GE Healthcare 6960-MON, 6961-MON User Manual

Monica Novii® Wireless Patch System

Instructions For Use

107-PT-005-EN rev P Information contained in this IFU manual corresponds to Novii Interface firmware ver 2.71 and POD firmware ver 2.54. © Copyright Monica Healthcare Ltd 2017. All rights are reserved worldwide. Reproduction in whole or part is strictly prohibited without prior consent of the copyright holder.

Declaration

The information and descriptions contained in this Instruction For Use are the property of Monica Healthcare Ltd and may not be copied, reproduced, disseminated, or distributed without written permission from Monica Healthcare Ltd.

Information in this Instruction For Use is believed to be accurate and reliable, but the information contained in this document is subject to change without notice. However, Monica Healthcare Ltd assumes no responsibility for its use, or any infringements of patents or other rights of third parties that may result from its use. No license is granted by implication or otherwise under any patent or patent rights of Monica Healthcare.

This Instruction For Use is intended for trained medical personnel (including obstetricians, midwives, nurses, and physicians) who are familiar with obstetric procedures.

Monica Healthcare only considers itself responsible for any effects on safety, reliability and performance of the equipment if:

1. Assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by Monica Healthcare, and

2. The electrical installation complies with national standards, and

3. The equipment is used in accordance with the Instructions For Use

Indications For Use

The Monica Novii POD is an intrapartum Maternal/Fetal Monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii POD acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the POD also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The POD is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

The Novii Patch is an accessory to the Novii POD that connects directly to the Novii POD and contains the surface electrodes that attach to the abdomen.

The Novii Interface is an accessory to the Novii POD which provides a means of interfacing the wireless output of the Novii POD to the transducer inputs of a Maternal/Fetal Monitor. The Novii Interface enables signals collected by the Novii POD to be printed and displayed on a Maternal/Fetal Monitor and sent on to a central network, if connected.

The Novii POD maternal-Maternal/Fetal Monitor and its accessories are intended for use by healthcare professionals in a clinical setting

Conventions Used in This Operator Manual

WARNING: A warning alerts you to a potential serious outcome, adverse event, or safety hazard.

Failure to observe a warning may result in death or serious injury to the user or patient.

CAUTION: A caution alerts you to situations where special care is necessary for the safe and

effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

On your monitor, this sign indicates that there is detailed information in this book, which you must read before proceeding with your task.

Monica and Novii are registered trademarks of Monica Healthcare Ltd in the USA, EU, China and Japan

Other brand names and product names are trademarks or registered trademarks of their respective holders.

Numbers in brackets ( ) refer to the key number in Figure 1.

CAUTION: US law restricts this device to sale by, or on the order of, a physician.

Contents

Symbols & Standards ............................................................................................................ 6

1.1 Symbols ....................................................................................................................................................................................................... 6

1.2 Standards .................................................................................................................................................................................................... 7

Safety ...................................................................................................................................... 8

2.1 Indications for Use ....................................................................................................................................................................................... 8

2.2 Contraindications ......................................................................................................................................................................................... 8

2.3 Warnings and Cautions ............................................................................................................................................................................... 9

2.4 Electromagnetic Compatibility (EMC) ........................................................................................................................................................ 15

2.5 Electrostatic Discharge (ESD) precautions ............................................................................................................................................... 19

2.6 Magnetic Resonance Environment (MRE) ................................................................................................................................................ 20

Unpacking ............................................................................................................................. 21

Product Description ............................................................................................................. 23

4.1 General description ................................................................................................................................................................................... 23

4.2 Data processing ........................................................................................................................................................................................ 23

4.3 Data viewing .............................................................................................................................................................................................. 24

4.4 Data accuracy ........................................................................................................................................................................................... 24

4.5 Classification of Medical equipment and marking ..................................................................................................................................... 24

4.6 Wireless Technology ................................................................................................................................................................................. 24

4.7 FCC Information (USA) ............................................................................................................................................................................. 27

Installation & Settings ......................................................................................................... 29

5.1 Initial Screen, Device Registration ............................................................................................................................................................ 30

5.2 Cable Connection ...................................................................................................................................................................................... 32

5.3 Accessing Settings .................................................................................................................................................................................... 33

5.4 Maternal Movement Alert using the UA trace ............................................................................................................................................ 35

5.5 Monica Identifier ........................................................................................................................................................................................ 36

5.6 Low UA Sensitivity ..................................................................................................................................................................................... 36

5.7 High UA Sensitivity .................................................................................................................................................................................... 36

5.8 TEST function ............................................................................................................................................................................................ 37

Operating Novii .................................................................................................................... 39

6.1 Introduction ................................................................................................................................................................................................ 39

6.2 Screen Format ........................................................................................................................................................................................... 40

6.3 Initial Screen and Standby Screen ............................................................................................................................................................ 41

6.4 Start Screen: ............................................................................................................................................................................................. 42

6.5 To Start Monitoring .................................................................................................................................................................................... 42

6.6 Novii Interface Icons and Status Controls/Messages ................................................................................................................................ 47

6.7 Novii Interface Monitoring alert/help messages ........................................................................................................................................ 49

