BAM Labs Biometric Monitoring System Instruction Manual
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Contents Customer Instructions...4 Intended Use...4 IMPORTANT SAFETY INSTRUCTIONS...5 WARNINGS...6 FCC Warning...7 LED Feedback...9 Connecting the Device...11 System Set-up and Use...12 Troubleshooting...17 Maintenance...21 Operating Environment...21 Warranty...22 3
Customer Instructions Thank you for purchasing the BAM Labs Biometric Monitoring System. All safety and operating instructions should be read and understood before using the system for the first time. This manual should be kept for future reference. Failure to follow these instructions may lead to improper system function, equipment damage, or personal injury. You may also download a more detailed setup guide at: http://www.bamlabs.com/support/setupguide.pdf Intended Use The BAM Labs Biometric Monitoring System is indicated for use as a patient bed monitoring system. This device is intended for use by caregivers to monitor patient movement while in bed, including in and out of bed events and timed alerts for position management to aid in the prevention of decubitus ulcers. This unit is designed for monitoring in and out of bed events and offers timed alerts for position management, it is not designed or intended for medical diagnosis. Measurement results are for monitoring purposes and long-term trend analysis only and should not be used as the basis for starting or modifying treatment without independent confirmation by medical examination. 4
IMPORTANT SAFETY INSTRUCTIONS SAVE THESE INSTRUCTIONS - DANGER TO REDUCE THE RISK OF FIRE OR ELECTRIC SHOCK CAREFULLY FOLLOW THESE INSTRUCTIONS Install in accordance with manufacturer s instructions only. Do not use this device in or near water or excessive moisture. Maintain a minimum distance of at least 15cm around the device for sufficient ventilation. This device should be kept clear of all items such as newspapers, linens, curtains, etc. in order to maintain proper ventilation. Do not install near any heat sources such as radiators, heat registers, stoves, or other device that can produce heat. Protect the USB cable from abrasion or binding particularly at plugs, convenience receptacles, and the point where they exit at the device. Refer all servicing to qualified service personnel. Servicing is required when the device has been damaged in any way, such as network adapter or cabled is damaged, liquid has been spilled or objects have been into device, the device has been exposed to rain or moisture, does not operate normally, or has been dropped. 5
WARNINGS WARNINGS Never open the Network Device or Sensor. There are no user serviceable parts inside the device. Do not try to service this product yourself! Contact your device supplier each and every time your device need maintenance. There is a risk of electric shock! In the event of damage, disconnect the device from AC power and contact device supplier. This applies, for example, if: The Device s metal prongs are damaged Liquid has been spilled on the device or objects have fallen into the device. The device has been exposed to rain or water. The device does not work, even though the operating instructions have been followed properly. The device s case or the Sensor cable is damaged. 6
FCC Warning The equipment described in this guide has been tested and found compliant with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules and found to comply with the limits of the standard for medical devices, IEC 60601-1-2. The unit also complies with the requirements of EN 60601-1-2, providing the presumption of compliance to the European Union s Medical Device Directive 93/42/EEC and as amended by 2007 / 47 / EC. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at his/her own expense. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the use is encourage to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that which the receiver is connected. Consult the dealer or an experienced radio/tv technician for help. 7
Biometric System Description Buttons, Connectors and LEDs AC Power Buttons 1. Calibrate 2. Put-Back-in-Bed USB Port 8
LED Feedback The green LEDs provide status feedback for the network device. Below are the meanings of each LED. A light being on indicates active status. Symbol Meaning Indicates connection is good to the BAM Labs service. Indicates the device has general Internet connectivity. If light is not on, it may indicate a problem with the local Internet access. When this is solid on local WiFi connection is established. If light is blinking: Once: device cannot find WiFi. Twice: Found Wifi but WPA password is incorrect. Three times: Found Wifi but WEP password is incorrect. This is generally off and only blinks if: optional Ethernet port is activated, an Ethernet cable is attached, and is receiving network packets. Power indicator 9
Sensor Mat Air Valve Open only during installation procedure to adjust air pressure TIghten firmly by hand to close System must be recalibrated after any adjustmen to air pressure USB Cable Connect to Network Device Model: B01.X only Route USB cable carefully to avoid interference with adjustable bed motion Keep USB clear of foot traffic 10
Connecting the Device Step One Insert the USB Cable into the USB port on the bottom of the device Step Two Plug the Network device into a power outlet. To ensure compliance with UL60601-1 and EN60601-1 use BAM Labs Network Device Model: B01.X and BAM Labs Biometric Sensor only. Network Device should be placed away from routine traffic and outside of the patient vicinity. Patient Vicinity: In areas in which Patients are normally cared for, the Patient Vicinity is the space with surfaces likely to be contacted by the Patient or an attendant who can touch the Patient. This encloses a space within the room 1.83m (6 feet) beyond the perimeter of the bed in its intended location, extending vertically 2.29m (7.5 feet) above the floor. 11
System Set-up and Use A. These items are needed to use the BAM Biometric Sensor BAM Biometric Sensor BAM Network Device USB memory stick Wireless internet access Your wireless access point SSID and password Mac or PC computer with browser and internet access iphone, ipod touch or ipad with the BAM Labs application installed B. Inflating the Sensor Mat Unroll the BAM Biometric Sensor on a flat surface. Unscrew the inflation valve, this will allow the mat to self-inflate within 15-20 minutes. Once the mat has fully inflated, tighten the inflation valve firmly by hand (do not use tools or overtighten). C. Sensor Mat placement Carefully place the BAM Biometric Mat between your mattress and box spring, taking care to center the pad under the area where you will be sleeping. Make sure the pad is flat and that none of the corners of the mat are bent under or extend beyond the edge of the bed in any direction. 12
It is recommended to place the Mat so that the sensor (corner with USB port) is on the outside edge of the bed. This will give easy access to the USB port. After the mat is placed between your mattress and box spring, replace your 13
normal bedding (sheets/blankets/pillows) on the bed. D. Network Device set-up The Network Device connects the Biometric Sensor Mat to the Internet and BAM Labs website. Step 1 Go to the BAM Labs web site to set up a USB key used to configure your Network Device. Log in at: http://health.bamlabs.com a. Click Settings b. Click tab Networks 14
c. Click Add New Network if one does not exist d. Insert USB stick in to computer and follow activation instructions on page. Step 2 Now that USB Key is configured, insert the key into the Network Device. Connect AC Power. 15
