Systo Monitor 100 - Blood pressure monitor SOEHNLE - Free user manual and instructions

USER MANUAL Systo Monitor 100 SOEHNLE

Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development
District, Zhongshan, 528437, Guangdong, China

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.

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Symbol for "COMPLIES WITH MDD 93/42/EEC REQUIREMENTS"

0123

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Symbol for "SERIAL NUMBER"

Symbol for "DIRECT CURRENT"

Symbol for "MANUFACTURE DATE"

Symbol for "TYPE BF APPLIED PARTS"

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Caution: These notes must be observed to prevent any damage to the device.

INTRODUCTION

INTRODUCTION. 26

Safety information

Scope of delivery

General description

Indications for Use

Device description

Power supply

The LCD screen

PRIOR TO THE FIRST MEASUREMENT.....35

Setting date, time, and unit of measure

Selecting the user

MEASURING. 36

Measurement information

Cuff placement

Starting the measurement

DATA MANAGEMENT 38

Recalling stored values

Deleting stored values

INTERPRETING THE

RESULTS 39

CUSTOMER INFORMATION 41

Maintenance & Storage

Contact

Customer Service

Guarantee

TROUBLESHOOTING 43

TECHNICAL DATA. 45

Information on use

• 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 functionality 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 wrists.
• 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 40kPa (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 wrist and push the START/STOP key to prevent further inflation.

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

• Avoid interference signals emitted by strong electromagnetic fields or rapid transient disturbances to prevent measuring errors.

• The device is not suited for continuous blood pressure monitoring in medical emergencies. Blood circulation may be disrupted.
• The cuff material has been tested 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 inform Soehnle customer service of unexpected operating status or events.
• Keep the device outside of the reach of small children/pets to prevent the inhalation or swallowing of small parts.
• 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 wrist on which other electrical medical devices are placed.
• Please ensure that the operation of the device does not interrupt blood circulation for a longer period.
• This device is in compliance with the basic requirements and the other pertinent regulations of the Directive 93/42/EEC.

Metrological maintenance and care information

• Do not perform any metrological 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 Product Operating Directive (MP-BetriebV). 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 50mmHg and 200mmHg ).
• 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 in a dry location away from heat, dust, fibres, 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 device 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 rechargeable batteries to your municipality's public collection or wherever batteries of the respective type are being sold.

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 electric and electronic devices. Further information is available from your municipality, your municipality's waste disposal services, or the retailer where you purchased your product.

CE 0123

Declaration of conformity

This device is in compliance with the basic requirements and the other pertinent regulations of the Directive 93/42/EEC.

Scope of delivery

1x wrist blood pressure monitor Systo Monitor 100
2x alkaline battery AAA 3V DC
1x user instruction

General description

Thank you for choosing the wrist blood pressure monitor Soehnle Systo Monitor 100. Measurements taken with Soehnle Systo Monitor 100 are equal to those taken by a trained professional. This user instruction contain important information concerning safety, care of the device, and explain the proper use step-by-step.

Indications for Use

The Soehnle Systo Monitor 100 is digital monitors intended for use in measuring blood pressure and

heartbeat rate with wrist circumference ranging from 13.5 - 21.5cm / 5.31 - 8.46 inch. It is intended for adult indoor use only.

Device description

Please note the fold-out page.

Cuff

LCD display

Pump

Battery compartment

Memory key (Q)

Settings key (O)

Start/Stop key (START)

Power supply

1. Battery operation:

2 alkaline batteries AAA 3V DC

The LCD screen

Symbol	Description Explanation
SYS	Systolic blood pressure Upper blood pressure value
DIA	Diastolic blood pressure Lower blood pressure value
PUL/min	Pulse display Pulse in beats per minute
Q	Memory Displays that the device is in memory mode
kPa	kPa	Unit of measurement for blood pressure (1 kPa = 7.5 mmHg, see page 35)
mmHg	mmHg	Unit of measurement for blood pressure (1 mmHg = 0.133 kPa, see page 35)
	Battery charge display Displays charge status of the battery
	Irregular pulse Irregular pulse detected during measurement

