Spengler 513 700 Series Mobi Tensiometer User Manual

: June 14, 2024
: Spengler

Spengler 513 700 Series Mobi Tensiometer

Product Information

Specifications

Product Name: Mobi Tensiometer
Manufacturer: SPENGLER
Model Numbers: 513 702, 513 700, 513 701, 513 703
Measurement Method: Auscultatory method (requires a stethoscope)
Measurement Range: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Product Usage Instructions

Step 1: Reading the Leaflet
Please read the provided leaflet before using the Mobi tensiometer. Keep the leaflet for future reference.

Step 2: Intended Medical Use
The Mobi tensiometer is a professional medical diagnosis device used by trained health professionals. It measures the pressure exerted by blood on arteries using the auscultatory method. This method requires the use of a stethoscope. The Mobi tensiometer accurately measures maximum systolic blood pressure (SBP) and minimum diastolic blood pressure (DBP).

Step 3: Understanding Blood Pressure
Blood pressure is the pressure exerted by blood flow on the walls of arteries. The highest pressure, known as systolic pressure, occurs when the left ventricle contracts. The lowest pressure, known as diastolic pressure, occurs when the ventricles relax. Blood pressure can fluctuate throughout the day and can be influenced by factors such as stress, nutrition, physical activity, medications, and diseases.

Step 4: Normal Blood Pressure
According to the World Health Organization (WHO), normal blood pressure is defined as systolic pressure below 130mmHg and diastolic pressure below 90mmHg. However, individual blood pressure can vary. Please refer to the WHO classifications table below for more information:

Blood Pressure Classification in Adults (mmHg)| Systolic Blood Pressure (mmHg)| Diastolic Blood Pressure (mmHg)
---|---|---
Optimum| < 120| < 80
Normal| 120-129| 80-84
Upper Normal| 130-139| 85-89
Grade 1 HBP| 140-159| 90-99
Grade 2 HBP| 160-179| 100-109
Grade 3 HBP| >= 180| >= 110

Step 5: Warnings
The following warnings are important to ensure accurate measurements and patient safety:

Possible measurement error: Only use the Mobi tensiometer cuffs and accessories from SPENGLER to avoid measurement errors.

FAQ (Frequently Asked Questions)

Can I use any stethoscope with the Mobi tensiometer?
Yes, you can use any stethoscope with the Mobi tensiometer as long as it provides clear and accurate sound.
Can I use the Mobi tensiometer for children?
The Mobi tensiometer is designed for use with adults. For pediatric patients, please consult a healthcare professional for appropriate blood pressure monitoring devices.
How often should I calibrate the Mobi tensiometer?
It is recommended to follow the calibration instructions provided by SPENGLER. Calibration frequency may vary based on usage and specific requirements.

SYMBOLOGY

Manufacturer
See the directions for use
Product reference
Batch number
Protect from humidity
Protect from light and sun
Storage temperature range
Dispose of used product at a collection point for recycling in accordance with local regulations.
This product complies with directive 93/42/CEE regarding medical devices.

INTRODUCTION

Thank you for purchasing a Mobi tensiometer.
When you choose a SPENGLER instrument, you are choosing experience and excellence that has been recognized since 1907.
Mobi is the result of several years of research and testing focused on providing health professionals with an instrument with unrivalled accuracy, design and practicality.

INSTRUCTIONS FOR USE

Please read the leaflet before use and keep it for future reference.

INTENDED MEDICAL USE

The Mobi tensiometer is a medical diagnosis professional device (used by health professionals trained in its use) that measures the pressure exercised by blood on arteries by the auscultatory method (a stethoscope is therefore required).
It accurately measures maximum systolic blood pressure or SBP (resulting from the left ventricle contracting) and minimum diastolic blood pressure or DBP (resulting from ventricles relaxing).

WHAT DOES “BLOOD PRESSURE” MEAN?

