background image

11

NUV
ANT

 MCT Instructions for Use

  

ENGLISH

Specifications, Compliance and Symbols

Specifications

The following performance specifications are at 20°C (68°F) unless otherwise stated

PiiX

zLink

Patient 
Trigger 
Magnet

Shelf life

Refer to PiiX 
pouch label

N/A

N/A

Battery Charger 
Power Requirement

N/A

100-240VAC, 
50/60Hz

N/A

Battery Life

7.5 days (180 
hrs), non-
rechargeable

Provides 12 hrs of 
function before 
recharging

N/A

Operating 
Temperature

0˚C to 41˚C  
(32˚F to 105.8˚F)

0˚C to 45˚C  
(32˚F to 113˚F)

N/A

Maximum 
Temperature of the 
Applied Part

44˚C (111.2˚F)

N/A

N/A

Storage Temperature 
(power off)

-20˚C to 65˚C 
(-4˚F to 149˚F)

-20˚C to 65˚C  
(-4˚F to 149˚F)

N/A

Operating Humidity

10% to 95%

10% to 95%

N/A

Storage Humidity

5% to 95%

5% to 95%

N/A

ECG

Sampling Rate
Digital Resolution
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

Cellular Phone 
between zLink and 
Server

N/A

Arrhythmia Detection Algorithms and Automatic ECG Collection

In addition to patient-driven collection of ECGs using the Patient Trigger Mag-
net, the NUVANT MCT system also uses proprietary algorithms based on rate, 
rhythm and morphology to continuously analyze rhythm abnormalities and 
to initiate automatic ECG collection.  ECGs are automatically collected upon 
detection of the following conditions:

• 

Heart Rate >= 130 bpm

• 

Heart Rate <= 40 bpm

• 

Pause >= 3 seconds

• 

Atrial Fibrillation

• 

Ventricular Tachycardia/Ventricular Fibrillation

Summary of Contents for NUVANT

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Reviews: