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NUV
ANT

 MCT Instructions for Use

  

ENGLISH

Frequently Asked Questions

What is a PiiX? 

A PiiX is a patient-worn medical device designed to comfortably adhere to the 
skin. The device contains sensors that collect your ECG waveform (a tool for 
analyzing the activity of your heart).

How long will my PiiX last?

Each PiiX device is designed to last up to 7.5 days (unless the memory fills up 
beforehand).  However, inappropriate PiiX application, or removal and reappli-
cation of the PiiX during use, will affect monitoring.  If this happens, you may 
be required to use another PiiX.

What information is transmitted to my physician?

Your heart activity is monitored 24 hours a day, 7 days a week. Any unusual 
heart activity is recorded, and transmitted for review to your physician.

What do I do when I feel symptoms?

Whenever symptoms occur, trigger the PiiX to record your heart activity by us-
ing the Patient Trigger Magnet (provided). Swipe the magnet along the entire 
length of the PiiX, once, at a uniform rate.  An ECG will be collected by the 
PiiX, transmitted to the zLink and then transmitted to the Corventis Monitor-
ing Center for review and delivery to your physician.

How can I report my symptoms?

Technicians from Corventis will occasionally call you to discuss your symptoms.  
Please make note of the type of symptoms, the duration of symptoms, when 
they happened and what you were doing so it can be discussed with a techni-
cian. 

Should I keep the Patient Trigger Magnet with me at all times? 

Yes, you should always carry the Patient Trigger Magnet with you. Please keep 
the Patient Trigger Magnet away from your credit cards or identity cards as 
the magnet may erase them. Also, please do not place the Patient Trigger 
Magnet in a shirt pocket or on a necklace, as that might cause unnecessary 
ECG collection.

Can I take a shower while wearing my PiiX?

Yes, the PiiX is water resistant so you can shower while wearing it.  However, 
do NOT submerge PiiX in water by swimming or sitting in a hot tub.  In addi-
tion, avoid excessive rubbing of the PiiX during showering.

Should I carry the zLink with me when I travel? 

Yes, take zLink with you at all times. zLink will remain charged for up to 12 
hours. If you plan to be away for longer than 12 hours, take the zLink charger 
with you.

Will I need to change the battery in the zLink or the PiiX?

Battery replacement is not required for the PiiX and the zLink.  However, we 
recommend that you charge the zLink every night.

How close must I be to zLink to ensure that the data collected by my 
PiiX are transmitted?

Remain within 30 feet (9 meters) of zLink for successful data transmission.

How often do I need to change the PiiX device? 

When both of the following two symbols   and   appear on the PiiX 
display, you should remove PiiX.  Please apply a new PiiX if your monitoring 
period has not ended.      

Содержание NUVANT

Страница 1: ...on of ECGs when they experience cardiac symptoms by using the Patient Trigger Magnet Data are automatically transmitted from the PiiX to the zLink which then automatically transmits the data to the Corventis Monitoring Center Certified cardiographic technicians at the Corventis Monitoring Center review received data and document symptoms reported by patients Clinical reports prepared by the Corven...

Страница 2: ...lects and transmits physiological data One or more PiiX devices may be included in the package depending on the length of the prescription power linked cell send zLink is a device that receives data from the PiiX and transmits it to Corventis Patient Trigger Magnet is used to collect a record of your heart rhythm ie ECG when symptoms are felt Link Holster is a wearable holder for the zLink zLink C...

Страница 3: ...iX will be applied and allow time to dry clean an area slightly larger than the PiiX Do not use any creams or lotions on your skin before application as this will impact monitoring IMPORTANT Monitoring will be affected if hair is not trimmed or if skin is not cleaned with the Prep Wipe If this happens you may be required to use another PiiX Remove the PiiX from the foil pouch by tearing at the not...

Страница 4: ...skin irritation do not place the PiiX over broken or damaged skin Sternum Collarbone MALE Sternum Collarbone MALE Sternum Collarbone FEMALE Petite patients can angle the PiiX slightly away from the nipple and towards the left arm for a comfortable fit as seen below Sternum Collarbone Once applied use the palm of the hand to firmly apply pressure across the surface of the PiiX Then use your fingers...

