Affected Products

All PageWriter TC (TC20/30/50/70) electrocardiographs manufactured before November 20, 2018, that can be used with battery power and have currently installed lithium-ion batteries are affected. Specifically, the following PageWriter TC electrocardiographs with software versions up to and including A.07.05.22:

Note: The PageWriter TC10 (860392) electrocardiograph is not affected by this safety notice.

Description of the Problem

Philips has received a report of overheating and fire involving the lithium-ion battery of a Philips PageWriter TC electrocardiograph. The battery has exceeded its average lifespan and must be replaced upon exceeding 300 charge/discharge cycles or when the remaining battery capacity is less than 80% of a new battery's capacity. Although Philips PageWriter TC electrocardiographs allow for the display of battery health status (SOH) and charge/discharge cycles, the current labeling does not include complete instructions on how to use this information to determine when to replace the battery.

Associated Risks

Battery overheating can cause the device's outer casing to overheat, which in turn can lead to melting and/or fire of the device, potentially causing injury to patients and nearby users or damage to objects.

How to Identify Affected Products

It is possible to determine if the device in use is affected by this communication by identifying its software version. This can be done in the following ways:

1. Locate and verify the PageWriter TC electrocardiograph part number on the cover of the Instructions for Use or on the electrocardiograph's rear label.
2. Locate and verify the software version in the System Utility screen of the PageWriter TC electrocardiograph.

To determine if the device is battery-powered, check for the battery icon in the upper right corner of the electrocardiograph's display.

Image depicting four PageWriter TC models: TC20, TC30, TC50, and TC70.

Measures to be Taken by the Customer/User

Upon receiving this communication, please carefully read the enclosed PageWriter TC Service Manual Addendum.

Immediately determine the number of cycles and the health status (SOH) on each affected Philips PageWriter TC (TC20/30/50/70) electrocardiograph, as specified in the attached Service Manual Addendum.

If the cycle count is greater than 300 and/or the SOH is less than 80%, the battery has reached the end of its useful life and must be replaced. An approved replacement battery can be ordered using Philips' standard replacement procedures. Details on how to replace the battery can be found in the PageWriter TC electrocardiograph Service Manual Addendum. After determining that the battery does not require replacement, or after replacing the battery, the PageWriter TC electrocardiograph is safe and can resume operation.

Additionally, review this information with all staff members responsible for device management for the Philips PageWriter TC electrocardiographs.

Keep the following Service Manual Addendum together with the Philips PageWriter TC Electrocardiograph Service Manual.

Complete and return the provided response form.

PHILIPS INTERVENTION PROGRAM

Philips plans to release a customer-installable software update for the PageWriter TC (TC20/30/50/70) electrocardiograph that will provide warning messages to support users in managing the battery replacement cycle. Customers will be notified once the user-installable software update is available.

FURTHER INFORMATION AND ASSISTANCE

For further clarification and assistance, please contact your local Philips organization:

0800 80 3000

Customer Response Form

Subject: Safety Notice Philips Healthcare
Response from customer for FSN86000263A
Electrocardiographs PageWriter TC (TC20/30/50/70)
Addendum to the service manual

Please complete and send via email to customercare.ch@philips.com

Send the completed form via email to the address provided above.

CUSTOMER CONFIRMATION:

The PageWriter TC (TC20/30/50/70) electrocardiograph Service Manual Addendum has been attached to the first page of the section related to battery maintenance, so that it can be correctly filed and kept together with the Service Manual for consultation.

Confirm that all batteries of PageWriter TC (TC20/30/50/70) electrocardiographs with a cycle count greater than 300 and/or a health status (SOH) ≤ 80% have been replaced with approved replacement batteries, as indicated in the Service Manual Addendum.

Send the completed response form via email to customercare.ch@philips.com. In case of problems with the instructions in this communication, please contact your local Philips organization.

PageWriter TC Cardiograph Service Manual Addendum - Battery Maintenance

About the Battery

The rechargeable lithium-ion battery used in the PageWriter TC cardiographs is a smart battery with built-in circuitry that communicates battery status information to the cardiograph.

