Directions for Use
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Vidacare.com EZ-IO® INTRAOSSEOUS VASCULAR ACCESS SYSTEM DRIVER INSTRUCTIONS FOR USE DESCRIPTION: • The EZ-IO® Intraosseous Vascular Access System provides fast, safe, efficient vascular access when time is critical. It can be used Drive Shaft for adult and pediatric patients anytime when vascular access is difficult to obtain in emergent, urgent or medically necessary situations. • The EZ-IO® Intraosseous Vascular Access Driver is a sealed, hand-held, lithium-battery powered medical drill. • The EZ-IO® Intraosseous Vascular Access Driver is intended for the rapid insertion of a single lumen intraosseous needle set into human bone.
Battery Indicator
TRIGGER
BODY
SEALED LITHIUM BATTERIES
PRODUCT INFORMATION: • Driver Part numbers: 9040 (Military Version); 9058 (Civilian Version); 9059 (Training Version). • Applied Parts: EZ-IO® Intraosseous Vascular Access Needles – 15mm Needle (9018); 25mm Needle (9001); 45mm Needle (9079). • Accessories: Trigger Guard, Vascular Access Pack (VAP)(9065); EZ-IO® Cradle (9072); Hard Sided Carrying Case (9074).
Lanyard Attachment Point
SAFETY INFORMATION: • Indications, Contraindications, Warnings, Precautions and other Safety Information are contained in the Instructions for Use for the EZ-IO® Intraosseous Vascular Access System. • Please consult the Instructions for Use for the EZ-IO® Intraosseous Vascular Access System before applying. If there are questions, or if this information sheet is missing, immediately contact your local Vidacare sales representative. • Additional product information can be found at Vidacare.com. • As with any emergency medical device carrying a backup is a strongly advised protocol. IMPORTANT INFORMATION FOR USERS: In order for Vidacare products to perform properly, Vidacare recommends the following conditions. Failure to comply with these conditions will void any applicable warranties. • Use this product only in accordance with this manual and applicable product labeling. • Adjustments, modifications, technical maintenance or repairs are not allowed. • Do not connect this product or its components to products not recommended by Vidacare. • Use only EZ-IO® Intraosseous Vascular Access needle kits with this product. • Visually inspect driver for cracks and sharp corners before use. • Avoid spilling fluids on any part of this product. • Do not use excessive force during insertion. Let the EZ-IO® Intraosseous Vascular Access Driver do the work.
PN 8047 REV C
Vidacare.com
BATTERY INFORMATION: • Drivers are sealed and not intended to be opened. • Batteries are not replaceable.
STORAGE: • The EZ-IO® Intraosseous Vascular Access Driver and accessories may be stored at temperatures between -20°C to 50°C (-4°F to 122°F). • Expected Shelf Life for the EZ-IO® Intraosseous Vascular Access Driver is 10 years or approximately 500 insertions. • Life expectancy is dependent on actual usage (bone density & average insertion time), storage and frequency of testing. • When storing in the soft Vascular Access Pack (VAP) remove the trigger guard to prevent accidental activation of the EZ-IO® Intraosseous Vascular Access Driver.
EMERGENCY NUMBER:
INDICATORS & ALERTS: • EZ-IO® Intraosseous Vascular Access Driver LED will be solid green when trigger is activated and has sufficient power. • EZ-IO® Intraosseous Vascular Access Driver LED will blink red when the trigger is activated and has only 10% of battery life remaining. • Purchase and replace the EZ-IO® Intraosseous Vascular Access Driver when the red LED begins blinking.
+1-800-680-4911
CARE AND CLEANING: 1. Maintain BSI or PPE precautions. 2. Wipe entire exterior surface of EZ-IO® Intraosseous Vascular Access Driver with soft, clean moistened cloth. Use soft bristled brush to remove any visible soil. 3. Spray exterior surface with anti-microbial solution following the solution manufacturer’s specific recommendations. 4. Gently wipe exterior surfaces with gauze pads until visible debris is removed. 5. Clean and manipulate trigger using cloth moistened with anti-microbial solution. 6. Using sterile swabs, moisten with anti-microbial solution, gently clean inside opening around metal drive shaft. 7. After cleaning, inspect to ensure no visible debris remains, and no damage has occurred. 8. Dry driver with a soft, clean cloth and return to appropriate location.
EZ-IO® INTRAOSSEOUS VASCULAR ACCESS DRIVER
4350 Lockhill Selma, Suite 150 Shavano Park, Texas 78249
Do not immerse or use excessive amount of liquid when performing cleaning and disinfecting. In the unlikely event of a driver failure, remove the EZ-IO® Intraosseous Vascular Access Driver, grasp the needle set by hand and advance the needle set into the medullary space while twisting the needle set.
Customer Service: +1 866 479 8500
If your clinical environment requires sterilization the EZ-IO® Intraosseous Vascular Access Driver can be sterilized using the STERRAD® 100S System, NX® System, and 100NX® System. STERRAD® Systems are products of ©ADVANCED STERILIZATION PRODUCTS, Division of Ethicon Inc., a Johnson & Johnson company.
