PAM-200 Operation Manual R01

Table of Contents 1.0 USER RESPONSIBILITY... 1 2.0 MANUAL REVISION HISTORY ... 2 3.0 WARRANTY... 3 4.0 INTRODUCTION... 4 5.0 SAFETY ... 5 5.1 Electrical ...5 5.2 Patient Connections ... 5 5.3 EMC (Electromagnetic Compatibility IEC 60601-1-2) ... 6 5.4 Description of Warning Labels ... 10 6.0 INSTALLATION... 11 7.0 OPERATION ... 12 7.1 Description ... 12 7.2 Classification (In Accordance with IEC 60601-1) ... 12 7.3 ECG Patient Acquisition... 13 7.4 Respiratory Acquisition ... 14 7.5 Peripheral Pulse (Pleth) Acquisition... 15 7.6 Hardware Interface ... 16 8.0 MAINTENANCE AND CLEANING ... 17 8.1 Cleaning the Respiration Pillow ... 17 8.2 Cleaning the Module ... 17 8.3 Cleaning Patient Cables ... 17 8.4 Preventative Maintenance ... 17 9.0 ACCESSORIES ... 18 9.1 Disposal ... 18 10.0 SPECIFICATIONS ... 19 10.1 Communications ... 19 10.2 Electrical and Optical Interfaces ... 19 10.3 Power Connector ... 20 10.4 PAM Physical Specifications... 21 10.5 Power Requirements ... 21 10.6 System Environmental Performance ... 21 10.7 Peripheral Pulse ... 22 10.8 System Noise Performance ... 22 10.9 Patient Isolation Scheme ... 23 10.10 Dielectric Withstand Test ... 23 10.11 Defribrillation Statement ... 23 10.12 Pacemaker Statement ... 23 10.13 Regulatory ... 24

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1.0 User Responsibility This product will perform in conformity with the description thereof contained in this Operation Manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, IVY Biomedical Systems, Inc. recommends that a telephone call or written request for service advice be made to IVY Biomedical Systems, Inc. Service Department. This product or any of its parts should not be repaired other than in accordance with instructions provided by IVY Biomedical Systems, Inc. trained personnel. The product must not be altered without the prior written approval of IVY Biomedical Systems, Inc. Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction, which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than IVY Biomedical Systems, Inc.

Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, Connecticut 06405 USA (203) 481-4183  (800) 247-4614  FAX (203) 481-8734 www.ivybiomedical.com e-mail: [email protected]

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2.0 Manual Revision History

Revision 00 01

Date February 6, 2011 May 24, 2016

PAM-200 Operator Manual

Description Initial Release of PAM-200 Operation Manual Updated manual to comply with IEC 60601-1 3rd edition

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3.0 WARRANTY All products manufactured by Ivy Biomedical Systems, Inc. under normal use, are warranted to be free from defects in material and workmanship and to operate within published specifications, for a period of one year from date of original shipment. All accessories such as patient cables and lead wires, supplied by Ivy Biomedical Systems, Inc. under normal use, are warranted to be free from defects in material and workmanship and to operate within published specifications, for a period of 90 days from date of original shipment. If an examination by Ivy Biomedical Systems, Inc. discloses such product(s) or component part(s) to have been defective, then our obligation is limited to repair or replacement (at our option). When a product or products need to be returned to the manufacturer for repair or examination, contact customer service personnel at Ivy Biomedical Systems, to obtain a Return Material Authorization number (RMA #) and the correct packing instructions: Customer Service Telephone: (203) 481-4183 or (800) 247-4614 Fax: (203) 481-8734 E-mail: [email protected] Website: www.ivybiomedical.com

All products being returned for warranty repair shall be shipped prepaid to: Service Department Ivy Biomedical Systems, Inc. 11Business Park Drive Branford, CT. 06405 USA Toll-Free (800) 247-4614 (203) 481-4183 Fax: (203) 481-8734 Email: [email protected] Ivy will prepay the shipment of the repaired or replacement product to customer.

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4.0 INTRODUCTION This manual is to provide information on the correct use of the Patient Acquisition Module (PAM200). It is up to the user to ensure that any applicable regulations regarding the installation and operation of the module are observed. The PAM-200 is a Medical Electrical device intended for use on patients requiring R-wave synchronization. The PAM-200 must be operated by trained and qualified medical personnel only. Manufacturer’s Responsibility The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the equipment only if: • Assembly operations, extensions, re-adjustments, or repairs are carried out by persons authorized by the manufacturer • The electrical installation complies with all applicable regulations • The equipment is used in accordance with the instructions in this manual. Incorrect operation or failure of the user to maintain the module in accordance with proper maintenance procedures relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, or injury. This manual explains how to use the PAM-200. Important safety information is located throughout the manual where appropriate. READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE OPERATING THE MODULE.

