Systo Monitor 300 - Blood pressure monitor SOEHNLE - Free user manual and instructions

USER MANUAL Systo Monitor 300 SOEHNLE

INTRODUCTION INTRODUCTION ...................... 18 Safety information Scope of delivery General description Indications for Use Device description Power supply Inserting and replacing the batteries The LCD screen

Symbol for “COMPLIES WITH MDD 93/42/EEC REQUIREMENTS” Symbol for “MANUFACTURER”

Symbol for “SERIAL NUMBER” Symbol for “DIRECT CURRENT” Symbol for “MANUFACTURE DATE” Symbol for “TYPE BF APPLIED PARTS” Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be dispo- sed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice” EC REP Symbol for “Authorised Representative in the European Community“ Caution: These notes must be observed to prevent any damage to the device. Safety informationEN

• The device is intended for the independent measurement and monitoring of arterial blood pressure. Only a medical doctor can provide a diagnosis.

• The user must review the func

tionality and proper condition of the device prior to using it. Continued use of a damaged device may result in injuries and erroneous measurement results or pose a serious risk. In case of technical problems with the device, please contact Soehnle’s CUSTOMER SERVICE. Never open or repair the device.

• The device is intended to be used only by adults. Do not use the device if you are pregnant or suspect a pregnancy.

• This device may be used only for the purpose described in these instructions. The manufacturer does not accept any liability for damages based on improper use.

• The device is designed only for personal use.

• It must not be used on any extremities but the arms.

• If you take medication please ask your doctor about the best time to measure your blood pressure.

• If the device is used for measurements on patients with widespread arrhythmia, e.g. extrasystoles of the atrium or ventricularextrasystoles, the best results are generally achieved with deviations. Please discuss the results with your doctor.

• If the cuff pressure is higher than 40 kPa (300 mmHg), the device releases air automatically. If the cuff does not release air at a pressure of 40 kPa (300 mmHg), please remove the cuff from your arm and push IMPORTANT INFORMATION! PLEASE KEEP! Carefully read these user instructions and in particular the safety information prior to using this device and keep these user instructions for future use. When handing the device over to third parties, please also include these user instructions. Non-compliance with these instructions may cause injuries or damage the device.EN

INTRODUCTION the START/STOP key to prevent further inflation.

• The device is not approved for AP or APG categories.

• Avoid interference signals emitted by strong electromag- netic fields or rapid transient disturbances to prevent measur- ing errors.

• The device is not suited for continuous blood pressure monitoring in medical emer- gencies. Blood circulation may be disrupted.

• The cuff material has been test- ed and is proven to correspond to the requirements of ISO 10993-5:2009 and ISO 10993- 10:2010. It does not cause skin irritation or other reactions.

• Please use only the ACCES- SORIES and removable parts prescribed by the manufacturer. Otherwise, danger may arise for the user and the device.

• Please inform Soehnle customer service of unexpected operating status or events.

• The adapter is part of the ELEC- TRONIC MEDICAL DEVICE.

• The plugs/pins of the adapter plug isolate the device against the mains power supply.

• Please do not place the device in a location in which it is difficult to disconnect from the power supply.

• Keep the device outside of the reach of small children/ pets to prevent the inhalation or swallowing of small parts. The cable/cord poses a risk of strangulation.

• When stored at the minimum storage temperature between uses, electrical medical devices must be warmed up for at least 30 minutes before they are operational. When stored at the maximum permissible storage temperature between uses, electrical medical devices must cool off for at least 30 minutes before they are operational.

• Please carefully monitor a possible interruption of blood circulation and a possible injury of the patient.

• Do not place the cuff over a wound as this may cause further injuries.

• Do not place the cuff on the same arm on which other electrical medical devices are placed.EN

• Please ensure that the operation of the device does not interrupt blood circulation for a longer period.

• Avoid squeezing or constriction of the connecting tube.

• The Blood Pressure Monitor has been clinically tested pursu- ant to the requirements of EN 1060-4:2004. Metrological maintenance and care information

• Do not perform any metrolog- ical maintenance if the device is in use.

• For reliable operation, we recommend that the device is subject to metrological control once every two years pursuant to Sec. 14 of the Medical Prod- uct Operating Directive (MPBe- triebV). We recommend testing the device’s performance once every two years and after metrological control and repair, at a minimum by testing the tolerance requirements of the pressure display and tightness of the cuff (testing at least at 50 mmHg and 200 mmHg).

• The metrological control must be performed by a licensed tester or testing institute.

