Zephyr BioModule. Instructions for Use

Transcription

1 Zephyr BioModule Instructions for Use

2 Contents Introduction... 2 BioModule Indications for Use... 2 Zephyr BioModule Intended Use... 2 Zephyr BioModule Warnings & Cautions... 2 Zephyr BioModule Contraindications... 2 Prepare BioModule for Use... 2 Skin Preparation... 2 BioModule Data... 2 BioModule Light Indicators... 2 To Replace a Discharged BioModule... 2 Care & Cleaning of the BioModule and BioModule Holder... 2 Troubleshooting Tips... 2 Specifications... 2 Parts List... 2 Manufacturer s Declaration and Guidance... 2 FCC Declaration... 2 Warranty

3 Zephyr Technology 1 Annapolis St. Suite 200 Annapolis MD USA Zephyr Support Phone:

4 Introduction Definitions and Abbreviations bpm brpm dbm DSSS ECG EDR GHz HR kbps kg kpa LED lbs MW OR OQPSK RF Term Meaning Beats per minute Breathing rate per minute decibel-milliwatts Direct sequence spread spectrum Electrocardiogram Enhanced Data Rate Gigahertz Hour Kilobytes per second Kilogram(s) Kilopascal Light-emitting diode Pounds Megawatt Operating room Offset quadrature phase-shift keying Radio frequency Overview This manual describes the features, setup and operation of the BioModule. Vital Sync Physiological Patch is an alternative name for the Zephyr BioModule. The function and form of the Vital Sync Physiological Patch are identical to that of the Zephyr BioModule. Safety Symbols Symbol Definition Warning: warnings alert users to potentially serious outcomes (injury or adverse events) to the patient, operator or environment 4

5 Caution: cautions inform users to exercise appropriate care for safe and effective use of the product. Note: Notes provide additional guidelines or information BioModule Indications for Use The BioModule is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments. The BioModule collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Respiration rate values are accurately transmitted only during sedentary periods. The BioModule is indicated for use as a general patient monitor to provide physiological information as part of a general ward monitoring system. 5

6 . Zephyr BioModule Intended Use The BioModule is intended to be used in conjunction with other receiving and display devices in a low acuity patient environment, either in a care facility or alternate care setting. 6

7 Zephyr BioModule Warnings & Cautions The BioModule should not be used in the following cases: o in an oxygen-enriched environment o as a life-supporting device o in the OR o in radiology o with electrosurgical equipment o during defibrillation o near electrical or medical equipment which may interfere with data transmission or reception The Zephyr BioModule holder is for single patient use. Respiration rate values are accurately transmitted only when sedentary and when not speaking. No respiration rate is reported in the first minute. If after the second minute no respiration rate is reported, alternate methods should be considered. Other physiological parameters may continue to function. If patient has arrhythmia, heart rate measurements may be inaccurate. Abnormal rhythms derived from aberrantly conducted QRS complexes may yield inaccurate heart rate measurements. This device does not provide ECG analysis. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. 7

8 Do not use the BioModule in the presence of explosive anaesthetics. When charging the BioModule, use only the components supplied by the manufacturer. The ECG electrodes should not contact any other conductive part, including earth. This is a non-sterile device. Small components such as the ECG electrodes may constitute a choking hazard. Store and dispose out of reach of infants and young children. The BioModule is not user serviceable. Stop use of the BioModule if the patient experiences discomfort or skin irritation. Contact the patient s clinician if discomfort or skin irritation occurs. Not for use on infants weighing less than 10 kg (22 lbs). Inspect the BioModule and BioModule holder before use for contamination or damage. Do not use if damage is suspected. The BioModule and BioModule holder may be removed from the patient or powered off at any time without risk. Remove the BioModule prior to bathing or showering. 8

