Bodyguardian Control Unit Base Kit Operator Manual SPMHBGW1-MAN Rev.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Contents CHAPTER 1 ........................................................................................................................................ 4 INFORMATION ABOUT SAFETY ................................................................................................... 4 1.1 INFORMATION ABOUT THE MANUAL ......................................................................... 4 1.1.1 CONVENTIONS .............................................
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 5 ...................................................................................................................................... 49 MAINTENANCE .............................................................................................................................. 49 5.1 GENERAL INFORMATION ABOUT MAINTENANCE ................................................ 49 5.2 SAFETY CHECKS .......................................................
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 1 INFORMATION ABOUT SAFETY 1.1 INFORMATION ABOUT THE MANUAL This document contains proprietary information. No part of this publication may be photocopied or reproduced without the prior written permission of the manufacturer PREVENTICE. Information in this document is subject to change and revision without notice. Issues: First edition: SPMHBGW1-MAN - Rev. A - November 2011 This manual is to be considered as a component of the equipment.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.1.1 Operator Manual CONVENTIONS In this Operator Manual the following conventions are used: NOTE The NOTE messages contain important information, which must be noticeable with respect to the regular text. Usually they have useful information for the operator: detailed data on the correct operating procedures of the instrument.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.2 Operator Manual DECLARATION OF RESPONSIBILITY BY THE MANUFACTURER MANUFACTURER: PREVENTICE 1652 Greenview Drive SW Rochester, MN 55092 Website www.preventice.com Tel: +1 866-830-4043 PREVENTICE is responsible for safety, reliability and performances of the equipment only when the equipment is used in compliance with the following conditions: Calibrations, modifications or servicing must be performed by qualified staff expressly authorized by PREVENTICE.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.3 Operator Manual USAGE RESTRICTIONS AND SAFETY PRECAUTIONS In order to guarantee the patient’s and the user’s safety as well as a correct working of the equipment, it is necessary to operate within the consented restrictions and adopt all the precautions listed below: ATTENTION Prior to usage, verify that all the safety requirements are satisfied. The equipment must not be supplied by or connected to other instruments until such safety conditions are restored. 1.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual To ensure the safety of the patient and the operator, please follow all the warnings and caution listed in this manual. Connect to the equipment the proper specified power supply only. In order to guarantee the electrical safety requirements, the recharge of internal battery pack of equipment, must be performed by means the proper medical AC/DC adapter only. The power supply is supplied by PREVENTICE with the equipment.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual with external conductive parts thus damaging the isolation level of the equipment. Do not connect additional Multiple Portable Socket-Outlet or extension cord. Multiple portable socket-outlet or extension cord shall not be connected to the system. Observe the IEC 60601-1-1 and the IEC 60601-1-2 standards in case of connection with other instruments.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual evaluate the skin condition under the electrode. Redness, blistering and permanent skin scarring can occur if electrodes are not regularly monitored. Using the equipment on patients with a heart pace-maker is not allowed.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual against the dripping, spraying and splashing of water and relevant harmful effects. Avoid submitting the equipment to the risk of water jetting or temporary and continue immersion because its protection degree do not guarantees protection of internal parts against ingress of liquids. Do not use the equipment where such risks are present.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.3.3 Operator Manual OTHER PRECAUTIONS Take care when using the equipment on patients who are pregnant. It is necessary to be careful when using the equipment in the case of patients who are pregnant. These patients should not undergo any examination with this equipment without authorization and under the severe control of a specialized physician. The equipment is intended for adult use only with a weight greater than 10 Kgs.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.4 Operator Manual GRAPHIC SYMBOLS IN COMPLIANCE WITH THE IEC 60601-1 STANDARD The following table shows description and localization of all graphic symbols in compliance with the IEC 60601-1 safety standards present on the equipment panels and/or on any other instruments or external devices to which the equipment may be used in cojunction to or present in the same environment.
