TV-100 Operators Manual Rev 121719

Table of Contents About this Manual ... 7 I. Scope ... 7 II. Indications for Use / Intended Use ... 7 III. Organization of this Manual... 7 About this Manual... 7 Chapter 1: Installation... 7 Chapter 2: Principles of Operation ... 7 Chapter 3: User Interface... 7 Chapter 4: Performance Checkout Procedures ... 7 Chapter 5: Alarm Handling ... 7 Chapter 6: Troubleshooting ... 8 Chapter 7: Specifications ... 8 IV. Symbols ... 9 V. Abbreviations ... 11 VI. Safety Statement ... 13 VII. Warnings, Cautions, and Notices ... 14 Document Conventions for Warnings, Cautions, and Notices ... 14 WARNINGS ... 14 CAUTIONS ... 17 NOTICES ... 18 VIII. Contact Information ... 20 IX. Recommended Maintenance Schedule ... 21 Chapter 1: Installation... 22 1.1 Unpacking ... 22 1.2 Accessories ... 22 1.3 Cleaning and Sterilization ... 23 1.3.1 LCD Touchscreen Keypad ... 23 1.3.2 Patient Circuit... 23 1.4 Batteries ... 24 1.4.1 Battery Overview ... 24 1.4.2 Battery Installation and Initial Charge ... 26 1.5 Patient Circuit Connection ... 27 1.6 USB Dock / Software Update Connection ... 28

Table of Contents 1.7 Training Recommendations ... 28 Chapter 2: Principles of Operation ... 29 2.1 General Overview ... 29 2.2 Phases of Breath ... 30 2.2.1 Inspiration ... 30 2.2.2 Expiration ... 30 2.3 Breath Types ... 30 2.3.1 Assisted Breath ... 30 2.3.2 Mandatory Breath ... 30 2.3.3 Manual Breath ... 31 2.3.4 Sigh Breath ... 31 2.3.5 Spontaneous Breath... 31 2.4 Ventilation Controls ... 32 2.4.1 Volume Control ... 32 2.4.2 Pressure Control... 32 2.4.3 Pressure Support... 34 2.5 Ventilation Modes... 34 2.5.1 A/C Mode (Assist/Control) ... 34 2.5.2 CPAP Mode (Continuous Positive Airway Pressure) ... 35 2.5.3 NIV Mode (Non-invasive Ventilation) ... 35 2.5.4 SIMV Mode (Synchronized Intermittent Mandatory Ventilation) ... 36 2.5.5 PRVC-AC Mode (Pressure Regulated Volume Control – Assist Control) ... 37 2.5.6 nCPAP/HFNC (High Flow Nasal Cannula) Mode ... 38 2.5.7 Apnea Detection ... 38 2.5.8 Standby Mode ... 38 2.6 Oxygen Delivery ... 39 2.6.1 Oxygen Controls ... 39 2.6.2 Oxygen Source ... 39 2.6.3 Oxygen ... 40 Chapter 3: User Interface... 41 3.1 Physical Interface ... 41 3.1.1 Case Overview... 41 3.2 Graphical User Interface (GUI) ... 43

Table of Contents 3.2.1 Startup... 43 3.2.2 Setup Assistant ... 46 3.2.3 Popup Menus ... 48 3.2.4 Status Bar ... 52 3.2.5 Main Page ... 55 3.2.6 Parameters ... 57 3.2.7 Alarms Page... 61 3.2.8 Monitoring Page... 64 3.2.9 Lung Mechanics Page ... 65 3.2.10 Graphs Page ... 66 3.2.11 Tools Page ... 68 Chapter 4: Performance Checkout Procedures ... 70 4.1 General Overview ... 70 4.2 Touchscreen Calibration ... 70 4.3 Oxygen Calibration ... 71 4.4 Leak Test ... 72 4.5 Compliance Measurement ... 73 4.6 Audio & Alarm Test ... 75 4.7 Resistance Measurement ... 75 Chapter 5: Alarm Handling... 77 5.1 General Overview ... 77 5.2 High Priority Alarms ... 77 5.3 Medium Priority Alarms ... 78 5.4 Alarm Silence and Alarm Inhibition ... 78 5.4.1 Alarm Silence ... 78 5.4.2 Alarm Inhibition ... 78 5.5 Displaying Alarms ... 79 5.5.1 Patient Parameter Alarms ... 79 5.5.2 Alarms Tab ... 79 5.5.3 Warning Popup ... 79 5.6 Alarm Parameter Ranges and Alarm Limits ... 82 Chapter 6: Troubleshooting ... 83 Chapter 7: Specifications ... 84

