Operator’s Manual Heart Failure PARTNER™ Model 2936 Heart Failure Diagnostic Retrieval System
The following symbol is a trademark of Guidant Corporation: Interrogation symbol
Table of Contents (English) Product Description 3 Intended Use 4 Contraindications 4 Warnings and Precautions 4 Federal Communications Commission (FCC) 5 Package Contents 5 Contacting Guidant 5 Inspection and Setup 6 How to Interrogate an Implanted Heart Failure Device 6 How to Print Reports 8 Qualified Printers 10 How to Delete Diagnostic Records 10 HF PARTNER Device Functions 11 Language selection 11 Speaker control 12 Table of Contents (English) 1
Voice Messages 12 Reminder Label 15 How to Care for the HF PARTNER Device 16 Cleaning 17 Operating Temperatures 17 Battery Replacement 17 Pairing the HF PARTNER Device with a Compatible Printer 19 Troubleshooting 20 Specifications 23 Explanation of Product Markings 24 Package Content Symbols 25 2 Table of Contents (English)
Product Description The Heart Failure (HF) PARTNER™ system consists of a Model 2936 HF PARTNER device, a printer adapter, and a printer. The HF PARTNER device is a handheld, battery-powered product used to communicate with an implanted device. It provides easy access to patient and device diagnostic data by interrogating the patient’s implanted heart failure device and sending the data to a printer through the printer adapter.
Figure 2. Reminder instructions on back of the HF PARTNER device. Intended Use The HF PARTNER device is intended for use in a clinical setting. Physicians and clinicians can use the HF PARTNER device to collect device and patient diagnostic data from an implanted heart failure device and send the data to a paired printer only. The HF PARTNER device has no programming abilities, or ability to provide therapy of any kind.
• Only Guidant-recommended accessories, such as the Bluetooth enabled printer and Bluetooth accessory should be used with the HF PARTNER device. • The HF PARTNER device is not intended to sound any physiological alarms. Federal Communications Commission (FCC) This device complies with Title 47, Part 15 of the FCC rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2.
Inspection and Setup Inspect the HF PARTNER device, printer and printer adapter package contents for any signs of damage or defects. If any defect or damage is visible, contact your Guidant sales representative or call Guidant Technical Services. See “Contacting Guidant” on page 5. The following steps explain how to setup your HF PARTNER system: 1. Connect the USB cable to the printer adapter and the USB port on the printer. 2. 3. 4.
will emit the “Interrogation complete” message. The Interrogation light stay on for five seconds after successful interrogation. will Figure 3. Hold the HF PARTNER device over the patient’s implanted device, with buttons and lights toward you. NOTES: • You have about 10 seconds from the time you press a button until you locate the implanted device. If the HF PARTNER device is unable to locate the device, the voice command “Locate implanted device” will be repeated.
HF PARTNER device over the patient’s implanted device to resume communication. • If the implanted device exhibited a lead or heart failure device fault, including when the implanted device’s battery is due for replacement, the fault detected light will stay on for five seconds after completion of the interrogation. Contact the physician who follows this patient’s implanted device.
Printer adapter Printer Figure 4. Hold the HF PARTNER device near the printer adapter.
• Implanted device fault • Lead fault • Battery fault If you see any of these messages, contact the physician who follows this patient’s implanted device. NOTES: • The availability of each report feature is dependent upon the device interrogated. Refer to the heart failure device’s system guide for information about available features or call Guidant Technical Services. See “Contacting Guidant” on page 5.
1. Press the blue PRINT button and the green INTERROGATE button within three seconds. You will hear the “Confirm request to clear all records” message. The “Delete” light will flash. 2. Press the blue PRINT button within 10 seconds of the voice message to confirm that you want to delete the records. Otherwise, the HF PARTNER device will time-out and no records will be deleted. The “Delete” light will stay on for five seconds to indicate the records have been deleted.
Subsequent communication will remain in that language until it is changed by accessing the Configuration Mode. All diagnostic reports will print in the selected language. Speaker control The speaker of your HF PARTNER device can be turned On or Off by pressing the green INTERROGATE button three times within a three second period of time. When the speaker is turned Off, the “Speaker Off” message will be heard. A tone will be heard when the speaker is turned back On.
