Essential Performance (Ref. Iec 80601-2-30:2018) - Progetti Rescue Life 9 Instructions For Use Manual

Defibrillator
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3 – ACQUISITION OF BIOMEDICAL PARAMETERS
Adverse Reactions
Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the formation of
urticaria (allergic reaction including raised edematous patches of skin or mucous membranes and intense
itching) caused by the fabric material of the cuff.
Petechia (a minute reddish or purplish spot containing blood that appears in the skin) formation or Rumple-
Leede phenomenon (multiple petechia) on the forearm following the application of the cuff, which may
lead to Idiopathic thrombocytopenia (spontaneous persistent decrease in the number of platelets
associated with hemorrhagic conditions) or phlebitis (inflammation of a vein) may be observed.
User Responsibility
This module is designed to perform in conformity with the description thereof contained in this operation
manual when operated, maintained and repaired in accordance with the instructions provided.

3.5.4 ESSENTIAL PERFORMANCE (REF. IEC 80601-2-30:2018)

Reproducibility of the blood pressure determination
Accessories
PART #
DESCRIPTION
91-0028-69
3 m Patient Hose w/CPC connectors
98-0092-02
APC Cuff, Infant (red)
98-0093-03
APC Cuff, Child (green)
98-0095-04
APC Cuff, Small Adult (blue)
98-0097-04
APC Cuff, Adult (dark blue)
Specifications
Method of Measurement:
Oscillometric. Diastolic values correspond to Phase 5 Korotkoff sounds.
Blood Pressure Range:
Systolic:
ADULT
PEDIATRIC
NEONATE
9
Rescue Life
– Instruction For Use
40 – 260 mmHg
40 – 160 mmHg
40 – 130 mmHg
3-44
MEASURE
Range: 8 – 13 cm
Range: 12 – 19 cm
Range: 17 – 25 cm
Range: 23 – 33 cm
Rev.0.5 – 30/03/2022

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