BODYGUARDIAN CONTROL UNIT – BASE KIT IEC 60601-1 DESCRIPTION Operator Manual POSITION SYMBOL Off (disconnected from the mains) Symbol placed on the off/on positions of the whole equipment general power switch. On (connected to the mains) Symbol placed on the off/on positions of the whole equipment general power switch. Off (for a single part of equipment) Symbol placed on the off/on switch of a single part of the equipment.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.5 Operator Manual OTHER GRAPHIC SYMBOLS The following table shows description and localization of all symbols placed on the equipment panels and/or on any other instruments or external devices to which the equipment may be used in cojunction to or present in the same environment. SYMBOL DESCRIPTION Input Symbol placed on the signal input or mains voltage input connectors of the equipment.
BODYGUARDIAN CONTROL UNIT – BASE KIT Date of manufacture Operator Manual Symbol placed on the identification label of the medical device together with the device manufacture date.
BODYGUARDIAN CONTROL UNIT – BASE KIT Temperature Limit 17 ` Operator Manual Symbol placed on the identification label of the medical device together with the indication of temperature limits (high and low limits) for the usage/storage of device.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.6 Operator Manual ATTENTION SYMBOL The ATTENTION symbol shown below, placed on the equipment casing, refers the user to the Operator Manual for information, warnings and suggestions which are particularly important for a correct and safe use of the equipment.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual potentially serious hazards during the normal use of the equipment, in order to be able to remove the source of such hazards with the best efficiency and timing. To the purpose of helping PREVENTICE take any timely and effective corrective measure, it is extremely important that the user performs a careful inspection of the equipment performances in order to identify or foresee any dangerous situation for the patient’s and the user’s health.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Enclosure 1.7 PRODUCT TRACEABILITY FORM To: PREVENTICE 1652 Greenview Drive SW Rochester, MN 55092 c.a. Quality Assurance Department System/device name………................................................................................................. Device code / reference number (REF) ............................................................................ Device serial (SN) / lot number (LOT) ...............................................
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Enclosure 1.8 POST-MARKETING VIGILANCE FORM To: PREVENTICE 1652 Greenview Drive SW Rochester, MN 55092 c.a. Quality Assurance Department System/device name.......................................................................................……….......... Device code/reference number (REF) ................................................................................ Device serial (SN)/lot number(LOT) .....................................….........
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.9 Operator Manual INFORMATION ABOUT RECYCLING OF MATERIALS In accordance with the specific worldwide regulations, PREVENTICE aims to continuously improve the design and the fitting of electromedical devices in order to reduce as much as possible any negative impact on the environment caused by the management of component parts, consumer materials, packaging and discharge of devices when at their “end of life”.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.10 Operator Manual ELECTROMAGNETIC COMPATIBILITY This medical device is designed for use in the electromagnetic environments declared in the tables below, in compliance with the IEC 60601-1-2:2001 (second edition) standard. The operator must assure that the device is used in an environment compliant to this standard. This device complies with Part 15 of the FCC Rules.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Table 2 - Electromagnetic Immunity Immunity Test Electrostatic Discharge (ESD) IEC 60601-1-2 Test Level 6 kV in contact Compliance Electromagnetic environment IEC 60601-1-2 Residential/Hospital Test Levels (Note 1) 8 kV on air IEC 61000-4-2 Electrical fast 2 kV for power supply transient/burst line IEC 60601-1-2 Residential/Hospital Test Levels (Note 2) (Note 3) IEC 61000-4-4 1 kV for input/output lines >3m Surge 1/0.
BODYGUARDIAN CONTROL UNIT – BASE KIT Power 3 A/m frequency (50/60 Hz) magnetic field IEC 61000-4-8 25 ` Operator Manual
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Table 3 - Electromagnetic Immunity for non-life supporting equipment Immunity Test IEC 60601-1-2 Test Level Compliance Electromagnetic environment Portable and mobile RF communications equipment should be used no closer to any part of this medical device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter (table 4 - Recommended separation distance).