To properly maintain the battery and prevent damage to the cardiograph, observe these guidelines:

• If a battery shows damage or signs of leakage, replace it immediately.
• Never use a faulty battery in a cardiograph.
• Never dispose of the battery in a normal waste container.
• Never leave a battery inside the cardiograph if the cardiograph is not being used for a long period of time.
• Never store a battery that is charged to more than 50% capacity.
• When operating a PageWriter TC20, TC30, TC50 or TC70 cardiograph with one battery or two, only supported batteries approved by Philips for use with the PageWriter TC cardiographs must be used. Supported batteries are listed below.

Supported Batteries

Note: If your cardiograph contains batteries with PN 989803160981, Philips strongly recommends that you replace these batteries as soon as possible with the supported batteries listed above.

When operating a PageWriter TC cardiograph with two batteries installed, both batteries must have the same part number. If a cardiograph is operated with two batteries with different part numbers, the cardiograph will display an error message and will not operate.

WARNING
Batteries other than those listed here are not supported. Failure to follow these instructions can lead to undesired consequences (battery overheating, shortened battery life, etc.).

Copyright ©2018 Koninklijke Philips N.V. All rights are reserved.

Manufacturer: Philips Medical Systems, 3000 Minuteman Road, Andover, MA 01810 USA, Tel: 1 (978) 687-1501

453564844701 Revision A, December 2018

• Lithium batteries are shipped with a 30% charge. Prior to initial use, charge the battery(ies) for 8 hours (for two batteries) or 5 hours (for one battery) before operating the cardiograph. Regularly and consistently charging the battery(ies) will prolong battery life.
• Charging, storing, or using the batteries at temperatures above 50°C (122°F) can damage the batteries and reduce overall battery life.
• Check the battery power indicator on the Status Bar. Tap the battery icon on the Status Bar for information on remaining battery power. See Figure 2-5 on page 7.
• Always charge the battery when the cardiograph is not in use. Plug the cardiograph into AC power. Ensure that the green AC power indicator light on the front of the cardiograph is lit. The battery will charge while the cardiograph is in use, but will charge at a slower rate.
• Operate the cardiograph, charge the batteries, and store the batteries at a room temperature of 25°C (77°F) or lower. Exposure to higher temperatures may reduce battery life, damage the batteries, and degrade overall cardiograph performance.
• Battery reserve capacity may be exhausted due to leakage currents if the cardiograph is stored for more than 60 days without use. If the cardiograph will be stored for more than sixty days without use, fully charge the batteries, and then remove AC power from the cardiograph, and remove the batteries from the cardiograph. Store the batteries in a cool, dry location. A set of fully charged batteries stored outside the cardiograph will need to be recharged every sixty days.
• When the state of health (SOH) of the battery has decreased to 80 percent, or battery cycle count is greater than 300, the battery is considered end-of-life and should be replaced.

TC20 Cardiograph

• The TC20 operates with only a single battery, that supplies power to the cardiograph during mobile use.

TC30 Cardiograph

• The TC30 cardiograph uses either one or two removable lithium ion batteries that supply power to the cardiograph during mobile use.
• When operating the TC30 cardiograph with one battery installed, battery charge time from depletion to 90% charge in normal use is maximum four (4) hours.
• The TC30 cardiograph supports printing with only a single battery installed.
• When operating the TC30 cardiograph with two batteries installed, ensure that both batteries contain the same Philips part number. The battery part number identification label is found on the bottom of the battery. The cardiograph cannot operate with two batteries that contain different part numbers.
• When operating the TC30 cardiograph with two batteries installed, battery charge time from depletion to 90% charge in normal use is maximum eight (8) hours.
• When operating the TC30 cardiograph with one battery installed, the battery may be inserted into either battery compartment.

TC50/TC70 Cardiograph

• The TC70 cardiograph requires two lithium ion batteries to support printing reports during mobile use. If printing during mobile use is not required, one battery can be used.
• The TC50 cardiograph uses either one or two lithium ion batteries that supply power to the cardiograph during mobile use.
• When operating the TC70 cardiograph or TC50 cardiograph with two batteries installed, ensure that both batteries contain the same Philips part number. The battery part number identification label is found on the bottom of the battery. The cardiograph cannot operate with two batteries that contain different part numbers.
• When operating the TC70 cardiograph or TC50 cardiograph with two batteries installed, battery charge time from depletion to 90% charge in normal use is maximum eight (8) hours.

