P hili ps Me dical Sy stems
|
| |
|
|
|
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 |
|
| defibrillator prompt or other indication. Check all electrical and |
|
| patient connections. |
|
|
|
|
CAUTION | The HeartStart FR2+ is designed to be used only with |
|
| accessories. The HeartStart FR2+ may perform improperly if |
|
|
| |
|
|
|
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