safety and performance information of viQtor

intended use

The intended use of the viQtor solution is to periodically transfer health data and events to a professional healthcare organization for assessment by healthcare professionals.

It measures oxygen saturation (SpO2), pulse rate (PR), and respiratory rate (RR) of adult (18 years and older) users in hospitals, nursing homes, and home settings, allowing remote monitoring and assessment of trends by healthcare professionals.

Additionally, viQtor monitors skin temperature, user activity and detects potential falls. In case of a possible fall, the device sends a request for attention to the professional healthcare organization. The user also has the option to send a request for assistance to the professional healthcare organization a by pressing the assistance request button.

non-intended use

The viQtor solution is not intended for use in the following situations:

• The viQtor solution is not intended to detect acute life-threatening situations and is not intended for use in high-acuity environments, such as ICU or operating rooms.
  
  
• The viQtor solution is not intended for use on acutely ill (cardiac) patients with the potential to develop life threatening deterioration, like arrhythmias or very fast atrial fibrillation. These patients should be monitored using a device with continuous ECG.
  
  
• The viQtor solution is not an apnea monitor. Do not rely on the respiration monitoring for detection of cessation of breathing.

contraindications

• Do not use the device on children under the age of 18 years.
  
  
• Do not use the device on patients with allergy to metals or plastics.
  
  
• Do not use the device on patients with tremors or convulsions.
  
  
• Do not use the device on patients with any of the following conditions without consulting your doctor: common arrhythmia (such as atrial or ventricular premature beats or atrial fibrillation), arterial sclerosis, poor blood flow, diabetes, pre-eclampsia, kidney disease, or pregnancy.
  
  
• viQtor cannot be used as a substitute for an ECG monitor.
  
  
• If one of the patient’s upper arm has any of the following conditions, do not use the device on that arm. Instead, use the device on the alternative upper arm if the condition does not affect it.
  
  
• Do not use the device on major deformities, swelling, irritation, worsening skin conditions, or oedema.
  
  
• Do not use the device on local infections, open sores, or skin lesions.
  
  
• Do not use the device on tattoos, broken skin, or areas under medical treatment.
  
  
• Do not use the device on areas where blood flow is impeded by a tourniquet or pressure cuff.
  
  
• Do not use the device on areas where a blood pressure cuff is not recommended.
  
  
• Do not use the device in the vicinity of strong electromagnetic fields (e.g. electromagnetic anti-theft systems, metal detectors).
  
  
• Do not use the device near high-frequency (HF) surgical equipment, MRI equipment or in a CT environment. Such use could cause the device to malfunction and/or could result in inaccurate measurements.
  
  
• Never diagnose or treat yourself on the basis of data recorded by the device. ALWAYS discuss the situation with your doctor.
  
  
• Keep the charging cable out of the reach of babies, toddlers and children to avoid the risk of strangulation.
  
  
• Do not use the device in conditions of high motion or when there is low arm blood perfusion.
  
  

The content presented above is aligned with the paper IFU, version 10.0.