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Measures to be taken Note 1: The floor should be in antistatic material (wood, ceramic, ect.). If covered by synthetic material, relative humidity should be maintained at least at 30%. Note 2: The quality of the electrical power supply and the mains frequency magnetic fields should be typical of domestic, commercial and hospital environments.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: (1) at 80MHz and 800MHz, the separation distance for the higher frequency range applies. (2) These guidelines may not apply in all situations.
BODYGUARDIAN CONTROL UNIT – BASE KIT 1.11 Operator Manual BIOCOMPATIBILITY AND INFECTIONS CONTROL No system component is intended to be in contact with the patient during the usage. Electrodes and sensors are not intended to be parts of the Bodyguardian Control Unit product.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 2 DESCRIPTION OF THE DEVICE 2.1 GENERAL OVERVIEW The Bodyguardian Control Unit is a wearable battery power device intended for use as a part of a Multi-Parameter Analysis System and is designed to be used by a System Builder in a Multi-Parameter Analysis Application.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual turn it on and off by using the appropriate button; manage the recharging of the Bodyguardian Control Unit using the dedicated charging station and power supply cable; monitor the status of the device by looking at the led lights and colors manage the devices by using the mobile phone application 2.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual All aspects related to safety and effectiveness of the whole ambulatory multi parametric monitoring system is under the complete responsibility of System Builder.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Figure 2-1 Components of Bodyguardian Control Unit base kit 33 `
BODYGUARDIAN CONTROL UNIT – BASE KIT 2.2 Operator Manual BODYGUARDIAN CONTROL UNIT DESCRIPTION The following figures (2-2 and 2-3) show the Bodyguardian Control Unit: 2 1 Figure 2.2 – Bodyguardian Control Unit: front view 4 INJ2 INJ1 3 SENSE1 SENSE2 Figure 2.3 - Bodyguardian Control Unit: back view In the previous figures the following components can be found: 1. Signaling Leds 2. Push button 3. Charger connectors (n° 2 contacts) 4.
BODYGUARDIAN CONTROL UNIT – BASE KIT 2.2.1 Operator Manual PATIENT CONNECTION Biologic input signals are acquired by Bodyguardian Control Unit through the patient connectors (fig. 2.4). Figure 2.4 - Patient connectors which uses the 4 ECG snaps to interconnect the Bodyguardian Control Unit with the Disposable electrodes patch. The connection is guaranteed through the four snaps on the SnapStrip. Figure 2.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual 2.2.2 BLUETOOTH CONNECTION The Bodyguardian Control Unit is equipped with an integrated Bluetooth network interface (for Protocol Specification please refer to the document BGP110006_Commend_Interface_Specifciations) that allows to establish a pairing connection with an external Associated Device (e.g. Android smartphone or other).
Led states BODYGUARDIAN CONTROL UNIT – BASE KIT OFF SLOW MEDIUM FAST ON d.n.c. LED Priority 37 ` Device BGD OFF ON charge FULL charge Identification Modes IDLE ENGAGED SERVICE ---> SERVICE (FOTA) ---> SERVICE (ACCEPTTEST) MONITORING STREAMING Events Symptomatic Event Electrodes Detached Low Battery Level Communic. Active Connection (In/Out) Data Transfer Failure HW/SW driven LED1 Charging Led Yellow STATE OFF ON (by HW) OFF d.n.c. d.n.c. d.n.c.
BODYGUARDIAN CONTROL UNIT – BASE KIT 2.2.4 Operator Manual MULTIFUNCTION PUSH BUTTON The following figure shows the multifunction push button placed on the front cover of the Bodyguardian Control Unit. Multifunction push button Figure 2-10 – Multifunction push button The push Button turns ON and OFF the device and insert symptomatic events notification from the patient.
BODYGUARDIAN CONTROL UNIT – BASE KIT 2.3 Operator Manual BODYGUARDIAN CHARGING CRADLE The Bodyguardian Control Unit is provided with a proprietary Charging Cradle which must be used to re-charge the internal battery (Figure 2.11). 5 6 Figure 2-11 – Bodyguardian Charging Cradle – Upper view 7 Figure 2-12 – Bodyguardian Charging Cradle – Side view In the previous figures the following components can be found: 5. Recharging contacts (to charge the Bodyguard Control Unit) 6.