INTRODUCTION

EN

Symbol	Description Explanation
I	Blood pressure level	Indicates blood pressure level (based on WHO scale, see page 40)
BBZBB	Current time Year/month/day, hour/minute
Heartbeat	Heartbeat	The blood pressure monitor detects the heartbeat during the measurement
1	User 1 Active user profile (user 1)
2	User 2 Active user profile (user 2)
	Movement indicator Indication of result distorting movement
AVG	Average value Average value of the blood pressure

Setting date/time/unit of measure

Date and time must be set prior to using the blood pressure monitor so that every measurement value that is stored can be time stamped.

1. If the device is switched off, push the key (O) to display the time. Then push and hold the key (O) to set the year.
2. Push the key (a) to change the [YEAR]. Each time you push the key, the year increases by one.
3. Once the year has been set, push key (O) to save the information and continue.
4. Repeat steps 2 and 3 to set [MONTH], [DAY], [HOUR], [MINUTE] 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.

1. 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 ( ) flashes.
2. Push key (Q) again to select between user 1, 2 or "Guest" (guest mode).

No measurements are stored in guest mode.

1. Confirm the selection of the respective user by pushing () . The respective user and "done" are shown before the display switches off.

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 wrist to return to normal.
• For a reasonable comparison of various measurement values, always attempt to measure in the same situations. For example, take your

measurement daily at around the same time and with the wrist in the position as shown to you by a doctor.

Apply the cuff

1. Remove all accessories form your wrist (watch, bracelet and so on.).
2. Apply the cuff around your exposed wrist in that way the display is upwards and you have a undisruptive view on it. (Fig. 1).
3. Position and close the cuff tightly about 1 - 1.5cm / 0.4 - 0.6 inch above your wrist.
4. Sit down comfortably and place your elbow, on which you perform the measurement, on a straight surface. Hold your wrist up, in a way that the cuff is on the same level as your heart. Turn your palms upward, sit straight and take 5-6 deep breaths.

Before starting the measurement, sit comfortably: do not cross your legs, place the soles of your feet on the ground and support your back and arm.

5. User with hypertension:

The middle of the cuff should be in the hight as the right heart atrium (Fig. 2).

Starting the measurement

1. If the blood pressure monitor is switched off, switch it on by pushing the key (START). The device performs the measurement.

2. The device will first zero adjust itself

3. The cuff will then be inflated and the device will measure the blood pressure and pulse.

Push the key (G) to stop the measurement at any time.

• 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.
• Push the key () to switch the device off. The device switches off automatically after 1 minute.

Recalling stored values

1. Push ( ) to switch the blood pressure monitor on. The average value of the last three datasets will be displayed.
2. Push the key ( ) or ( ) to get to the desired datasets. While scrolling, the number of the displayed dataset and the total number of stored measurements 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 automatically.

1. If you would like to recall the datasets of another user, first push the key (START) to switch the device off if the blood pressure monitor is still in the "recall memory" mode.

Push and hold the key (Q) to enter the mode "select user", push the key (Q) again to select between user 1 and user 2. Push the key (O) to confirm the user, then recall the measured datasets of the selected user with (Q).

The most current dataset (1) is shown first. 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 performed correctly, you can delete all measurement results for the selected user as follows.

1. Push and hold key (9) for approximately 3

DATA MANAGEMENT INTERPRETING THE RESULTS

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 without deleting datasets.

2.Push() to confirm deletion, and "user+dEL done" will be displayed. The blood pressure monitor then switches off automatically.

What is systolic and diastolic blood pressure?

When the heart ventricles contract 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 categorized?

