Cirvo Compression System Physician Instructions for Use Caution: Federal law restricts this device to sale by or on the order of a physician Company Information Headquarters: Radial Medical, Inc. 2500 Grant Road Mountain View, CA 94040 United States IFU-00387 Rev 01 Phone: (650) 534-0154 Fax: (650) 962-4555 Email: customerservice@radialmedical.
Table of Contents Company Information ..................................................................................................................... 1 Section 1 Contents…………………………………………………………………………………………………………………….3 Section 2 - General Information ..................................................................................................... 4 The Cirvo Compression System ...............................................................................................
Figure 1: Packaging Figure 3: Cirvo Device – Front View (Shin) IFU-00387 Rev 01 Figure 2: Cirvo Device – Back View (Calf) Figure 4: AC Charger Page 3 of 34
Section 1 - Contents FA-00430 IFU-00387 IFU-00444 Cirvo Compression Device and AC Charger – Qty: 2 ea. Physician Instruction For Use (IFU) – Qty 1 ea. Patient User Manual – Qty 1 ea. Section 2 - General Information The Cirvo Compression System The Cirvo Compression System consists of a compression device, the Cirvo Compression Device (Figures 2 & 3) and an AC Charger (Figure 4). The system is designed to provide compression to the calf area to assist blood flow in the venous or arterial system.
sequential compression therapy when other compression options are not available, cannot be used, or have failed to aid in venous leg ulcer healing after prolonged compression therapy4. The Cirvo Compression System has been specifically designed to address the limitations of existing sequential compression systems. The Cirvo Compression Device is portable, quiet, and does not have tubes and cables, allowing the patient to remain mobile during therapy and potentially enhancing compliance with the therapy.
Section 4 - Contraindications The Cirvo Compression System is contraindicated in the following cases: • • • • • • • • • • • • Acute thrombophlebitis In medical situations where increased venous and lymphatic return is undesirable Severe atherosclerosis or other ischemic vascular diseases Suspected or known acute deep vein thrombosis Severe congestive cardiac failure Existing pulmonary edema Existing pulmonary embolism Extreme deformity of the limbs Any local skin or tissue condition which the device would
• • • • Electromagnetic interference may occur in the vicinity of other household appliances and/or electronic equipment. Move the device away from other appliances and /or electronic devices if interference occurs. Electromagnetic interference/disturbance may also occur if Cirvo Device is in the vicinity of the following sources of electromagnetic disturbances: Diathermy, Lithotripsy, Electromagnetic anti-theft systems and metal detectors.
Section 6 - Wireless Security 1. It is recommended that the iOS Mobile device be password protected to prevent unauthorized access (See Section 8 – Use: Accessing Physician Window (Password Required) for instructions on how to change the PIN code). 2. The Cirvo Compression Device is delivered with two default PIN codes: o One is for access to the Physician environment and the other is for access to the Diagnostics environment.
Section 7 - Symbols SYMBOL STANDARD REFERENCE ISO 15223-1, Clause 5.1.1 ISO 15223-1, Clause 5.1.3 ISO 15223-1, Clause 5.1.6 ISO 15223-1, Clause 5.1.7 ISO 15223-1, Clause 5.1.5 ISO 15223-1, Clause 5.1.4 IEC 60601-1, Table D.2, Symbol 10 ISO 15223-1, Clause 5.4.4 IFU-00387 Rev 01 STANDARD TITLE Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 15223-1, Clause 5.3.4 ISO 15223-1, Clause 5.3.7 ISO 15223-1, Clause 5.4.2 IEC 60601-1, Table D.1, Symbol 20 ISO 15223-1, Clause 5.2.7 ISO 15223-1, Clause 5.2.8 EN 50419 Caution: Federal law restricts this device to sale by or on the order of a physician. IFU-00387 Rev 01 21 CFR 801.15(c)(1)(i)F 21 CFR 801.109 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Bluetooth Special Interest Group (SIG) Bluetooth wireless technology Bluetoothenabled device Wireless products featuring Bluetooth® technology Regulatory Compliance Notices: USA-Federal Communications Commission (FCC) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Section 8 - Use Opening Package and Charging Cirvo Compression Device Figure 5: Charging. Connect AC Charger onto Cirvo Compression Device (Left) and plug into AC outlet; light on top of controller (Right) will show charging status. Blinking Green: Charging Solid Green: Fully charged 1. Remove Cirvo Device and AC Charger from packaging. Inspect for any visible physical damage such as cracked components, sharp edges, loose components, etc.
