Cirvo Compression System Instructions for Use REST Trial Protocol CL00383 Company Information Headquarters: Radial Medical, Inc. 2500 Grant Road Mountain View, CA 94040 United States IFU-00522 Rev A Phone: (650) 530-0154 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: Shin pad magnetic clasp IFU-00522 Rev A Figure 2: Cirvo on leg (side view) Figure 4: Charger (plugged in) Page 3 of 26
Section 1 - Contents FA-00430 IFU-00522 Cirvo Compression Device and AC Charger – Qty: 2 ea. Clinical Instruction For Use (IFU) – Qty 1 ea. Section 2 - General Information The Cirvo Compression System The Cirvo Compression System consists of a compression device packaging (Figure 1), the Cirvo Compression Device (Figures 2 & 3) and 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 (pending FDA clearance) 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
• • • • • Do not turn on the Cirvo Device if it has not been attached to the calf/leg. The attachment assembly might fly around and cause injury. 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.
Section 6 - Wireless Security 1. It is recommended that the iOS Mobile device be password protected to prevent unauthorized access. 2. All data sent by Cirvo is AES-128 encrypted across the Bluetooth wireless transport to avoid interception. 3. It is recommended that the iOS device operates with the latest version of the Radial App upon notification from Radial. 4. Firewall/Virus protection is provided via the iOS. 5.
Launching App 1. Tap on the Cirvo App icon to launch the application. Privacy Policy 1. App will launch with Radial Medical Privacy Policy and option to allow “I agree” or decline “I do not agree” collection of personal information. This information will enable sending of text and email alerts to patient to reinforce compliance with therapy. Declining collection of personal information will not affect ability to proceed to therapy.
User Information Figure 7: Personal Information (optional) 1. Enter patient (optional) information as prompted.
Initiating Therapy Figure 8: Start treatment 1. Cirvo app will automatically detect and connect to Cirvo devices. Text next to battery icon will show “Charging” when device plugged in and charging, “Not connected” upon initiation and then battery status once connected. Bluetooth connection is not required once therapy has initiated. Touch icon labeled “Start Treatment” Figure 8 to initiate fitting process. Do not attempt to run device while device is plugged in and charging.
Fitting and Starting Therapy Figure 9: Placing and fitting Cirvo 1. 2. 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 Figure 9 (left), Note: It is highly recommended that fitting process be performed while patient is seated in chair with feet planted on the ground for consistent fitting. 3. 4. 5. 6.
Stopping Therapy Figure 10: Stopping Therapy 1. When inner circle is completely filled (light blue instead of white), the minimum therapy session is complete. 2. Touch “Stop Treatment” in center discontinue therapy Figure 10. 3. App will confirm you would like to stop treatment. If so, tap Stop treatment pop up. 4. Cirvo can be also be stopped by touching and holding the green light on top of device for 6 seconds. 5.
Section 8 - 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 9 - 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 vapor 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 12 - Troubleshooting The following table provides a troubleshooting guide for the Cirvo Compression System.
Section 14 - 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-00522 Rev A 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-00522 Rev A 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 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 .
(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.