The classification of blood pressure published in 1999 by the World Health Organization (WHO) and the International Society of Hypertension (ISH) is as follows:

INTERPRETING THE RESULTS

Classification

SYS nmHg)

DIA nmHg)

Grade 3 HT >180 > 110

Grade 2 HT 160 - 179 100 - 109

Grade 1 HT 140 - 159 90 - 99

High normal 130-13985-89

Normal 120-12980-84

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 pressure. 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 result also displays a warning signal for irregular pulse.

The warning "irregular pulse" shows that an irregular pulse has been de

terminated during the measurement, which might indicate arrhythmia. Generally, this is NOT a cause for concern. However, if the symbol is displayed frequently, we recommend that you speak with your doctor. The device does not replace a cardiology examination but provides an early detection of irregular pulse.

Maintenance & 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 environments or varying temperatures.
• Do not clean the reusable cuff with water and do not submerge 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, Leifheitsstraße 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

ECREP European representative:

MDSS - Medical Device Safety Service GmbH, Schiffgraben 41, 30175 Hanover, Germany

Guarantee

EN

Leifheit AG offers a 2 year guarantee for this quality product as of the purchase date (or in case of orders, as of receipt of the goods). Guarantee claims must be asserted 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 natural wear,
2. Damage caused by improper use or handling (e.g. impact, shock, drop),
3. Damage caused by non-compliance with these user instructions. In case of a guarantee claim, Leifheit, 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 seller 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, continue to apply and are not limited by this guarantee.

FEHLER ZU PRÜFEN ABHILFE
Display does not show, is hardly visible or slow	Batteries are empty Replace batteries
	Batteries are not inserted correctly.	Insert batteries correctly.
lo + is displayed	Low battery charge The charge status of the battery is too low; batteries must be replaced.
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 wrist and repeat the measurement.

TROUBLESHOOTING

EN

FEHLER ZU PRÜFEN ABHILFE
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” occurred. (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.
“Out” is displayed Outside of the measurement range		Relax for a moment. Reposition the cuff and repeat the measurement. If the problem occurs again please contact your doctor.
Item no. SN		68095 (Modell: TMB-1598)
Power supply Battery operation: 2 alkaline batteries AAA 3V DC
Display mode LCD display (45 mm x 33 mm / 1.77 × 1.30 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		A temperature range of: +5°C to +40°C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of: 700 hPa to 1060 hPa

TECHNICAL DATA

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 wrist	13.5 cm – 21.5 cm / 5.31 – 8.46 inch
Weight approx. 100 g / 3.52 oz (excluding batteries)
External dimensions	ca. 86 × 66 × 22 mm / 3.38 × 2.60 × 0.86 inch
Accessories 2 alkaline batteries AAA
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

WARNING: Modifications of the device are not permitted.

REMARQUES IMPORTANTES! À CONSERVER IMPÉRATIVÉMENT!

GESTION DES DONNÉES. 61

Service clients Soehnle

Garantie

DEPANNAGE 67

Service clients Soehnle

Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development
District, Zhongshan, 528437, Guangdong, China

INFORMATIONS POUR LE CLIENT

Garantie

Guangdong Transtek Medical

Electronics Co., Ltd.

Zone A, No.105, Dongli Road,

Torch Development District,

Zhongshan, 528437, Guangdong,

Cina

ECREP Rappresentanza europea:

MDSS - Medical Device Safety Service GmbH, Schiffgraben 41, 30175 Hannover, Germania

Garanzia

Zone A, No.105, Dongli Road, Torch Development District,

Zhongshan, 528437, Guangdong, China

ECREP Goedgekeurde Europese representant:

MDSS - Medical Device Safety Service GmbH, Schiffgraben 41, 30175 Hannover, Duitsland

Garantie

Zone A, No.105, Dongli Road,

Torch Development District,

Zhongshan, 528437, Guangdong,

China

ECREP Distribuidor autorizzato en Europa:

MDSS - Medical Device Safety Service GmbH, Schiffraben 41, 30175 Hannover, Alemania

Garantía

56377 Nassau/Germany

www.soehnle.com