6.8 How to continue monitoring when the Low Battery alert is activated ........................................................................................................ 52

6.9 Placing/Removing PODs from the Novii Interface Charging Wells ........................................................................................................... 52

6.10 Monitoring Alert priority ............................................................................................................................................................................. 54

6.11 Turning Off the Interface ........................................................................................................................................................................... 54

6.12 Novii FHR, MHR, UA synchronization & mixed modality monitoring ......................................................................................................... 54

6.13 The two blue LED lights on the POD ......................................................................................................................................................... 55

Interface Visual Alerts ......................................................................................................... 57

7.1 Return POD to charging bay visual alert ................................................................................................................................................... 57

7.2 POD removed from Patch visual alert ....................................................................................................................................................... 57

7.3 POD left in Patch without responding to skin/electrode problems............................................................................................................. 58

7.4 A non-Monica Patch is detected at the start of monitoring visual alert...................................................................................................... 58

7.5 A non-Monica Patch is detected during monitoring ................................................................................................................................... 58

Help icon ............................................................................................................................... 60

Cleaning ................................................................................................................................ 61

9.1 Cleaning (Patch is single used and should be disposed of as hazardous waste) ..................................................................................... 61

Accessories & Part Numbers ............................................................................................ 62

10.1 Interface Cables ........................................................................................................................................................................................ 62

Patch Specification ............................................................................................................ 63

Interface Specification ....................................................................................................... 64

POD Specification .............................................................................................................. 66

Fault Finding ...................................................................................................................... 69

FHR Gaps Troubleshooting Table .................................................................................... 74

Allergic Reaction to Patch ................................................................................................ 76

16.1 Overview ................................................................................................................................................................................................... 76

16.2 Guidelines ................................................................................................................................................................................................. 76

16.3 Treatment .................................................................................................................................................................................................. 77

Servicing ............................................................................................................................. 78

Maintenance & Fault Reporting ........................................................................................ 79

18.1 Maintenance .............................................................................................................................................................................................. 79

18.2 Calibration ................................................................................................................................................................................................. 79

18.3 Firmware version for Novii Interface and Pod ........................................................................................................................................... 79

18.4 Disposal of Product Waste ........................................................................................................................................................................ 79

Symbols & Standards

This section describes symbols used in this Instructions For Use and the safety precautions that appear as symbols or labels on the Novii Wireless Patch System itself and the standards that it complies with.

1.1 Symbols

Consult Instructions for use

Do Not Use If Package is Damaged

Use by Batch code

Manufacture date

Manufacturer

ESD - Static sensitive device

WEEE logo:

This symbol indicates that the waste of electrical and electronic equipment including battery must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

Include RF transmitters

Class II Insulation

TYPE BF EQUIPMENT: Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment has an F-type applied part. The applied Parts of the Novii System are the five electrodes of the Novii Patch that are placed on the patient abdomen. This applied part connects to the pins at the bottom of the Novii POD.

Do not reuse

LOT

No Latex used

No PVC used

Temperature limitation

The Novii system is not to be taken into a Magnetic Resonance (MR) environment

FCC ID: YOM-

6961-MON

Federal Communication Commission identification number. Complies with United States Radio communication requirements.

1.2 Standards

The Monica Novii Interface complies with the following safety standards

Standard

Description

IEC 60601-1:2005 +A1: 2012 incl. USA deviations

Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007

Medical Electrical Equipment Part 1-2 General Requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – requirements and tests

EN ISO14971: 2012

Medical Devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

ANSI /AAMI EC12

Disposable ECG electrodes

EN 62133: 2nd Edition 2012

Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications

EN ISO 10993

Biological evaluation of medical devices

FCC CFR 47: Part 15.107 & 15.109

Title 47--Telecommunication Chapter I – Federal Communications Commission 15 – Radio Frequency devices

EN 60529:1992 +A2:2013

Specification for degrees of protection provided by enclosures (IP code)

EN ISO 15223-1:2012

Graphical Symbols for use in the labelling of medical devices

Safety

2.1 Indications for Use

The Novii Patch is an accessory to the Novii POD that connects directly to the Novii POD and contains the surface electrodes that attach to the abdomen.

The Novii POD maternal-Maternal/Fetal Monitor and its accessories are intended for use by healthcare professionals in a clinical setting

2.2 Contraindications

The Novii Interface is contraindicated for use in preterm gestation (≤36 completed weeks). The uterine contraction trace generated by the Novii POD and monitored by the Maternal/Fetal Monitor via the Novii Interface may show deflections from baseline that do not represent uterine contractions. These deflections from baseline may represent electrical activity in the myometrium that is not sufficiently organized to cause the uterine smooth muscle to contract. In the context of a preterm pregnancy, clinical misinterpretation of the uterine tracing may lead to unnecessary intervention, such as tocolysis, diagnostic procedures, and/or preterm delivery.

IMPORTANT NOTE: The Monica Novii system is contra-indicated for use with: Magnetic Resonance Imaging (MRI) scanners, Computer Tomography (CT) scanners, Diathermy / electro surgery, Metal Detectors, Transcutaneous Electrical Nerve Stimulation (TENS) machines, Cardiac Pacemakers, Cardiac Defibrillators.

