PressureWire Receiver Instructions for Use Rev 02 June 2008

ENGLISH TABLE OF CONTENTS CONTENTS DESCRIPTION 1. INTENDED USE / INDICATION FOR USE 2. CONTRAINDICATIONS 3. GENERAL WARNINGS 4. GENERAL PRECAUTIONS 5. INSTALLATION 6. PREPARATIONS FOR USE 7. DIRECTIONS FOR USE - Normal operation - Adjust pressure offset (equalization) - Balance PressureWire® Receiver and cathlab recording system - Receiver light indicators - Change of PressureWire®

8. CLEANING AND MAINTENANCE 9. PRESSURE SIGNAL PERFORMANCE 10. TECHNICAL SPECIFICATIONS - Physical - Radio - Electrical interface compatibility - Environmental conditions - Transport and storage

11. COMPLIANCE WITH REGULATORY REQUIREMENTS PATENTS WARRANTY AND LIMITATIONS SYMBOLS WITH EXPLANATIONS

CONTENTS

• PressureWire® Receiver • PressureWire® Receiver mounting bracket NOTE: A monitor cable is required to connect PressureWire® Receiver to a compatible cathlab recording system. (Not part of contents but part of the delivery according to customer order)

3

DESCRIPTION (See Diagram 1)

• PressureWire® Receiver is a receiver to the PressureWire® transmitter and is connected to a cathlab hemodynamic recording system. • PressureWire® Receiver receives PressureWire® signal via radio and converts it to a pressure signal compatible with standard invasive blood pressure transducers. • PressureWire® Receiver is connected to a recording system with a standard invasive blood pressure connection (ANSI/AAMI BP22-1994, DC excitation). • Refer to section Technical Specifications for compatibility with hemodynamic recording systems • PressureWire® Receiver user interface consists of three buttons with different light indicators and buzzer sound. Diagram 1: PressureWire®

C

A

F

B A B C D E F G H

PressureWire® Receiver Transmitter (Not a part of this package) PressureWire® (Not a part of this package) CONNECT button Plus/Minus buttons Plus/Minus light indicators Function light indicators Monitor cable connector

E

D G

F

H

1. INTENDED USE/ INDICATION FOR USE INTENDED USE:

PressureWire® Receiver is intended for use as an interface between PressureWire® and a compatible cathlab recording system. INDICATION FOR USE:

PressureWire® Receiver together with PressureWire® is indicated for use in catheterization and related cardiovascular specialty laboratories for measurement of physiological parameters on patients requiring such information for further treatment.

2. CONTRAINDICATIONS No identified contraindications.

3. GENERAL WARNINGS No identified general warnings.

4

4. GENERAL PRECAUTIONS Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. PressureWire® Receiver is only intended for use as an interface between PressureWire® and a compatible cathlab recording system. PressureWire® Receiver shall only be used with monitor cable approved by Radi Medical Systems. Before using PressureWire® Receiver refer to instructions for use supplied with PressureWire® for warnings, precautions, contraindications and instructions for use. Make sure PressureWire® Receiver is connected to intended PressureWire® and not to adjacent or previously used PressureWire® units. The PressureWire® receiver housing is protected against the effects of a discharge of a cardiac defibrillator. Handle and dispose of PressureWire® Receiver in accordance with medical practice and applicable local, state and federal laws and regulations.

5. INSTALLATION 5.1 Open the PressureWire® Receiver package and use the enclosed mounting bracket to fasten PressureWire® Receiver on or near cathlab table. At delivery the mounting bracket is assembled for pole mounting. If mounting on the table rail is desirable, disassemble the mounting bracket and reassemble according to the picture below.

If PressureWire® Receiver is used in a sterile environment it is recommended to cover it in a sterile plastic bag or under a plastic sheet. 5.2 Connect PressureWire® Receiver to one available invasive blood pressure channel on the cathlab hemodynamic recording system using the monitor cable supplied by Radi Medical Systems. 5

NOTE: Refer to section Technical Specification for compatibility with hemodynamic recording systems. NOTE: Radio range is reduced by objects and walls, keep transmitter and receiver in line of sight wherever possible. CAUTION: PressureWire® Receiver is powered by the excitation voltage from the invasive blood pressure channel. Therefore the cathlab hemodynamic recording system must be powered in order for PressureWire® Receiver to be activated. On some cathlab systems the pressure channels must also be activated and zeroed before the excitation is available.

