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.
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.
Contents Symbols & Standards ............................................................................................................ 6 1.1 Symbols ....................................................................................................................................................................................................... 6 1.2 Standards .............................................................................................................................................
6.10 Monitoring Alert priority ............................................................................................................................................................................. 54 6.11 Turning Off the Interface ........................................................................................................................................................................... 54 6.12 Novii FHR, MHR, UA synchronization & mixed modality monitoring .........................
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.
No Latex used No PVC used Temperature limitation The Novii system is not to be taken into a Magnetic Resonance (MR) environment FCC ID: YOM6961-MON 1.2 Federal Communication Commission identification number. Complies with United States Radio communication requirements. Standards The Monica Novii Interface complies with the following safety standards Standard IEC 60601-1:2005 +A1: 2012 incl.
Safety 2.1 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.
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: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. 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).
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.
(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.
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 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.
▪ 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.
Quality of service only when prior to monitoring the POD is placed in an Interface charging bay The Novii Interface and Novii POD do not allow multiple connections to the Bluetooth Interface. The connection between the POD and Interface is one to one and the full bandwidth is dedicated to transmitting the patient data. The Bluetooth interface allow data transmission up to 2,178 kilo bit per second(kbps).
Data Rate Distance Quality of service 4.7 Up to 115 kilo bit per second (kbps). The Novii system utilizes 9600 kilo bit per second. Up to 30 cm/20 cm. The Novii Pod transceiver is tuned so that it can only be detected 1 cm away from it. The IrDA transceivers of the Novii Pod continuously send the Bluetooth address when placed on the Interface charging bay up until the Interface can connect to the Pod via Bluetooth before the transceiver turns off. FCC Information (USA) 4.7.
to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
Installation & Settings Installation of the Novii Wireless Patch System should be performed by a trained healthcare professional. Novii Interface settings allow the audio alerts and MHR display to be adjusted to the hospital requirements.
5.1 Initial Screen, Device Registration 5.1.1 Power on/off When the Novii Interface is switched on, by connecting the power supply (there is no on/off switch) the following splash display will be shown, indicating the Interface program version number, for around 5 seconds while the device starts and internal checks are performed. If this is the first time the Interface has been switched on the following language selection screen will appear.
5.1.2 Device Registration The Novii Interface and PODs cannot be used until they have been registered with Monica Healthcare Ltd. The screen below will only be seen when the Interface or a POD placed in the charging bay has yet to be registered: Warranty will start from the date registered and the data you provide will be used to keep you informed of software updates and key device critical information. Any information entered will be treated as confidential and will not be circulated to third parties.
5. Once you have completed the registration process you will be given a pass code to enter on the Interface display. 6. Once the Interface has been unlocked any un-registered POD placed in the Interface charging bay will bring up the Registration display and the process will need to be repeated to unlock the POD(s). CAUTION: To avoid any confusion register one POD at any time, by placing the POD in the left charging bay only.
adaptor if using the Corometrics 259) and then into the port labelled MECG (3) on the rear of the Novii Interface, tighten screw with a screwdriver. 4. Connect the cable of the Novii power supply (107-PT-002) to the power socket on the rear of the Novii Interface (socket labelled PSU), and then connect the power supply to the AC power source. 5. The Power Supply of the Novii Interface is regarded as part of the Medical Electrical Equipment.
5.3.2 DISPLAY MHR ON INTERFACE Touching this item ‘bar’ will Enable or Disable the MHR display on the Novii Interface. Selecting to display the MHR on the Novii Interface will automatically turn on the “MHR/FHR coincidence Alert”. The default is not to display the MHR on the Novii Interface. As well as a visual alert there is also an audio alert and this will be enabled if the AUDIO ALERTS are turned ON, see Section 5.3.3 below. 5.3.
5.3.4 ABOUT Touching the About item ‘bar’ will display the Novii Interface firmware version and serial number along with the firmware version and serial number of any PODs docked and the Monica contact details. 5.3.5 UPGRADE INTERFACE A confirmation screen shows that the Novii Interface is in Bluetooth upgrade mode with instructions. This should only be carried out by a trained bio-med engineer or a trained Monica authorized person, who has access to the upgrade instructions. 5.3.