Table of Contents 7.1 Specifications ... 84 7.2 Operating and Storage / Shipping Environment ... 85 7.3 Electrical Specifications... 85 7.4 Physical Characteristics ... 85 7.5 Pneumatic Characteristics... 85 7.6 EN 60601-1 Safety Ratings ... 86 7.7 AC Adapters and Inverters ... 86 7.7.1 Land Operation ... 87 7.7.2 Air Operation – Fixed or Rotary Wing Aircraft ... 87 7.7.3 Inverter Operation ... 87 7.8 EMC Compatibility ... 88 7.8.1 Additional Guidance and Manufacturer’s Declaration – Electromagnetic Emissions/Immunity ... 88 7.9 Device End-of-Life Disposal ... 93 7.9.1 Disassembly Hazards (for service or EOL device disposal)... 93 Addendum A ... 95 Changes in IFU... 95 Additional Information per IEC 60601-1 & 60601-1-8 Standards ... 95 Addendum B ... 96 Changes in IFU... 96 Additional Information... 97 Addendum C ... 98 Changes in IFU... 98

About this Manual I. Scope This manual describes the features and operation of Bio-Med Devices Inc. TV-100 ventilator. To help ensure patient safety and proper performance of the TV-100, read and familiarize yourself with this manual before operating the TV-100.

II. Indications for Use / Intended Use The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both invasive and non-invasive ventilation modes. The TV-100 is a transportable device, but can also be used in a fixed or permanently-installed installation. The TV-100 is intended for use in hospital including intrahospital transport, pre-hospital, and air transport settings. The TV-100 is intended for use in ground / road ambulances and in air ambulances (both helicopters and fixed-wing aircraft).

III. Organization of this Manual About this Manual This section provides introductory information about the TV-100. This section includes scope, intended use, symbols, abbreviations, and safety information.

Chapter 1: Installation This section provides information on unpacking, installing, and connecting the TV-100 ventilator; provides a list of the accessories included with the TV-100; provides information on the TV-100; and provides cleaning and sterilization information.

Chapter 2: Principles of Operation This section provides a detailed description of the TV-100 principles of operation.

Chapter 3: User Interface This section provides a detailed description of the TV-100 user interface.

Chapter 4: Performance Checkout Procedures This section provides procedures to set up and test the TV-100 prior to patient use.

Chapter 5: Alarm Handling This section provides a detailed description of how to recognize and respond to TV-100 alarm conditions. Bio-Med Devices, Inc.

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About this Manual Chapter 6: Troubleshooting This section provides a top level troubleshooting guide for the TV-100.

Chapter 7: Specifications This section provides TV-100 product specifications. This section also provides information on operating environment, physical and pneumatic characteristics of the unit, AC adapters and inverters, and EMC compatibility.

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About this Manual IV. Symbols Symbol

Description Alarm Silence Type BF Equipment

Manufacturer

Date of Manufacture

MR Unsafe Direct Current Warning

Caution

Notice

Consult Accompanying Documents

Follow Instructions for Use

Power On / Off

Must be disposed of in accordance with WEEE Directive. At the unit’s “end of life”, it may be returned to the manufacturer for proper reclamation.

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About this Manual Symbol

Description

Rx Only

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner EC Representative Patient Output Connector

Flow Sensor Connector

Exhalation Valve Connector

Airway Pressure Connector

O2 Connector

Do Not Obstruct

Product should be kept dry The CE mark displayed on this product signifies that this device is in compliance with the European Medical Devices Directive (Council Directive 93/42/EEC). As a prerequisite for the CE mark, Bio-Med Devices operates under an ISO 13485 compliant quality system (covering the design and manufacture of medical devices). The four-digit code underlying the CE mark (0086) pertains to BioMed's Notified Body, the British Standards Institute, whose function is to investigate and attest to the validity of CE-mark claims. Humidity Limitation

Temperature Limit

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About this Manual V. Abbreviations Abbreviation