9 A quality ECG signal requires fresh electrode patches and evaluation of skin integrity every 24 hours, or per Care Area guidelines. The BioModule holder should be disposed of as per care area policy. Zephyr BioModule Contraindications Not for use with patients fitted with an implanted cardiac device such as an internal pacemaker or automatic defibrillator. 9

10 Prepare BioModule for Use a) Obtain your clean and charged BioModule from the charging cradle. b) Clean BioModule using instructions found in this guide. c) Snap the BioModule into the BioModule holder (larger notch in the upper rim), with the BioModule Zephyr logo at the bottom of the holder. d) To remove, press the BioModule holder from the rear as shown. e) Verify that the electrode expiration date has not passed and the gel is moist. Keep the electrode package in a zip top bag after opening to keep electrodes moist. f) Snap two (2) electrodes to the holder. It is ready to apply. g) Press and hold the device center firmly to turn it on. The red light will light up and the blue light will flash. Recommended electrodes: Covidien Kendall 530 Foam 10

11 Skin Preparation a) Select the area to prepare as indicated in the figure. b) Clip hair to make sure electrodes adhere to the skin. c) Wash skin with soap and water to remove dirt, lotions and dry skin cells. Rinse well. d) Dry the area with a cloth to remove any hair or soap. e) Peel the backing from the electrodes. f) Apply firmly in line with the breast bone as shown, between the sternal notch and the xiphoid process. g) The BioModule, holder, and electrodes may be removed at any time without risk to the wearer. Replace electrodes daily or as instructed. Once the BioModule is attached to the patient and flashing green, the device is functioning properly. This may take up to 1 minute. 11

12 BioModule Data Once the BioModule is properly attached and the indicator light is blinking green, please proceed to the instructions supplied with your software user interface, such as the ECG Intermittent Module Reference Manual Addendum to the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager Reference Manual. There, instructions can be found on how to establish device connection, adjust settings and gather data. 12

13 BioModule Light Indicators a) GREEN: flashing working normally. Data is transmitting. b) BLUE: flashing loss of signal. Make sure device is within the designated monitoring area. Confirm network and monitoring system are connected and operational. c) ORANGE: Flashing low battery. Recharge in cradle. d) RED: constant No heart rate detected. Check electrode connection. Re-prep skin and apply fresh electrodes if necessary. In Charging Cradle: a) Flashing Orange = Charging (1 hr to 90%) b) Constant Orange = Charged (3 hrs to 100%) Ready to use. Once the BioModule is attached to the patient and flashing green, the device is functioning properly. This may take up to 1 minute. 13

14 To Replace a Discharged BioModule Remove the BioModule from the patient. Turn off the BioModule by pressing the center for five seconds or until all the lights turn off. Remove the BioModule from the holder by pressing firmly on the back while retracting on the snap wings as shown. Insert the BioModule in the charging cradle, making sure the crescent notch is upward as shown. The cradle (both single bay and 5- bay charger) is powered by a wall plug adaptor. A full charge of a fully-depleted battery will take approximately 3 hours. A solid non-flashing orange light means the BioModule is fully charged. Patient 14

15 Care & Cleaning of the BioModule and BioModule Holder Instructions for Use The BioModule holder is for single patient use and can be reused by that patient. Electrodes are single-use only; dispose of them in accordance with your institution s guidelines. The BioModule is reusable and should be surface cleaned with one of the products below. Wipe BioModule with cloth soaked in bleach or peroxide solution. Let air dry. Recommended cleaning product options Sani-Cloth HB Sodium Hypochlorite (8.25% bleach, diluted 1:10 to 1:100) Hydrogen Peroxide (3% solution) The BioModule holder is intended to be cleaned consistent with generally accepted clinical methods and agents that may have superficial patient contact such as a blood pressure cuff or finger oximetry unit. Sani-Cloth HB Hydrogen Peroxide Bleach Sani-Cloth is a registered trade mark of Professional Disposables International, Inc. Consult the instructions supplied with each cleaning product for appropriate cleaning procedure. 15