Table 1. Voice Messages (Continued) Interrogation unsuccessful, please interrogate again Action: The diagnostic interrogation request was unsuccessful. Interrogate the device again. Connecting Action: You requested that a diagnostic report be sent to the enabled printer and pointed the HF PARTNER device toward the printer adapter. Connection with the printer adapter can take up to 30 seconds.This message is repeated up to two times while attempting to connect with the printer system.
Table 1. Voice Messages (Continued) Confirm request to clear all records Action: You pressed the blue PRINT button and green INTERROGATE button ; the HF PARTNER device will ask you to confirm that you want to delete all records. Press the blue PRINT button within 10 seconds of this voice message to confirm that you want to delete all records. Battery Low Action: You should replace the HF PARTNER device batteries. This voice message will be heard with the speaker control turned On or Off.
Table 1. Voice Messages (Continued) Printer status error Action: There are several errors that may cause this message: the printer top may be open, the printer carriage may be jammed, or the printer may be busy. Table 2 provides a summary of HF PARTNER device commands and their associated button sequences. Table 2.
One button means to push the button just once and wait for the requested information. Multiple buttons means to push the buttons in the sequence shown and wait for requested information. The buttons in the parenthesis ( )means to press those buttons first. Figure 5. Reminder label on the back of the HF PARTNER device. How to Care for the HF PARTNER Device The HF PARTNER device is designed to be handled on a daily basis.
Cleaning When necessary, clean the HF PARTNER device with a soft cloth moistened in water or mild detergent. Do not allow moisture to accumulate on or around the labels, speaker holes, or the case seam. Operating Temperatures The HF PARTNER device will operate with best results at temperatures between 10° C and 50° C (50° F and 122° F). Keep the HF PARTNER device within this range of temperatures if possible. Allow it to warm up if it has been in colder conditions.
Figure 6. Turning the fastener. 3. Slide the rubber case bottom off. Figure 7. Removing the bottom case. 4. 18 Remove the batteries from the HF PARTNER device.
Figure 8. Removing the batteries from the HF PARTNER device. 5. 6. Insert the new batteries. Replace the rubber case bottom on the HF PARTNER device. 7. 8. Properly dispose of the old batteries. Press the green INTERROGATE button device is functioning properly. to ensure that the HF PARTNER Pairing the HF PARTNER Device with a Compatible Printer A printer must be paired to the HF PARTNER device to transmit a diagnostic report securely. Reports can only be printed to a paired printer.
2. 3. 4. 5. 6. 7. 8. Wait for the configuration mode tone to sound, then press the blue PRINT button . When a printer has been located, a double tone will be heard and a system status page will be printed. Press the blue PRINT button within 60 seconds of the double tone to confirm. The double tone will then be heard again. If the double tone is heard but the status page is not being printed, or is being printed from the wrong printer, press the green INTERROGATE button to start the pairing process again.
Problem Possible Solution You replaced the batteries but still received the “Battery low” message. If you just printed diagnostic reports, let the HF PARTNER system recharge for 30 to 60 minutes. If you still hear this message after letting the batteries recharge, call Guidant Technical Services. See “Contacting Guidant” on page 5. The HF PARTNER device cannot communicate with an implanted device.
Problem Possible Solution The printed reports appear incomplete (only black lines or only colored areas printed) Check the printer cartridges and replace if empty. The printed reports appear faded Replace the printer’s toner cartridges. The printer won’t turn On Check the power cord and make sure it is plugged in to a standard wall outlet and securely attached to the printer.
Specifications Plastic Box Dimensions (inches): 6.75 x 2 x 6.63 Device Dimensions (inches): 4.7 x 2.8 x 1.1 Power Source: Two 3.
Explanation of Product Markings Refer to the Instructions For Use ! SN Serial Number Conformity with the applicable EU Directives; AIMD 90/385/EEC, RTTE Dir 99/5/EC, and EMC Directive 899/335/EEC, with involvement of Notified Body No. 0086. (Medical Electrical Equipment) WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1/CAN/CSA C22.2 NO. 601.
Package Content Symbols Package contents + ! HF PARTNER device with batteries installed Refer to the Instructions For Use Radio and Telecommunications Terminal Equipment (RTTE). Indicates that device does not operate in a harmonized bandwidth.
26 Package Content Symbols
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