Definition

A/C AC Ah

assist/control alternating current amp-hour

BPH BPM

breaths per hour breaths per minute

C CCW cm cmH2O CPAP CW

degrees Celsius counter-clockwise centimeter centimeters of water pressure continuous positive airway pressure clockwise

DARV dB DC

diaphragm actuated relief valve decibel direct current

E-Time, E, or EXP ESD ESDS Exh

expiratory time electrostatic discharge electrostatic discharge sensitivity exhalation

F

degrees Fahrenheit

Hz

hertz (cycles per second)

I:E Ratio I-Time, I, or INSP

inspiratory to expiratory ratio inspiratory time

kg kPa

kilogram kilopascal

L lbs LCD

liter pounds liquid crystal display

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About this Manual Abbreviation

Definition

LED LPM

light emitting diode liters per minute

mA mL mm MRI ms mV MV MVe

milliamp milliliter millimeter magnetic resonance imaging millisecond millivolt minute volume exhaled minute volume

N/A

not applicable

Paw PCB PEEP PIP P/N PSI

pressure at the patient connector (airway pressure) printed circuit board positive end expiratory pressure peak inspiratory pressure part number pounds per square inch

SIMV Sec SN

synchronized intermittent mandatory ventilation second serial number

Te Ti

expiratory time inspiratory time

UI

user interface

VA VAC VDC VER VT VTe

volt amp volt alternating current volt direct current software version tidal volume exhaled tidal volume

W

watt

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About this Manual VI. Safety Statement Bio-Med Devices, Inc. TV-100 ventilator performs in conformity with the specifications and descriptions contained in this manual, when operated in accordance with the information provided herein. It is your responsibility to read and familiarize yourself with this manual before operating Bio-Med Devices, Inc. TV-100 ventilator. The TV-100 should only be used by qualified medical personnel. Attempting to use the TV-100 without a comprehensive understanding of its operation may result in patient injury. Before connecting the TV-100 to a patient complete the procedures detailed in Chapter 4: Ventilator Performance Checkout Procedures. If the TV-100 fails during a checkout procedure remove the TV-100 from use, contact Bio-Med Devices, Inc., and return the unit to be serviced by a qualified technician.

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About this Manual VII. Warnings, Cautions, and Notices Document Conventions for Warnings, Cautions, and Notices Warnings, cautions, and notices are presented in this manual in a format dissimilar to their surrounding text in order to clearly delineate the important information provided by these messages. An example of each message is presented below: WARNING: When the ventilator is connected to a patient, qualified medical personnel should be present at all times, or within hearing range of the ventilator alarm system. CAUTION: Touchscreen control buttons should be pressed by hand only. Care should be taken not to allow buttons to be contacted by sharp objects, as damage may result. NOTICE: The batteries should be replaced at least every 2 years. Only use batteries supplied by Bio-Med Devices, Inc. part number PRT5567.

WARNINGS  

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When the ventilator is connected to a patient, qualified medical personnel should be present at all times, or within hearing range of the ventilator alarm system. In case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient death. In transport / EMS situations, the alternative life supporting method would usually be a manual resuscitator bag. For longer periods of usage time, e.g. in case of ventilator failure in a hospital setting, another ventilator should be used to replace the original ventilator. Only qualified medical personnel should operate the TV-100. The operating instructions provided in this manual are not intended as recommended clinical protocols. Do not attempt to ventilate a patient until thoroughly familiar with the operating instructions. Always test the TV-100 prior to use. Ventilate a test lung to verify proper operation prior to connecting the TV-100 to a patient. If the TV-100 fails a checkout procedure discontinue use, Bio-Med Devices, Inc. technical support should be contacted, and the TV-100 should be serviced by a qualified technician. If a ventilator malfunction should occur, Bio-Med Devices, Inc. technical support should be contacted, the TV-100 should be removed from use and serviced prior to use on another patient. Only qualified, trained, service technicians should attempt repairs and service when necessary. Serious personal injury and/or equipment damage can result if repairs are performed by unqualified personnel. If a system error persists after cycling power remove the TV-100 from use and contact Bio-Med Devices, Inc. technical support.