Refer to instructions for use for the cathlab hemodynamic recording system for correct handling instructions. 5.3 A steady yellow light and a short beep on PressureWire® Receiver indicate that it is successfully connected and powered. 5.4 Zero pressure channel on the cathlab hemodynamic recording system.

6. PREPARATION FOR USE 6.1 If necessary, verify balance between PressureWire® Receiver and cathlab recording system, see chapter “Balance PressureWire® Receiver and cathlab recording system” below. 6.2 Activate the receiver by pressing the CONNECT button. The receiver is now ready to connect to PressureWire® transmitter (during 60s), indicated by blinking green light on the receiver. 6.3 Turn on the PressureWire® transmitter. PressureWire® will now calibrate and connect to the receiver. Refer to Instructions for use for PressureWire® Aeris for correct handling before calibration. 6.4 When the receiver is successfully connected to the transmitter the CONNECT button indicators changes to steady green light and a double beep is heard. - If a connection is not established and the green light on the receiver is still blinking, restart the transmitter by turning it off and then on again. - If a connection is not established within 60s the receiver returns to standby mode, indicated by a yellow light and a long beep. Reactivate PressureWire® Receiver by pressing the CONNECT button, then restart the transmitter by turning it off and then on again. - Refer to the table below for other light indicators. 6.5 After calibration, confirm that the pressure reading on the cathlab monitor is zero; re-zero the cathlab pressure channel if necessary. PressureWire® is now ready for use. 6

7. DIRECTIONS FOR USE NORMAL OPERATION

After successful connection to the PressureWire® transmitter, pressure is received by PressureWire® Receiver and converted for the cathlab hemodynamic recording system. ADJUST PRESSURE OFFSET (EQUALIZATION) To remove any residual pressure difference between aortic and PressureWire® pressure use the plus (+) and minus (–) buttons on the PressureWire® Receiver. To increase PressureWire® offset, in steps of 1 mmHg, press the plus (+) button. The plus (+) indicator (F) is lit as long as there is a positive pressure offset. To decrease PressureWire® offset, in steps of 1 mmHg, press the minus (-) button. The minus (-) indicator (F) is lit as long as there is a negative pressure offset. Alternatively, the equalization function on the cathlab recording system can be used to remove pressure offset. Refer to the Instructions for use for the cathlab recording system. NOTE: Before equalization, the height of the aortic pressure transducer should be aligned to heart level. If the ratio PressureWire®/Aortic pressure after height alignment is higher than 1.1 or below 0.9 it is recommended to take out PressureWire®, place it in the packaging coil, flush and then recalibrate according to PressureWire® Aeris Instructions for use, before adjusting pressure offset. BALANCE PRESSUREWIRE® RECEIVER AND CATHLAB RECORDING SYSTEM

It is recommended to daily verify that the pressure output from PressureWire® Receiver is in balance with the pressure displayed on the cathlab recording system. To provide reference pressure output levels to the cathlab recording system, enter Refout mode by pressing and holding the CONNECT button >3s. When Refout mode is activated, the plus (+) and minus (-) indicators (F) are lit. To increase/decrease pressure reference output level press plus (+) / minus (-) buttons. Pressure output level changes according to 0, 20, 40, 100, 200 mmHg, indicated by the function light indicators, see picture.

40 20

100

0

200

NOTE: Reference output levels are unaffected by any previous pressure offset.

To exit Refout mode shortly press the CONNECT button. For complete information about light indicators see table below.

7

RECEIVER LIGHT INDICATORS light indicators Yellow steady light

explanation At startup: Unit power on and self test passed During measurement: Lost connection to PressureWire® or PressureWire® disconnected from transmitter.

Green blinking light

Connect mode – searching for connection to PressureWire®. Connect mode is automatically deactivated if no connection has been found after 60s, or if the CONNECT button is pressed again.

