Pulse Oximeter; Device Classification - ZOLL Z Vent Operator's Manual

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Pulse Oximeter

Parameter
Range
Accuracy
Pulse Rate (bpm)
Resolution
Low Perfusion
Performance
Interfering Substances

Device Classification

The following table describes the ventilator's device classification:
Type of Protection against Electric
Shock
Degree of Protection against
Electric Shock
Applied Parts
Degree of Protection against
Harmful Ingress of Water
9650-002360-01 Rev. A
Specification
Saturation (% SpO2):1% to 100%
Pulse Rate (bpm): 25 to 240
Perfusion: 0.02% to 20%
Saturation (% SpO
Adults, Pediatrics: 70%-100% +/- 2 digits, 0%-69% unspecified
Neonates: 70%-100% +/- 3 digits, 0%-69% unspecified
Saturation (% SpO
Adults, Pediatrics: 70%-100% +/- 3 digits, 0%-69% unspecified
Neonates: 70%-100% +/- 3 digits, 0%-69% unspecified
Pulse Rate (bpm) - During No Motion Conditions:
Adults, Pediatric, Neonates: 5 to 240 +/- 3 digits
Pulse Rate (bpm) - During Motion Conditions
Adults, Pediatric, Neonates: 5 to 240 +/- 5 digits
Saturation (% SpO
>0.02% Pulse Amplitude Saturation (% SpO
and% Transmission >5% Pulse Rate +/- 3 digits
Carboxyhemoglobin may erroneously increase readings. The level of
increase is approximately equal to the amount of carboxyhemoglobin
present. Dyes, or any substance containing dyes, that change usual
arterial pigmentation may cause erroneous readings.
Category
The medical power supply (which contains the system's safety
barrier) is labeled as Class I or Class II. Electrical shock
protection is not dependent upon earthing since this power
supply design includes double insulation.
The ventilator circuit is Type BF applied part.
The pulse oximeter is Type BF Defibrillation Proof Applied Part.
IPX4: Splash-proof equipment rating, include:
• Padded case with rain flap
• Bacterial/viral filter to protect the compressor
ZOLL Z Vent Ventilator Operator's Guide
) - During No Motion Conditions:
2
) - During Motion Conditions
2
): 1%, Pulse Rate (bpm): 1
2
2
Classification
Specifications
) +/- 2 digits
A-3

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