Dualstetho PRO - Sphygmomanometer Medel - Free user manual and instructions
Find the device manual for free Dualstetho PRO Medel in PDF.
| Product Type | Upper Arm Blood Pressure Monitor |
| Brand | Medel |
| Model | Dualstetho PRO |
| Measurement Method | Oscillometric |
| Cuff Type | Adjustable arm cuff (22-42 cm) |
| Display | Digital LCD screen |
| Memory | Up to 90 readings |
| Blood Pressure Range | Systolic: 60-260 mmHg, Diastolic: 30-200 mmHg |
| Pulse Rate Range | 40-200 beats/min |
| Accuracy | Blood pressure: ±3 mmHg, Pulse: ±5% |
| Power Source | 4 AA batteries (1.5V) or AC adapter (6V, 600 mA) |
| Auto Power Off | Yes, after 1 minute of inactivity |
| Dimensions | Approximately 15 x 10 x 7 cm (device only) |
| Weight | Approximately 300 g (without batteries) |
| Operating Environment | Temperature: 5°C to 40°C, Humidity: 15-85% RH |
| Storage Environment | Temperature: -20°C to 55°C, Humidity: 10-95% RH |
| Clinical Validation | Validated according to protocols |
| Maintenance | Clean cuff and device with a soft dry cloth; avoid immersion |
| Safety Standards | Complies with applicable medical device directives |
| Spare Parts Available | Cuff (replacement), AC adapter (optional) |
| Warranty | 2 years (except cuff and accessories) |
| Included Accessories | Arm cuff, instruction manual, batteries |
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USER MANUAL Dualstetho PRO Medel
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Line drawing of a medical pressure monitor setup with tubing and gauges (no text or labels)Thank you for buying a MEDEL aneroid blood-pressure monitor. This blood-pressure monitor works according to the Riva Rocci/Korotkoff auscultating method.
MEDEL has a complete range of aneroid blood-pressure monitors with different features according to their usage: home, or doctor's practice.
Each MEDEL blood-pressure monitor is gauged and undergoes an accurate quality control.
Before usage read carefully and entirely this instruction manual and keep it in a safe place.
Please, check equipment and product characteristics described on the box.
2. WARNING
To carry out a measurement with the auscultating method requires a specific knowledge of this technique. Incidental wrong interpretations and damages which can result from wrong usage cannot be ascribed to the device.
This device is not a diagnostic device but a measurement system.
The measurement results must be evaluated by a doctor.
Auscultating method blood-pressure monitors are not recommended to persons with hearing problems.
- COMPONENTS OF MEDEL ANEROID
MEDEL aneroid blood-pressure monitors consist in (Pic. 1):
4. WORKING PRINCIPLES
MEDEL aneroid blood-pressure monitors work according to the Riva Rocci/Korotkoff auscultating method.
Measurement is carried out by occluding the radial artery through the pressure of a muff wrapped around one arm (cuff) and the following observation of the heart pulse tones (with the stethoscope) during the deflating phase.
It is recommended to use the following points for auscultation:
• K5 in auscultation of adults
• K4 in auscultation of children aged 3 to12
• K5 in pregnant female patients, unless sounds are audible with cuff deflated, in which case K4
should be used (K5 is the point at which Korotkoff sounds can no longer be heard; K4 is the change in the tones heard through a stethoscope from a clear tapping sound to a muffled sound.)
In case of doubts about the method consult your doctor. The latex bulb enables to generate the necessary air pressure inside the cuff in order to occlude the radial artery. The release valve allows an accurate regulation of the air outlet from the cuff, permitting a gradual deflation.
The stethoscope (furnished only with some models) allows to survey the heart pulse tones.
Each manometer has a reading scale ranging from 0 to 300 mmHg (mmHg=millimeters of mercury). The scale is traced every 2mmHg, with larger notches every 10mmHg for an easy reading.
The measurement has a precision of +- 3mmHg.
- CARRYING OUT A MEASUREMENT
Before the measurement:
- Avoid eating, smoking as well as any form of exertion before the measurement. All these factors influence the measurement results. Try to relax by sitting in an armchair in a quiet atmosphere for about ten minutes before the measurement.
- Remove any garment that fits closely to your upper arm.
• Measure always on the same arm (normally left).
- Try to carry out the measurements regularly at the same time of day, as the blood-pressure changes during the course of the day.
Common sources of error:
Note: Comparable blood-pressure measurements require always the same conditions!
These are normally quiet conditions.
- All efforts by the patient to hold up the arm can increase the arterial pressure. Make sure to sit down in a comfortable, relaxed position, with legs uncrossed and not to activate any muscle of the measurement arm during the measurement. Use a cushion for support if necessary.
• If the arm artery lies considerably lower (higher) than the heart, an erroneously higher (lower) bloodpressure will be measured.
- Cuffs that are too narrow or too short result in false measurement values.
- Selecting the correct cuff is very important. The cuff size depends on the arm circumference (measured in the middle). The permissible range is printed on the cuff. If this is not suitable for
your arm, please contact your dealer.
• Use only Medel original cuffs!
• The device is furnished with a standard adult cuff for arms of circumference between 26-38 cm.
6. HOW TO USE THE BLOOD PRESSURE MONITOR
Make sure the cuff is completely flat. Fasten the cuff on the upper part of the left arm, making sure that
the tubing is facing downwards. If the device is provided with D-ring (please, check the equipment on the box) put on the cuff, place it in the correct way, pull the cuff leftwards sliding it inside the metal bracket and fix it to the velcro. (Pic. 2). The lower edge of the cuff must be at least 2 centimeters above the elbow, at heart's height (Pic. 3). There should be enough space between cuff and arm to fit a finger inside.
The arrow in the cuff label must be in correspondence with the radial artery. The stethoscope diaphragm should lie on the pulse position. Ask your doctor to show it if necessary. Take the bulb and make sure that the pressure-release valve
is closed (turn it clockwise). Inflate the cuff by squeezing the bulb, keep pumping until you reach 20-30mmHg beyond the highest expected pressure.
Slowly deflate the cuff turning the pressure-release valve anticlockwise, to obtain a pressure decrease of 2-3mmHg per second.
The first audible tone corresponds to the highest (or systolic) pressure and the last one corresponds to the lowest (or diastolic) pressure.
Open the release valve in order to deflate completely the cuff. If it is necessary to interrupt a blood pressure measurement for any reason (e.g. if the patient feels unwell), deflate immediately the cuff by opening completely the release valve.
7. IMPORTANT RECOMMENDATIONS
- Never let air in beyond 300mmHg.
- The time used to measure blood pressure must not exceed 2 minutes.
- Never make a second measurement before at least 5 minutes after the first one.
- Do not drop the device and handle it with care.
- Do not drop the device to avoid strong vibrations.
- Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight.
- Keep the device at a temperature between 10 and 40°C with a relative humidity not exceeding 85%.
- Keep the device and especially the rubber parts away from UV rays.
- Beware of damaging the rubber parts with sharp, cutting objects.
- Do not excessively bend the cuff and the tubings.


