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PageWriter Trim Cardiograph Lithium Ion Battery Update

Appendix A

This document contains updated information about the PageWriter Trim I, II, III, and Rx model cardiographs when operated with the optional lithium ion battery (Philips part number 989803164611). This information is not included in the enclosed PageWriter Trim Cardiograph Instructions for Use. Please read carefully all of the information included in this document before installing or using the optional lithium ion battery. This document includes the following topics. Special Note about the Lithium Ion Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Table 1. Guidance and Manufacturers Declaration: Electromagentic Emissions. . . . . . . . . . . 2 Guidance and Manufacturers Declaration for Electromagnetic Immunity. . . . . . . . . . . . . . . . 2 Electromagnetic Environment Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Sensitivity to ESD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Avoiding Electrostatic Discharges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Sensitivity to EFT Burst . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Recommendations for Reducing EFT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Table 2. Guidance and Manufacturers Declaration: Electromagnetic Immunity . . . . . . . . . . . 4 Table 3. Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the PageWriter Trim Cardiograph: for equipment and systems that are not life-supporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Rational for Reduced Level Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Special Note about the Lithium Ion Battery

Figure 1 The Optional Lithium Ion Battery with AC/DC power supply

The PageWriter Trim lithium ion battery (Philips part number 989803164611) provides the cardiograph with extended periods of battery powered operation.
CAUTION

For best results, always operate the cardiograph on battery power only when acquiring ECG data from the patient. Do not connect the lithium ion battery to the AC/DC power adapter (Philips part number 453564099301 or 453564149709) when acquiring ECG data from the patient. Only connect the lithium ion battery to the AC/DC power adapter when the cardiograph is not in active clinical use.

PageWriter Trim Cardiograph Lithium Ion Battery Update

Electromagnetic Compatibility (EMC)

The design of the lithium ion battery does make the PageWriter Trim I, II, III, or Rx model cardiographs susceptible to Electromagnetic Interference (EMI) in specific operating situations. These vulnerabilities are confined to static discharge events that can occur on some exposed areas of the PageWriter Trim cardiograph, including high levels of electrical noise on the A/C power input. If EMI does occur when operating the cardiograph on AC power, the cardiograph may stop printing or may cease to operate. If this occurs, remove AC power from the cardiograph, and then remove the lithium ion battery from the cardiograph. Wait approximately 10 seconds, and then reinstall the battery, and reconnect the cardiograph to AC power in order to restore system operation. EMI vulnerabilities can be avoided by not touching the rear panel of the cardiograph, or the LCD display of the PageWriter Trim I cardiograph while actively conducting ECG testing. Please note that these electrical noise faults do not occur when the cardiograph is powered solely by the lithium ion battery (no AC power is applied). The PageWriter Trim I, II, III, and Rx model cardiographs operated with the lithium ion battery do meet IEC 60601-1-2 General Requirements for Safety Electromagnetic Compatibility with the exceptions that are noted above.

Electromagnetic Compatibility (EMC)

The PageWriter Trim cardiograph is intended for use in the electromagnetic environment specified in Table 1. The customer or the user of the PageWriter Trim cardiograph should ensure that it is used in such an environment.
Table 1 Guidance and Manufacturers Declaration: Electromagentic Emissions Compliance Electromagnetic Environment: guidance

Emissions Test

RF Emissions CISPR 11

Group 1

The PageWriter Trim cardiograph uses RF energy only for its internal function. Therefore, its RF emissions are very low are not likely to cause any interference in nearby electronic equipment. The PageWriter Trim cardiograph is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Class B Class A Complies

Guidance and Manufacturers Declaration for Electromagnetic Immunity

The PageWriter Trim cardiograph is intended for use in the electromagnetic environment specified in Table 2 on page 4. The customer or the user of the PageWriter Trim cardiograph should ensure that it is used in such an environment. Refer to Appendix C Specifications of the PageWriter Trim Instructions for Use (found on the enclosed User Documentation CD) for further information.
2 PageWriter Trim Cardiograph Lithium Ion Battery Product Update

PageWriter Trim Cardiograph Lithium Ion Battery Update

Electromagnetic Environment Guidance

Electromagnetic Environment Guidance

During EMC verification by Philips Medical Systems of the PageWriter Trim model cardiographs with the optional lithium ion battery and charger, the device complied with most EMC tests, but was found to be sensitive to Electrostatic Discharge (ESD) and Electrical Fast Transient Bursts.

Sensitivity to ESD
The PageWriter Trim I cardiograph may be sensitive to 8kV Air Discharges applied to display bezel areas which may cause the LCD display to dim or to disappear entirely, and this may include the loss of software menu functionality. This condition is due to static charge building up on the internal display. This condition can be corrected by cycling power to the cardiograph. Additionally, the PageWriter Trim cardiograph may be sensitive to 6kV Contact Discharges to the rear protective earth ground stud, to the ECG leads, and to the battery DC inlet that may cause prolonged (up to 17 seconds) instances of leads off, or blank ECG lead trace conditions that can occur during the use of Auto ECG or Rhythm printing. The PageWriter Trim III or Rx model cardiographs may be sensitive to 6kV Contact Discharges applied to the optional LAN card that may result in the cardiograph printer stopping abruptly, and also may include a system lockup. This condition can be corrected by temporarily removing both AC and lithium ion battery power from the cardiograph.

Avoiding Electrostatic Discharges

Electrostatic discharges (commonly known as ESD) can occur in the hospital environment. For example, the act of walking across carpeted flooring, and then touching a conductive object (such as a door knob) can create an electrical arc. ESD can also affect the operation of electronic devices when it occurs either directly to that device, or indirectly to nearby objects. Whenever possible, discharge yourself to a conductive metal surface that is connected to earth ground before making contact with the PageWriter Trim cardiograph. In most cases, ESD abnormalities can be corrected by resetting power to the cardiograph. If further assistance is needed, contact the nearest Philips Response Center.