TC50 Cardiograph One Battery Operation

• The TC50 cardiograph with installed software version A.06.03 or higher can operate on a single battery.
• When operating a TC50 cardiograph with only one battery installed, a Philips approved battery must be used.
• The battery capacity for the TC50 cardiograph with a single battery installed is 30 minutes of continuous rhythm printing, or 30 total ECG reports.
• When operating the TC50 cardiograph with one battery installed, the single battery may be inserted into either battery compartment.
• When operating the TC50 with one battery installed, battery charge time from depletion to 90% charge in normal use is maximum four (4) hours.
• The TC50 cardiograph supports printing with only a single battery installed.

Viewing Battery Information

As a battery ages, its capacity decreases, and the battery status indicator becomes increasingly less accurate as the total number of charges and discharges increase. You can view information about the battery on the About the Cardiograph screen. To access this screen, see “Using the About the Cardiograph Screen” in Chapter 4 of the Service Manual. Ensure that the monitor is connected to AC power before attempting to review battery information.

Note: If only one battery is installed, information will not be displayed for the empty battery compartment.

Battery information displayed on the About the Cardiograph screen includes:

• Current Status: displays the current status of the battery: No Bat (no battery), No activity, Charging, Discharging.
• Battery Voltage: displays the voltage of the battery.
• Expected Max Error (%): the expected margin of error in the state of the charge calculation.

• Full Cap. (mAh): the predicted capacity of the battery when it is fully charged. The value in the Full Cap. field decreases as the battery ages.
• Remaining Cap. (mAh): shows the remaining capacity, in mAh, of the battery.
• Percent Charged: the current charge expressed as a percent of the total charge.
• Charge Current: current value while the battery is charging.
• Discharge Current: current value while the battery is discharging.
• Cycle Count: the number of full charge and discharge cycles calculated by the battery.
• Temperature: current temperature of the battery in degrees Celsius.
• B1 Unique ID: battery ID information, including battery type, date of manufacture (YYYYMMDD, e.g., 20170808).
• B2 Unique ID: battery ID information, including battery type, date of manufacture (YYYYMMDD, e.g., 20170809).

Image showing the 'About the Cardiograph' screen with various battery status details.

If the battery cycle count exceeds the recommended limit of 300 cycles, or the battery's state of health (SOH) has decreased to 80%, the battery should be replaced. A battery's state of health can be determined using the following formula:

SOH = Full capacity/Design capacity*

* See page 1 for design capacity.

Installing or Replacing the Batteries

WARNING
Properly dispose of or recycle depleted batteries according to local regulations. Do not disassemble, puncture, or incinerate the depleted batteries.

WARNING
Carefully follow the instructions for replacing the batteries. Only use batteries with Philips part number 989803194541 or 989803170371 (available only in China).

WARNING
Incorrect replacement of lithium batteries or fuel cells or replacement by inadequately trained personnel could result in an unacceptable risk (e.g., excessive temperatures, fire, explosion).

Caution

• Before removing and replacing battery(ies) from the cardiograph, press down and hold the On/Standby button (located on the front of the cardiograph), to shut down the cardiograph. Ensure that the cardiograph is shut down. When the cardiograph is fully shut down, the screen is black, and the On/Standby button is not illuminated. Once the cardiograph is shut down, proceed to remove and replace the battery(ies).
• When removing battery(ies) from the cardiograph, the battery(ies) could feel warm to the touch.

Note: If the status Recommend Calibration appears in the Battery Status window, calibrate the battery(ies) per the calibration procedure on page 7. If the status Recommend Replacement appears, the battery(ies) have reached the end of their useful life and need to be replaced. Note that the Recommend Replacement notice only appears after you have calibrated the battery(ies).

Notes about Battery Installation

• The TC20 cardiograph uses only a single battery.
• The TC70 cardiograph requires two batteries for operation if printing is required; otherwise, a single battery may be used.
• If operating the TC70, TC50 or TC30 cardiograph with one battery installed, the battery may be inserted into either battery compartment.
• When operating the TC70, TC50 or TC30 cardiograph with two batteries installed, ensure that both batteries have the same Philips part number. The battery part number identification label is found on the bottom of the battery. The cardiograph cannot operate with two batteries that have different part numbers.