Страница 5: ...omer Service at 1 877 247 PiiX 7449 Key Things to Remember Wear the PiiX continuously until you see the following two symbols and appear on the PiiX display You can wear the PiiX while you shower it is water resistant but do NOT submerge PiiX in water for example by swimming or sitting in a hot tub Avoid excessive rubbing of the PiiX while showering Once applied do not remove and then reapply or r...

Страница 6: ... lace as that might cause unnecessary ECG collection IMPORTANT You may be contacted by a technician from the Corventis Monitoring Center to discuss symptoms when the Patient Trigger Mag net is used When you experience any symptoms please make note of the following to discuss with a technician Type of symptoms Time of symptoms Duration of symptoms What you were doing How to use the zLink The zLink ...

Страница 7: ...operate with normal wear and tear over the course of use for up to 7 5 days The PiiX is also water resistant You can keep wearing the PiiX while you shower but do not submerge it in water for example in a bath or hot tub Depending on the length of your prescription you may need to wear more than one PiiX As seen in the diagram below the PiiX display will let you know when it should be removed If y...

Страница 8: ...riod This helps to ensure that all of your data are transmitted What to do at the End of Monitoring How to return your zLink When your prescription is complete it will be necessary to return the zLink the zLink Charger and the Patient Trigger Magnet to avoid being billed for the value of the system You do NOT need to return used PiiX devices Follow the steps below to return the materials to Corven...

Страница 9: ...ta to prescribing physicians for the diagnosis and identification of various clinical conditions events and or trends Based on the indications the NUVANT System may be used for 1 Patients who require monitoring for suspected or known non life threat ening arrhythmias 2 Patients with symptoms such as chest pain syncope lightheadedness or near syncope vertigo dizziness fall palpitations transient is...

Страница 10: ...h Corventis physicians can prescribe NUVANT MCT for up to 30 days at a time As each PiiX is designed to last for up to 7 5 days unless the memory on PiiX becomes full beforehand prescription lengths greater than one week will be enabled through the use of more than one PiiX Clinical Reports Clinicians can receive clinical reports including Episode Daily and End of Use Reports directly from the Cor...

Страница 11: ...ion Input Dynamic Range Input Offset Dynamic Range 200Hz 5 10bits 5mV 300mV N A N A N A N A N A N A N A N A Impedance Measurements Peak current injection RMS current injection 40 uA 29 uA N A N A N A N A Measurement Ranges Heart Rate 25 to 250 BPM N A N A Data Storage Capacity 7 5 days N A N A Weight 50g 1 8oz max 150g 5 3oz max Portable Communication Means Bluetooth between PiiX and zLink Cellula...

Страница 12: ...MIT BIH 88 MIT BIH 82 as measured by EC 57 standards testing on 10 25 2011 Redundant reporting of ECGs for this select set of arrhythmias is managed as follows The PiiX will report no more than two 2 ECGs for each of these arrhythmias each hour The PiiX will wait ten 10 minutes before allowing a subsequent ECG to be reported for each of these arrhythmias Note a ECGs are reported for all Tachycardi...

Страница 13: ...accessories that are not expressly approved by Corventis might violate FCC RF exposure guidelines Specific absorption rate data The zlink device meets the US Government requirements for exposure to radio waves when used as directed in this section The zlink is a radio transmitter and receiver It is designed and manufactured not to exceed the emission limits for exposure to radio frequency RF energ...

Страница 14: ...ber Non Sterile Manufacturer s Name and Address Temperature Limitations Collection of electrical and electronic equipment Type BF applied part Denotes device is not in direct contact with cardiac muscle Wireless Transmission Symbol IP 35 Ingress Protection 3 means protection against objects 2 5mm in diameter tools 5 means protection against water jets shower Federal USA law restricts this product ...

Страница 15: ...oms the duration of symptoms when they happened and what you were doing so it can be discussed with a techni cian Should I keep the Patient Trigger Magnet with me at all times Yes you should always carry the Patient Trigger Magnet with you Please keep the Patient Trigger Magnet away from your credit cards or identity cards as the magnet may erase them Also please do not place the Patient Trigger M...

Страница 16: ...erate these devices as they will not affect performance of the PiiX Can I be close to wireless phones WiFi or other electromagnetic devices Yes although some sources of Electromagnetic Interference EMI may temporarily disrupt data transmission Can I carry my cellphone while wearing PiiX Yes but do not place your cellphone in a pocket directly over PiiX Some cellphones have magnets that can lead to...

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