Connecting via Bluetooth and Prescribing Therapy (If the iOS mobile device is not pre-loaded with the most current version of the Cirvo App, please contact Radial Medical Inc.
Figure 7: Adjusting Cirvo Device straps to correct tension – Left Leg.
Figure 8: Adjusting Cirvo Device straps to correct tension – Right Leg. 8. To confirm that the therapy is as prescribed, touch on the Rx (Physician) icon to access Physician window – (See Section 8 “Accessing Physician Window (Passcode Required). a. The therapy parameters include the following – Figure 9: i. “Placement”, ii. “Start Pressure” iii. “End Pressure”, iv.
v. “Session” vi.
Fitting Figure 10. Placement – Loosen Strap; Grasp handles. Place around leg. Snap to fasten 1. 2. 3. 4. 5. Physician will instruct the patient in proper fitting the first time. Loosen all hook and loop straps completely. Pull the magnetic clasp apart by grasping the handles and pulling the two flaps of the clasp away from each other. Center the controller unit onto your calf area as illustrated in Figure 8, approximately 1” below the back of your knee.
Initiating and Stopping Therapy Fig. 11: (a) “START NOW”; (b) “Treat in Progress” 1. Touch icon labeled “START NOW” Figure 11a. Compression therapy session will begin. Do not immerse Cirvo Device or AC Charger in water. When inner circle is completely filled (light blue instead of white), the therapy session is complete. 2. Touch “STOP TREATMENT” in center circle once to discontinue therapy Figure 11b.
Rapidly Blinking Blue – Device being fitted Blinking Green – Device fitting successful Solid Green – Device Running Slow Blue Blink – Device in Deep Sleep mode Figure 12. LED Indicators – Cirvo Device status.
Compliance and Therapy Progress Figure 13. “Treatment-in-Progress” screen 1. To check compliance with prescribed therapy, touch “Compliance” icon (arrow) at bottom of screen. a. The overall progress with the total prescribed therapy is shown in the “Overall” pie chart (yellow arrow) and weekly progress is shown below in corresponding pie charts (green arrow) i.e. “Week 1”; “Week 2” Figure 15. 2. To return to patient view, touch “Patient” icon on bottom of screen.
Figure 14. “STOP TREATMENT” screen Accessing Physician Window (Passcode required) 1. Touch the Rx (Physician) symbol and key in correct passcode (1-2-3-4) and touch “OK” – Figure 15 2. Confirm the following tabs a. “Prescription”: This window is used to set the treatment prescription for the patient including “Start Pressure”; “End Pressure” “Dwell Time” “Placement”; “Session”; “Treatment” etc., b. “Compliance”: This window illustrates how well the patient is complying to the prescribed treatment, c.
b. Touch “ID Numbers” tab, c. Touch “Change” and follow prompt, i. Type in “Current passcode”, ii. Type in “New passcode”, iii. Type in “New passcode” again, iv. Touch “Change” v. Verify “Passcode successfully changed” dialogue box vi.
Accessing Diagnostic Window (Passcode required) (This window is similar to the physician window but also includes information that Radial Medical technicians and engineering support use to diagnose/troubleshoot the Cirvo Compression Device). 1. Touch the Rx (Physician) symbol and key in correct passcode (7-2-3-4-2-5) and touch “OK” – Figure 15 2. Confirm the tabs a. “Patient”, b. “Prescription”, c. “Compliance”, d. “Accessory” e. “More”. i. Storage ii. Details iii. Color iv.
Section 9 - Specifications and Performance Technical Specifications All Dimensions are Approximations (Inches) - Controller Unit: 5 ½ x 2 ¾ x 1 ¼ Size - Compression Plate Pad: 6 ¾ x 7 ½ (Curved) - Velcro Straps: 8 ½ ~10 oz Weight Battery 7.4VDC, 750mAH, Rechargeable Lithium Polymer Recharge Time ~2Hrs Mains Supply AC Adapter, 12Vdc x 2A Active Mode Sequential Compression Pressure 40-60 mmHg Dwell 30 – 120 seconds Water Ingress IPX4 Dust Ingress IP5X Enclosures IP54 Frequency of Transmission 2.4 GHz – 2.