16 Troubleshooting Tips Question How do I know if the BioModule is fully charged? How long does it take to charge? What does it mean if the red light on the BioModule is constantly on? What does a flashing blue light mean? Is it important to place the BioModule in the pictured positions? What to do The orange light is steady, not flashing when in the charging hub or cradle. See BioModule Light Indicators page. 1 hour for 90% charge and 3 hours for 100%. See BioModule Light Indicators page. A steady red light indicates no heart rate was detected check that the BioModule holder is firmly attached to the electrodes and that the electrodes are securely attached to the patient s chest. See BioModule Light Indicators page. A flashing blue light indicates a loss of wireless communication. See BioModule Light Indicators page. Yes, to get the most accurate data it is very important to position as shown. See Skin Preparation page. 16

17 Specifications BioModule Prescription Device Heart Rate Respiration Rate Battery Performance Type Operating Battery Charging Charge Time Single Device Charge cradle bpm ±1 bpm static (R-R interval) 6 40 brpm +/- 1 brpm static Rechargeable Lithium Polymer, V 24 hours minimum when new and fully charged Place in charger 24 hours if unused for 3 months. Charge periodically if unused to avoid full discharge state 1 hr to 90% capacity, 3 hrs to 100% capacity USB connector provided AC Adaptor, V input 5V/0.5A output 5 Device Charge cradle V input, 7.5V /2.0A output power supply provided Classifications per IEC Installation & Use Portable, body-worn Degree of Protection Type CF-Applied Part Supply Connection Internally powered ECG type (BH3-M2) Ambulatory Electrocardiograph (IEC : 2012) Transmitter Bluetooth Compliance Supported Profile Discoverability Frequency Output Power Operating Range Sensitivity Antenna Type Compliance Frequency Output Power Operating Range Sensitivity Max Data Rate Modulation Type Spread Spectrum Compliance RTTE FCC ID IC ID Contains Transmitter Module FCC ID IC ID Version EDR Serial Port Configurable GHz 10 dbm Up to 30ft/10m -91 dbm Internal IEEE GHz 100mW Up to 300 yards / 275 m -89 dbm 250 kbps OQPSK DSSS Directive 1999/5/EC VZ6-BH3 7565B-BH3 T7V Q

18 Electromagnetic Compliance Emissions IEC :2007 Immunity IEC :2007 Environmental (Operating) Temperature Temperature - charging Relative Humidity Atmospheric Pressure Ingress Protection Environmental (Storage & Transportation) Temperature Relative Humidity Atmospheric Pressure Service Life BioModule Battery Maintenance BioModule Holder Bio Module ECG electrodes Instructions for Use -20º C to +45º C (-4º F to 113º F) inclusive 0º C to +45º C (32º F to 113º F) inclusive 15% to 95% non-condensing 12kPa to 107kPa IP67 protected from dust and against the effect of immersion in water to depth between 15 cm and 1 meter (6 in to 3 ft) -20º C to +45º C (-4º F to 113º F) inclusive 15% to 95% non-condensing 12kPa to 107kPa 300 charge cycles minimum Other than cleaning and charging, no other maintenance is required. Single Patient use Reusable Single use Disposal Return Local Disposal WEEE Dimensions BioModule Holder Weight BioModule Holder The BioModule, charge cradle and BioModule holder contain no hazardous components. All electrical components are lead-free. Zephyr Technology will undertake to dispose of any end-of-life components which are returned to their facility. Where specific provision is made in a particular region for disposal and recycling of electrical goods, Zephyr advises following local guidelines for conscientious disposal of equipment. Zephyr BioModule is WEEE compliant 48 x 46 x 10 mm (1.9 x 1.8 x 0.4 in) 90 x 50 x 10 mm (3.5 x 2.0 x 0.4 in) 18 grams (0.63 oz) 14 grams (0.49 oz) 18

