WelchAllyn 719 Series Lithium Ion Handle and USB Charging Accessory Owner’s Manual

WelchAllyn 719 Series Lithium Ion Handle and USB Charging Accessory

Welch Allyn 719 Series Lithium Ion Handle and USB Charging Accessory
Directions for use

© 2018 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication. The purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.
Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.
For information about any Welch Allyn product, contact Welch Allyn Technical Support.

727009 DIR 80022350 Ver. D Revised: 2018-07

901087, Instrument Handle

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA www.welchallyn.com

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland

Introductory information

Introduction

Thank you for purchasing the Welch Allyn 719 Series Lithium Ion Power Handle. The handle is intended to be used as a power source for all Welch Allyn standard instrument heads. The 719 series represents a new generation of handles from Welch Allyn. Taking advantage of new battery technology, the 719 series provides you double the on-time in a smaller and lighter weight package. Smarter battery technology means that “memory” is no longer an issue. What’s more, the 719 reminds you to recharge with its low battery indicator. The soft rheostat section provides a sure grip and the overall design is ergonomically sound.
Before using this product, please read the following warnings and instructions.

Symbols

Documentation symbols

• Warning : The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death.
• Caution: The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data.
• Consult directions for use (DFU). A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days.

Power symbols

Direct current (DC)

Shipping, storing, and environment symbols

• Relative humidity limits: Operating : 10% – 95% Transport/storage : 10% – 95%

• Temperature limits:
                    Operating : 50° F (10° C) –104° F (40° C)
  Transport/storage : –4° F (–20°C) –120° F (49° C)

• Recycle

• Fragile

• Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

• Atmospheric air pressure: 500 hPa – 1060 hPa

• Do not use if box is damaged

• Keep dry

Miscellaneous symbols

• For use by or on the order of a licensed medical professional
• Product Identifier
• Reorder number, Model number
• Global Trade Identification Number
• Lot code
• Meets essential requirements of the European Medical Device Directive 93/42/EC
• Manufacturer
• Authorized Representative in the European Community
• IPXO : Equipment not protected against the ingress of water

Intended use and environment
The handle and charging accessory is primarily intended to be used by clinicians in professional healthcare facility environments such as general physician’s offices, hospitals, specialist’s offices, urgent care facilities, clinics, and clinical training sites. Do not use in environments where the intensity of EM disturbances is high, such as near HF surgical equipment or RF shielded rooms for MRI.

About warnings and cautions
Caution statements can appear on the Welch Allyn device, the charging accessory, the packaging, the shipping container, or in this Directions for use.
The Welch Allyn device and charging accessory are safe for patients and clinicians when used in accordance with the instructions and caution statements presented in this Directions for use.
Before using the device and charging accessory, you must familiarize yourself with all cautions, with the steps to power up the device and charging accessory, and with the sections of this Directions for use that pertain to your use of the device and charging accessory. In addition to reviewing the general cautions presented in the next section, you must also review the more specific cautions that appear throughout the manual in conjunction with operation and maintenance tasks.

• Failure to understand and observe any warning statement in this manual could lead to patient injury or illness.
• Failure to understand and observe any caution statement in this manual could lead to damage to the equipment or other property.

General warnings and cautions

• Warning Electric shock hazard. Do not open the handle or charging accessory or attempt repairs. The handle and USB charger have no user-serviceable internal parts. Only perform routine cleaning and maintenance procedures specifically described in this manual. Inspection and servicing of internal parts shall only be performed by qualified service personnel.
• Warning Patient injury risk. To avoid the risk of fire, burns, or damage to your battery pack or lamp, prevent metal objects from touching across the positive and negative battery contacts.
• Warning Patient injury risk. Charge the device outside the patient vicinity.
• Warning Fire and explosion hazard. Do not operate the device or charging accessory in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched environments; or in any other potentially explosive environment.
• Warning Personal injury risk. Improper handling of the battery can lead to heat generation, smoke, explosion, or fire. Do not short-circuit, crush, incinerate, or disassemble the battery. Never dispose of batteries in refuse containers. Always recycle batteries according to national or local regulations.
• Warning Personal injury risk. No modification of this equipment is allowed.
• Warning Personal injury risk. Use only Welch Allyn approved accessories, and use them according to the manufacturer’s directions for use.
• Warning Personal injury risk. This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.
• Warning Electromagnetic interference risk. The device complies with applicable domestic and international standards for electromagnetic interference. These standards are intended to minimize medical equipment electromagnetic interference. Although this device is not expected to present problems to other compliant equipment or be affected by other compliant devices, interference issues still may occur. As a precaution, avoid using the device in close proximity to other equipment. In the event that equipment interference is observed, relocate the equipment as necessary or consult the manufacturer’s directions for use.
• Warning Personal injury risk. Use of accessories other than those specified may result in increased emissions or decreased immunity of the equipment.
• Warning Personal injury risk. Do not use if device, accessory, or packaging appears and/or is damaged.
• CAUTION This device is intended only for adult use in homes.
• CAUTION Use only with USB compliant power and/or data ports.
• CAUTION Use the 719 Series handle only with Welch Allyn approved accessories and charging accessories.

Parts list

No.              Feature

1.           Low battery indicator

2.           On/Off button

3.           Instrument head attachment

4.           Rheostat section
   No.          Feature

5.                          Chrome ring

6.                   Battery section (71960)

7.                 USB charging module

8.                   USB Micro-B port

9.                Charging indicator light

Device information

Charge the device

1. Remove instrument head and insert the T-stud on the USB charging module into theT- slot on the battery section.

2. Rotate 90° in either direction. The T-stud will lock into place.

3. Using the Welch Allyn-supplied USB cable, connect the Micro-B end of the cable to the charging module.
   CAUTION Use only with USB compliant power and/or data ports.