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5.0 SAFETY 5.1 Electrical WARNING: Do not place the module in a position that may cause it to fall on the patient. Do not lift the module by the external cables. WARNING: Electric shock hazard! Do not remove covers or panels. Refer service to qualified service personnel. WARNING: Do not clean module while it is on and/or connected to a power source. WARNING: If unit is accidentally wet, discontinue use until dry and then test unit for proper operation before reuse on a patient. WARNING: This unit uses a common isolation path for the ECG leads. Do not connect any non-isolated accessories to the ECG input when connected to a patient, as this may compromise the safety of the unit. When attached to other devices, insure that the total chassis leakage currents of all units do not exceed 300 μA. WARNING: Equipment not suitable for use in the presence of flammable anesthetic mixtures with air, oxygen or nitrous oxide. WARNING: Equipment not for use with oxygen or oxygen enriched atmospheres. 5.2 Patient Connections Patient connections are electrically isolated. For all connections use isolated probes. Do not let patient connections contact other conductive parts, including ground. See instructions for patient connections in this manual. Carefully route patient cables to reduce the possibility of patient entanglement or strangulation. Leakage current is limited internally by this monitor to less than 50 μA. However, always consider cumulative leakage current that can be caused by other equipment used on the patient at the same time as this monitor. To ensure that the leakage current protection remains within the specifications, use only the patient cables specified in this manual. This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an unreasonable risk of adverse health consequences or death.

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WARNING: Hazard of RF energy burns from improperly placed cables. Avoid direct contact of cable with patient skin. Loops of cable must not be permitted! Such loops tend to collect burning levels of RF energy. Use extreme caution and check with patient frequently, especially when average S.A.R exceeds 1.0 W/Kg.

WARNING: Do not use four-lead MRI cable in magnet.

5.3 EMC (Electromagnetic Compatibility IEC 60601-1-2:2001) This equipment has been certified to be protected to emissions and immunity according to IEC60601-1-2. CAUTION: Medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the following section. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. Please refer to the following table for detailed emissions information.

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The PAM-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the PAM-200 should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The PAM-200 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The PAM-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the PAM-200 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment –guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8kV air

±6 kV contact ±8kV 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

±1.5 kV for power supply lines ±1 kV for input/output lines

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

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common mode

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

Voltage dips, short interruptions, and voltage variations on

< 5% UT ( > 95% dip in UT) for 0.5 cycle

<5% UT Mains power quality should be (>95% dip in UT) for 0.5 that of a typical commercial or cycle hospital environment. If the

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power supply input lines IEC61000-4-11

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 cycle

40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

user of the MDC-1 requires continued operation during power mains interruptions, it is recommended that the MDC-1 be powered from an uninterruptible power supply.

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

3 A/m

Not applicable

Not applicable

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The PAM-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the PAM-200 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

PAM-200 Operator Manual

Compliance level Electromagnetic environment –guidance

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Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3 Vrms 3 V/m

Portable and mobile RF communication equipment should be used no closer to any part of the MDC-1, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 p 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 meters (m). Field strengths from fixed RF transmitters, as determined by an a electromagnetic site survey , should be less than the compliance level in each b frequency range. Interference may occur in the vicinity of the equipment marked with the following symbol:

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5.4 Description of Warning Labels

Consult Instructions For Use

Warning

Caution

RoHS Compliant

Date of Manufacture

WEEE Compliance

Type BF Applied Part

Manufacturer

Earth (Ground)

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6.0 Installation Host MRI system shall provide a suitable enclosure sufficient not to allow the patient or operator access to the PAM-200 during normal use. The PAM-200 shall be protectively earthed by the host MRI system. Input fuse for MRI system to be determined by host installation instructions. Installer information Place PAM-200 in designated location indicated in the host installation instructions. Connect rearpanel cables as specified in host installation instructions. Make sure all cables are connected properly and securely. Technician Information Connect patient cables properly and securely to the front panel connectors.

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7.0 Operation 7.1 Description The PAM Module is an embedded instrumentation pack which provides an asynchronous gating trigger for use in an MRI environment. PAM MRI Gating Module can be supplied with three applied parts consisting of an ECG cable, an Optical Plethysmograph and a pneumatic respiration pad. There are no patient electrical connections on the Optical Plethysmograph or pneumatic respiration pad.

