by sharp objects (needles, scissors, etc.
Causes Measures 0 error Weak pulse signal Switch the device off, reapply the cuff and repeat the measurement. Remarks Error messages Causes Measures Remarks 5 error Air released too quickly Switch the device off, reapply the cuff and repeat the measurement. If this error message appears repeatedly, have the device checked by the manufacturer. If this error message appears repeatedly, have the device checked by the manufacturer.
Causes Measures Remarks 10 error Internal read error Switch off the device and restart. If this error message appears repeatedly, have the device checked by the manufacturer. Error messages Causes Measures Remarks 21 error (BPM105) No wireless module found Switch off the device and restart. If this error message appears repeatedly, have the device checked by the manufacturer. Switch off the device and restart. Measurement cannot be carried out.
Device type: Wrist blood pressure meter Model: tenso-comfort BPM105 tenso-comfort BPM205 Serial no.: Measuring method: Display: Measuring range – Pressure: – Pulse: Emergency off function: 40 Specied on the type plate (bottom of measuring device) Oscillometric blood pressure measurement with automatic measuring sequence LCD 0–300 mmHg 40–199 beats per minute By pressing the On/Off button during measurement, the measuring process is automatically terminated and air is let out of the cuff.
Type BF: Device is not protected against the effects of defibril-lators - EN 1060 : 1997 Non-invasive blood pressure meters Part 3: Supplementary requirements for electromechanical blood pressure meters ANSI/AAMI SP10:2002 /A1:2003 Classification: Europe: Class 2a (EC directive 93/42/EWG, Medical devices) USA: Device class 2 - This device meets the regulations of EC directive 93/42/EWG (directive for medical devices) and is developed and manufactured according to the regulations of the 21CFR 820.
Guidance and manufacturer’s declaration – electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic emissions The BPM105/BPM205 is intended for use in the electromagnetic environment specified below. The customer or the user of the BPM105/BPM205 should assure that it is used in such an environment. The BPM105/BPM205 is intended for use in the electromagnetic environment specified below.
Guidance and manufacturer’s declaration – electromagnetic immunity The BPM105/BPM205 is intended for use in the electromagnetic environment specified below. The customer or the user of the BPM105/BPM205 should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the BPM105/BPM205 The BPM105/BPM205 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
10 Symbols and abbreviation The device contains an HF trans mitter (radio transmitter). (BPM 105 model only) You will find the symbols shown below with the following meanings on the device, the packaging materials and the operating manual: Symbol for separate collection of electric and electronic devices The serial number of the device is composed as follows and can be found under the barcode. Art. no. Prod. no. Device type: Prod.
11 Limited Product Warranty Information This product is subject to the Biocomfort OneYear Limited Warranty separately included in this box and also available from Biocomfort or any authorized Biocomfort dealer or from Biocomfort’s website at http://www.biocomfort.com/support.
business information, loss of earnings, compensation or benefits, or any other pecuniary loss, and including under any claim of negligence, strict liability, design defect, or other theory, arising from (1) any defect in the software or the use of or inability to use the software or firmware installed on any hardware sold to you, or furnished with or referenced, in this user manual or from the licensing of the software or firmware by Biocomfort or the provisionany services by Biocomfort or Biocomfort USA, (