• We recommend cleaning the device and cuff only with a soft cloth. Storage information

• If the device is not being used, store it and the adapter in a dry location away from heat, dust, fibres, lint, and out of direct sunlight. Do not place heavy objects on the storage box. Information about handling batteries

• Do not mix new and used batteries.

• Do not use different types of batteries at the same time.

• Do not throw batteries into a fire. Batteries may explode or leak. Remove the batteries if the de

vice is not used for a long time. Disposal information Battery disposal EC Directive 2008/12/EC Batteries are not a part of your regular household waste. You must return batteries or recharge- able batteries to your municipali- ty’s public collection or wherever batteries of the respective type are being sold.EN

INTRODUCTION Disposal of electric and electronic devices, EC Directive 2012/19/EU This product is not to be treated as regular household waste but must be returned to a collection point for recycling elec- tric and electronic devices. Further information is available from your municipality, your municipality’s waste disposal services, or the retailer where you purchased your product.

Declaration of conformity This device is in com- pliance with the basic requirements and the other pertinent regulations of the Directive 93/42/EEC. Scope of delivery 1x blood pressure monitor Systo Monitor 300 1x cuff (22 – 42 cm /

4x alkaline battery AA 6 V DC 1x user instruction A power adapter is NOT included in the scope of delivery. It is available separately, if needed. Information is available under “Power supply”. General description Thank you for choosing the blood pressure monitor Soehnle Systo Monitor 300 for use on the upper arm. Measurements taken with Soehnle Systo Monitor 300 are equal to those taken by a trained professional. This user instruction contain important information concerning safety, care of the device, and ex- plain the proper use step-by-step.EN

INTRODUCTION Indications for Use The Soehnle Systo Monitor 300 is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circum- ference ranging from 22 – 42 cm /

It is intended for adult indoor use only. Device description Please note the fold-out page.

Power plug connection

1. Battery operation:

4 alkaline batteries AA 6 V DC

2. Power adapter operation:

6V 1A Please use only the adapter approved by the manufacturer. Available separately (Item No. 89165/5). Inserting and replacing the batteries

1. Open the battery compartment.

3. Close the battery compartment

cover. The normal service life of new and unused batteries is 300 measurements at a meas

INTRODUCTION Symbol Description Explanation Systolic blood pressure Upper blood pressure value Diastolic blood pressure Lower blood pressure value Pulse display Pulse in beats per minute Symbol pressure release Air is released from the cuff Memory Displays that the device is in memory mode kPa Unit of measurement for blood pressure (1 kPa = 7.5 mmHg, see page 25) mmHg Unit of measurement for blood pressure (1 mmHg = 0.133 kPa, see page 25) Battery charge display Displays charge status of the battery Irregular pulse Irregular pulse detected during measurement Blood pressure level Indicates blood pressure level (based on WHO scale, see page 29) Current time Year/month/day, hour/minute Heartbeat The blood pressure monitor detects the heartbeat during the measurement User 1 Active user profile (user 1) User 2 Active user profile (user 2) Movement indicator Indication of result distorting movement Average value Average value of the blood pressure The LCD screenEN

Setting date, time, and unit of measure Date and time must be set prior to using the blood pressure mon- itor so that every measurement value that is stored can be time stamped.

1. If the device is switched off,

push the key ( ) to display the time. Then push and hold the key ( ) to set the year.

) to change the [YEAR]. Each time you push the key, the year increases by one.

3. Once the year has been set,

push key ( ) to save the infor- mation and continue.

4. Repeat steps 2 and 3 to set

[MONTH], [DAY], [HOUR], [MIN-

UTE] and [UNIT OF MEASURE] You can switch between the unit of measure “kPA” (kilo pascal) or “mmHg” (millimetre mercury column), where mmHg is the most common unit for measuring blood pressure.

After setting the unit of measure, the LCD display shows “done” and then displays all settings entered by you before switching off. Selecting the user A total of two users can be programmed. 60 datasets can be stored for each user.

1. If the device is switched off,

push and hold the key ( ) to select the user. The user symbol

) again to select between user 1, 2 or “Guest” (guest mode). No measurements are stored in guest mode.

3. Confirm the selection of the

respective user by pushing (

The respective user and “done” are shown before the display switches off.EN

MEASURING Measuring information The measurements may be incorrect under the following circumstances:

• Within 1 hour after a meal or a drink

• Measurements immediately after consuming tea, coffee, or after smoking

• Within 20 minutes after a bath

• While speaking or moving fingers

• In a very cold environment

• With a strong urge to urinate

• Relax for 5 minutes before measuring.

• Wait at least 3 minutes between two measurements. This allows the blood flow in your arm to return to normal.