To install the batteries:

1. Open the battery door.
2. Locate the two gold pull tabs inside of the battery compartment. Pull the tabs straight out of the battery compartment and lay flat.
3. Insert the battery with the external connector facing the bottom rear of the compartment.
   Note: If operating the TC70, TC50 or TC30 cardiograph with one battery installed, the battery may be inserted into either battery compartment.
4. Push in the battery and ensure that the battery is fully inserted into the slot. The pull tab will insert along with the battery. Insert the second battery following the same procedure.
5. Replace the battery door.
6. Connect the AC power cord to the cardiograph. Charge the batteries for five hours before operating the cardiograph on battery power only.

Battery Calibration

Battery calibration may be necessary in order to enhance the accuracy of the battery level indicator that displays on the Status Bar. If the accuracy of this indicator is affected, the other battery indicators included on the Battery Status window (that is opened by tapping the battery icon on the Status Bar) may also be less accurate.

Figure 2-5 Battery Power Indicator on the Status Bar

Image showing the Status Bar of the PageWriter TC cardiograph with battery indicators.

The recommended intervals for battery calibration are dependent upon factors in your clinical use model. When the battery power indicators are not functioning so that they are useful in your daily work environment, calibrate the batteries as described here.

The battery calibration procedure requires that the cardiograph be taken out of active use for up to 35 hours.

Note: If the status Recommend Calibration appears in the Battery Status window, calibrate the battery(ies) per the following procedure. If the status Recommend Replacement appears, the battery(ies) have reached the end of their useful life and need to be replaced. Note that the Recommend Replacement notice only appears after you have calibrated the batteries.

To calibrate the batteries on the cardiograph:

1. Attach the AC power cord to the cardiograph. Ensure that the AC power supply is connected to a grounded electrical outlet and that the cardiograph is receiving AC power. Check that the AC power indicator light (located next to the power button) is lit.
2. Fully charge the batteries. To ensure that the batteries are fully charged, view the Charge Current field in the Service Utility. Touch the Setup button on the tool bar. Select the Service Utility from the Configuration Setup and Service Utilities main menu.
   Note: Accessing the Service Utility may require entering a password. If a password is lost and cannot be retrieved, contact Philips Customer Service for assistance.
3. From the Service Utility screen, ensure that the About the Cardiograph button is selected (top of screen). A selected button is highlighted in blue.
4. Underneath the Battery Status column (middle of screen), check that the Charge Current field for both batteries display 0 mA, ensuring that both batteries are fully charged.
   Note: For devices with battery PN 989803194541 or 989803170371, the battery should remain in fully charged status for 5.25 hours or longer.
5. Touch the Print button (top of screen) to print out a report of the cardiograph settings displayed on this screen.
6. Touch the Exit button (lower right hand corner of screen). Touch the Exit button again on the Setup main menu.
7. After the Main screen appears, touch the ID button to open the ID entry screen. Ensure that the ID screen remains open.
8. Unplug the cardiograph from AC power. Ensure that the AC power indicator light (located next to the power button) is not lit.
9. Keep the ID screen displayed and allow the batteries to deplete of all battery power. This process will take approximately 8 hours to complete. When the batteries are depleted of all power, the screen is black and the cardiograph cannot be returned to active use by touching the power button.
10. Once the batteries are fully depleted, reconnect the cardiograph to AC power. Press the On/Standby button to power on the cardiograph in order to confirm successful calibration. Afterward, charge the batteries fully before returning it to active use.
    Note: For devices with battery PN 989803194541 or 989803170371, the battery should remain in fully depleted status for 5.25 hours or longer.
11. On the Main screen, touch the Setup button.
12. Select the Service Utility from the Configuration Setup and Service Utilities main menu.
13. From the Service Utility screen, ensure that the About the Cardiograph button is selected (top of screen). A selected button is highlighted in blue.
14. Underneath the Battery Status column, check the Expected Max Error (%) and Full Capacity (mAh) values as viewed on the screen are different than the values printed on the report generated from the Service Utility screen. If the values are different, the battery calibration procedure is complete.
    Note: If the Expected Max Error (%) field has not been reset to 2%, another calibration procedure may be necessary

Ordering a Replacement Battery

To order a replacement lithium ion battery, contact your Philips Customer Care center. For information on how to contact Philips Customer Care for your country, go to http://www.healthcare.philips.com. Select your country and language, then navigate to the Customer Care page.

* World-wide, except China
** China only

Note: Battery PN 989803160981 is no longer available for purchase. If your cardiograph is using batteries with PN 989803160981, you will need to replace both batteries as soon as possible.