Blood pressure is the pressure exercised by blood flow on the walls of arteries. The highest pressure, produced in the arteries by each heart beat, is called “systolic pressure” whereas the lowest is “diastolic pressure”.
Blood pressure fluctuates several times a day and can also vary with stress, nutritional factors, physical activity, medicines or diseases.

WHAT IS “NORMAL” BLOOD PRESSURE?

According to the WHO (World Health Organization), normal blood pressure is systolic pressure less than 130mmHg (millimetres of mercury) and diastolic pressure below 90mmHg. However, blood pressure can vary depending on the individual. The WHO classifications table can be found below.

WARNINGS
The warnings in this document highlight conditions or practices which could cause injury, disease or potentially death of a patient.

Warning: Possible measurement error. Only use the tensiometer cuffs and Mobi accessories from SPENGLER to avoid measurement errors.
Warning: Risk of inaccurate measurement. Before use, check that all the connection points, the cuff and tube are completely airtight. Excessive leakage can affected measurement.
Warning: No changes can be made to this equipment as this could affect measurements.

CHOOSE AN CUFF THAT SUITS THE PATIENT’S MORPHOLOGY

SPENGLER is taking on the fight by informing health professionals in using an cuff that suits a patient’s morphology, as the size of the cuff impacts the quality of measurements:

A too narrow cuff over-estimates blood pressure.
A too large cuff could under-estimate blood pressure.

Note:

The index marker showing the arterial index on the cuff must be within the range shown on Mobi cuffs.
When the cuff is positioned on the patient’s arm, the “index” marker shown on the cuff must be within the range shown on Mobi cuffs. If the “index” marker or the edge of the marker does not reach this range, we recommend that you see the table below in order to adapt the cuff to a patient’s morphology.

SPENGLER innovation: With its magnetic connectors, the “Life Link®“ tube of the Mobi tensiometer means that the cuff can be changed effortlessly in one second.

AMBIDEXTROUS: CHANGE THE CONFIGURATION
The Mobi is especially designed to be ambidextrous, change the position of the following parts:

Decompression valve,
Spoon
LifeLink® connection

Instructions: changing the Life Link® connection

Unscrew the bulb and remove it from the device. With the decompression valve closed, unscrew the magnetic “Life Link®“ connector with a screwdriver. (Schema 1)
Remove the cartridge by pulling on the decompression valve. To make it easier, you may use a tumbling tool through the hole of the removed magnetic connector.
Warning: The cartridge includes an O-ring. Make sure that you do not lose or damage it during the process
Before replacing the cartridge in the right position, keep pushing the bulb upwards in order to line up both openings enabling cartridge positioning. Replace the cartridge, making sure that holes are placed up and down. They will allow air flow between the bulb and the manometer.
When the cartridge is in place, you may screw the “Life Link®“ connector back.

Instructions: changing the bulb

Unscrew the bulb and then remove it
Unscrew the 2 screws and invert the bulb
Tighten the 2 screws
Tighten the bulb

USING THE MOBI ANEROID TENSIOMETER

Steps

Leave the patient to rest for 5 minutes
Place the patient in a comfortable position, with legs uncrossed, and the back and arm elevated, ideally without moving or speaking
Check that the marker index for arterial index is within the range shown on the Mobi cuffs
Keep the cuff at heart height during measurement
Keep the pneumatic circuit closed (check the decompression valve)
Inflate the cuff for an initial SBP estimation (when the blood circulates again, it causes a noticeable beating sound on the stethoscope) until radial pulse disappears (so-called Korotkoff sounds)
Inflate again to 30mmHg above the estimated SBP
Deflate by opening the valve at a speed of 2mmHg per second and simultaneously read the blood pressure on the manometer
Read the SBP for phase I of Korotkoff sounds
Read the DBP for phase V of Korotkoff sounds (complete disappearance of sounds noted at the stethoscope)
Measure the heart rate
Continue decompression until complete purge of the cuff
Warning: A blood flow stoppage carries risks.