5.5 Monica Identifier This feature is always enabled. The Maternal/Fetal Monitor will print a Monica Identifier (a small identifying spike) on the UA trace every 5 minutes and, during the first 10 seconds prior to the start of a new Novii monitoring episode, a Monica Mark resembling an M will be sent to both the UA and FHR Maternal/Fetal Monitor inputs. Monica Mark Monica Identifier Every 5 minutes.
5.8 TEST function To confirm that the Novii Interface, Maternal/Fetal Monitor, GE Y adaptor and cables work correctly, touch the TEST icon from the Start screen. A signal will be sent to the Maternal/Fetal Monitor to check correct functionality. Monica recommends that whenever the user requires evidence to demonstrate the correct operation of the Interface and Maternal/Fetal Monitor e.g.
The test values shown on the digital Maternal/Fetal Monitor display should be continuous and stable. If not, check the GE Y adaptor and if faulty, quarantine and contact your local GE Healthcare representative. The FHR digital display should read 120±1bpm, the MHR digital display should read 70±1bpm and the TOCO should read 105±10% full scale deflection.
Operating Novii 6.1 Introduction To help set-up the Novii Interface and provide status information of how the POD and Patch are operating; a touch color screen is used. There is no on/off switch; the Novii Interface will always be on when connected to a live AC power source.
6.2 Screen Format The screen on the Novii Interface guides the user when starting a monitoring session and then helps the user achieve the best signal quality, through status alerts and control options. The format of the main monitoring screen is shown below: 4 2 3 1 1 Novii POD status when placed and removed from right/left Novii Interface charging bays below display.
6.3 Initial Screen and Standby Screen 6.3.1 Power on/off When Novii Interface is switched on, by connecting the power supply (there is no on/off switch) the following splash display will be shown, indicating the Interface program version number, for around 5 seconds while the device starts and internal checks are performed. If the device has not been registered it will ask for the language to be selected. It will then go to the registration screen, please refer to Section 5.1.2.
Touching the Standby icon, or removing and redocking a POD will take the user to the ‘start-screen‘, Section 6.4. 6.4 Start Screen: The Start Screen will be displayed if the following conditions are met: Novii Interface and PODs have been registered One or more PODs have been placed in the charging bays A POD has sufficient battery life (>4.
3. Remove the backing from the sticky central area of the Patch under the POD clip. 4. The POD clip should be placed on the midline over the center of the uterus. For most patients the umbilicus is a good anatomical reference. See below for women with a displaced umbilicus. Ensure the Patch is placed correctly as shown in Fig. 2, with the three central electrodes #2, 4 and 5, aligned along the patient’s mid-line and the red arrow at top, pointing towards the head, then stick down. 5.
c. Position POD clip so that the top edge of electrode #2 is 5”/10-12cm below the fundus. The electrode on the flexible cable, electrode #5, Fig. 2, should be placed on top of pannus approximating to the point 2.4”/6cm horizontally from the symphysis pubis looking vertically down. This is difficult to estimate and if the FHR signal is poor, reposition this electrode lower down on abdomen to maximize FHR signal and consider placing under the pannus just below turn ensuring the electrode is not folded. 6.5.
5. If the POD is not attached to the Novii Patch within the 2-minute countdown it will switch off and the blue lights will go out and an audio/visual alert will be generated immediately after the countdown finishes. 6. If the 2nd POD is removed from the charging bay whilst the 1st POD is monitoring a patient, it will not turn on. 7. Once the POD is attached to the Patch, an electrode check screen will appear indicating if the skin preparation at each electrode site has been successful.
10. If you need to end the setup, or monitoring session, remove the POD from the Patch and return it to the charging bay on the Novii Interface that it came from. 11. The monitoring screen helps the user achieve the best signal quality, control the monitoring mode, view status alerts and if enabled display the MHR. The format of the display is shown above. 12. Once the POD identifies and extracts the MHR both blue lights will flash together every 2 seconds. 13.
