Starkey Surflink BKLT0209 Wireless Programmer User Manual

PROGRAMMER

OPERATIONS MANUAL

This document contains instructions for connecting SurfLink Programmer to your laptop or desktop PC via a USB connection. SurfLink Programmer requires the latest available Inspire X software to be installed.

Description

SurfLink Programmer is a USB hearing aid programmer functioning as the interface between wireless hearing aids and computer fitting software.
It consists of a USB cable and SurfLink Programmer.

Physical and Performance Characteristics:

• Indicator lights for power and data transfer activity
• SurfLink Programmer to PC connection on

USB is capable of up to 480 Mbps (USB 2.0 high speed)

Installation

1. Confirm that Inspire X 2011 or higher is installed. (SurfLink Programmer is not supported on earlier versions of Inspire X fitting software.)
2. Plug the square end of the USB cable into the back of SurfLink Programmer making sure it is inserted fully.
3. Insert the rectangular end of the USB cable into an open USB port on your PC.
4. Follow the on-screen prompts in the “Add New HardwareWizard” screens. SurfLink Programmer is designed to be “plug and play” and does not require a CD or a restart of the PC.
5. Locate SurfLink Programmer at least 5 feet/1.5meters from the patient.

Operation

Once installed, SurfLink Programmer is ready to use.

To use:

1. Verify SurfLink Programmer is connected to the PC
2. Launch Inspire X 2011 or higher
3. Search for SurfLink Programmer (if needed)

Safety Precautions

Please read the following safety precautions before using SurfLink Programmer for the first time.

Markings and Symbols
The following markings and symbols are used in these safety precautions and/or on the device label.

Power from a USB port
Data transfer indicator

Regulatory and Service Information

Classification

• Classification to the Medical Device Regulation: Class I.
• Classification to IEC 60601-1 Class II Continuous Operation.
• Any associated computer used with SurfLink Programmer must be an IEC 60950-1 or IEC 62368-1 approved computer.

Power Supply

• Operating Voltage: 5.0 vDC supplied from the USB port of an IEC 60950 or IEC 62368-1 approved computer.

Important Safety and Usage Information

Storage and Shipping Conditions:

• Temperature: -20 to 70° C, -4 to 158° F
• Humidity: 30 – 90%
• No condensation

Operating Conditions:

• Temperature: 15 – 35° C, 59 – 95° F
• Humidity: 30 – 90%
• No condensation

Avoid using SurfLink Programmer in areas subject to the following conditions:

• Extreme heat or cold
• Static electricity
• Large amounts of dust
• Rough handling

Rough handling or dropping SurfLink Programmer can cause damage. If you think you may have damaged SurfLink Programmer, or if SurfLink
Programmer is suffering an obvious malfunction, immediately unplug it from your computer and contact your authorized dealer to request servicing.
DO NOT continue to use a damaged SurfLink Programmer.
DO NOT place heavy objects on top of SurfLink Programmer.
Never insert foreign objects into the connections.
Avoid spilling liquid on SurfLink Programmer.
The exterior of SurfLink Programmer may be wiped with a damp cloth or sterile hand wipe. Never use paint thinner, benzene, cosmetics, or other volatile
agents to clean the exterior of SurfLink Programmer.
Never try to take apart or modify SurfLink
Programmer. Doing so creates the danger of fire and electrical shock, as well as SurfLink Programmer malfunction. There are no user-serviceable parts inside SurfLink Programmer. All services must be performed by the authorized dealer. SurfLink
Programmer should not be used on aircraft unless specifically permitted by the flight personnel.
We are required by regulations to provide the following warnings:
WARNING: Use of the SurfLink Programmer directly next to other electronic equipment should be avoided because it could result in improper performance. If such use is necessary, note as to whether your hearing aids and the other equipment are operating normally.
WARNING: Use of accessories, components or replacement parts other than those provided by the manufacturer of SurfLink Programmer could result in increased electromagnetic emissions and decreased electromagnetic immunity and could result in degradation of performance.
WARNING: If Portable Radio Frequency communications equipment is used closer than 30 cm (12 inches) from the SurfLink Programmer, degradation of the performance of your hearing aid could result. If this occurs, move away from the communications equipment.
Any serious incident that has occurred in relation to your Starkey device should be reported to your local Starkey representative and the Competent
Authority of the Member State in which you are established. A serious incident is defined as any malfunction, deterioration in the characteristics and/or performance of the device, or inadequacy in the device Operations Manual/ labeling which could lead to the death or serious deterioration in the state of health of the user OR could do so
upon recurrence.