cuff edge
tube

Pic.2

- Clean the device with a soft, dry cloth. Do not use petrol or solvents.
• Never open the device!
8. MANTAINANCE AND CARE
1) Manometer: the manometer requires no maintenance. If necessary, address to an authorized techni-
cal service centre or to your own dealer.
2) Bulb: if you have to replace the bulb make sure that the connecting parts are completely dry and clean so that they can firmly hold together. You will thus avoid any air leak.
3) Cuff: before cleaning the cuff, remove the inner tube and close the velcro (placing the metal ring inside in case of D-ring models). The cuff can be washed at 30^ with a programme and a detergent for delicate clothes.
DO NOT IRON
You can also clean the cuff with a sponge or a soft brush and a detergent for delicate clothes. Rinse with water.
9. SERVICING AND GAUGING
Each Medel blood-pressure monitor is gauged before being commercialized.
No recalibration is required.
Never open the device!
There are no user-serviceable parts. The device requires no lubrication or maintenance.
In case of misfunctioning, address to MEDEL CUSTOMER SERVICE
10. TECHNICAL SPECIFICATIONS
- TECHNICAL SPECIFICATIONS
Storage and transportation conditions: -20 to +70 C Humidity: 15 to 95% radiation, humidity (mmol/L)
Humidity: 15 to 85% relative humidity (non-condensing)
Operation temperature: 10 to 40°C
Measuring method: auscultating method
Measuring range: 0 to 300 mmHg
Accuracy: +3 mmHg
Accessories: check equipment and product characteristics described on the box
Medical Device Im Class (with measuring function)
Medical Device III Class Y The device complies with:
The device complies with.
EU Medical Devices Directive 93/42/EEC and following amendments
Standards EN ISO 81060-1:2012 Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type.
11. SYMBOLS WARRANTY CONDITIONS


[Non-Text]
MANUFACTURER

0107 The CE labelling certifies that the product complies with the essential requirements of
0197 Directive 93/42/EEC on medical products.

Batch number

Serial number
ECDER Authorised Representative in the Euro-
CREF pean Community

pean community

manufacturer's catalogue device number
- The device is covered by a 2-year warranty from date of purchase for any defects in the design or in the material used.
- The warranty consists in the replacement and/or repair free of charge of originally detective components.
- The warranty does not cover the accessories supplied with the equipment and those parts subject to normal wear and tear.
• The equipment must be repaired by authorized technical service centres only - The equipment must be repaired by authorized technical service centres only.
- The equipment must be sent to the authorized technical service centre for repair within 8 days after the defect is noticed.
- The transport costs for the equipment are at user's charge. Any repair out of the warranty conditions are at user's charge.
- The warranty does not cover failures resulting from misuse, abuse of the product or in case the damage is not due to manufacturer's liability (accidental fall, rough transportation, etc...)
- The warranty does not involve any compensation for any kind of damages to persons or things, either direct or indirect, occurred when the equipment is not operating.
- The warranty is valid from the date of purchase certified by the ticket or the invoice which have to be peremptorily attached to the warranty coupon.
- The lack of warranty coupon properly filled in and validated by a certification of purchase voids the warranty.

Manufacturer.
Wenzhou Bokang Instruments Co., Ltd.
Haining Road, Haibin, Longwan, Wenzhou 325024
PEOPLE'S REPUBLIC OF CHINA
EITVER EC- Renasantativa
Shanghai International Trading Com. GmbH
Shanghai International Housing Corp. (SH) Eiffestrasse 80, 20537 Hamburg Germany
Distributed by
Model International Srl
Meuer International St Via Villanizzano 26, 2015/ Milano / Italy