EMERGO EUROPE
AUSTRALIAN SPONSOR
Molenstrat 15 2513 BH, The Hague The Netherlands
Emergo Australia Level 20, Tower 11 Darling Park 201 Sussex Street Sydney NSW 2000 Australia
EC REP
European Authorized Representative Service
At the completion of the EZ-IO® Intraosseous Vascular Access Driver’s service life, proper disposal is the responsibility of the institution or service (directive 2012/19/EU). Degree of protection against electric shock BF Applied part.
4001639 The EZ-IO® Driver Conforms to the Medical Device Directive (93/42/EEC)
Instructions for Use Serial Number Consult instructions for use
Intraosseous Vascular Access
©
2006, 2009, 2011, 2013 Vidacare Corporation, all rights reserved. Vidacare, EZ-IO® Product System, EZ-Connect® and EZ-IO® Intraosseous Vascular Access System are trademarks of the Vidacare Corporation.
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Vidacare.com Vidacare Declaration Electromagnetic Emissions
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The EZ-IO® Intraosseous Vascular Access Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the EZ-IO® Intraosseous Vascular Access Driver should assure that it is issued in such an environment.
The EZ-IO® Intraosseous Vascular Access Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the EZ-IO® Intraosseous Vascular Access Driver should assure that it is used in such an environment.
Emission Test
Compliance
Compliance
Immunity test
RF Emissions CISPR 11
Group 1
The EZ-IO® Intraosseous Vascular Access Driver uses RF energy only for its internal function. Therefore, its RF Emissions are very low and are not likely to cause interference in nearby electronic equipment.
RF Emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker emissions IEC 61000-3-3
Not applicable
The EZ-IO® Intraosseous Vascular Access Driver is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
Vidacare’s Declarations – Electromagnetic Immunity The EZ-IO® Intraosseous Vascular Access Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the EZ-IO® Intraosseous Vascular Access Driver should assure that it is issued in such an environment Immunity test
IEC 60601 test level
Compliance Level Electromagnetic Environment-Guidance
Electrostatic discharge (ESD) IEC 61000-4-2
+/- 6 kV Contact +/- 8 kV air
+/- 6 kV Contact +/- 8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material the relative humidity should be at least 30%.
Electrical fast Transient/burst IEC 61000-4-4
+/- 2 kV for power supply lines +/- 1 kV for input. output lines
Not applicable (battery powered) Not applicable (no I/O lines)
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
+/- 1 kV differential Not applicable mode (battery +/- 2 kV common mode powered)
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
< 5% Ur (>95% dip in Not applicable Ur) for 0.5 cycles (battery 40% Ur (60% dip in powered) Ur) for 5 cycles 70% Ur (30% dip in Ur) for 25 cycles <5% Ur (95% dip in Ur) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the EZ-IO® Intraosseous Vascular Access Driver requires continued operation during power mains interruptions, it is recommended that the Power Driver be powered from an uninterruptible power supply or a battery.
3 A/m
Power frequency magnetic fields should be at levels characteristic of typical location in typical.
Power frequency (50/60Hz) magnetic field IEC 61000-4-8
3 A/m
NOTE: Ur is the a.c. mains voltage prior to application of the test level.
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
IEC 60601 test level
3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz
Compliance Level
Not applicable (battery powered) 3 V/m
Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the driver including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 3,5 P V1 d = 3,5 P E1 d= 7 P E1 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 the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
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 radio broadcast and TV 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 the measured field strength in the location in which the EZ-IO® Intraosseous Vascular Access Driver is used exceeds the applicable RF compliance level above, the EZ-IO® Intraosseous Vascular Access Driver should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EZ-IO® Intraosseous Vascular Access Driver. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
VIDACARE LIMITED EXPRESS WARRANTY AND DISCLAIMERS
Recommended separation distances between portable and mobile RF communications equipment and the [EQUIPMENT or SYSTEM] The EZ-IO® Intraosseous Vascular Access Driver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EZ-IO® Intraosseous Vascular Access Driver can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EZ-IO® Intraosseous Vascular Access Driver recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W .01 .1 1 10 100
Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 3,5 P V1
80 MHz to 800 MHz d = 3,5 P E1
800 MHz to 2,5 GHz d= 7 P E1
0.12 0.38 1.2 3.8 12
0.12 0.38 1.2 3.8 12
0.23 0.73 2.3 7.3 23
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. • • •
• •