Regulatory Notices

INTENDED USE
SurfLink Programmer is an accessory to a wireless hearing instrument. It is intended to function as the interface between wireless hearing aids and computer fitting
software.

Original SurfLink Programmer
FCC ID: EOA-WP
IC: 6903A-WP
Model A00
FCC ID: EOA-WPA
IC: 6903A-WPA

FCC/IC NOTICE

This device complies with part 15 of the FCC rules and with Industry, Science, and Economic Development Canada’s license-exempt RSS standard(s). Operation is subject to
the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation of the device.

NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user’s
authority to operate the equipment.

Hereby, Starkey declares that SurfLink Programmer is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. A copy of
the Declaration of Conformity can be obtained from the addresses on page 14 and from docs.starkeyhearingtechnologies.com

Transmitter/Receiver RF Information
In Europe, the SurfLink Programmer operates in the 863-865 MHz band, with a 300 kHz necessary transmit bandwidth and a 500 kHz receive bandwidth, using GFSK FM modulation with an effective radiated power of 3 dBm.

In North America, the SurfLink Programmer operates in the 902-928 MHz band, with a 323 kHz necessary transmit bandwidth and a 500 kHz receive bandwidth, using GFSK FM modulation with an effective radiated power of -7 dBm. SurfLink Programmer has been tested to, and has passed, the following emissions and immunity tests:

• IEC 60601-1-2 radiated and conducted emissions requirements for a Group 1 Class B device as stated in CISPR 11.
• Harmonic distortion and voltage fluctuations affect the power input source as stated in Table 2 of IEC 60601-1-2.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz as well as higher field levels from communications devices as stated in Table 9 of IEC 60601-1-2.
• Immunity to power-frequency magnetic fields at a field level of 30 A/m.
• Immunity to proximity magnetic fields as stated in Table 11 of IEC 60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air discharge.
• Immunity to electrical fast transients on the power input at a level of +/- 2 kV at a 100 Hz repetition rate.
• Immunity to surges on the power input of +/- 1 kV line to line.
• Immunity to conducted disturbances inducedby RF fields on the power input as stated in Table 6 of IEC 60601-1-2.
• Immunity to voltage dips and interruptions on the power input as stated in Table 6 of IEC 60601-1-2.

Starkey Hearing Technologies
6700 Washington Ave. South
Eden Prairie, MN USA
EC REP
Starkey Laboratories (Germany) G.m.b.H
Weg beim Jäger 218-222
22335 Hamburg
Germany

Symbol

| Symbol Meaning| Applicable Standard|

Symbol Number

---|---|---|---
| Manufacturer| BS EN ISO 15223- 1:2016| 5.1.1

EC REP

| Authorized Representative in the European Community| BS EN ISO 15223 – 1:2016| 5.1.2
| Date of Manufacture| BS EN ISO 152231:2016| 5.1.3

REP

| Catalog Number| BS EN ISO 15223-1:2016| 5.1.6

MD

| Medical Device| ISO/DIS 15223-1:2020(E) DRAFT| 5.7.7
| Kee p Dry|  BS EN ISO 15223- 1:2016| 5.3.4
| Temperature Limit| BS EN ISO 15223-1:2016| 5.3.7
| Humidity Limitation| BS EN ISO 15223- 1:2016| 5.3.8
| Caution| BS EN ISO 15223-1:2016| 5.4.4
| General warning sign| EC 60601-1, Reference no.
Table D.2, Safety sign 2| ISO 7010- W001
| Refer to instruction manual/booklet| EC 60601-1, Reference no.
Table D.2, Safety sign 10| ISO 7010- M002
| Collect Separately| DIRECTIVE 2012/19/EU (WEEE)| Annex IX
| Class II equipment| IEC 60417
Reference no. Table D.1| Symbol 9 (IEC 60417- 5172)
| Regulatory Compliance Mark (RCM)| AS/NZS 4417.1:2012| N/A
| Non-ionizing electromagnetic radiation| IEC 60417| 7000-5140
| Direct current| IEC 60601-1
REFERENCE NO.
TABLE D.1, 5031| IEC 60417-
| Recycling Symbol| European Parliament and
Council Directive 94/62/EC| Annex I-VII

SurfLink, Starkey, and Inspire are trademarks of Starkey Laboratories, Inc.
©2021 Starkey Laboratories, Inc. All Rights Reserved.
84603-007 10/21 BKLT0209-05-EE-XX

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