Section 10 - Storage and Handling • • • • • • • • Storage parameters as follows: a. Temperatures between -25oC to +5oC (-13oF – 41oF) and b. +5oC to +35oC (41oF – 95oF) at relative humidity up to 90%, non-condensing; c. >35oC to 70oC at a water vapour pressure up to 50 hPa Operation parameters as follows: d. Temperatures between +5oC to +40oC (50oF – 104oF) e. Relative Humidity (RH) range of 15 % to 90 % non-condensing; f. Atmospheric pressure range of 700 hPa to 1060 hPa; Avoid excessive heat and cold.
Section 13 - Troubleshooting The following table provides a troubleshooting guide for the Cirvo Compression System.
Section 15 – Electromagnetic Interference This device has been tested and found to comply with the limits for medical devices in accordance with EN60601-1-2:2014 . These limits are designed to provide reasonable protection to assure the safety of medical devices from interference from other electrical equipment and devices. This equipment can be affected by radio frequency energy and, if not installed and used in accordance with the instructions, may cause interference to other devices in the vicinity.
(Valid for test levels: HOME HEALTHCARE ENVIRONMENT) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Cirvo Compression System is intended for use in the electromagnetic environment specified below. The customer or user of the Cirvo Compression System should ensure that it is used in such an environment.
(Valid for test levels: 3V for 150kHz to 80MHz; 10V for 80MHz to 2700 MHz) HOME HEALTHCARE ENVIRONMENT Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Cirvo Compression System is intended for use in the electromagnetic environment specified below. The customer or the user of the Cirvo Compression System should assure that it is used in such an environment.
(Valid for test levels: 3V for 150kHz to 80MHz; 10V for 80MHz to 2700 MHz) HOME HEALTHCARE ENVIRONMENT Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT The Cirvo Compression System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
(Valid for test levels: In Table 9) PROFESSIONAL HEALTHCARE FACILITY and HOME HEALTHCARE ENVIRONMENT Immunity to RF Wireless Communications Equipment Test Frequency MHz Band a) MHz Service a) Modulation Maximum Power b) W TETRA 400 Pulse modulation 18 Hz 450 430 - 470 GMRS 460, FRS 460 FM c) ± 5 kHz deviation 1 kHz sine 710 745 780 LTE Band 13, 17 Pulse modulation 217 Hz b) 704 - 787 Pulse modulation 18 Hz b) 800 - 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modula
Section 16 – Electromagnetic Emissions (Valid for test levels: HOME HEALTHCARE ENVIRONMENT) Guidance and manufacturer’s declaration – Electromagnetic Emissions The Cirvo Compression System is intended for use in the electromagnetic environment specified below. The customer or the user of the Cirvo Compression System should assure that it is used in such an environment. Emissions Test Compliance RF emissions Group 1 The Cirvo Compression System uses RF CISPR 11 energy only for its internal function.
(Valid for test levels: HOME HEALTHCARE ENVIRONMENT) Guidance and Manufacturer’s declaration – Electromagnetic Immunity The Cirvo Compression System is intended for use in the electromagnetic environment specified below. The customer or the user of the Cirvo Compression System should assure that it is used in such an environment.
(Valid for test levels: in Table 9) PROFESSIONAL HEALTHCARE FACILITY and HOME HEALTHCARE ENVIRONMENT Test Frequency (MHz) 385 450 Immunity to RF Wireless Communications Equipment Band Maximum Distance Service a) Modulation b) Power (MHz) (W) (m) Pulse 380 –390 TETRA 400 modulation b) 1.8 0.3 18 Hz FM c) GMRS 460, ± 5 kHz 430 – 470 2 0.3 FRS 460 deviation 1 kHz sine a) 710 745 0.3 9 Pulse modulation b) 18 Hz 2 0.3 28 Pulse modulation b) 217 Hz 2 0.3 28 2 400 – 2 570 Bluetooth, WLAN, 802.