Sensitivity to EFT Burst

The PageWriter Trim I cardiograph may be sensitive to electrical fast transients >=1.5kV appearing on the AC power line. Symptoms of this condition include an Auto or Rhythm report that suddenly ceases to print, and then the appearance of an error message on the cardiograph display. Additionally, recorded ECG lead traces may change from solid to dashed (lead off condition), and the cardiograph printer may advance blank pages. In each case, restarting Auto/Rhythm printing is required to resume normal operation.

PageWriter Trim Cardiograph Lithium Ion Battery Product Update

PageWriter Trim Cardiograph Lithium Ion Battery Update

Electromagnetic Environment Guidance

Recommendations for Reducing EFT

Fast Transient Bursts are electrical noise phenomena typically caused by, for example, the interruption of inductive loads, or by relay contact bounce. The user may not be aware of the phenomena, and this phenomena can enter the medical device through the product AC power mains connection, or I/O signal connections (such as the modem or LAN). While performing product troubleshooting, it is important to isolate the noise source by first removing AC power and other signal connections, and then operating the device under lithium ion battery power only. Once the EFT source is isolated, attempt to attenuate the interference by distancing the product from the source to the greatest extent possible. When EFT noise is present, Philips Medical Systems recommends operating the cardiograph under lithium ion battery power only with I/O signal connections removed. Otherwise, power line, signal filtering, and conditioning devices may be necessary. If assistance is needed, contact the Philips Response Center.
Table 2 Guidance and Manufacturers Declaration: Electromagnetic Immunity Compliance Compliance Level Electromagnetic Environment: guidance

Emissions Test

Electrostatic Discharge (ESD) IEC 61000-4-2

+/- 6 kV contact +/- 8 kV air

+/- 4 kV contact +/- 6 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Refer to Avoiding Electrostatic Discharges on page 3. Mains power quality should be that of a typical commercial or hospital environment. Refer to Recommendations for Reducing EFT on page 4.

Electrical Fast transient/burst IEC 61000-4-4

+/- 2 kV for power supply line +/- 1 kV for input/output lines

+/- 1 kV for power supply line +/- 1 kV for input/output lines +/- 1 kV differential mode +/- 2 kV common mode

Surge IEC 61000-4-5

+/- 1 kV differential mode +/- 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

PageWriter Trim Cardiograph Lithium Ion Battery Product Update

PageWriter Trim Cardiograph Lithium Ion Battery Update

Electromagnetic Environment Guidance

Table 2

Guidance and Manufacturers Declaration: Electromagnetic Immunity (continued) Compliance Compliance Level Electromagnetic Environment: guidance

Emissions Test

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (>30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 seconds

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (>30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the PageWriter Trim cardiograph required continued operation during power mains interruptions, it is recommended that the PageWriter Trim be powered from an uninterruptable power supply or a battery.

Power frequency (50./60 Hz) magnetic field

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

PageWriter Trim Cardiograph Lithium Ion Battery Product Update

PageWriter Trim Cardiograph Lithium Ion Battery Update

Electromagnetic Environment Guidance

Table 2

Guidance and Manufacturers Declaration: Electromagentic Immunity (continued) IEC 60601 Test Level Compliance Level Electromagnetic Environment: guidance

Emissions Test

Portable and mobile RF communications equipment should be used no closer to any part of the PageWriter Trim, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Recommended separation distance

d =

3.5 3Vrms

P 80 MHz to 800 MHz

Radiated RF IEC 61000-4-3

3 Vrms 80 MHz to 2.5 GHz

3 Vrms

d =

3.5 3V/m 7 3V/m

d =

P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from surfaces, objects, and people.

PageWriter Trim Cardiograph Lithium Ion Battery Product Update

PageWriter Trim Cardiograph Lithium Ion Battery Update

Electromagnetic Environment Guidance

a.

b.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PageWriter Trim cardiograph is used exceeds the applicable RF compliance level above, the PageWriter Trim cardiograph should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PageWriter Trim cardiograph. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m. Table 3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the PageWriter Trim Cardiograph: for equipment and systems that are not life-supporting

The PageWriter Trim cardiograph is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PageWriter Trim cardiograph can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PageWriter Trim cardiograph as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter (m)

150 KHz to 800 KHz d = 1.2 P 0.01 0.1 1 10 100 0.1 m 0.4 m 1.2 m 4.0 m 12.0 m

800 MHz to 2.5 GHz d = 2.3 P 0.2 m 0.7 m 2.3 m 7.0 m 23.0 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection from structures, objects, and people.

PageWriter Trim Cardiograph Lithium Ion Battery Product Update

PageWriter Trim Cardiograph Lithium Ion Battery Update

Rational for Reduced Level Acceptance

Rational for Reduced Level Acceptance

Each of the test conditions where the PageWriter Trim cardiograph passed at reduced levels of performance were evaluated and carefully reviewed by a team of experts skilled in various disciplines associated with the design, manufacture, and clinical use of this product. This review took into consideration the following factors: the probability that an event inducing the failure (reduced level of performance) could occur in the intended use model of the product the severity of injury to the user or to the patient should the event occur the potential disruption to workflow or product usability when following the recommended mitigation or risk avoidance procedure The result of this evaluation concluded that the operational improvements to the PageWriter Trim cardiograph operating with the optional lithium ion battery far outweighed the potential inconvenience of reduced performance levels. In no instance was patient risk compromised to an extent that would warrant additional mitigating design measures.

Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 USA Copyright 2009 Koninkjilke Philips Electronics N.V. All rights are reserved. 453564149141 Edition 4 Printed in USA

*453564149141* *Edition 4*
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