BODYGUARDIAN CONTROL UNIT – BASE KIT 2.4 Operator Manual AC/DC MEDICAL POWER SYPPLY The following figure shows the specified medical AC/DC adapter for Bodyguardian Charging Cradle powering up and their parts: 8. AC/DC Medical power supply 9. Mains plug 10. Isolated voltage output connector with cable 8 10 9 Figure 2-13 – AC/DC Medical Power Supply 2.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 3 POWERING UP THE DEVICE The Bodyguardian Control Unit is powered through an internal battery. The battery is rechargeable by means of the Bodyguardian Charging Cradle connected to the mains trough the AC/DC power supply. 3.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Figure 3-1 – Connection to Bodyguardian Charging Cradle 3.1.1 RECORDING AUTONOMY The autonomy of operating and recording of the Bodyguardian Control Unit is determined by many factors linked each other. Main factors determining the duration are the following: Battery charge level Batteries performance Data Sampling frequencies Operative Mode. The Rechargeable battery integrated in the device has a capacity of 380mA.
BODYGUARDIAN CONTROL UNIT – BASE KIT 3.2 Operator Manual SWITCHING ON/OFF THE DEVICE In order to switch ON the Bodyguardian Control Unit, push with a short pressure the button area in middle of the upper face (Push button). LED 2 and LED 3 will flash when the Bodyguardian Control Unit is turned on. After the Bodyguardian Control Unit completes its initialization, the middle led ( ) will flash green.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 4 WORKING MODE 4.1 PREPARING THE PATIENT The stage of preparing the patient is very important in order to obtain a good acquisition of the biological signals and can be divided in the following phases: Identification of the Disposable adhesive electrodes patch application site. Preparation of the skin. Application of the Disposable adhesive electrodes patch. 4.1.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Prepare the skin area by cleaning with soap and water. If hair is present, shave the area. Make sure application area is dry with no lotion or cream applied. 4.1.3 PLACING THE DISPOSABLE ADHESIVE ELECTRODES PATCH Follow the following instructions in order to correctly place the Bodyguardian Control Unit. 1.
BODYGUARDIAN CONTROL UNIT – BASE KIT 4.2 Operator Manual OPERATIVE MODES The Bodyguardian Control Unit can be configured to run in different operative modes depending from the conditions (i.e. presence of Bluetooth connection with an Associated Device, configuration settings received, etc.) as described below: IDLE Mode: is when the Bodyguardian Control Unit is powered ON and it is waiting to establish a Bluetooth pairing connection with the Associated Device.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual The upload frequency depends on the Configuration Specifications. The Bodyguardian Control Unit is equipped with an internal memory capable to store up to 24 hours of data recording, enabling the device to work as an Holter equipment. 4.2.2 STREAMING MODE In Streaming mode the Bodyguardian Control Unit operates as an acquisition and transmitter of the physiological data.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual Asymptomatic Events recording: while wearing the Bodyguardian Control Unit some asymptomatic events can be recorded. Asymptomatic events occurs when the values of physiological parameters detected violates the medical protocol specified by the configured thresholds. In case of asymptomatic event detection the Bodyguardian Control Unit will send a notification of the event to the Associated Device.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 5 MAINTENANCE 5.1 GENERAL INFORMATION ABOUT MAINTENANCE In order to keep the Bodyguardian Control Unit working for a long time and to ensure the patient’s and the operator’s safety, it is necessary that the general checks indicated below are periodically performed by medical or paramedical qualified staff or by technical staff authorized by Preventice.