This symbol is displayed on the Novii Interface, Novii POD packaging and Novii Patch Packaging labels to indicate the Novii system is not to be taken into a Magnetic Resonance (MR) environment.

2.3 Warnings and Cautions

2.3.1 Clinical

WARNING: The Novii Wireless Patch does not replace observation and evaluation of the

mother and fetus at regular intervals, by a qualified care provider, who will make diagnoses and decide on treatments and interventions. Clinical assessment of the Maternal/Fetal Monitor’s display or trace when using the Novii Wireless Patch solution must be combined with knowledge of patient history and risk factors to properly care for the mother and fetus.

WARNING: If you are concerned with the clinical data provided by Monica it should be verified

by an alternative method, such as palpation of the maternal pulse to exclude MHR/FHR confusion or hand held Doppler to confirm the FHR.

WARNING: The safety and effectiveness of Novii FHR, MHR and UA have NOT been cleared

by the FDA for the following patient populations:

• Preterm gestation (i.e. ≤ 36 completed weeks gestation)

• Antepartum (i.e. at term, but not in labor)

• Multiple gestations

WARNING: A labor monitor is intended for use by clinical professionals who are trained in the

medical procedures, practices, and the terminology required when monitoring obstetric patients. The monitor is only one clinical indicator of labor progress and fetal/maternal well-being. The monitor is designed to assist the clinical staff in assessing the status of the patient and her unborn baby.

WARNING: Monica Healthcare recommends establishing the presence of the fetal heartbeat

by auscultation before starting continuous monitoring by either using a Pinard stethoscope or hand held Doppler.

WARNING: If the signal quality indicator on the Novii Interface display is red for an extended

period, use an alternative method to confirm FHR.

WARNING: Monica UA provides information on the frequency and timing of the contraction

peak. Interpretation of the Monica UA pattern should be done in the clinical context of the patient. It is always good practice to use manual palpation, maternal perception of UA and observation in conjunction with the UA trace. It is important to note that there will be a delay of 10 seconds or more from maternal perception and/or manual palpation when compared to the display on the Maternal/Fetal Monitor and trace paper.

WARNING: MHR/FHR confusion. When the FHR is tracking close to the MHR you should

always confirm the FHR using another modality.

WARNING: Monica does not recommend or support mixing Novii UA with US/FSE FHR

monitoring.

There is a 10-second delay (5mm on the tracing) in the Novii UA trace with respect to the US/FSE FHR trace; late decelerations could appear as early decelerations masking a potential fetal compromise.

Using the US transducer in addition to Novii FHR, MHR and UA to confirm the FHR, for short periods, during gaps or suspected artifact can be used, but the potential for missing a fetal compromise remains, due to US FHR and Novii UA desynchronization.

WARNING: Monica does not recommend or support mixing Novii FHR/MHR with

TOCO/IUPC UA monitoring.

If the Novii UA cable is disconnected and the TOCO/IUPC is used (against this recommendation), it is clinically important to understand that the FHR/MHR shift will have changed from a 10 second to a 6 second delay (3 mm). Early

decelerations may appear as ‘subtle’ late decelerations. This could lead to an

unnecessary intervention.

CAUTION: The 10 second (or 6 second, if the Novii UA cable is disconnected) MHR delay

should be taken into consideration when monitoring the patient’s response to a test dose during epidural placement. There is a 6 or 10 second MHR delay in reporting the MHR with respect to real time events.

CAUTION: The 10 second (or 6 second, if the Novii UA cable is disconnected) FHR shift

should be taken into consideration during prolonged FHR decelerations when resuscitative measures are being used, the impact of any maneuver will not be seen for 10 seconds.

CAUTION: The 10-second UA delay should be taken into consideration when coaching

patients to push during the second stage. The patient may sense the contraction before it appears on the monitor tracing- the contraction has already been building for 10 seconds.

CAUTION: When the patient is moving and/or the fetus is active caution should be exercised

in interpreting the UA trace. If the interpretation of uterine contractile pattern(s) is uncertain, another modality to monitor uterine contractions should be considered and clinical management of the patient adjusted appropriately. The Novii POD

monitors uterine activity by measuring the electrical signals (EMG) generated by the uterine muscle when it contracts, as opposed to the tocodynamometer (TOCO transducer) which monitors uterine activity as measured by the displacement of a plunger or button with respect to a guard ring caused by the tightening of the uterus during a contraction. Small relative changes in the electrode positions used to monitor the uterine EMG resulting from maternal or fetal movement cause electrical signals that can look like uterine activity.

CAUTION: The Novii POD when attached to the Novii Patch can remain on the patient while

taking a bath or shower (rated IP57), but monitoring will not work when the woman is in the bathtub and the POD is fully submerged under water (restricting the Bluetooth signal) and cannot be guaranteed during a shower. However, the POD needs to remain attached to the patch while exposed to water to maintain the integrity of the Patch.

CAUTION: We recommend that the Novii fetal/maternal ECG waveform is not displayed on

Coro 259 series monitor by manually turning this option off. No diagnostic information can be inferred from waveform sent from Novii Interface to the Maternal/Fetal Monitor. It is a pulse that can be used by the monitor to accurately calculate the FHR and MHR.