CAUTION: The PAM-200 is not intended for use with any other physiological monitoring unit. CAUTION: The PAM-200 is restricted to use on one patient at a time. CAUTION: The PAM-200 is not intended for analysis of the ECG and QRS complexes. 7.2 Classification: Safety Approved (in accordance with UL-60601-1 Second Edition) Classification: Degree of protection against electric shock: Degree of protection against ingress of water: Methods of Maintenance and Cleaning:

Degree of safety of application:

Mode of operation:

PAM-200 Operator Manual

Class I Equipment Type BF Applied Part IPXO No sterilization or disinfecting required. See Maintenance and Cleaning section of this manual. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Continuous

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7.3 ECG Patient Acquisition Good placement has no loops and runs straight out from center of bore. Cables should make no unnecessary skin contact. Bad Placements run with slack and looping paths on way out of bore, or electrodes spread apart. Proper time and attention must be given to the routing of patient monitoring cables. There exists a great hazard of RF energy burns from improperly placed cables. Avoid direct contact of cable with patient skin. Loops of cable must not be permitted! Such loops tend to collect burning levels of RF energy. Use extreme caution and check with patient frequently, especially when average S.A.R exceeds 1.0 W/kg.

The PAM utilizes a 4 lead configuration in a Right Arm, Left Arm, Right Leg and Left leg setup. The Green is the reference lead with White, Black and Red as the active leads. The PAM provides for two simultaneous vectors. The first vector is White and Red. The second vector is White and Black. The two vectors are 45 degrees to each other and will result in one vector less affected by magnetic gradients.

PAM-200 Operator Manual

White

Black

Green

Red

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7.4 Respiratory Acquisition The PAM utilizes a pneumatic technique which responds to the expansion of the chest during respiration. A foam filled pillow is attached to the patient with a strap, and the air pressure in the pillow changes as the chest moves and compresses the pillow. The internal foam provides the spring action to return the pillow to the pre-compressed state. The pillow is attached to the PAM System Module by a flexible plastic tube, there is no electrical connection. The pillow has a stiff backing which aids in the compression action of the chest movement. Positive pressure (exhalation) will result in a positive going signal. The respiratory signal is transmitted in the digital stream to the console computer.

WARNING: Do not position the respiratory bellows or Velcro strap directly on the patient’s skin. Position the respiratory bellows and Velcro Strap on the patient’s clothes. CAUTION: Overtightening the Velcro strap may cause patient discomfort and poor respiratory monitoring performance. CAUTION: A loose or undertightened Velcro strap may cause a weak respiratory signal. CAUTION: Carefully route the respiratory hose to avoid potential kinking. Do not place the respiratory hose underneath the patient.

WARNING: Anatomical placement only. Do not position the respiratory bellows or Velcro strap directly on the patient’s skin.

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7.5 Peripheral Pulse Acquisition (Pleth) The PAM has provision to perform cardiac gating by way of an optical based peripheral pulse, which is acquired on the patient finger. The optical emitter and detector are located within the PAM housing and the light energy is coupled to the patient through fiber optic cable. The patient connection is through a finger clip similar to a pulse oximetry sensor. The peripheral pulse signal is transmitted in the digital stream to the console computer, which could be located on the gantry or magnet housing.

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7.6 Hardware Interface

ECG Connector Pin number A B C

Function Right Arm (RA) Left Arm (LA) Left Leg (LL)

Pin number D E F

Function N.C. Right Leg (RL) N.C.

Pulse Connector: 9 Pin Sub-D Female Pin number 1 2, 4 6 3, 5

Function Photo Diode Cathode LED Anode Photo Diode Anode LED Cathode

DC Power Connector: 9 Pin Sub-D Male Pin number 2 3 6

Function +15V to ± 1V -15V to ± 1V PSGND

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8.0 MAINTENANCE AND CLEANING 8.1 Cleaning and Disinfecting for Ivy Biomedical Reusable Respiration Bellows If the respiration bellows or strap has been grossly contaminated with blood or other bodily fluids, it should be discarded. Cleaning the Respiration Pillow For normal cleaning with mild detergents / dilute bleach solution (1-2%), wipe the bellows and plastic with cleaning solution, rinse with water and dry. If the strap becomes soiled, it should be discarded and replaced. Reorder Ivy Biomedical p/n 2842-00-10. Disinfecting Instructions Using a disinfecting solution, such as Isopropyl alcohol (70%), Ethanol (70%), wipe or spray the respiration bellows and allow to stand approximately one minute, rinse well with water and dry. 8.2 Cleaning the Module Although not exposed, when necessary, clean the exterior surfaces of the module with a cloth or swab dampened with a warm water and mild detergent solution. Do not allow liquids to enter the interior of the instrument.

CAUTION: • Do not autoclave, pressure sterilize, or gas sterilize the module. • Do not soak or immerse in any liquid. • Use cleaning solution sparingly. Excessive solution can flow into the module housing and cause damage to internal components. • Do not use petroleum based or acetones solutions, or other harsh solvents, to clean the module.

8.3 Cleaning Patient Cables Wipe the cables using a mild detergent solution. Never submerge the cables in any liquid or allow liquids to enter the electrical connections. 8.4 Preventive Maintenance Check before connecting the module to a new patient that cables and leads are clean and intact.

CAUTION: There are no user serviceable items contained in the PAM-200.

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