• For a reasonable comparison of various measurement values, al- ways attempt to measure in the same situations. For example, take your measurement daily at around the same time and with the upper arm in the position as shown to you by a doctor. Cu placement

1. Place the cuff on the upper arm

and then turn the hose towards the inside of the arm in line with the pinkie finger. You can also align the arterial mark so that it is placed above the largest artery (on the inside of the arm). You can find the largest artery by gently pushing 2 fingers approximately 2 cm above the crook of your arm, on the inside of your left arm. Find where the pulse can be felt the strongest. This is where the largest artery is located. (Fig. 1)

2. The cuff should be snug but not

too tight. It must be possible to insert one finger between the cuff and your arm. (Fig. 2)

3. Sit in a comfortable position

and place the arm on which the measurement will be taken on a level surface. Sit down comfortably prior to starting the measurement: do not cross your legs, place the soles of your feet on the floor, your back and arm should be supported.

4. For users with hypertension:

The centre of the cuff should be at the level of the right atrium (Fig. 3).EN

MEASURING Starting the measurement

1. If the blood pressure monitor

is switched off, switch it on by pushing the key ( ). The de- vice performs the measurement.

• The device will first zero adjust itself

• The cuff will then be inflated and the device will measure the blood pressure and pulse. Push the key ( ) to stop the measure

• Once the measurement is completed, the air is released from the cuff and the measured values will be displayed. They will be automatically allocated to the selected user and stored. Year, date, and time are shown alternately.

) to switch the device off. The device switches off automatically after 1 minute.EN

pressure monitor on. The average value of the last three datasets will be displayed.

) or ( ) to get to the desired datasets. While scrolling, the number of the displayed dataset and the total number of stored measure- ments will be shown in the upper right corner. If you leave a dataset displayed, date and time of the measurement will also be shown. They will be put through automat

3. If you would like to recall the

datasets of another user, first push the key ( ) to switch the device off if the blood pres- sure monitor is still in the “recall memory” mode. Push and hold the key ( ) to enter the mode “select user”, push the key ( ) again to select between user 1 and user 2. Push the key ( ) to confirm the user, then recall the measured datasets of the selected user with (

The most current dataset (1) is shown rst. Each new measurement is stored at dataset (1). All other datasets are moved back by one (2 becomes 3, etc.) and the last dataset (60) is removed from the list. Deleting stored values If a measurement is not perfor- med correctly, you can delete all measurement results for the selected user as follows.

for approximately 3 seconds while the blood pressure monitor is in the “recall memory” mode. “dEL ALL” (delete ALL) will flash and the selected user will be displayed. Push ( ) to exit the “delete” mode wi

thout deleting datasets.

to confirm deletion, and “user+dEL done” will be displayed. The blood pressure monitor then switches off automatically.EN

What is systolic and di- astolic blood pressure? When the heart ventricles con- tract to pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, the so-called systolic value. The blood pressure reaches its lowest value in the cycle when the heart ventricles relax. This is the diastolic blood pressure. How are blood pressure values usually catego- rized? The classification of blood pressure published in 1999 by the World Health Organization (WHO) and the International Society of Hypertension (ISH) is as follows: Classifi- cation SYS (mmHg) DIA (mmHg) Grade 3 HT > 180 > 110 Grade 2 HT 160 – 179 100 – 109 Grade 1 HT 140 – 159 90 – 99 High normal 130 – 139 85 – 89 Normal 120 129 80 – 84 Optimal < 120 < 80 HT = Hypertension (high blood pressure) IMPORTANT Only a medical doctor can determine your normal blood pressure range. Please see a doctor if your measurement results are outside of this range. Recognizing irregular pulse The device recognizes irregular pulse (arrhythmia) if the heartbeat fluctuates while measuring the systolic and diastolic blood pres- sure. The blood pressure monitor records heartbeat intervals and calculates the average value during each measurement. If an average value is greater than or equal 25%, the measurement re- sult also displays a warning signal for irregular pulse. The warning “irregular pulse” shows that an irregular pulse has been determined during the measure

ment, which might indicate arrhythmia. Generally, this is NOT a cause for concern. However, if the symbol is displayed fre

quently, we recommend that you speak with your doctor. The device does not repla

ce a cardiology examination but provides an early detection of irregular pulse.EN

CUSTOMER INFORMATION Maintenance and Storage Your device will provide the best measurement accuracy if you comply with the following instructions:

• Store in a dry location and avoid direct sunlight

• Avoid contact with water, clean with a soft cloth if necessary.

• Avoid strong vibrations and impact.