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About this Manual         

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Do not connect the TV-100 to a patient or ventilate a patient if there is any connection made to the USB dock. Do not make any connection to the USB dock while ventilating a patient. If the TV-100 is connected to a PC via the USB dock, starting TV-100 Utility while the TV-100 is powered on will turn off TV-100 power. Whenever an alarm condition exists it should be rectified immediately. Do not allow ventilation for an extended length of time with an alarm condition. Alarm limits set by alarm auto set may need to be adjusted manually. Verify that clinically appropriate alarm limits are set prior to connecting the TV-100 to a patient. VTe and MVe alarm limits are not set in alarm auto set functionality. Verify that clinically appropriate VTe and MVe alarm limits are set prior to connecting the TV-100 to a patient. It is imperative to verify that clinically appropriate alarm limits are fully operational following connection of the ventilator to a patient. The patient should not be left unattended after the alarm silence key is pressed as this will be followed by a period when the audible alarms are deactivated. The alarm port on the TV-100 should never be obstructed. In the event of an AC power failure, the TV-100 will automatically switch to battery operation and sound an alarm. The audible alarm may be silenced by pressing the alarm silence button, which will be flashing. On fully charged batteries, there will be approximately 7 hours of battery powered operation. No further lost external power alarm will sound until the low battery alarm. The low battery alarm may be temporarily silenced by pressing the alarm silence button. It is imperative to restore external power at this time to assure continued safe operation of the ventilator. Rapid blinking of the battery charge indicator LED indicates a problem charging; Bio-Med Devices, Inc. technical support should be contacted. It is extremely important that the pressure trigger control be carefully adjusted to assure proper operation in the SIMV and CPAP modes. In CPAP mode manual breaths will be delivered according to the set value of the backup breath. It is important that the backup ventilation parameters be carefully adjusted to assure proper operation of the manual breath feature. Under certain conditions in SIMV, with PEEP, even though the low peak pressure alarm is set correctly for assisted breaths there may be no low peak pressure alarm following a patient disconnect until the next delivered assisted breath. This period can be up to one minute. As an added precaution, set the low PEEP/CPAP and low exhaled tidal volume alarms so that they are appropriately operative. Always be certain that the maximum pressure limit is set correctly and is operative even when volume limiting to prevent possible inadvertent administration of high pressure. Increased pressure can be caused by blockage, changes in patient compliance or resistance, or system malfunction. If the control pressure is set to a value greater than the peak pressure high alarm limit, then the TV-100 will set the high alarm limit 1 cmH2O above the control pressure value. If the pressure at the patient connector exceeds the peak pressure high alarm limit, then the TV100 will initiate pressure cycle to the set PEEP low alarm limit pressure.

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About this Manual   

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Operation of the TV-100 in a contaminated environment can be hazardous to the patient. A patient filter should always be used in the patient breathing circuit to prevent cross contamination. Do not re-use disposable breathing circuits. Re-use of disposable (single-use) breathing circuits can result in contamination (patient infection) or circuit degradation (circuit can fall apart, develop holes, or exhibit polymer decay). Extreme care should be taken to assure that the patient circuit components are connected correctly. Improper connection can cause ventilator malfunction. The exhaled volume of the patient can differ from the measured exhaled volume due to leaks around the mask, or any other leaks in the breathing circuit. The ventilator is to be provided with CO2 monitoring equipment for the measurement of expiratory carbon dioxide concentration, e.g., in the expiratory limb or at the patient connection port, in accordance with the standard BS EN ISO 80601-2-55, before being put into service. Do not apply tension to the flow sensor tubing. The flow sensor should not be in the patient circuit when not connected to the ventilator. Do not operate the TV-100 without batteries since it will fail to operate if the external power supply is disconnected. The TV-100 battery will require increased time to charge if the battery is depleted to less than 1% of charge capacity. The battery will not charge above 54 degrees Celsius (131 degrees Fahrenheit). Extended exposure to temperatures above 45 degrees Celsius can degrade battery performance and life. Breathing through the negative pressure relief valve requires greatly increased work of breathing and only air is provided. A situation in which the patient is breathing through this valve should be rectified immediately in order to prevent possible adverse effects to the patient. The TV-100 shall not be covered or positioned in such a way that the operation or performance of the TV-100 is adversely affected. Do not position the TV-100 in such a way that there is a risk of overheating. Do not block the gas intake port or emergency intake port. If the gas supply fails or there is a total electrical power failure, the patient may breathe atmospheric gas through the emergency intake port. This is, however, only a temporary emergency measure, which requires elevated inspiratory effort and it should be corrected immediately. Adding attachments or other components or sub assemblies to the ventilator breathing system can change the pressure gradient across the ventilator breathing system, and such changes to the ventilator breathing system can adversely affect the ventilator performance. Nebulization or humidification can increase the resistance of breathing system filters, and the operator needs to monitor the breathing system filter frequently for increased resistance and blockage. The accuracy of the ventilator can be affected by the gas added by use of a nebulizer. The TV-100 should be used while it is in an upright position. Do not continue to use a ventilator which has been seriously impacted or abused.