CAUTION: Only touch the UA zero reference button on the Maternal/Fetal Monitor when

prompted by the Novii Interface at the start of the monitoring. Do not touch the UA reference button during a monitoring session since it could result in masking contractions, unless it is confirmed by palpation of the uterus that no contraction is present.

CAUTION: If the Maternal/Fetal Monitor UA reference button is accidently touched during

monitoring wait until you are confident the woman is not having a contraction (by using palpation) and then re-touch the UA reference button on the Maternal/Fetal Monitor.

CAUTION: Any unexpected data from the Novii Interface as shown on the Maternal/Fetal

Monitor display or trace must result in further examination of the mother and fetus in a hospital environment.

CAUTION: The Novii POD transmits FHR, UA and MHR data to the Maternal/Fetal Monitor

with a short delay of 10 seconds. Data is synchronized allowing accurate interpretation of decelerations in relation the peak of contractions. Duration of Novii Wireless Patch contractions can be shorter than mechanical contractions, hence when palpating the uterus there will be a delay between manual detection of a contraction and the display of the contraction on the Maternal/Fetal Monitor.

CAUTION: It may prove difficult to use the Novii UA to coach patients to commence

contraction pain coping strategies or actively push in the second stage of labor. Its value lies in providing an accurate picture of the pattern of uterine contractions over time.

CAUTION: High and Low UA sensitivity gives the user the choice to best conform with the

clinical situation; the Low UA sensitivity setting is less sensitive to UA and removes some of the small deflections that may represent artifacts or inconsequential contractions. It is, however, important to switch to High sensitivity once the patient is in established labor. Novii will automatically switch back to High UA sensitivity after 60 min of Low UA sensitivity monitoring. No warning is given.

CAUTION: Prior to the connection of the Novii POD, the Novii Patch must not come in contact

with water since any water trapped in the POD connection area may damage the POD. An example of this situation could be when a bed bath is given after the Patch has been fitted, but before the POD has been connected.

2.3.2 Uterine EMG Activity; Potential Problems with Clinical Interpretation

WARNING: The Novii POD may monitor UA deflections from baseline that do not represent

uterine contractions that cause an increase in intra-uterine pressure. These deflections from baseline may represent electrical activity in the myometrium that is not sufficiently organized to cause the uterine smooth muscle to contract. When this occurs, the “false contraction” often does not attain the amplitude of true uterine contractions. If the interpretation of uterine contractile pattern(s) is uncertain, another modality to monitor uterine contractions should be considered and clinical management of the patient adjusted appropriately.

WARNING: The Novii POD monitors uterine contractions by measuring electrical activity

(EMG) of the uterus as opposed to a tocodynamometer (TOCO transducer) which monitors uterine activity as measured by the movement of a button with reference to a guard-ring. The button is pressed in by a tightening of the uterine muscle as measured on the abdominal wall. Occasionally, low amplitude electrical activity insufficient to cause a contraction detected by a TOCO transducer is displayed as a deflection above baseline on the Novii Interface Maternal/Fetal Monitor tracing. These deflections from baseline may represent electrical activity in myometrium that is not sufficiently organized to cause the uterine smooth muscle to contract. Thus, caution should be used in interpreting as contractions deflections from baseline that have relatively lower amplitude compared to contractions characteristic of the overall uterine activity pattern. False positive UC could also occur from maternal activity or vigorous fetal movement. Any movement that changes the maternal abdominal surface contours can produce, what appears on the trace to be, a UC. This is caused by small changes in the electrode positions in relation to each other and to the underlying skin. This may create confusion

particularly during early induction monitoring, when regular true contractions are not present. Before any definitive clinical interpretation of UC information generated by Novii is made, ensure, if possible that the patient is not moving and is in a comfortable and relaxed position. If there is concern about false positive contractions during early labor or induction, it can be helpful to have the patient use the event marker on the GE Corometrics 259 Series Maternal/Fetal Monitor to indicate when she feels a contraction and/or the fetus move.

Irregular high amplitude ‘ragged’ looking contractions that are coincidental with

fetal or maternal movements with no other clinical indication of UC should be discounted. They are unlikely to be real contractions. As such, they should not influence medical intervention unless corroborated by another device or clinical assessment.

For example, in the following sample Maternal/Fetal Monitor tracing using uterine EMG, there are deflections above the baseline in the tracing that does not correspond to uterine contractions in a the simultaneously monitored IUPC tracing (e.g., deflections identified by arrows). IUPC is considered the gold standard for monitoring uterine contractions.

WARNING: Users should not use the low sensitivity setting during active labor; the onset of the

contraction trace will be further delayed and the amplitude will be reduced. The peak will remain synchronized with the FHR trace.

Deflections do not correspond to a uterine contraction as monitored by IUPC

Deflections corresponding to ‘true’ uterine contractions

Uterine EMG trace:

IUPC trace:

2.3.3 Safety

WARNING: Only use the Novii Interface with the GE Corometrics 259 Series Maternal/Fetal

Monitor with the specific interface cable for that monitor, see Section 10.1.

