SyneScope, EasyScope, SyneCom

Precautions for use

The software should be used in accordance with the manual to avoid handling errors. Please refer to the precautions for use in the installation guide.



For SyneScope and EasyScope:

In some cases the software may make errors in diagnosis. This risk is inherent to all automatic analysis systems, particularly with artifacts.

WARNING: Be careful to place the electrodes correctly to limit artifacts linked to poor placement (see the section concerning placement precautions in the ELA Medical digital recorder manuals).

WARNING: As the entire recording period is accessible via SyneScope, you can make a manual diagnosis in all cases.



SyneCom

Precautions for use

The software should be used in accordance with the manual to avoid handling errors. Please refer to the precautions for use in the installation guide.



SpiderView

SpiderView is a digital ECG Holter recorder intended for ambulatory ECG recording with duration up to 96 hours and up to 12 channels and short-term recording of High-Resolution ECG.

WARNING: To download and analyze recordings of more than 3 channels and more that 24 hours, the Holter analyzing software SyneScope is needed.



Agilis

DO NOT use in the presence of flammable anesthetics; this could cause an explosion.

DO NOT immerse the monitor in any fluid, place fluids on top, or attempt to clean the unit with any liquid detergents or cleaning agents. This may cause an electrical hazard. If accidental wetting occurs, please return to Ela Medical (refer to page 19 for shipping instructions). Refer to page 18 for instructions on maintenance and cleaning.

DO NOT remove unit covers. The monitor does not contain any user serviceable components. Refer to page 19 for service instructions.

DO NOT use the monitor if it has failed its diagnostic self-test, or if it displays greater than zero pressure with no cuff attached. The values displayed by such a unit may be inaccurate.

DO NOT use on neonates.

DO NOT use on patients known to be readily susceptible to bruising.

DO NOT attach the cuff to a limb being used for IV infusions. The cuff inflation can block the infusion, causing harm to the patient.

CAUTION: Substitution of a component different from that supplied may result in measurement error. No repair should be undertaken or attempted by anyone not service trained by Ela Medical or other approved service agents.

CAUTION: If cuff fails to deflate within 3 minutes, instruct patient on manual removal of cuff.

CAUTION: Check that operation of the unit does not result in prolonged impairment of the circulation of the patient.

CAUTION: Avoid compression or restriction of pressure tubes.



Precautions:

If any abnormality occurs in the unit, suspend the operation immediately and disconnect the unit from the patient. This device may not meet performance specifications if unit has been used or stored outside its acceptable environmental conditions (see "Specifications" on page 3). If cuff fails to deflate, the patient should be instructed on proper and safe removal of the cuff. Use only the cuffs supplied with this unit, or cuffs approved by Ela Medical.



Precautions:

  • Allergic Exanthema (symptomatic eruption) in the area of the cuff

  • 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)

  • Rumple-Leede phenomenon (multiple petechia) on the forearm

  • Idiopathic thrombocytopenia (spontaneous persistent decrease in the number of platelets associated with hemorrhagic conditions)

  • Phlebitis (inflammation of a vein)