Green steady light

Established connection to PressureWire®, receiving pressure data.

Incremental green lights

Reference pressure level output. See chapter “Balance PressureWire® Receiver and cathlab recording system”.

Plus indicator steady Positive pressure offset added to PressureWire® blue pressure.

Minus indicator steady blue

Negative pressure offset added to PressureWire® pressure.

Green steady light & PressureWire® battery low. It is recommended to Yellow blinking light finish case or to exchange PressureWire®.

Yellow blinking light

8

Internal error. Attempt restart by dis- and re-connecting PressureWire® Receiver from cathlab recording system.

CHANGE OF PRESSUREWIRE®

When changing PressureWire® be sure to re-activate PressureWire® Receiver by pressing the CONNECT button before turning on a new PressureWire® transmitter to secure correct connection. Refer to Instructions for use for PressureWire® Aeris.

8. CLEANING AND MAINTENANCE PressureWire® Receiver shall only be cleaned with regular cleaning agents. No maintenance other than normal functional control needed. See section “Balance PressureWire® Receiver and cathlab recording system”. If PressureWire® Receiver performance is outside specification contact a Radi Medical Systems representative.

9. PRESSURE SIGNAL PERFORMANCE (All values together with PressureWire® Aeris) Operating pressure: Zero Thermal Effect: Sensitivity Thermal Effect: Zero drift: Total Accuracy for the combination of PressureWire® and PressureWire® Receiver:

Frequency response: Delay time:

-30 to +300 mmHg 0.3 mmHg/°C 0.3%/°C < 7 mmHg/h ±1 mmHg plus ±1% of reading (over the pressure range – 30 mmHg to 50 mmHg) ±3% of reading (over the range 50 mmHg to 300 mmHg) DC to 25 Hz <10 ms

10. TECHNICAL SPECIFICATIONS Physical Weight: Dimensions: Material:

60 g 100 x 55 x 27mm PC/ABS

Radio Frequency range: Type: Range:

2.4000-2.4835 GHz (ISM-band) Frequency Hopping Spread Spectrum 0-2m

NOTE: Radio range is reduced by objects and walls, keep transmitter and receiver in line of sight wherever possible. WARNING: Changes or modifications not expressly approved by Radi Medical Systems could void user´s authority to operate the equipment.

9

Electrical interface compatibility

Compatible with invasive blood pressure channels on cathlab hemodynamic recording systems according to: Signal: ANSI/AAMI BP 22-1994 Excitation voltage: 4-8 VDC Excitation impedance: 200 to 500 Ω Signal impedance with tolerance: 56±10 Ω Nominal sensitivity: 5 µV/V/mmHg Environmental conditions

Temperature: Air humidity: Ambient pressure:

15-35°C 30-75% 425-850 mmHg

Transport and storage

Transportation temperature: Air humidity: Store at room temperature in a dry place.

-25 -70°C 10 to 95%

11. COMPLIANCE WITH REGULATORY REQUIREMENTS Hereby, Radi Medical Systems AB, declares that this PressureWire® Receiver is in compliance with the essential requirements and other relevant provisions of Medical Device Directive (93/42/EEC), Radio and Telecommunications Terminal Directive (1999/5/EC) and Quality System Regulation (US). GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS

PressureWire® system is intended for use in the electromagnetic environment specified below.The customer or the user of PressureWire® system should assure that it is used in such an environment.

10

Emission test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The PressureWire® system uses RF energy only for its internal function.Therefore, its RFemissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

The PressureWire® system is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies building for domestic purposes.