WARNING: Do not position the Novii Interface so as to make it difficult to disconnect its AC/DC

adapter. Position the Interface on a stable surface more than 20 cm from the patient or user during normal use.

WARNING: The Novii Interface power cable and other interconnecting cables must be

positioned and/or restrained to avoid users and patients tripping over them.

WARNING: The operator should not touch the unearthed metal parts of the Novii Interface and

the patient at the same time. In particular do not touch the metal shielding of the

connectors at the back of the Novii Interface and the patient at the same time. WARNING: The Monica Novii is not suitable for use in an Oxygen rich environment WARNING: The Novii Interface is not explosion-proof and must not be used in the presence of

flammable anesthetic gases. WARNING: SHOCK HAZARD. Do not attempt to connect the power cable with wet hands.

Make certain that your hands are clean and dry before touching a power cable or

plug.

WARNING: Use only the power supply supplied with the device. WARNING: Unplug the Novii Interface from the AC power supply before cleaning. Do not

immerse the unit in water or allow liquids to enter the case. WARNING: Examine the Novii Interface and accessories periodically to ensure that the cables,

connectors and the device itself do not have visible evidence of damage that may

affect performance. The recommended inspection interval is once per week or

less. Do not use the device if there is any visible sign of damage. WARNING: Do not attempt to service the Novii Interface. Only Monica approved and qualified

service personnel should attempt any necessary internal servicing. WARNING: The Novii Interface is not specified or intended for operation in conjunction with

any other type of monitoring equipment except the specific devices that have been

identified for use in this Instruction For Use. WARNING: Novii should not be used for primary monitoring in applications where any loss of

the FHR and UA signal is unacceptable.

WARNING: No Modification of this equipment is allowed. WARNING: Do not use a new Novii Patch if the Package is damaged or open. WARNING: The Novii POD contains a Li-ion battery. Do not throw the Novii POD into a fire or

other heat source. Do not put the Novii POD into any liquid such as water or

gasoline (except when attached to the Patch and used during a shower or bath).

Do not put the Novii POD into a pocket or bag without adequate protection. Do not

disassemble the Novii POD. Do not crush or pierce the Novii POD. Do not leave

the Novii POD close to a fire or heat source above 30 °C. Do not use the Novii

POD if there are any signs of visible damage. Do not discharge the Novii POD in

any way other than it’s intended use. Do not use the Novii POD if there is any discoloration, unusual heat, odor or

discharge. Do not put the Novii POD into a microwave or pressurized container. If liquid leaks from the Novii POD onto your clothes or skin wash well immediately

with fresh water. If liquid leaks from the Novii POD and comes into contact with your eye, do not rub

your eye, wash well with clean edible oil and see a doctor immediately.

WARNING: Do not charge the Pods on an external wireless charger, only charge via the Novii

Interface CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable

materials, and extremes of temperature. The Novii Interface and all cable

connectors should be kept clean and free of electrode gel and other substances. CAUTION: The Novii Interface is rated IPX0. Do not operate the Novii Interface if it is damp or

wet because of condensation or spills. Avoid using the equipment immediately

after moving it from a cold environment to a warm, humid location. CAUTION: The Novii POD on its own is rated IPX0. The Novii POD is rated IP57 only when

mated with the Novii Patch. Do not submerse the Novii POD in any liquid if not

mated to a patch. CAUTION: Never use sharp or pointed objects to operate the touch screen display. Do not

exert excessive pressure when operating the touch screen. CAUTION: The POD gold connection pins need to be kept clean, and should be protected at

all times; only keep your PODs in the Interface charging bays or clipped to a Patch.

Placing it down anywhere else could result in damage to the gold pins.

2.4 Electromagnetic Compatibility (EMC)

2.4.1 Electromagnetic Interferences

The Novii System has been designed to minimize the impact of electromagnetic interference from other electrical equipment and also to minimize the interference caused to other electrical equipment by the Novii System. The Novii system has been tested and found to comply with the Medical Electrical Equipment - General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility, EN60601-1-2:2007, and FFC CRF47 Parts 15.107 & 15.109, Class A limits. However because of proliferation of radio-frequency transmitting equipment and

other sources of electrical noise in the health-care environments, it is possible that high levels of such interference due to proximity or strength of the source may result in the disruption of performance of the Novii system.

Risks and Characterization associated with Electro Magnetic Interferences:

Risk

EMI characterization

High EMI interrupting the Bluetooth transmission between the Novii POD and Novii Interface

This will present as a simultaneous gap in the FHR, MHR and UA data to the user The Bluetooth connection can be interrupted intermittently or constantly. The Bluetooth communication interruptions will create gaps on the tracing of the Maternal/Fetal Monitor attached to the Novii System. In the event of such interference these gaps will typically occur simultaneously on the FHR, MHR and Uterine Activity tracing even if the patient is in close proximity of the Novii Interface.

High EMI present on the inputs of the Novii POD

This will present to the user as gaps in FHR data only On some occasions, the electromagnetic interference will not disrupt the Bluetooth transmission of all signals simultaneously, but gaps will occur in the FHR tracing only since the Novii System will stop detecting the FHR if the noise in the abdominal recording is too high to detect signals accurately.

