PHILIPS 100605C DreamStation Cellular Modem Installation Guide

PHILIPS 100605C DreamStation Cellular Modem Installation Guide

Intended Use

The DreamStation Cellular Modem is designed for use with select Philips Respironics therapy devices. Once installed, it can transfer data between the therapy device and Philips Respironics proprietary compliance software. If available on your model, the modem is able to receive oximetry data and transfer it to the therapy device.

Package Contents

DreamStation Cellular Modem

Warnings and Cautions

Warnings

• If you notice any unexplained changes in the performance of this device, if the device is dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact Philips Respironics for assistance.
• Repairs and adjustments must be performed by Philips Respironics-authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly damage.
• To reduce the risk of bodily injury and damage to the equipment, retain and follow all product safety and operating instructions.
• The Health Industry Manufacturers Association recommends that a minimum separation of six inches be maintained between a wireless phone and a pacemaker to avoid potential interference with the pacemaker. The DreamStation Cellular Modem should be considered a wireless phone in this regard.
• If you use any other personal critical medical device, such as a pacemaker, consult the manufacturer of your device to determine if it can co-exist in close proximity with our device in terms of RF interferences. Your physician may be able to assist you in obtaining this information.
• Do not use this product in gas stations, fuel stores, chemical plants, and locations containing explosives.
• Do not use accessories, detachable parts, and materials not described in the instructions for use.

Cautions

• Remove power from the therapy device by unplugging the power supply cord’s connector from the power inlet on the back of the device before proceeding with the installation instructions.
• If the modem has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature before beginning the installation procedure.
• Pins of connectors should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. Precautionary procedures include methods to prevent build-up of electrostatic charge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic clothing), discharging one’s body to the frame of the equipment or system or to earth or a large metal object, and bonding oneself by means of a wrist strap to the equipment or system or to earth.

Important! Refer to the therapy device manual for additional warnings and cautions.
Important! From time to time, electronic devices can be affected by irregularities in the electrical power supplies and other electrical equipment. To prevent electrical interference that could affect the performance of your medical equipment, always keep accessories (power supplies, battery packs, etc.) and other electrical devices (telephones, radios, etc.) away from your CPAP when used with the cellular modem.

Symbols Glossary

| Operator’s manual; operating instructions Consult instructions for use.| IEC 60878
ISO 7000-1641
Symbol 5.4.3, ISO 15223-1

|

• Non-ionizing electromagnetic radiation
• Indicates that the equipment includes RF transmitters.

| IEC 60878
IEC 60417-5140

| Drip proof equipment| IEC 60529

|

• Reorder number
• Indicates the manufacturer’s catalogue number so the medical device can be identified.

| ISO 7000-2493
Symbol 5.1.6, ISO 15223-1

|

• Serial number
• Identify the manufacturer’s serial number for the medical device.

| IEC 60878
ISO 7000-2498
Symbol 5.1.7, ISO 15223-1

|

• Manufacturer
• Indicates the medical device manufacturer.

| IEC 60878
ISO 7000-3082
Symbol 5.1.1, ISO 15223-1

|

• Date of manufacture
• Indicates the date when the medical device was manufactured.

| IEC 60878
ISO 7000-2497
Symbol 5.1.3, ISO 15223-1

|

• Temperature limit
• Indicates the storage temperature limits to which the medical device can be safely exposed.

| IEC 60878
ISO 7000-0632
Symbol 5.3.7, ISO 15223-1

|

• Humidity limitation
• Indicates the range of humidity to which the medical device can be safely exposed.

| IEC 60878
ISO 7000-2620
Symbol 5.3.8, ISO 15223-1

|

• Keep dry
• Indicates the medical device that needs to be protected from moisture.

| IEC 60878
ISO 7000-0626
Symbol 5.3.4, ISO 15223-1

|

• Fragile, handle with care
• Indicates the medical device can be broken or damaged if not handled carefully.

| IEC 60878
ISO 7000-0621
Symbol 5.3.1, ISO 15223-1
Standards Reference
ISO 7000:2014, Graphical symbols for use on equipment – Registered symbols
ISO 15223-1:2017, Medical devices—Symbols to be used with medical devices labels – General requirements IEC 60417:2002 DB, Graphical symbols for use on equipment
IEC/TR 60878:2015, Graphical symbols for electrical equipment in medical practice
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)

Installing the Modem

In order for the modem to work properly, it must be installed in a therapy device.

1. Ensure the therapy device is turned off.
   

2. Open the accessory door on the therapy device.

3. Remove the accessory door from the therapy device by lifting and firmly sliding the door to the left and pulling the right side of the door toward you until it pops out. This may take several attempts.

4. Slide the modem into the accessory slot until it clicks into place.
   

Note: After powering on, up to 30 seconds may elapse before the modem is ready to make a call.

Important! The modem will automatically call within 5 minutes of installation if the blower is off and a manual call has not been successfully completed.

Making a Call

Normally, the modem will automatically make a call and upload therapy data at predetermined times set by your provider. The modem will not make a call while the blower is on and the therapy device is delivering therapy.

If instructed to do so by your provider, you can manually make a call by navigating to the My Provider menu on the therapy device and selecting “Upload.” The device will then display the animated Sending screen, then display that the upload was competed.

• My Provider Screen
  

• Upload Screen

• Animated Sending Screen
  

• Upload Complete Screen
  

Note: When located near a clock radio, speaker, or other electronic device, an occasional buzzing noise may be heard. Relocate the therapy device and modem away from the electronic device to reduce or eliminate this noise

Modem On/Off

If necessary, you may turn the modem off temporarily by navigating to the My Setup menu and selecting “Modem Off.” The modem will not be able to make any calls while off, and an airplane icon will appear on the upload screen. When you are ready to turn the modem back on, navigate to the My Setup menu and select “Modem On.”

• My Setup Screen
  

• Modem Off Icon

• Upload Screen when Modem is Off
  

• Modem On Icon

Error Messages

If a connection or upload attempt fails, an error message that indicates the error number will be displayed on the therapy device screen.

Example of an Error Message

Number

| Displayed Text| Meaning|

Action

---|---|---|---

1-0

1-1

|

Carrier Network Issue

|

Connection Error

| Try removing power from the therapy device by unplugging the power supply cord’s connector from the power inlet on the side of the device, wait 10 seconds, then plug the cord in again. Then try initiating a manual call by navigating to the My Provider menu on the therapy device and selecting “Upload.” See the “Making a Call” section of this guide. If problem persists, contact your provider.

The provider should check the Philips Respironics proprietary compliance software for additional information.

1-2

1-3

1-4

|

Call Again Later

2-0

2-1

2-2

2-3

2-4

2-5

|

Call Again Later

|

Internal Communication Error

| Try initiating a manual call by navigating to the My Provider menu on the therapy device and selecting “Upload.” See the “Making a Call” section of this guide. If problem persists, contact your provider.

The provider should check the Philips Respironics proprietary compliance software for additional information.

3-0

|

Call Product Support

|

Software Configuration Error

| Try initiating a manual call by navigating to the My Provider menu on the therapy device and selecting “Upload.” See the “Making a Call” section of this guide. If problem persists, contact your provider.

The provider should check the Philips Respironics proprietary compliance software for additional information.

3-1

|

Check Enore Setup

3-2

|

Call Again Later

4-0

4-1

4-2

4-3

|

Modem Service Required

| Invalid Device Configuration Error| Contact your provider. The provider should check the Philips Respironics proprietary compliance software for additional information.

Note: Philips Respironics proprietary compliance software is developed by Philips Respironics and is intended for use by physicians and home care providers.

Removing the Modem

1. Ensure the therapy device is turned off.

2. Gently pull the modem out of the therapy device.
   
   Remove the Modem

3. Replace the accessory door on the therapy device. To do so, hold the right “hook” in place in the upper right side of the opening and firmly push the left “hook” into the left side of the opening. Apply pressure until the door clicks into place.