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About this Manual    

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To avoid risk of electrical shock when using the TV-100 with AC power connected, this equipment must only be connected to a supply mains with protective earth. Because this is a CE marked device, the TV-100 must never be modified without prior expressed written consent from Bio-Med Devices, Inc. If using this ventilator in conjunction with a humidifier, a temperature monitor with alarm must be used if such a monitor is not a part of the base humidifier unit. The TV-100 requires the oxygen input to be within the pressure range of 40-90 PSI. For units with the low pressure oxygen concentrator available as the oxygen source (not available in all regions), the required input pressure range includes 1-32 PSI. When the pressure falls outside that range, the TV-100 will display an O2 Pressure Inlet Out of Range alarm condition. Outside of this specified range, the delivered oxygen concentration cannot be guaranteed to remain in specification. The alarm condition should be corrected as quickly as possible. This device is MR unsafe and not to be used in an MRI environment. Do not use in a hyperbaric chamber. Do not use with nitric oxide. Do not use with helium or with gas mixtures containing helium. The initial charge of the TV-100 battery will be 30% or less of the rated capacity in accordance with IATA transport safety guidelines. The battery should be charged fully prior to operating the TV-100 ventilator. Volume-limited ventilators should not be used on unattended patients. Avoid exposure to known sources of EMI (electromagnetic interference) with medical devices such as magnetic resonance imaging MRI systems, diathermy, lithotripsy, electrocautery, RFID (Radio Frequency Identification), and electromagnetic security systems such as metal detectors. Note that the presence of RFID devices may not be obvious. If the ventilator is dropped, it should be examined by qualified personnel for both external and internal damage. A complete checkout should be performed before returning the ventilator to service.

CAUTIONS      

Only replace the battery pack with Bio-Med Devices, Inc. part number PRT5567. Do not substitute. The battery pack thermal fuse goes open circuit and non-resettable (rendering the battery nonfunctional) if the cell case temperature reaches 93 degrees Celsius (200 degrees Fahrenheit). When using an AC power source, only the power supply provided with the TV-100 is approved for use with this ventilator. Any other power supply may cause damage and/or unreliable operation. Any more comprehensive DC power supply than that which is supplied must be short circuit protected and must comply with all of the specifications as listed in Chapter 7: Specifications. When it is necessary to operate the TV-100 from an AC inverter, only inverters in compliance with NEMA standards should be used. Touchscreen control buttons should be pressed by hand only. Care should be taken not to allow buttons to be contacted by sharp objects, as damage may result.

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About this Manual    

Do not place liquids on or near the TV-100. Liquid entering the unit can cause severe damage and malfunction. Do not position the equipment in such a way as to make it difficult to operate the disconnect device (applies to either end of power cord: the wall plug or the connector to the AC adapter). Antistatic or electrically conductive hoses or tubing should not be used with the TV-100. Under no circumstances should the TV-100 unit be gas sterilized, steam autoclaved, or submerged in liquid. The components of the unit are incompatible with these sterilization methods and severe damage can result.

 Moisture or dirt can affect the operation of the TV-100. Any input oxygen supply source must always be clean and dry; the oxygen should be “medical oxygen” per FDA terminology, that is, at least 99.0% pure. The oxygen also must contain < 37.5 milligrams of water per cubic meter of gas (mg/m3) or < 50 ppm H2O.

 When using a low pressure oxygen source option, the maximum attainable FiO2 will be limited by the oxygen flow limits, the oxygen purity, and the MVE.

 When utilizing an oxygen concentrator, the oxygen concentration may not be constant due to limitations in flow, pressure, purity and concentration of the supplied oxygen. The inspired oxygen concentration will vary, depending on the pressures, volumes, flows and circuit leak.