• Do not store in dusty environ- ments or varying temperatures.

• Do not clean the reusable cuff with water and do not submer- ge it in water. Contact Soehnle Customer Service Hotline [phone] – 977 0 Mon – Fri, 7:00 a.m. – 6:00 p.m. Further information about our products can be found at www. soehnle.com. Distributor: Soehnle is a brand of Leifheit AG, Leifheitstraße 1 56377 Nassau/Germany Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China EC REP European representative: MDSS - Medical Device Safety Service GmbH, Schiffgraben 41, 30175 Hanover, GermanyEN

CUSTOMER INFORMATION Guarantee Leifheit AG offers a 2 year guaran- tee for this quality product as of the purchase date (or in case of orders, as of receipt of the goods). Guarantee claims must be asser- ted within the guarantee period and immediately after occurrence of the defect. The guarantee includes product quality. The following are excluded from the guarantee:

1. Wear caused by use or other

2. Damage caused by improper

use or handling (e.g. impact, shock, drop),

3. Damage caused by non-com-

pliance with these user instruc- tions. In case of a guarantee claim, Leif- heit, at its own discretion, either repairs the defective components or replaces the product. If a repair cannot be performed and an identical product is no longer available in the product range for the purpose of replacement, you will receive a replacement product of the closest equivalent value. Reimbursement of the purchase price is not possible in case of a guarantee claim. This guarantee furthermore does not grant any claims for damages. To assert the guarantee, please contact the sel- ler where you have acquired the product and present the defective product and the purchase receipt (copy). This guarantee is valid worldwide. Your statutory rights, in particular warranty rights, con- tinue to apply and are not limited by this guarantee.EN

PROBLEM POSSIBLE CAUSE RESOLUTION

Display does not light up Batteries are empty Replace batteries Batteries are not inserted correctly. Insert batteries correctly. The DC adapter is not inserted correctly. Insert the DC adapter correctly. Display is dicult to see or slow Battery charge is too low. Replace batteries E 01 is displayed The cuff is too tight or too loose. Reposition cuff and repeat measurement E 02 is displayed The blood pressure monitor displays movement during the measurement. Movements may affect the measurement. Relax for a moment and repeat the measurement. E 03 is displayed No pulse was detected during measurement. Remove the clothing from your arm and repeat the measurement. E 04 is displayed A precise measurement could not be performed. Relax for a moment and repeat the measurement. EExx is displayed. A “calibration error” oc- curred. (XX can indicate a digital signal, e.g. 01, 02 etc.) Repeat the measurement. If the problem occurs again please contact your seller or our customer service for further assistance.

displayed Low battery charge The charge status of the battery is too low; batteries must be replaced. “Out” is displayed Outside of the measure- ment range Relax for a moment. Reposition the cuff and repeat the measurement. If the problem occurs again please contact your doctor.EN

68099 (Model: TMB-1597) Power supply Battery operation: 4 alkaline batteries AA 6V DC Power adapter operation 6 V 1 A (Please use only the recommended power adapter.) Display mode LCD display (73 × 49 mm / 2.87 × 1.92 inch) Measurement mode Oscillographic testing mode Measurement range Target cuff pressure: 0 mmHg – 300 mmHg (0 kPa – 40 kPa) measurement pressure SYS: 60 mmHg – 230 mmHg (8.0 kPa – 30.7 kPa) DIA: 40 mmHg – 130 mmHg (5.3 kPa – 17.3 kPa) Pulse: (40 – 199) beats per minute Accuracy Pressure: 5 °C – 40 °C within ± 3 mmHg (0.4 kPa) pulse at: ± 5 % Normal operating conditions Temperature range from +5°C to +40°C; Non-condensing, relative humidity from 15% to 90%; Partial water vapour pressure higher than 50 hPa is not applicable. Inflation pressure between: 700 hPa to 1060 hPa Storage and transport conditions Temperature:-20°C to +60°C A relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa Measurement perimeter on the upper arm 22 – 42 cm / 8.66 - 16.53 inch Weight approx. 258 g / 9.10 oz (excluding batteries and cuff) External dimensions approx. 118 × 126 × 72 mm / 4.64 × 4.96 × 2.83 inch Accessories 4 alkaline batteries AA Operating mode Continuous operation Protection category Applied part type BF Water ingress protection IP21 means that the blood pressure monitor is protected against solid foreign bodies with a size of 12.5 mm / 0.49 inch and larger as well as vertically dripping water. Software version A01

Modifications of the device are not permitted.FR

DYREKTYWY 93/42/WE DLA WYROBÓW

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