Quality Assurance & Regulatory Affairs
Contents
1. Wel o i elchAllyn E Welch Allyn Ltd IDA Business Park Dublin Road Navan Co Meath Ireland URGENT FIELD SAFETY NOTICE This is a Field Safety Notice containing important information regardin the safe operation of the Welch Allyn Welch Allyn AED 10 or MRL JumpStart defibrillator Note AED10s with serial numbers beginning with AL are not affected by this field safety notice e g AL09E060042 Dear Valued Customer We are writing to inform you that the directions for use of your Welch Allyn AED 10 or MRL JumpStart defibrillator contained in the user manual have been updated to improve the clarity of describing what should be done when the device displays a low battery status icon The primary update to the directions for use is addition of the following information regarding the low battery status e The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced at the first opportunity The AED 10 remains operable when the flashing low battery is activated and it can be used on a patient in this condition or continued in use when connected to a patient if the low battery indicator activates Replace the battery as soon as possible e If the AED 10 is subjected to cold temperatures near or outside of its low temperature operating limit of 0 C 32 F the low battery status indicator may be triggered even with a new battery The low battery indicator caused by2. cold temperature may cease when the device is warmed Discharging the device to defibrillate a patient may cause sufficient warming to eliminate the low battery indicator or cause it to be intermittent Enclosed with this letter is an updated user manual for your device Please discard the original user manual and replace it with this updated version Note AED10s with serial numbers beginning with AL are not affected by this field safety notice e g ALO9E060042 We appreciate your cooperation in this matter Yours sincerely si P _ _ oe m Paul Reynolds Director International Quality Assurance amp Regulatory Affairs EMEA FSN Battery Status Icon Customer Letter 80015616 Rev C WelchAllyn RESPONSE FORM Welch Allyn Automatic external defibrillator AED 10 and MRL Jumpstart _ Please tick We have read and understand the instructions provided in the field safety notice letter To be completed by Customer Title Telephone No Dee mone SSS PLEASE FAX COMPLETED RESPONSE FORM WITHIN 5 WORKING DAYS TO FAX 00353 4690 67755 fieldsafetynotice welchallyn com Regulatory Department Welch Allyn Ltd IDA Business Park Dublin Road Navan Co Meath Republic of Ireland EMEA FSN Battery Status Icon Customer Letter 80015616 Rev C
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