Electrostatic Discharge (ESD) present on the Novii System (either POD or Interface)

ESD present on the Novii System could create artifacts. Specifically, this artifact will present as transient changes to the FHR trace, appearing as deflections on the FHR trace of 35 BPM maximum (e.g. from a reading of 120 BPM down to 85 BPM). These FHR deflections are very short in duration and would appear to the user as a spike on the FHR trace. Once the source of ESD interference has been removed the Novii System will go on working as normal, there will be no permanent damage to the system.

If you suspect your Novii System is affected by electromagnetic interference from another electrical device, it may be necessary to take mitigation measures, such as re-orienting or relocating the Novii Interface or the device creating the interference. In general, the further away the Novii System is from the interfering device, the lower the interference will be (please follow guide lines of Warning G below for minimum distances with other electrical equipment). If the device creating interference is not in use, it is advised to turn it off. Turning equipment in the vicinity off and on can help to isolate the offending equipment.

WARNING: A) The Novii system is medical electrical equipment and needs special precautions

regarding EMC: it needs to be installed and put into service according to the EMC

information provided in this section. WARNING: B) Portable and mobile RF communications equipment can affect medical electrical

equipment.

WARNING: C) Use of accessories and cables other than those specified in Section 10.1 of this

manual may result in increased EMC emissions and/or decreased immunity of the Novii system to other electrical equipment.

The cables listed in Section 10.1 are to be used exclusively with the Monica Novii Interface and Monica IF24. If these cables are used with systems other than the Novii Interface and IF24, it may result in an increase of emissions or decrease in the immunity of that system.

WARNING: D) The Novii Interface connects to a Maternal/Fetal Monitor; hence it will be adjacent to, or stacked on top of, a Maternal/Fetal Monitor. It should be verified that the Novii Interface is correctly calibrated with the Maternal/Fetal Monitor it is connected to and the operation is normal and as expected in the configuration in which it will be used. To confirm correct calibration the TEST function of the Novii Interface should be used. The equipment or system (e.g. the Maternal/Fetal Monitor) should be observed to verify normal operation in the configuration in which it will be used.

WARNING: E) For Electromagnetic Compatibility the Novii Interface has been tested to IEC EN 60601-1-2. The Essential Performance for that test is the Recording Mode when the Novii Interface collects via Bluetooth the patient data from a Novii POD and transfers the data to a Maternal/Fetal Monitor through the connecting cables. Essential performance in Transmission

Mode was defined as “no FHR/UA gaps greater than 30s, no FHR error greater than 15 BPM

for 15s, no UA error larger than 20% of full scale for more than 30s and no interruption of the transmission mode”.

WARNING: F) This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Novii or shielding the location.

WARNING: G) The Novii Interface may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.

Guidance and manufacturer’s declaration – electromagnetic emissions Table 1 of EN60601-1-2

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

Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The Novi™ system uses RF energy only for its internal function.

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

RF emissions

CISPR 11 Class A

The Novi™ system 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. Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

Guidance and manufacturer’s declaration – electromagnetic immunity Table 2 of EN60601-1-2

The Novi™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the Novi™ Interface 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 ± 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 %.

Transient/burst IEC 61000-4-4

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

AC power should meet the standards of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

AC power should meet the standards of a typical commercial or hospital environment.

IMMUNITY test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

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 s

AC power should meet the standards of a typical commercial or hospital environment. If the user of the Novii system requires continued operation during power mains interruptions, it is recommended that the Novii Interface be powered from an uninterruptible power supply or a battery.

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

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 AC mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity Table 4 of EN60601-1-2

Novi™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the Novi™

Interface should assure that it is used in such an environment.

IMMUNITY test

IEC 60601 TEST LEVEL

Compliance level

Electromagnetic environment – guidance

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 V

3 V/m

Portable and mobile RF communications equipment should be used no closer to any

part of Novi™ system, 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 150 kHz to 80 MHz d= 1.2 √P 80MHz to 800MHz d = 2.3 √P 800MHz to 2.5GHz

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 electromagnetic site survey, a should be less than the compliance level in each frequency range.b

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 structures, objects and people.

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 Novi™ system is used exceeds the applicable RF compliance level above, the Novi™

system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Novi™ system

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Novi™ system Table 6 of EN60601-1-2

The Novi™ system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Novi™ system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Novi™ system 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 80 MHz d = 1.2√P

80 MHz to 800 MHz d= 1.2 √P

800 MHz to 2,5 GHz d = 2.3 √P

0.01

0.12

0.23

0.1

0.38

0.73

1.20

2.3

3.80

7.3

100

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 absorption and reflection from structures, objects and people.

WARNING: H) The Novii system may be interfered with Radiofrequency identification (RFID)

systems (tag and reader). Ensure RFID reader is placed as far as possible from the Novii Interface. If an RFID tag is placed on the Novii POD or Novii Interface and you experience poor quality data (Data transmission loss, gaps in FHR data, Gaps in MHR data, uninterpretable uterine activity) please remove the RFID tag and RFID reader and check again the Novii System data quality. If the presence of the RFID correlates with the poor performance of the Novii System, please report the issue to your distributor or to Monica Healthcare and do not use the RFID system in conjunction with the Novii System.