BODYGUARDIAN CONTROL UNIT – BASE KIT 5.2 Operator Manual SAFETY CHECKS It is essential to periodically check the equipment and the devices or systems it is connected to and all the connections in order to ensure that the equipment continues working efficiently and safely. It is also necessary to check the equipment to remove any dust deposits. Preventive or corrective maintenance operations must be performed by qualified technical staff expressly authorized by Preventice.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual WARNING The state of battery charge is not guaranteed for inactivity periods longer than 1 month of storage at temperatures up to +45 ° C. It is generally recommended to perform a cycle of discharge/charging the battery after periods of inactivity. 5.3 CLEANING THE DEVICE It is necessary to keep the equipment clean in order to avoid dust deposits, which could interfere with the efficiency of all the system components.
BODYGUARDIAN CONTROL UNIT – BASE KIT 5.4 Operator Manual PARTICULAR WARNINGS FOR CRITICAL COMPONENTS ATTENTION The internal battery installed in the equipment cannot be accessed by the user and its replacement must be performed only by qualified staff expressly authorized by Preventice. In every case please follow the general warnings listed below (for exemple in case of discard of components replaced by servicing technicians).
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 6 TECHNICAL CHARACTERISTICS 6.1 BODYGUARDIAN CONTROL UNIT Product name Description Bodyguardian Control Unit Active, non-invasive medical device Intended use The Bodyguardian Control Unit is used for ambulatory monitoring of non-lethal cardiac arrhythmias. Bodyguardian Control Unit is a wearable electronic device that is worn on the chest.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual The “Body Guardian” Control Unit is intended from adult without race exclusion. Patient with implanted device are excluded to wear this device. Applied Standards Standard Edition / year Description IEC 60601-1 Ed. 2 + A1 + A2 + Deviation UL/CSA Medical Electrical Equipment – General requirement for safety IEC 60601-1-1 Ed. 2 Collateral standard: Safety requirements for medical electrical systems Ed.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual - Temperature: - Relative humidity: - Atmospheric pressure: External dimensions and weight Height: Width: Depth: Max Weight: Case Material: from -30°C to +60°C from 5% to 95% RH (excluding condensation) from 500hPA to 1060hPA ~ 17 mm ~ 60 mm ~ 50 mm ~ 35 g PC Polycarbonate Battery Capacity 350 mAh min, 380 mAh typical, 1.
BODYGUARDIAN CONTROL UNIT – BASE KIT Accelerometer Operator Manual 3 axis 12-bit Sampling Rate ECG 128/256 Hz Impedance 32 Hz Accelerometer 50 Hz Measurement Ranges Heart Rate 25 to 240 BPM Respiration 0 to 30 BrPM Posture ± 2g range in x,y,z direction Data Storage Capacity 24 hours continuous recording Type Internal NAND Flash Communication Means Bluetooth communication between Bodyguardian Control Unit Smatphone Communication Frequency 2.
BODYGUARDIAN CONTROL UNIT – BASE KIT 6.3 6.3.1 6.4 Operator Manual AC/DC MEDICAL POWER SUPPLY OPTION 1 Manufacturer Model Input Output Safety standards FRIWO AC/DC ADAPTER FW7662M/06 100-240 VAC – 50-60 Hz 5.9VDC @ 1A Fulfils Class II SELV for IEC 60601-1, UL 2601, VDE, CE label, SIQ, Fulfill medical application class B / BF / CF Electrical protection level Case Class II Material: Plastic Dimensions: 52 x 52 x 35.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual CHAPTER 7 REQUEST FOR ASSISTANCE 7.1 OBTAINING SERVICE In case of problems such as failure of the device or anyway in case of partial or incorrect working that cannot be solved through usual maintenance operations, please contact one of the main offices or branches of Preventice or the nearest retailer or authorized servicing center.
BODYGUARDIAN CONTROL UNIT – BASE KIT 7.2 Operator Manual PREVENTICE MAIN OFFICES OPERATING OFFICES PREVENTICE 1652 Greenview Drive SW Rochester, MN 55902 Phone 800-509-0503 Fax 507-281-3630 Website www.preventice.com Any other authorized assistance center or Technical assistance numbers.
