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MAC® 1200 Operator’s Manual. 2012250-022 21 July 2004 The information in this manual only applies to MAC 1200 software version 6. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. Listed below are GE Medical Systems Information. U.S.) interface for the MAC 1200/1200 ST unit. Forge install manual mac pro. Information in this manual differs from operating information for MAC 1200 units developed for use in the United States. Please refer to PN 2012250-022 for information on using the U.S. Mac manual clean up. MAC 1200/1200 ST The MAC 1200/1200 ST is a electrocardiograph with the following performance features.
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510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards |
CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC |
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Ge Mac 1200 Operator's Manual Instructions
GE HEALTHCARE MAC 1200 GENERIC LEAD WIRES NON INVASIVE CARDIOLOGY DEVICES | Back to Search Results |
| Event Date 09/02/2008 | Event Type Other | Event Description | It was reported that it is possible to transpose ecg lead wires on the mac 1200 system. No patient injury was reported. | Manufacturer Narrative | The device was not returned to ge healthcare for evaluation. The event occurred since the user plugged lead wires into incorrect sockets of the patient acquisition module. Steps are being taken to prevent misuse of the leadwires, by including a warning statement in the instructions for use for future leadwires. This warning statement is already present in all of the mac user manuals. Following warning statement is displayed in manuals: 'caution. Trace each individual leadwire from its colored id'ed connector back to the acquisition module label to insure that it is matched to the correct label location. Manual battery hydrometer mac tools bt12 free. Improper connection will cause inaccuracies in the ecg. '. | Search Alerts/Recalls |
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New Search | Submit an Adverse Event Report |
Ge Mac 1200 Operator S Manual
Type of Device | NON INVASIVE CARDIOLOGY DEVICES |
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Manufacturer (Section D) | |
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Manufacturer (Section G) | |
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Manufacturer Contact | ann lebar | 9900 innovation dr | mail code - rp2138 | wauwatosa , WI 53229 | 4147213947 |
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MDR Report Key | 1188455 |
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Report Number | 1651104-2008-00004 |
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Device Sequence Number | 1 |
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Product Code | DPS |
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Report Source | Manufacturer |
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Source Type | Foreign,Company Representative |
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Reporter Occupation |
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Type of Report | Initial |
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Report Date | 09/29/2008 |
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1 Device Was Involved in the Event |
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0 PatientS WERE Involved in the Event: |
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Date FDA Received | 09/29/2008 |
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Is This An Adverse Event Report? | No |
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Is This A Product Problem Report? | Yes |
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Device Operator | HEALTH PROFESSIONAL |
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Was Device Available For Evaluation? | Yes |
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Is The Reporter A Health Professional? | Yes |
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Date Manufacturer Received | 09/02/2008 |
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Was Device Evaluated By Manufacturer? | Device Not Returned To Manufacturer |
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Is The Device Single Use? | No |
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Is this a Reprocessed and Reused Single-Use Device? | No |
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Type of Device Usage | Unkown |
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