19 - Measurement process
Warning
If the patient is wearing an additional ME device on the same limb for monitoring purposes, the
placement and inflation of the cuff may trigger the temporary loss of the existing ME device's
function.
The operation and use of the automated non-invasive blood pressure monitoring device may lead
to longer impaired blood circulation in the patient or respective limb.
Examine the patient.
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Question the patient regarding previous treatments.
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Observe the patient closely.
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Instruct the patient to turn off the device, remove the cuff, and notify the doctor if they are
experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
Caution
Risk of injury caused by incorrect application of the cuff.
The doctor must ensure that, due to the patient's medical condition, the use of the device and the
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cuff does not result in impaired blood circulation.
If the patient has limited cognitive abilities, the device may only be used under supervision.
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When used on children, the device must only be applied with special care and under permanent
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supervision.
It is imperative that you instruct the patient in the correct seating of the cuff.
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Inform the patient that the cuff may only be used on the upper arm.
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Ensure that neither the shoulder strap nor the cuff tubing can ever wrap around the patient's neck.
Always place the cuff tubing under the outer clothing (even at night).
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Instruct the patient to place the device in such a way that, while the cuff is inflated, the tubing is not
compressed or kinked, especially during sleep.
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Petechiae, haemorrhages or subcutaneous haematoma may occur in some patients.
Instruct the patient to turn off the device, remove the cuff, and notify the doctor if they are
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experiencing pain, swelling, redness or numbness in the limb where the cuff is placed. (It is expected
that the patient may experience some mild to moderate discomfort during a blood pressure
measurement.)
Caution
Intolerances caused by the use of disinfectants.
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Wash to remove residues.
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Wash the cuff sleeve with a mild detergent in the washing machine at max. 30°C without spinning.
Attention
Damage to device
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Do not wear the ABPM 7100 while showering. If you suspect that liquid has entered the device while
cleaning or using it, the device shall no longer be used on the patient.
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In the device was exposed to moisture, switch off the device and remove the batteries.
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Inform your service immediately and send the device in for inspection.
The device may not be operated around MRI scanners or in the immediate vicinity of other medical
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electrical equipment.
During a defibrillator discharge, the device shall not be in contact with the patient. Such a discharge
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may damage the ABPM 7100 and cause it to display incorrect values.
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The ABPM 7100 is not suitable for simultaneous use with HF surgical equipment.
Measurement can be interrupted at any stage by pushing a random button. This deflates the cuff and
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the device can be removed.
Attention
Hygiene
• Ensure hygiene in accordance with the maintenance schedule.
Attention
Measurement errors
The use of components not included in the scope of delivery may lead to measurement errors. Only
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use the accessories offered by Welch Allyn.
Although the ABPM 7100 fulfills all EMC standard requirements, it should not be exposed to any
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strong electromagnetic fields, as this may lead to malfunctions outside the limit values.
Medical electrical equipment is subject to special EMC precautions. Please observe the directives
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attached.
The cuff tubing between the ABPM 7100 and the cuff may not be knotted, compressed or pulled
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apart.
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The cuff connection must always engage with an audible "CLICK". A loose connection between the
tubing and the device leads to measurement errors.
Note
Severe malfunctions are indicated by a continuous beep.
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In the event of a continuous beep, switch off the device, remove the cuff and inform your
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doctor.
Hand the data sheet "Patient information – operation of the ABPM 7100" to each patient.
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The data sheet is attached as a copy template.
Portable and mobile HF communication equipment may influence medical electrical devices.
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Extreme temperatures, humidity or air pressure can influence measurement accuracy.
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Please observe the operating conditions.
There are currently no clinical studies against reference methods available at respect to the
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application of pulse wave analysis on children.
The pulse wave analysis provides additional indicators for possible risks, but is not
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permissible as a sufficient indicator for individual illness or as a treatment recommendation.
Initial measurement
Note
An initial measurement is required for starting the measurement log. The initial measurement
must be checked by a physician for plausibility!
24-hour measurement
1. Ensure sufficient battery voltage. At least 2.6 volts for NiMH batteries and at least 3.10 volts for
alkaline batteries!
2. The doctor must go through these instructions together with the patient before a 24-hour
measurement.
3. The doctor must explain the possible hazards in detail on the basis of the warnings above!
4. Ensure that the patient has understood all functions and observable points!
Safety:
For your own safety during the following steps, please observe the safety instructions at the
start of this chapter, as well as the functional overview.
Performing a measurement
1. To trigger a measurement, press the START button.
The number of stored measurements will be shown on the LCD display.
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An audio beep will announce the upcoming measurement.
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Manual measurement will start.
2. The patient should stay calm during the measurement process, until the measurement is completed.
Allow your arm to hang loose, or place your lower arm loosely on the table or on a support whilst
sitting. Avoid any movement!
3. Doctor: Please check the values of the first measurement for plausibility, so that subsequent automatic
measurements can be processed correctly and correct cuff position is ensured.
4. In the event of an error measurement, please follow the instructions in sections Measurement
preparations and Troubleshooting.
Measurement process - 20