6.6 Novii Interface Icons and Status Controls/Messages Symbol Description Digital display of the maternal heart rate (MHR). Needs to be enabled in the settings, Section 5.3.2. Please note – MHR is not shown when alert or help messages are being shown When the MHR is shown on the Novii screen. This alert symbol is displayed when the MHR and FHR are within 10 bpm of each other for longer than 60 seconds.
Uterine Activity is set low and many users find this low sensitivity setting better for pre/early induction Labor. In low sensitivity artifact produced by fetal and maternal movement is suppressed. Touching the icon will change the mode to high sensitivity as shown above, which is the default start-up setting. When using the Low UA sensitivity setting the Interface will automatically switch back to High UA sensitivity after 60 min.
6.7 Novii Interface Monitoring alert/help messages To help the user the Novii Interface provides a number of help/alert messages or displayed symbols during monitoring. The messages are dynamic. These alerts/help messages are shown below. 6.7.1 Patient out of Bluetooth range Patient is out of wireless range and the Interface cannot pick up the Bluetooth signal. Message will flash. Note loss of signal and battery information.. Patient out of range 6.7.
6.7.3 Lost FHR Unacceptable FHR quality (red): No message is displayed when fECG signal quality is poor and the FHR cannot be extracted. No alert sound.
6.7.4 Electrode disconnection: The Novii Interface will create a priority visual alert if an electrode has become disconnected. Electrode disconnection: The Novii Interface will create a priority visual alert if an electrode has become disconnected. If only one electrode has become disconnected then the display will indicate the electrode to check. Reattach the highlighted electrode to the skin, if required micropore tape can be used to ensure the electrode is held in place.
6.7.5 MHR/FHR coincidence: The Novii Interface will create an audio/visual alert if the MHR and FHR are coincident (+/10BPM for more than 60s). This visual alert is available only when Display MHR on Interface option is enabled. In this example an audio alert will be heard. The audio alert will be silenced for 60 minutes by touching the 'SOUND IS ON' icon. The alert will disappear if the coincidence disappears. 6.
flash slowly to indicate that the POD is charging. The charging bay will be ‘un-locked’ when the monitoring session is ended. The color of the battery icon indicates if the docked POD has sufficient charge to start a monitoring session. Green means yes, orange means no. If a POD is removed from the charging bay showing an orange battery shaped icon, the blue lights on the POD will not turn on. The POD is off and cannot be used to connect to a Patch.
6.10 Monitoring Alert priority Priority order is: 6.11 1. PATIENT OUT OF RANGE 2. CHECK ELECTRODES for a possible disconnection 3. BATTERY LOW 4. MHR/FHR COINCIDENCE (only if MHR is displayed on Interface) 5. POD not returned Turning Off the Interface There is no power button on the Novii Interface, removing the power supply will turn the Interface off. Once the PODs are fully charged, the Interface can be turned off.
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 5 mm to 3 mm ( 6 seconds). Early decelerations may appear as ‘subtle’ late decelerations. This could lead to an unnecessary intervention. WARNING: DO NOT USE THE NOVII MHR TO MONITOR THE PATIENTS RESPONSE TO A TEST DOSE DURING EPIDURAL PLACEMENT.
2. POD is ‘on/active’ when removed from charging bay: if and only if LEDs flash alternately on/off 3. Connected to Patch: Both LEDs are on continuously when connected to patch and waiting for monitoring to start 4. Monitoring/MHR detected: Both LEDs flash slowly together 5. If both LEDs are off when removed from Interface, POD is off and should be returned to Interface for storage and charging. 6. If both LEDs are off when POD is on the Interface, POD is fully charged.
Interface Visual Alerts 7.1 Return POD to charging bay visual alert If a POD is removed from a charging bay when no monitoring session is in progress and POD has sufficient charge there will be an audio and visual alert after 2 mins if it has not been placed in a Patch or re-docked. The following alert message will be displayed: The alert shown above can be cancelled by touching the forward/exit arrow button and it will not be repeated or by returning the POD to charging bay. 7.