Temperature and Storage Information

 |

Operation

|

Transport & Storage

---|---|---
Temperature:|

41° to 95° F (5° to 35° C)

|

-4° to 140° F (-20° to 60° C)

Humidity:|

15% to 95% non-condensing

|

15% to 95% non-condensing

Disposal

Dispose of this device in accordance with local regulations.

Additional Notices

• Notice: This device contains an FCC certified cellular radio module.
  Only certified co-location with other radio transceivers (e.g. with the Bluetooth® radio in the Philips Respironics DreamStation therapy device) is permitted, as per the instructions in this manual or the manuals of the host device this accessory may be used with.
  For compliance with FCC RF exposure guidelines, a minimum distance of 20 cm between the Cellular Modem and the user’s body should be maintained during its operation.
  Notice: For regulatory identification purposes, the DreamStation Cellular Modem is assigned a model number of XXXXXXC.

• Notice: There are no user-serviceable parts within the cellular modem.

• Notice: The cellular modem is not suitable for use on airlines.

• Notice: Use of non-original manufacturer-approved accessories may violate your local RF exposure guidelines and should be avoided.

• Notice: This cellular modem contains a certified cellular radio module with
  FCC-ID XPY2AGQN4NNN.

• Notice: This device complies with part 15 of the FCC Rules. 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.
  This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio, TV reception, or other devices, which can be determined by turning the equipment on and off, the user is encouraged to try to correct the interference by one or more of the following measures:

  • Reorient or relocate the receiving antenna (on the radio, TV, or other device).
  • Increase the separation between the equipment and receiver.
  • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
  • Consult the dealer of the device for help.

• Notice: Any changes or modifications made to the device that are not expressly approved by Respironics may void the user’s authority to operate the equipment.

For Canada only:

Notice: This ISM device complies with Canadian RSS-GEN.
Notice: This device complies with ISED license-exempt RSS(s).
Notice: This Wireless Modem contains IC: 8595A-2AGQN4NNN
Notice: Operation is subject to the following two conditions;

1. This device may not cause interference and
2. This device must accept any interference, including interference that may cause undesired operation for the device.

The Term “IC:” before the certification/registration number only signifies that registration was performed based on a Declaration of Conformity indicating that ISED technical specifications were met. The term “IC:” before the certification/ registration number does not imply that ISED approved the equipment.

Product Support

Should you experience trouble with this equipment or require assistance setting up, using, or maintaining the equipment, contact your home care provider or Philips Respironics at 1-800-345-6443 or 1-724-387-4000.

Specifications

The cellular modem has an expected service life of 5 years.
Mode of Operation: Continuous

Radio Specifications

• Maximum Output Power: 23 dBm
• Modulation: OFDM/SC-FDMA
• Channel Bandwidth: 1.4 MHz
• Operating Frequency Ranges:
  746 – 756 MHz Receive
  777 – 787 MHz Transmit

Limited Warranty

Respironics, Inc., a Philips company, warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two (2) years from the date of sale by Respironics, Inc. to the dealer. If the product fails to perform in accordance with the product specifications, Respironics, Inc. will repair or replace – at its option – the defective material or part. Respironics, Inc. will pay customary freight charges from Respironics, Inc. to the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse, alteration, water ingress, and other defects not related to material or workmanship or the discontinuance of a network (e.g. 2G, 3G, etc.) by a carrier (e.g. ATT, Verizon, etc.). The Respironics, Inc. Service department shall examine any devices returned for service, and Respironics, Inc. reserves the right to charge an evaluation fee for any returned device as to which no problem is found after investigation by Respironics, Inc. Service. This warranty is non-transferable by unauthorized distributors of Respironics, Inc. products and Respironics, Inc. reserves the right to charge dealers for warranty service of failed product not purchased directly from Respironics, Inc. or authorized distributors.

Respironics, Inc. disclaims all liability for economic loss, loss of profits, overhead, or consequential damages which may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This warranty is given in lieu of all other express warranties. In addition, any implied warranties – including any warranty of merchantability or fitness for the particular purpose – are limited to two years. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state. To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contact Respironics, Inc. at:

1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8550
1-724-387-4000

Respironics Inc.
1001 Murry Ridge Lane
Murrysville. PA 15668 USA

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