Spacelabs Healthcare 98000, Руководство по эксплуатации

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070-2567-03 Rev. A
16-1
16. Sleep Apnea
An estimated Apnea / Hypopnea score can be given for Holter ECG in Pathfinder SL. Optimum
results are achieved with recordings from the Lifecard CF, Lifecard 12 or evo recorders, which the
analyzer can use to create a derived respiratory rate.
Apnea is an option for the Pathfinder SL software. It assists a physician to screen for these types
of Sleep Disordered Breathing.
1. Obstructive sleep apnea
2. Mixed apneas
3. Hypopneas.
Note:
Pathfinder SL cannot distinguish between these events and gives no indication of the types
of Sleep Disordered Breathing the patient may have. By analysing certain parameters of
the amplitude and interval variability of the electrocardiogram (ECG), Apnea reports the
Estimated Apnea Hypopnea Index (Est. AHI), indicating the probability that the patient
suffers from Sleep Disordered Breathing. The recording must include at least 4 continuous
hours while the patient is sleeping.
16.1 Indications and Intended Use
The device is intended for screening adults for the probability that they suffer from
Obstructive Sleep Apnea, Mixed Apnea or Hypopnea, in order to evaluate the necessity for a
polysomnographic examination.
The ECG recording may be obtained at any location specified by a physician including home,
hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4
hours duration during which the ECG is predominantly sinus rhythm in nature.
A qualified medical practitioner should make any diagnosis.
16.2 Warning
Pathfinder SL must not be used in full or part as a life supporting device for apnea.