16 USB Port Step 3 Insert the USB cable from the Biometric Sensor in to the USB port on the Network Device.
To ensure compliance with UL60601-1 and EN60601-1 use BAM Labs Network Device Model: B01.X and BAM Labs Biometric Sensor only. Step 4 Configuration with Mobile device (ipad, iphone, Touch) The final step in setting up your BAM Biometric Sensor is to verify the WiFi signal strength, check the mat pressure, calibrate the mat, and assign a Room name. Using your iphone, ipad or ipod touch; locate and open the BAM Labs App. Log in using your BAM Labs account information. Select Settings at the bottom of the screen, and then touch Configure Devices. Select the device you wish to configure. If there is more than one device without a room name, you can identify the device by looking at the number labeled MAC: xx:xx:xx:xx:xx:xx: on the back of the Network Device. Troubleshooting A.What do I do if LEDs on the Network Device continue to blink? 17
All LEDs except for the Ethernet LED should be lit. It may take up to a minute for all of the LEDs to light up. If any of the LEDs are blinking, the Network Device could not connect to the Internet. This may be related to the access point SSID or password, of if the Internet connection is down. LED 1 LED 2 LED 3 LED 4 LED 5 LED 1: Power If not on, the device is not powered. Check AC power source. LED 2: Ethernet Not used for Network Device Model: B01.X LED 3: Wi-Fi Status This LED indicates Wi-Fi connection status. It has the following possible states: 18
OFF: Not using Wi-Fi ON: Connected to wireless access point Single blink: Unable to locate Access Point Double blink: Bad WPA/WPA2 password Triple blink: Bad WEP password LED3 Solutions Single blink - the Network Device cannot locate the wireless Access point. There are two possible causes: The SSID is not correct. Please go back to Step 3 to re-generate a USB key with the correct SSID. The wireless Access Point is out of range. Move the Network Device closer to the Access Point, or verify that you are able to access the wireless access point from a mobile device such as an ipod touch. Two or three blinks - the Network Device is able to find your wireless access point, but the password is incorrect. Go back to Step 3 to re-generate a USB key with the correct password. LED 4: Internet Connection Status This LED indicates general Internet connectivity status. This light will be on if general connectivity exists. It has the following possible states: OFF: Not connected to a LAN via Wi-FI or Ethernet 19
ON: Connected to the Internet (not necessarily BAM Labs) Single blink: Network Device is able to connect to the local LAN (wireless Access Point or Ethernet), but is not able to communicate to the Internet. LED4 Solutions Check your Internet connection or verify that you are able to access the Internet from a PC on the same network. LED 5: BAM Labs Status This LED indicates connectivity to BAM Labs servers. OFF: Not connected to the Internet ON: Connected to BAM Labs Single Blink: Unable to connect to BAM Labs, or receiving an error LED5 Solution If this problem persists, contact support@bamlabs.com. B. How do I add a Person and Assign to a Room? Log on to the BAM Labs web site https://health.bamlabs.com: 20
1. Navigate to People menu 2. Click the Add New Person button. 3. Fill in person information, assign to room. 4. Use room drop down menu to select room. 5. Click Save button. Click Home button - person and room should appear. C. Where do I go for additional help? 21
Talk to your distributor, or use the Contact Us tab in the Trouble Shooting section, or email support@bamlabs.com. Maintenance User maintenance is limited to the following: The Biometric Sensor may be cleaned with a slightly damp cloth using water or mild detergent and wiped dry with a clean cloth. The Network Device requires no maintenance and has no user serviceable parts. Do not disassemble or attempt to service the unit, there are no user serviceable parts. Repairs should be carried out by authorized personnel only. If the device or mat is splashed or contaminated with liquid, stop operation and remove all power. Do not immerse the device or mat in liquids or clean any of the unit surfaces with organic solvents. Do not puncture mat with sharp objects Operating Environment Operation/Storage Environment: 5degC - 40degC Humidity: < / = 80%, non-condensing 22
Warranty BAM Labs warrants its products and services, including the Biometric Mat (18 months) and the Network Device (6 months), from the date of receipt by the customer. Defective products must be returned through an RMA process. An RMA number can be obtained by contacting the BAM Labs authorized reseller where the product was purchased. Please follow the authorized reseller warranty claims process to ensure efficient processing of your claim. BAM Labs may make the final determination as to whether the product was defective or if the product became defective through misuse, handling or storage. 23
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