Spengler 140223 Lian Metal Blood Pressure Monitor User Manual

MANUEL UTILISATEUR
USER’S MANUAL
MANUAL
LIAN® MÉTAL

Thank you for purchasing a Lian® Métal sphygmomanometer.
When you choose a SPENGLER instrument, you are choosing experience and excellence that has been recognized since 1907.

INSTRUCTIONS FOR USE

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

INTENDED MEDICAL USE

The Lian® Métal 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 withstress, 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.

Blood pressure classification in adults (mmHg)

| Systolic blood pres- sure (mmHg)| And/or| Diastolic blood pres- sure (mmHg)
---|---|---|---
Optimum| <120| and| < 80
Normal| 120-129| and/or| 80-84
Upper normal| 130-139| and/or| 85-89
Grade 1 HBP| 140-159| and/or| 90-99
Grade 2 HBP| 160-179| and/or| 100-109
Grade 3 HBP| a. 180| and/or| a 110

ESH 2007 Recommendations.
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 sphygmomanometer cuffs and Lian® Mé- tal 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 Lian® Métal 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 Lian® Métal 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.
Available sizes of cuffs for Lian® Métal sphygmomanometer

USING THE LIAN® MÉTAL ANEROID SPHYGMOMANOMETER
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 Lian® Métal 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 sphygmomanometers 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,
  – Tube,
  – Cuffs and bladers (all sizes).
  CLEANING AND DISINFECTION:
  – manometers: wipe clean with a solution of appropriate disinfectant ; rinse with a wet non-woven tissue. Do not immerse.
  – cotton or nylon cuffs: wash in machine, water not exceeding 30-35 °C. Important: the cuffs should be fastened during cleaning. Do not dry in machine.
  – bladders and tubes: obturate the extremity of the tube with a clamp (included) before washing in mild soapy water or immerse in a disinfectant solution. Rinse thoroughly and dry flat.

TECHNICAL SPECIFICATIONS:

Lian® Métal Manometer
Accuracy: +/-3mmHg
Operating range: 0 to 300mmHg
Displayed range: 0 to 300mmHg
Indication type: radial scale
Scale grading: increments of 2 mmHg
Pressure generation: bulb
Pressure reduction: air release valve
Case: matt chrome zamak
Mechanism: copper-beryllium alloy
Bulb: PVC
Tube : «high-resistance» rubber.
Cuff : polycotton Velcro fastening or nylon Velcro fastening depending on the models. Clinic® : see Clinic® cuff instructions.
PRECAUTIONS FOR USE
– Avoid impacts, particularly on the dial glass.
– Do not expose to heat, sun or humidity, dust.
WARRANTY
The Lian® Métal sphygmomanometer 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 sphygmomanometer (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.
STANDARD
Lian® Métal is compliant with the European reference standard NF EN ISO 81060-1.
QUALITY ASSURANCE
NF EN ISO 13485
CE MARKING
CE certification aneroid sphygmomanometer 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.

with local regulations.
| •  This product complies with directive 93/42/CEE regarding medical devices.
| • Medical Device

Spengler S.A.S.
30 rue Jean de Guiramand
13290 Aix en Provence
FRANCE
CHRN-AR-20002390
TAS SAT AG
Tél. : + 33 (0) 4 42 52 89 89
Fax : + 33 (0) 4 42 52 89 09
Mail : [email protected]
www.spengler.fr
Date marquage CE : 01/2006 1 st CE marking date: 2006/01 Réf. : NU_LIANMETAL_1vG_130121

References

• Spengler | Fabricant Français de dispositifs médicaux depuis 1907

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