Recommandation:

Use K5* for adult auscultation
Use K5 for auscultation of pregnant patients, so long as the sounds are noticeable when the cuff is deflated, in which case the K4 can be used
Use K4* for auscultation of children between 3 and 12 years.
See the table describing the phases of Korotkoff sounds.

Environmental specifications:

Operating temperature: +10°C to +40°C
Operating relative humidity: 20% to 85%
Storage temperature: -20°C to +70°C
Relative humidity at storage: 20% to 85%

MAINTENANCE AND MAINTENANCE VERIFICATION

Comply with current regional regulations for the disposal of manual tensiometers or accessories.

Metrological inspection by an approved body
Check accuracy and watertightness:

At least once every 2 years (manometer)
At least once per year (cuffs, tube, bulb)
After each maintenance operation or repair or replacement of removable parts.
- Note: In accordance with international and national metrological standards, the operator or the body responsible for maintenance must ensure traceability of benchmark manometer used for calibration.
- Note: The manufacturer undertakes to deliver the spare parts replacement following the instructions from the end user.

Removable parts & accessories:
Please contact your approved retailer to purchase the parts and accessories below:

Replacement bulb,
LifeLink® tube,
Cuffs (all sizes).

CLEANING AND DISINFECTION

Warning: Never immerse the manometer in liquid or in a decontamination device. Use a neutral detergent to clean the surface of product. Should disinfection be necessary, use a cloth soaked in 75% alcohol.
Warning: Avoid placing your Mobi too close to heat, excessive cold, solvents or greases. Avoid long-term contact with sweat, as the PVC could easily stiffen (bulb and tube). Keep hands dry.
Warning: To clean the cuff, do not use alcohol but use warm, soapy water to avoid damaging the printing.

TECHNICAL SPECIFICATIONS

Mobi Manometer
- Accuracy: +/-3mmHg
- Operating range: 0 to 300mmHg
- Displayed range: 0 to 300mmHg
- Indication type: radial scale
- Scale grading: increments of 2 mmHg
- Tube adapter: magnetic adapter for Life Link® connection
- Pressure generation: bulb
- Pressure reduction: air release valve
- Case: ABS
- Mechanism: copper-beryllium alloy
- Bulb: PVC
- Spoon: ABS
- Valve: Zamack Z3
Life Link® tube
PVC tube with magnetic nickel steel connection.
Mobi cuff
- Cuff: TPU.
- Tube adapter: magnetic adapter for Life Link® connection.

PRECAUTIONS FOR USE

Avoid impacts, particularly on the dial glass.
Do not expose to heat, sun or humidity, dust.
Avoid twisting the tubing while using Life Link® and be careful to hold the connector (not the tube) while unplugging to change cuff

CONTRAINDICATION

The magnetic Life Link® connectors must be held over 5 cm from any ferromagnetic or electronic implant with sensitivity to magnetic fields.

WARRANTY

The Mobi tensiometer is guaranteed against any part and labour or operating fault, in accordance with the manufacturer’s specifications, under normal maintenance and usage conditions. The 3-year guarantee for the tensiometer (excluding cuff and tube) starts from the date of purchase from an approved retailer.
SPENGLER’s obligations are limited during the guarantee period to the repair or replacement of components deemed to be defective by SPENGLER
Guarantee for Mobi accessories:
- Life Link® tube: 1 year guarantee
- Mobi inflation bulb: 1 year guarantee
- Mobi cuff: 1 year guarantee

STANDARD

Mobi is compliant with the European reference standard NF EN ISO 81060-1.

QUALITY ASSURANCE

NF EN ISO 13485

CE MARKING

CE certification aneroid tensiometer provided by GMED, notified body no. 0459. Class Im device (measurement of blood pressure by auscultatory method) in accordance with European directive 93/42/CEE regarding medical devices.