2.5 Electrostatic Discharge (ESD) precautions

The symbol on the Novii system indicates that it is a Static sensitive device. The Novii POD pins and the Novii Interface connectors are extremely static sensitive and should

be handled using electrostatic discharge precautions.

Once the source of ESD interference has been removed the Novii System will go on working as normal, there will be no permanent damage to the system.

WARNING: A) Although precautions have been taken to ensure otherwise, static electricity could cause damage to the pins of the Novii POD or the pins of all three connectors located at the back of the Novii Interface and render the system inoperable. Pins of the Novii POD or pins of the Novii Interface connectors should not be touched, and connection to these connectors should not be made unless ESD precautionary measures are used.

WARNING: B) ESD precautionary measures should be taken to minimize the risk of damage to the Novii system. More specifically:

• The pins of all connectors at the back of the Novii Interface and the pins of the Novii POD should not be touched by any part of the body, including the fingers.

• Always connect the interface cables first to the Maternal/Fetal Monitor, and then to the Novii Interface.

• If the interface cables are not connected to the Maternal/Fetal Monitor, disconnect the interface cables from the Novii Interface.

• Do not touch any metallic parts of the Novii Interface and the patient at the same time.

WARNING: C) Staff who uses the Novii system should receive an explanation of the ESD

warning symbol and training in ESD precautionary procedures.

WARNING: D) The minimum contents of ESD precautionary procedure training should be the

explanation of the ESD symbol and the understanding of the principles listed in warning B.

2.6 Magnetic Resonance Environment (MRE)

WARNING: The Novii Wireless Patch System cannot be used or placed in a MR Environment.

This could result in serious injuries and death of patients and other individuals.

Unpacking

The box should contain (but not limited to) the following items:

• x1 Monica Novii Interface device

• x1 Power Supply for Interface device

• x3 Cables to connect the Novii Interface to your GE Corometrics Fetal Monitor (FECG,

TOCO and MECG input cables).

Some package variations exclude the MECG cable

• x2 Monica Novii PODs

Some package variations include an additional POD as a backup/replacement device for loss, damage or breakdown. This spare POD should remain in the box and placed in a secure location that does not see extremes in temperature e.g. a locked cabinet/drawer in the nurse Manager’s office

• x1 3M red Dot 2236 skin prep tape

• x1 Getting Started / Registration card (Novii Wireless Patch System requires one time

registration before use, see Section 5.1.2)

• CD containing Instructions For Use and support materials

Check that you can identify all the items in the box.

(2) Novii Pod charging

bays, shown with two

docked Novii Pods

(1) Touch Screen Display

Fig 1a - Monica Novii Interface, front view; showing the start screen, with a POD in each of the two charging bays. Numbers in brackets ( ) in this user manual refer to the key numbers in this figure

(3) Port connectors for the three

cables specific to the GE Corometrics 259 monitor, shown connected. The cables connect to the UA/TOCO, MECG and FECG ports on the GE Corometric 259 monitor. The DC power input socket is on left of UA/TOCO socket. The serial port to the right of the FECG socket is only used for maintenance by an employee of Monica Healthcare or by a Monica trained and nominated person

Fig 1b - Monica Novii Interface, rear view, showing the three cables that connect to the GE Corometrics 259 monitor and powers supply cable. Numbers in brackets ( ) in this user manual refer to the key numbers in this figure.

Product Description

4.1 General description

The Monica Novii Interface is a device that allows a Novii POD to send fetal, maternal and UA data to the GE Corometrics 259 Series Maternal/Fetal Monitor. The Monica Novii POD is a wearable, battery-powered device for surveillance of fetal and maternal well-being. The Novii POD is designed to passively monitor Fetal Heart Rate (FHR), Uterine Activity (UA) and Maternal Heart Rate (MHR) during pregnancy. The Novii Wireless Patch system is cleared for use from 36 completed week’s gestation for intrapartum use in singleton pregnancies. The Novii POD is attached via a magnetic clip directly on to the Novii Patch which locates 5 ECG electrodes on the abdomen of a pregnant woman, using the umbilicus as reference location point (when the umbilicus has been displaced the midpoint between the fundus and the edge of symphysis pubis should be used, see Section 6.5.2). The Novii POD then monitors the electrical signals present at the electrode sites: fetal ECG, maternal ECG and Uterine EMG (Electromyography) plus noise and interference signals. The acquired signals are then converted by the Novii POD into a digital format and processed in real-time to extract clinically relevant information, such as Fetal Heart Rate, Uterine Activity and Maternal Heart Rate.

The Novii POD sends the FHR, UA and MHR data along with maternal movement from the onboard three axis accelerometer, signal quality and POD battery status signals to the Novii Interface. This digital data is sent wirelessly via Bluetooth. The Novii Interface receives the Bluetooth data and converts the FHR, MHR and UA data into an analogue signal before feeding it to a Maternal/Fetal Monitor via the external DECG (FHR), TOCO (UA) and MECG inputs (analogue signals). The plugs and cables are specific to the Maternal/Fetal Monitor being connected. The Maternal/Fetal Monitor will display, print, and connect to a central station the data from the Novii Interface as if it was acquired from traditional transducers.