 Portable and mobile RF communications equipment can affect medical electronic equipment.

NOTICES    

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With constant flow on, pressure trigger and pressure support are inoperative. Additionally, peak pressure and PEEP read continuous pressure during CPAP mode. The maximum pressure should always be set higher than PEEP in order to achieve the PEEP setting. It is recommended that an external filter be used at all times in order to provide greater protection to the internal components of the TV-100. If a patient filter is not used there is a possibility of contamination with bodily fluids or expired gases during normal or single fault condition to the following components in the gas pathway: pressure relief valve assembly, oxygen sensor, mass flow sensor, main proportional valve, compressor assembly, and input manifold. If the ventilator is contaminated internally due to use without a patient filter, do not attempt to clean the internal components of the device. Instead, return the ventilator to the factory for evaluation. When using a patient filter connect it directly to the patient connector then connect the patient circuit. Due to the fact that O2 sensors sometimes change output over time once exposed to atmosphere, a calibration should be performed periodically (once a month) in order to assure optimal accuracy. When the sensor is consumed and does not calibrate properly, it should be discarded and a new sensor installed and calibrated.

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About this Manual 

The batteries should be replaced at least every 2 years. Only use batteries supplied by Bio-Med Devices, Inc., part number PRT5567. The TV-100 is capable of approximately 7 hours of operation with fully charged batteries under typical patient parameters. When running with two batteries installed, approximately 20 minutes of operation will remain after the second low battery alarm (charge below 10%) assuming properly maintained batteries in good condition. Prior to disposal of any component, with particular attention to the batteries and PCB, check with your local controlling authority for disposal regulations. Only you may make a claim against the carrier for damage occurring in shipment. Notify the carrier if any damage is observed. Non Bio-Med Devices, Inc. brand circuit compliance data is unknown, and volume compensation will be unavailable until the circuit compliance is measured. The TV-100 is equipped with automatic barometric pressure compensation for measured exhaled tidal volume. TV-100 components in contact with respiratory gases are shipped from the manufacturer clean, but not sterilized. Some portion of any oxygen supplied to the oxygen high pressure gas inlet is used as “fresh gas” (i.e. patient gas, gas supplied to the ventilator breathing system) if the delivered oxygen percentage is set above 21%. The possibility of hazards arising from errors in the software program is minimized via the use of the standards EN 62304 & ISO 14971 in design control. Negative pressure (subatmospheric) is not available with this ventilator during the expiratory phase.

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NOTES ON USE IN EMS ENVIRONMENT 

Exposure to sunlight should not have any appreciable effect on the ventilator.

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When using the ventilator for extended periods of time in a high dust environment the external filter should be changed more frequently.

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About this Manual VIII. Contact Information Authorized Representative in the European Community

Bio-Med Devices’ Official Agent in Europe is: Medical Market I.N.T. AB Sehlstedtsgatan 6 115 28 Stockholm Sweden Telephone: +46-8-767-70 00 Fax: +46-8-731 90 09

Service If service is required in the USA, the TV-100 must be properly packed and shipped pre-paid, directly or through your dealer, to the address below. Bio-Med Devices, Inc. 61 Soundview Road Guilford, CT 06437 USA Toll Free Telephone: 800-224-6633 If service is required internationally, contact your local distributor for further instruction. WARNING: Only qualified, trained, service technicians should attempt repairs and service when necessary. Serious personal injury and/or equipment damage can result if repairs are performed by unqualified personnel.

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About this Manual IX. Recommended Maintenance Schedule Periodic preventative maintenance should be performed to insure continued proper operation of the TV-100 Ventilator. The frequency of preventative maintenance is determined by many factors, some of which are: 

Frequency & length of use

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Quality of compressed gas source(s)

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Environmental conditions

Timeline The following is a list of routine maintenance procedures and maintenance schedule:

Interval

Recommended Procedures

Prior to each use Periodic Annual

Check battery condition Performance check Verify calibration Recommend return to factory for this service Major overhaul, cleaning and calibration Battery Replacement1 Recommend return to factory for this service

Every 2 years

1.

Replace only with batteries supplied by Bio-Med Devices, Inc. P/N PRT5567. Do not substitute.

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