4. Connect the USB-A end of the cable to the charging source.

5. Charge for 18 continuous hours to charge a fully discharged battery.
   The charging indicator on the USB charger will blink during charging and then stay on when the battery section is fully charged.
   The battery may be charged after partial discharge without negatively affecting overall battery memory (unlike Ni-Cad cells).
   Note Do not attempt to use or service the instrument during charging. The handle will not supply power to any instrument head while charging.

6. When charging is complete, disconnect the handle and charging accessory from the USB cable.
   Do not leave the USB charging module plugged into a USB port without the handle attached.

7. After charging is complete, remove the USB charging module from the battery section if desired.

CAUTION The battery section is not shipped fully charged. For maximum performance, charge the battery section for 18 hours when new or after a long period of inactivity.

Note : The handle is only compatible with the 71943 charging base, 71950 AC charging accessory, 71955 USB charging accessory, and the 7114X desk charger.

Low battery indicator
The low battery indicator will illuminate several minutes before the handle shuts off, depending on the age of the battery.
Once the battery is fully discharged, the low battery indicator may flicker.

Operate the device

1. Connect instrument head to the handle.
2. To turn on, press the On/Off button on the rheostat section and rotate the rheostat section clockwise (CW).
3. To intensify the light, continue to rotate CW until a stop is reached.
4. To turn off, rotate counter clockwise (CCW). The On/Off button will click when fully off.

Note: Turn fully off after each use to ensure maximum on-time from the battery.

Clean the device

• Do not soak/saturate the handle assembly or charger.
• Do not immerse handle assembly or charger in any solution.
• Do not sterilize the 719 Series power handle, charging base, or charger.
  

1. Wipe the handle and charger with an appropriate health care low- or intermediate-level cleaner/disinfecting wipe that incorporates either a 1:10 sodium hypochlorite (bleach) solution or isopropyl alcohol as the active disinfection ingredient.
2. Follow wipe manufacturer’s instructions for appropriate use, contact times and applicable warnings and precautions.

Battery replacement

Remove the battery section

1. Hold the instrument handle firmly by the battery section.
2. Turn the rheostat section counterclockwise until it detaches from the battery section.

Replace a new battery section

1. Insert the rheostat section into the new battery section.
2. To connect the two sections, turn the rheostat section clockwise until tight.
3. Ensure that the rheostat section is secure on the battery section of the instrument handle.

Device disposal

This product and its accessories must be disposed of according to local laws and regulations. Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply.

Service and support

Service
If the product fails to function properly or if assistance, service, or spare parts are required, contact the nearest Welch Allyn Technical Support Center.
Support
http://www.welchallyn.com/about/company/locations.htm

Appendices

Specifications **

**

Warning: No modification of this equipment is allowed.

Specifications and design may change without notice.

Guidance and manufacturer’s declaration
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical equipment. This device complies with IEC 60601-1-2:2014/EN 60601-2-1:2015.

• All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this Directions for use.

• Portable and mobile RF communications equipment can affect the behavior of medical electrical equipment.
  The device complies with all applicable and required standards for electromagnetic interference.

• It does not normally affect nearby equipment and devices.

• It is not normally affected by nearby equipment and devices.

• It is not safe to operate the device in the presence of high-frequency surgical equipment.

• However, it is good practice to avoid using the device in extremely close proximity to other equipment.

Note : The handle and charging accessory has no essential performance requirements.
WARNING The use of the handle and charging accessory adjacent to or stacked with other equipment or medical electrical systems should be avoided because it could result in improper operation. If such use is necessary, the handle and charging accessory and other equipment should be observed to verify that they are operating normally.
WARNING Use only Accessories recommended by Welch Allyn for use with the handle and charging accessory. Accessories not recommended by Welch Allyn may affect the EMC emissions or immunity.
WARNING Maintain minimum separation distance between the handle and charging accessory and portable RF communication equipment. Performance of the handle and charging accessory may be degraded if proper distance is not maintained.
WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of the handle and charging accessory, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Emissions and immunity information

Electromagnetic emissions
The handle and charging accessory is intended for use in the electromagnetic environment specified below. The customer or user of the handle and charging accessory should assure that it is used in such an environment.

Electromagnetic immunity
The handle and charging accessory is intended for use in the electromagnetic environment specified below. The customer or the user of the handle and charging accessory should assure that it is used in such an environment.

Electromagnetic immunity
The handle and charging accessory is intended for use in the electromagnetic environment specified below. The customer or the user of the handle and charging accessory should assure that it is used in such an environment.

Note1 : 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 handle and charging accessory is used exceeds the applicable RF compliance level above, the handle and charging accessory should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the handle and charging accessory.
bovver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the handle and charging accessory
The handle and charging accessory is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the handle and charging accessory can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the handle and charging accessory as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distanced 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.

• For some services, only the uplink frequencies are included.
• The carrier shall be modulated using a 50 percent duty cycle square wave signal.
• As an alternative to FM modulation, 50 percent pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

Warranty

The 719 series Power Handle and USB Charging Accessory is guaranteed by Welch Allyn against all manufacturing defects for one year. Welch Allyn will repair or replace, free of charge, any parts of its own manufacture proven to be defective through causes other than misuse, neglect, damage in shipment, or normal wear.
Welch Allyn warrants that the Welch Allyn 71960 Battery Section will perform to original specifications during the two years from the date of manufacture, when used with the Welch Allyn 719 series Power Handle. This warranty does not apply to the use of the 71960 battery in other products. A defective battery will be replaced if it fails within two years of the date of manufacture.

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