P hili ps Me dical Sy stems

 

5-3

 

 

 

 

safety level

possible improper device performance

 

 

 

 

WARNING

Prolonged or aggressive CPR to a patient with defibrillator pads

 

 

attached can damage the pads. Replace the defibrillator pads if they

 

 

are damaged during use or handling.

 

 

 

 

WARNING

Using damaged or expired equipment or accessories may cause the

 

 

HeartStart FR2+ to perform improperly, and/or injure the patient or

 

 

the user.

 

 

 

 

WARNING

CPR rates significantly above 100 compressions per minute can

 

 

cause incorrect or delayed analysis by the HeartStart FR2+.

 

 

 

 

WARNING

Poor electrode pad-to-patient contact may result in a related

 

 

defibrillator prompt or other indication. Check all electrical and

 

 

patient connections.

 

 

 

 

CAUTION

The HeartStart FR2+ is designed to be used only with Philips-approved

 

 

accessories. The HeartStart FR2+ may perform improperly if

 

 

non-approved accessories are used.

 

 

 

 

CAUTION

Follow all instructions supplied with the HeartStart defibrillator pads. Use

 

 

the defibrillator pads before the expiration date shown on the package. Do

 

 

not reuse the defibrillator pads. Discard them after use.

5

CAUTION

Aggressive handling of the defibrillator pads in storage or prior to use can

 

 

damage the pads. Discard the defibrillator pads if they become damaged.

 

 

 

 

CAUTION

Follow all instructions supplied with the M3863A FR2 standard battery.

 

 

Install the battery before the expiration date shown on the battery.

 

 

 

 

CAUTION

Follow all instructions supplied with the M3848A FR2+ rechargeable

 

 

battery. Recharge using the M3849A charger only.

 

 

 

 

CAUTION

Do not use the M3849A charger on aircraft.

 

 

 

 

CAUTION

The HeartStart FR2+ was designed to be sturdy and reliable for many

 

 

different field use conditions. However, excessively rough handling can

 

 

result in damage to the HeartStart FR2+ or its accessories. Inspect the

 

 

unit and accessories periodically according to instructions.

 

 

 

 

CAUTION

Alteration of the factory default setup of the FR2+ can affect its

 

 

performance and should be performed under the authorization of your

 

Medical Director. Modifications to device operation resulting from changes to the default settings should be specifically covered in user training.

Clinical and Safety Considerations

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Philips M3860A, M3861A manual Safety level Possible improper device performance