If the POD has not been re-attached to the Patch or placed in charging bay at the end of the 2 minutes countdown, the monitoring session ends. The POD switches off and the Interface will return to the Start Screen. The return POD to charging bay audio/visual alert, Section 7.1, will appear after 2 minutes if the Pod is not returned to a charging bay. 7.
Help icon When the help icon is selected from the start screen, the user will be guided on how to access further support and instructions.
Cleaning 9.1 Cleaning (Patch is single used and should be disposed of as hazardous waste) To avoid damage to any parts of the Novii system, clean and disinfect only according to the following instructions. Care MUST be taken to preserve labels on the Novii POD, Novii Interface and the Maternal/Fetal Monitor cables. CAUTION: Disconnect Novii Interface from the AC power supply before cleaning.
Accessories & Part Numbers 10.1 Part No.
Patch Specification General Information This symbol on your device indicates that you should consult information contained in this book Manufacturer Monica Healthcare, Unit 8, Interchange 25 Business Park, Nottingham, NG10 5QG, UK, Phone: +44 115 949 6960 Model Single Patch Box (10 patches) Box (50 patches) 107-PT-004 107-PT-004-10 107-PT-004-50 Input Electrophysiological signals picked up from the skin surface via the 5 ECG Electrode contact areas integrated into the patch Output Electrical signal
Interface Specification General Information This symbol on your device indicates that you should consult information contained in this book Manufacturer Monica Healthcare, Unit 8, Interchange 25 Business Park, Nottingham, NG10 5QG, UK, Phone: +44 115 949 6960 Model 107-PT-001 Software revision Select 'About' in the Set-Up menu of the level Interface to display software version, see Section 5.3.4 Mode of operation Data I/O Continuous use Bluetooth Wireless Bluetooth V2.1 + EDR Class 1.
Power Supply Monica reference 107-PT-002-US Input 100V~ to 240V~, 50Hz to 60Hz, 400mA Output 5V DC / 3000mA Dimensions 152 mm x 137 mm x 150 mm Weight 688g IP rating IPX0 Accessories Interface Connection Cables for GE Corometrics 259 Series Maternal/Fetal Monitor: FHR (105-PT-102); MHR (105-PT-104) UA (105-PT-106) Novii Interface Power Cable (107-PT-002-US) Operating Temp +10 deg C to +30 deg C Storage Temp +10 deg C to +30 deg C 65
POD Specification This symbol on your device indicates that you should consult information contained in this book General Information Manufacturer Monica Healthcare, Unit, 8, Interchange 25 Business Park, Nottingham, NG10 5QG, UK, Phone: +44 115 949 6960 Model 107-PT-003 Software revision level Select 'About' in the options of the Interface to display software version (see Section 5.3.
UA Range Resolution Accuracy Power Battery Battery Life Battery Charging 0-500 microvolts 0-255 levels representing 100% of full scale Produced 4 time per second from a rolling 2s average 98% percent agreement (95% confidence limit: 96.6%), 86.05% Positive Percent Agreement (95% confidence limit 81.9%) Rechargeable lithium polymer 3.
Figure 3: FHR Bland Altman Novii / Predicate device (percent difference) Figure 4: MHR Bland Altman Novii / Predicate device (difference) Figure 5: MHR Bland Altman Novii / Predicate device (difference) 68
Fault Finding For further support visit www.monicahealthcare.
Novii Interface Troubleshooting Table continued ID Symptom Description Possible Causes Monitoring session is in Progress S4 Novii Interface does not respond when a POD is placed in charging bay Faulty Pod Insufficient battery charge to allow POD to switch on Monitoring session is in progress S5 Novii Interface does not respond when a POD is removed from the charging bay Battery has insufficient charge Actions and Solutions A POD placed in the empty charging bay, vacated by the monitoring POD, wi
Novii POD Troubleshooting Table ID Symptom Description Possible Causes Actions and Solutions User is not performing the skin preparation properly. Make sure to follow the skin preparation instruction provided on patch pouch and in IFU. Confirm the Patch is in date and the pack has not been opened for a long time allowing the electrolyte on the electrode central foam pad to dry out; Confirm the skin-prep exfoliation finger pad (provided with product) or 3M skin-prep tape are used.