Voltage fluctuations /flicker emissions IEC 61000-3-3

Complies

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

The PressureWire® system is intended for use in the electromagnetic environment specified below.The customer or the user of the PressureWire® system should assure that it is used in such an environment. Immunity test

IEC 60601 Test level

Compliancelevel

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 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%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/ output lines

N/A 1) 2)

N/A

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

N/A 2)

N/A

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

N/A 1)

N/A

3 A/m

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

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 sec

Power frequency (50/60 Hz) magnetic filed IEC 61000-4-8

3 A/m

NOTE: UT is the a.c. mains voltage prior to application of the test level. 1) No mains power input 2) Patient connection

11

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

The PressureWire® system is intended for use in the electromagnetic environment specified below.The customer or the user of the PressureWire® system should assure that it is used in such an environment. Immunity test

IEC 60601 Test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communication equipment should be used no closer to any part of the PressureWire® system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

N/A Conducted RF 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz 1)

d = 1,2√ P

3 V/m 3 V/m Radiated RF IEC 61000-4-3 80 MHz to 2,5 GHz

d = 1,2√ P 80 MHz to 800 MHz d = 2,3√ 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 800MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, 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 PressureWire® system is used exceeds the applicable RF compliance level above, the PressureWire® system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PressureWire® system. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 1) No mains power input

12

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE PRESSUREWIRE® SYSTEM

The PressureWire® system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PressureWire® system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PressureWire® system as recommended below, according to the maximum output power of the communications equipment.

Separation distance to frequency of transmitter (m) Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 Mhz to 2,5 GHz output power d = 1,2√ P d = 2,3√ P of transmitter (W) d = 1,2√ P 0,01

0,12

0,12

0,24

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in metres (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 absorption and reflection from structures, objects and people.

STANDARDS

PressureWire® Receiver is classified as follows in accordance with relevant parts in: IEC 60601-1 ed.02 Amd 1 & Amd 2 IEC 60601-1-4 IEC 60601-1-2 (2001) Amd 1 (2004) EN 300328 v.1.7.1 ANSI/AAMI BP 22-1994 Conforms to UL 60601-1 Certified to CAN/CSA C22.2 No. 601.1 -M90

PATENTS

USA: Re 35648, Re 39863, US 4996082, 5085223, 5938624, 6089103, 6112598, 6142958, 6167763, 6196980, 6248083, 6336906, 6409677, 6428336, 6565514, 6615667, 6672172, 6754608, 6908442; Europe: 877574, 907335, 968547, 973438, 1055392, 1012912, 1076511, 1125548, 1310215, 1475036, 1165171, 1616521; Canada: 1271930; Japan: 2659944, 2719425, 3675835, 3679419, 3692014, 3692035, 3774237, 3830528, 3880884; SE 460396, 506 135, 523337. Other patents pending worldwide.

13

WARRANTY AND LIMITATIONS

Although PressureWire® Receiver, hereafter referred to as “product”, has been manufactured under carefully controlled conditions, Radi Medical Systems AB, hereafter called Radi, has no control over the conditions under which the product is used. Radi, therefore disclaims all warranties, both expressed and implied, with respect to the product, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. Radi shall not be liable to any person or entity for any medical expenses or any direct, incidental or consequential damages caused by any use, defect, failure or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort or otherwise. No person has any authority to bind Radi to any representation or warranty with respect to the product. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict with applicable law by court of competent jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Disclaimer of Warranty did not contain the particular part or term held to be invalid. PressureWire® is developed and manufactured according to Medical Device Directive 93/42/EEC, Radio and Telecommunication Terminal Equipment Directive 1999/5/EC and Quality System Regulation (US). PressureWire® and RadiAnalyzer® are registered trademarks of Radi Medical Systems AB. Designed, developed and manufactured by Radi Medical Systems AB. Radi Medical Systems AB Palmbladsgatan 10 Box 6350 751 35 Uppsala, Sweden Tel + 46 (0) 18 16 10 00 Fax: 46 (0) 18 16 10 99 e-mail: [email protected] Radi Medical System contacts and further information: www.radi.se

14

SYMBOLS WITH EXPLANATIONS: Caution, (Attention, consult accompanying documents)

See Instructions for Use

Type CF equipment Contents of the package REF

Catalogue number

Do not use if package is damaged.

Complies with the Medical Device Directive 93/42/EEC and Radio and Telecommunication Terminal Equipment Directive 1999/5/EC. RX only

Caution: Federal law (USA) restricts this device to sale by or on the order of a Physician. Electronic waste bin. Disposal according WEEE.

cETLus valid for Canada and US. Conforms to UL 60601-1. Certified to CAN/CSA STD C22.2 NO 601.1 –M90.

15