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service accordingly to the EMC information provided in this manual. Portable and mobile RF communications can affect Medical Electrical Equipment. The use of accessories, transducers, and cables other than those specified by the manufacturer, may result in increased Emissions or decreased Immunity of the EZ-IO® Intraosseous Vascular Access Driver. The EZ-IO® Intraosseous Vascular Access Driver should be observed to verify normal operation in the configuration it will be used. The EZ-IO® Intraosseous Vascular Access Driver is designed and tested to run intermittently with a duty cycle of 30 seconds on, 1 minute off for 5 consecutive cycles. Allow 1 hour cool down time. Equipment Classification
Type of protection against electric shock
NA internal powered equipment
Degree of protection against electric shock
Type BF applied part
Degree of protection against ingress of water
IPXO Ordinary protection
Degree of safety or application in the presence of Equipment not suitable for use in the presence a flammable anesthetic mixture of a flammable anesthetic Mixture with air or with oxygen or nitrous oxide
(1) Warranty. Vidacare warrants to the original purchaser of the new products only (“Purchaser”) that during the applicable warranty period: (a) the hardware Products will conform with Vidacare’s written product specifications for such Products in all material respects for the shorter of (i) one year after shipment to Purchaser or (ii) the number of uses of such hardware Product as are specified by Vidacare, and (b) the Disposables will conform with Vidacare’s written product specifications for such Products in all material respects until the expiration date designated therefore on such Disposables (collectively, the “Warranty Period”). The foregoing warranty shall not apply if the Products have been subjected to physical abuse, misuse, abnormal use, use not consistent with Vidacare’s published directions and instructions for use, fraud, tampering, unusual physical stress, negligence or accidents. (2) Limited Remedy; Warranty Procedure. If a Product fails to conform to the warranty set forth under Section (1) above, Vidacare agrees to, in its discretion, repair, replace or refund the purchase price to Purchaser for the nonconforming Product. If a Product fails to conform to the warranty set forth under Section (1), Purchaser shall return the nonconforming Product to Vidacare during the applicable Warranty Period, at Purchaser’s expense; provided, however that Purchaser shall first give prompt written notice to Vidacare, at which time Vidacare shall issue a Return Material Authorization (“RMA”) number for the nonconforming Product. Products sent to Vidacare for warranty replacement without a valid RMA number displayed on the outside of the shipping container may, in Vidacare’s discretion, be returned to Purchaser at Purchaser’s expense. If a Product is returned in compliance with the foregoing requirements, Vidacare shall repair or replace the returned Product as soon as reasonably practicable at no additional cost to Purchaser if Vidacare has previously received payment for the returned Product or, at Vidacare’s discretion, refund the purchase price. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS WARRANTY, THE REMEDIES PROVIDED UNDER THIS SECTION (1) SHALL BE PURCHASER’S SOLE AND EXCLUSIVE REMEDY FOR A FAILURE OF A PRODUCT TO CONFORM TO THE WARRANTY SET FORTH UNDER SECTION (1) ABOVE. (3) Warranty Disclaimers. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE EXPRESS WARRANTY SET FORTH IN SECTION (1) IS THE SOLE AND EXCLUSIVE WARRANTY AND GIVEN IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY OR SUITABILITY. IF THE DISCLAIMER OF ANY IMPLIED WARRANTY IS NOT PERMITTED BY APPLICABLE LAW, THE DURATION AND SCOPE OF SUCH WARRANTY IS LIMITED TO NINETY (90) DAYS FROM THE DATE OF ORIGINAL PURCHASE. OTHER THAN AS WARRANTED UNDER SECTION (1), THE PRODUCTS ARE PROVIDED “AS IS.” THE PRODUCTS ARE DESIGNED FOR USE SOLELY BY TRAINED AND LICENSED MEDICAL PERSONNEL USING REASONABLE MEDICAL DISCRETION IN EMERGENCY MEDICAL SITUATIONS OR MEDICALLY NECESSARY SITUATIONS. VIDACARE DISCLAIMS ANY AND ALL LIABILITY WITH RESPECT TO THE PRODUCTS ARISING FROM ANY USE OF THE PRODUCTS THAT IS NOT CONSISTENT WITH VIDACARE’S PUBLISHED DIRECTIONS AND INSTRUCTIONS FOR USE. (4) Limitation of Liability. IN NO EVENT SHALL VIDACARE BE LIABLE TO PURCHASER, ANY CUSTOMER OR ANY OTHER THIRD PARTY IN ANY MANNER FOR ANY SPECIAL, NONCOMPENSATORY, CONSEQUENTIAL, INDIRECT, INCIDENTAL, STATUTORY OR PUNITIVE DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, FOR LOST PROFITS, LOST SALES, LOST REVENUE OR LOSS OF USE, REGARDLESS OF THE FORM OF ACTION, WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT PRODUCTS LIABILITY, OR OTHERWISE, EVEN IF VIDACARE HAS BEEN INFORMED OF OR IS AWARE OF THE POSSIBILITY OF ANY SUCH DAMAGES IN ADVANCE. VIDACARE’S TOTAL AGGREGATE LIABILITY IN CONNECTION WITH THIS AGREEMENT OR THE PRODUCTS SHALL BE LIMITED TO THE SUM OF THE AMOUNTS PAID TO REPRESENTATIVE BY VIDACARE DURING THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE DATE OF THE EVENT GIVING RISE TO A CLAIM AGAINST VIDACARE.