19 Symbols on Device Blue LED Wireless communication status/error Orange LED low battery indication/charging indication Red LED Heart Rate not detected indicator Green LED normal operations indication Symbols on Device Label Manufacturer s designation for device Device Model [BH3-M2] Device Serial Number XXXXXX Consult user manual before use Type CF-Applied Part IP67 Ingress Protection Rating WEEE Europe Contains radio transmitter (non-ionizing radiation) FCC radio emissions compliance FCC ID Zephyr BioModule ID 19

20 Symbols on Shipping Label Prescription-only device Read instruction manual (this manual) before use Transport atmospheric pressure range: 12kPa (minimum) to 107 kpa (maximum) Transport humidity range: 15 to 95% RH Transport temperature range: -4º to 113ºF / -20º to 45ºC Keep dry Package quantity Manufacturer Lot number 20

21 Parts List The BioModule should only be used in conjunction with the following accessories, supplied with the system kit: Component Zephyr BioModule BH3-M2 Part Number Description Zephyr BioModule BioModule Holder White holder, stainless steel snaps ECG Electrode Single charge cradle Covidien Kendall 530 Foam Electrode, pack of 30 (recommended) White single BioModule charge cradle USB cable USB cable for single BioModule charge cradle USB A/C Adaptor AC adaptor for single BioModule cradle 5 Device charge cradle White charge cradle for 5 BioModules with power supply For information on use of BioModule data with compatible systems, refer to sections of this manual titled Zephyr BioModule Intended Use and BioModule Data. 21

22 Manufacturer s Declaration and Guidance Electromagnetic Emissions Electromagnetic Emissions Guidelines and Compliance Guidance and Manufacturer s Declaration Electromagnetic Emissions (IEC :2007, Table 1) The BioModule is intended for use in the electromagnetic environment specified below. The customer or the user of the BioModule should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF emission CISPR 11 Harmonic Emission IEC Voltage fluctuation/ flicker emissions IEC Group 1, Class B N/A N/A BioModule uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. N/A N/A 22

23 Electromagnetic Immunity Electromagnetic Immunity Guidelines and Compliance Guidance and Manufacturer s Declaration Electromagnetic Immunity (IEC :2007, Table 2) The BioModule is intended for use in the electromagnetic environment specified below. The customer or the user of BioModule should assure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge (ESD) IEC ± 6 kv contact ± 8 kv air ± 6 kv contact ± 8 kv air Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power frequency (50/60 Hz) magnetic field IEC A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 23

24 Recommended Separation Distance Calculations Guidance and Manufacturer s Declaration Electromagnetic Immunity (IEC :2007, Table 4) The BioModule is intended for use in the electromagnetic environment specified below. The customer or the user of BioModule should assure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the BioModule, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC Radiated RF IEC Vrms 150 KHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz Not applicable 3 V/m d = 1.2 P d = 2.3 P 80 MHz to 800 MHz 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than compliance level in each frequency range b Interference may occur in the vicinity or equipment marked with the following symbol: 24

25 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. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If measured field strength in the location in which the BioModule is used exceeds the applicable RF compliance level above, the BioModule should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BioModule. b Over the frequency range 150 khz to 80 MHz, fields strengths should be less than 3 V/m Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and BioModule The BioModule is intended for use an electromagnetic environment specified below in which radiated RF disturbances are controlled. The customer or user of the BioModule can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BioModule as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m (meters) W (watts) 150 khz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5 GHz d = 2.3 P

26 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 At 80 MHz and 800 MHz, the separation distance for 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. FCC Declaration NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. This device complies with Part 15 of 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. Any computer used in conjunction with this device must be covered by a Declaration of Conformity or must be FCC certified in its own right. Warranty The product is tested and validated with the components supplied. Substituting may alter functionality. Use only parts which are supplied. Changes or modifications to the BioModule and/or BioModule Holder may void the user s authority to operate this equipment. 26