The Novii POD has no controls only an LED to indicate when it is on and working. Placing the POD in a free Novii Interface charging bay that is switched on will allow it to wirelessly connect with the Novii Interface and for its battery to be charged inductively. The POD will then be automatically activated when removed from the charging bay. Set-up and operation instructions are communicated to the user via the Novii Interface display as described in Section 6.

On dispatch the Interface and all PODs making up one Novii Wireless Patch System are ‘locked’ i.e. cannot be used until they have been registered, see Section 5.1.2.

4.2 Data processing

Digital data from the Novii POD is received by the Novii Interface by a Bluetooth wireless connection; fetal heart rate (FHR), uterine contraction (UA) and maternal heart rate (MHR) signals are then converted to analogue signals in real-time by the Novii Interface for transfer to

the Maternal/Fetal Monitor. The Novii POD generates a rolling two second average FHR and MHR updated every ¼ second. The UA resolution is 1 step out of the 255 steps full range i.e. 1/255 and the amplitude is updated every ¼ second from a low pass filtered signal.

4.3 Data viewing

No data is stored by the Novii Interface; the screen provides user feedback on the signal quality, Bluetooth status and other settings with help information when appropriate. There is an option to display a digital value of the maternal heart rate when MECG is not available as a monitoring option on the Maternal/Fetal Monitor or the MHR cable has not been connected, see Section

5.3.2.

4.4 Data accuracy

The FHR and MHR output to the Maternal/Fetal Monitor is within 1 BPM (Beat Per Minute) of the data received from the Novii POD. The UA resolution is 1 step out of the 255 full range i.e. 1/255.

4.5 Classification of Medical equipment and marking

Protection against Electrical Shock

Novii Interface: Class II ME Equipment Novii POD: Internally Powered ME Equipment with Type BF applied parts.

IP rating

The Novii Interface is rated IPX0 The Novii POD and Patch are rated IPX0 when not connected together and IP57 when connected together

Method of sterilization

Not intended to be sterilized. See Section 9 for cleaning instructions

Suitability for use in an OXYGEN RICH ENVIRONMENT

Not suitable for use in an oxygen rich environment

Mode of Operation

Continuous Operation

4.6 Wireless Technology

The Monica Novii System uses Wireless Technology to perform four main functions, specifically:

▪ to communicate patient monitoring data from the POD/Patch to the Interface via

Bluetooth, and;

▪ to charge the battery in the Novii PODs when docked to the Interface using wireless

induction charging (WPC 1.1). The Interface has two charging bays allowing two PODs to be charged at the same time

▪ to authenticate the Bluetooth communication between the POD and Interface using

wireless infrared communication (IrDA).

4.6.1 Novii Bluetooth wireless characteristics:

During patient monitoring the Novii Interface and POD communicate wirelessly via two Bluetooth Transceivers. Bluetooth uses a radio technology called frequency-hopping spread spectrum, which chops up the data being sent and transmits chunks of it on up to 79 frequency bands of 1 MHz each in the range 2,400-2,483.5 GHz (allowing for guard bands). This helps to ensure the performance and accuracy of transmitted data. The Bluetooth module is Class 1.5 (with transmit power control) with a maximum transmit power of 10.5dBm. The power is controllable by software and is typically 4dBM.

The Bluetooth set up and configuration is fully automatic and does not require any user set up (Bluetooth Address and Pin are automatically exchanged via an IrDA connection which is initiated by a POD proximity detector, see Section 4.6.2. A key characteristic of the Novii wireless system is that it uses a very low power transmission setting (100 times less than a mobile phone) to mitigate any risks from harmful radio frequencies. Another key characteristic of the Novii system is that it is designed to communicate over a short distance and if the patient goes out of range (typically greater than 100 feet) there will be a visual alert.

The Novii Interface can only connect to a POD that is placed in the charging bay. The Bluetooth characteristics of the Novii system are as follow:

FFC ID of Novii POD and Interface

T7V1315

Radio Technology

Bluetooth: Frequency-hopping spread spectrum

RF frequencies

79 bands (1 MHz each; centered from 2.402 to 2.480 GHz) in the range 2,400-2,483.5 GHz (allowing for guard bands).

Bluetooth Class / Power

Class 1.5 Bluetooth module. Software controllable power. Max power 10.5 dBm. Typical power 4dBm

Bluetooth specification

v2.1 + EDR (Enhanced Data Rate)

Sensitivity

-93 dBm

Data rate

Up to 2,178 kilo bit per second (kbps). The Novii POD sends data by packet of 80 bytes every 2 seconds

Protocol

Bluetooth HCI via ACL data packets including Forward Error Correction scheme. CRC mechanism for error detection

Data Encryption / Security

The Bluetooth link between the Novii POD and Novii Interface is encrypted (128 bit private key link). The Novii POD and Interface are not discoverable

Distance

Up to 30 meters line of sight

Alert

Bluetooth out of range alert on the Novii Interface

Pairing process

Automatic pairing process using a separate IrDA to transmit the POD Bluetooth address and pin to the Interface. This is initiated

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GE Healthcare 6960-MON, 6961-MON User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual