Teleflex Arrow EZ-IO, 9040, 9058 - Power Driver Manual

Also See for Arrow EZ-IO:

Instructions for use (2 pages)

Instructions for use manual (152 pages)

Table of Contents

Contents

1 DESCRIPTION
2 INFORMATION
3 SAFETY INFORMATION
4 IMPORTANT INFORMATION FOR USERS
5 STORAGE
6 BATTERY INFORMATION
7 INDICATORS & ALERTS
8 CARE AND CLEANING
9 Declaration-Electromagnetic Emissions
10 Declarations - Electromagnetic Immunity
11 Documents / Resources
- 11.1 Download manual

Teleflex Arrow EZ-IO, 9040, 9058 - Power Driver Manual

DESCRIPTION

Product Overview

The EZ-IO® Power Driver is a sealed, hand-held, lithium battery powered medical device.

INFORMATION

Driver Ref. numbers: 9040 (Tactical); 9058 (Civilian).
Applied Parts: EZ-IO® Intraosseous Vascular Access Needles - 15 mm; 25 mm; 45 mm.

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 Teleflex sales representative.
Additional product information can be found at ArrowEZIO.com.
As with any emergency medical device carrying a backup is a strongly advised protocol.

IMPORTANT INFORMATION FOR USERS

In order for EZ-IO® Intraosseous Vascular Access System products to perform properly, the following conditions are recommended. 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 Teleflex.
Use only EZ-IO® Intraosseous Vascular Access needle sets 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® Power Driver do the work.

STORAGE

The EZ-IO® Power 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® Power Driver is 10 years or approximately 500 insertions.
Life expectancy is dependent on actual usage (bone density and average insertion time), storage, and frequency of testing.
When storing the Vascular Access Pak (VAP) remove the trigger guard to prevent accidental activation of the EZ-IO® Power Driver.

BATTERY INFORMATION

Drivers are sealed and not intended to be opened.
Batteries are not replaceable.

INDICATORS & ALERTS

EZ-IO® Power Driver LED will be solid green when trigger is activated and has sufficient power.
EZ-IO® Power Driver LED will blink red when the trigger is activated and has only 10% of battery life remaining.
Purchase and replace the EZ-IO® Power Driver when the red LED begins blinking.

CARE AND CLEANING

Maintain BSI or PPE precautions.
Wipe entire exterior surface of EZ-IO® Power Driver with soft, clean moistened cloth. Use soft bristled brush to remove any visible soil.
Spray exterior surface with anti-microbial solution following the solution manufacturer's specific recommendations.
Gently wipe exterior surfaces with gauze pads until visible debris is removed.
Clean and manipulate trigger using cloth moistened with anti-microbial solution.
Using sterile swabs, moisten with anti-microbial solution, gently clean inside opening around metal drive shaft.
After cleaning, inspect to ensure no visible debris remains, and no damage has occurred.
Dry driver with a soft, clean cloth and return to appropriate location.

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® Power Driver, grasp the needle set by hand, and advance the needle set into the medullary space while twisting the needle set.

If your clinical environment requires sterilization, the EZ-IO® Power Driver can be sterilized using the STERRAD® 100S System. STERRAD® Systems are products of ©ADVANCED STERILIZATION PRODUCTS, Division of Ethicon Inc., a Johnson & Johnson company.

No modification of this equipment is allowed.

Declaration-Electromagnetic Emissions
The EZ-IO® Power Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the EZ-IO® Power Driver should assure that it is issued in such an environment.
Emission Test	Compliance	Compliance
RF Emissions CISPR 11	Group 1	The EZ-IO® Power 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	The EZ-IO® Power 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.
Harmonic emissions IEC 61000-3-2	Not applicable
Voltage fluctuations/flicker emissions IEC 61000-3-3	Not applicable

Declarations - Electromagnetic Immunity
The EZ-IO® Power Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the EZ-IO® Power 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 mode +/- 2 kV common mode	Not applicable (battery 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 Ur) for 0.5 cycles 40% Ur (60% dip in Ur) for 5 cycles 70% Ur (30% dip in Ur) for 25 cycles <5% Ur (95% dip in Ur) for 5 sec	Not applicable (battery powered)	Mains power quality should be that of a typical commercial or hospital environment. If the user of the EZ-IO® Power 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.
Power frequency (50/60Hz) magnetic field IEC 61000-4-8	3 A/m	3 A/m	Power frequency magnetic fields should be at levels characteristic of typical location in typical commercial or hospital enviroment.
NOTE: Ur is the a.c. mains voltage prior to application of the test level.