Maternal/Fetal Monitoring Troubleshooting Table ID Symptom Description Possible Causes Actions and Solutions Maternal/Fetal Monitor is switched off S8 FHR/UA or MHR data not being displayed by Maternal/Fetal Monitor Cables are not correctly connected Cables are damaged 72 Confirm that the Maternal/Fetal Monitor is ON and confirm that the Maternal/Fetal Monitor works using the Ultrasound and TOCO transducers.
Maternal/Fetal Monitoring Troubleshooting Table continued ID Symptom Description Possible Causes Actions and Solutions S8 FHR/UA or MHR data not being displayed by Maternal/Fetal Monitor POD problems S9 FHR quality on the Maternal/Fetal Monitor trace is poor in some patients Unfortunately this can happen in some patients especially during stage 2.
FHR Gaps Troubleshooting Table For further support visit www.monicahealthcare.com/support ID Action and Solution1 Possible Cause 1 During the ‘Electrode Check’ did you bypass a red X • Restart the monitoring session to identify which or an orange O on the top or bottom midline electrode has O or X electrode? This could result in FHR gapping. • Peel the electrode back, remove excess gel from skin. Wait until skin is dry then abrade skin and reapply electrode.
ID Action and Solution1 Possible Cause continued • If the patient is in bed, the simple use of a pillow behind their back to make them more comfortable/ relaxed can improve FHR following 10 Patient position/posture has changed • If possible return patient to a position where Novii worked well • If possible turn/encourage patient to lie on left • Review causes 1 and 2 • Has the patient a ‘mobile’ abdomen or pannus? If yes has the Patch position changed with respect to the uterus? If you suspect this has
Allergic Reaction to Patch 16.1 Overview When an individual’s skin is exposed to ingredients to which they are allergic, any degree of inflammation that occurs is clinically known as contact dermatitis. The severity of contact dermatitis can vary from mild irritation and redness, to rash and even to blistering, depending on the sensitivity of the skin. This inflammatory response is the skin’s way of over protecting the rest of the body from the allergen.
they are far more likely to accept this, and won’t be as upset if there appears to be redness when the electrodes are removed. 16.3 Treatment If contact dermatitis has occurred, initially the area should be thoroughly cleansed to remove any allergen. In most cases, the best treatment is then to do nothing further to the affected area, as contact dermatitis usually resolves spontaneously over time without complications once the allergen has been removed.
Servicing Servicing of the Novii Interface must be carried out by Monica Healthcare authorized personnel. Further information is available from your local GE representative or contact Monica Healthcare below: Company: Monica Healthcare Limited Address: Unit 8, Interchange 25 Business Park Bostocks Lane Nottingham, NG10 5QG, UK Phone: (+44) 115 949 6960 E-Mail: novii.info@ge.com WARNING: No Modification of this equipment is allowed.
Maintenance & Fault Reporting 18.1 Maintenance There is no recommended maintenance schedule other than visual inspection for damage. Please refer to the Troubleshooting Tables, Section 14 and 15 and in the event of device failure, please contact your local GE service representative. 18.2 Calibration No calibration is required.
retained battery charge will make the Novii POD unusable. It is essential that the Novii POD and its battery are disposed of safely. Please contact Monica Healthcare as listed in Section Section 17 The Disposal authority should contact Monica Healthcare for instructions to separate the battery from the waste electronics prior to disposal.
Monica Healthcare Limited Unit 8, Interchange 25 Business Park, Bostocks Lane, Nottingham, NG10 5QG, UK T +44 115 949 6960 / E novii.info@ge.com www.monicahealthcare.
