The WSI01 features an M.2 interface for connectivity. It also
includes an NFC antenna for specific functions and MBAN antennas
for improved wireless performance.

2.1 WSI M.2 Interface

The M.2 interface allows for fast and reliable data transfer
between the WSI01 device and other compatible systems.

2.2 NFC Antenna

The NFC antenna enables near field communication capabilities,
allowing for seamless interactions with supported devices.

2.3 MBAN Antennas

The MBAN antennas enhance the wireless connectivity of the WSI01
device, ensuring stable and efficient communication.

3. WSI SW Description

The software aspect of the WSI01 includes configuration files
and the WSI SW application for managing device settings.

3.1 WSI.conf file

The WSI.conf file contains important configuration settings that
can be customized to suit specific requirements.

3.2 WSI_antenna.conf file

The WSI_antenna.conf file is used to configure antenna settings
for optimal performance.

3.3 WSI SW

The WSI SW application provides a user-friendly interface for
controlling and monitoring the WSI01 device.

4. WSI Radio Certifications

The WSI01 device holds various certifications to ensure
compliance with regulatory standards in different regions.

4.1 EU RED

The EU RED certification signifies that the device meets
European regulatory requirements.

4.2 US FCC

The US FCC certification indicates compliance with Federal
Communications Commission guidelines in the United States.

4.3 Canada ISED

The Canada ISED certification confirms adherence to Innovation,
Science, and Economic Development Canada regulations.

Frequently Asked Questions (FAQ)

Q: How do I update the firmware of the WSI01 device?

A: To update the firmware of the WSI01 device, please follow
these steps: 1. Download the latest firmware update package from
our official website. 2. Connect the WSI01 device to your computer
using a compatible cable. 3. Launch the firmware update tool and
follow the on-screen instructions to complete the update
process.

Q: Can I use multiple WSI01 devices together for extended
coverage?

A: Yes, you can use multiple WSI01 devices together to extend
coverage or create a mesh network. Ensure proper configuration to
avoid interference between devices.

View Fullscreen

WSI01 User Manual

2 Table of Contents

3 Change history ……………………………………………………………………………………………………………… 2

4 Glossary ……………………………………………………………………………………………………………………… 3

5 References …………………………………………………………………………………………………………………… 6

6 1 Introduction ………………………………………………………………………………………………………………. 7

7 2 WSI HW Description ……………………………………………………………………………………………………… 8

2.1 WSI M.2 Interface…………………………………………………………………………………………………………………. 9

2.2 NFC Antenna……………………………………………………………………………………………………………………… 12

2.3 MBAN Antennas …………………………………………………………………………………………………………………. 13

11 3 WSI SW Description ……………………………………………………………………………………………………. 14

3.1 WSI.conf file………………………………………………………………………………………………………………………. 15

3.2 WSI_antenna.conf file ………………………………………………………………………………………………………… 16

3.3 WSI SW ……………………………………………………………………………………………………………………………… 16

15 4 WSI Radio Certifications ……………………………………………………………………………………………… 17

4.1 EU RED ……………………………………………………………………………………………………………………………… 17

4.2 US FCC ……………………………………………………………………………………………………………………………… 18

4.3 Canada ISED ……………………………………………………………………………………………………………………… 19

4.4 Other Countries …………………………………………………………………………………………………………………. 19

38 Change history

Date 5-Aug-2025

Author Timo Hakala

Comments Initial version.

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41 Glossary

Term CE
CFR
CPU CSONE CxPC
ECC
EMC ETSI
FCC FPC FW GEHC HLA Host Device HW I2C IC IEC IO ISED ISO KDB LED

Description Conformité Européenne The CE mark means that the product meets the EU regulatory requirements and thus can be used and marketed in the EU. Code of Federal Regulations The regulations defined by the US governmental departments and agencies representing a broad area of federal regulations. The title 47 covers telecommunication is maintained by the FCC. Central Processing Unit Carescape ONE GEHC patient monitor, the lead product for the WSI module Class 1, 2, 3 or 4 Permissive Change The FCC or ISED process which allows modifications to an already certified device (existing FCC ID or ISED IC). Envelope Correlation Coefficient Antenna performance parameter indicating signal correlation between two antennas. The spatial RX diversity requires uncorrelated antennas. Electromagnetic compatibility Regulatory requirements relating device’s electrical immunity and emissions. European Telecommunications Standards Institute The organization that defines radio and communication standards in Europe. The standards are used to show the RED compliancy. Federal Communications Commission Authority that regulates radio communication in US. Flexible Printed Circuit Firmware GE HealthCare High Level Assembly GEHC product with all parts included (PWA, display, mechanics etc.) GEHC monitoring device that integrates the WSI module as part of the end product. Hardware Inter-Integrated Circuit Two-wire low speed digital control interface. Integrated Circuit International Electrotechnical Commission A global electrotechnology standards organization Input Output Innovation, Science and Economic Development The authority that regulates radio communication in Canada. International Organization for Standardization A global broad range of industry standards organization Knowledge Database FCC guidance document to clarify radio certifications requirements and procedures. Light Emitting Diode

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MBAN MCAL
MCU MDR MWS NB
NFC OS OTA PC PCB PCI-SIG PMU PPM PWA RED
RFU
RX SAR
SCAL

Medical Body Area Network GEHC’s proprietary radio system for wireless patient monitoring. MBAN Calibration file A host device specific calibration file that enables accurate MBAN TX power control for a host device with fixed antenna. The MCAL file is generated either during Hub PWA manufacturing based on the RF measurements or converted from the WSI SCAL file based on the host device antenna parameters. Microcontroller Unit A component integrating CPU, memories and miscellaneous digital peripherals. Medical Device Regulation The EU MDR 2017/745 regulates medical devices in the European Union countries. MyWorkshop GEHC document database Notified Body An accredited person and company (typically a test house) which reviews a RED technical file and gives a NB RED certificate if the material complies with the requirements. Near Field Communication The standard short range radio technology used for pairing Portrait wireless sensors. Operating System Computer operating system like Linux or Windows Over The Air Test setup or use-case in which radiated RF signals through antennas are used. Personal Computer Printed Circuit Board Peripheral Component Interconnect Special Interest Group The organization that defines and maintains the M.2 standards. Power Management Unit Component or block which generates and controls the VDD supplies inside a device. Parameter Platform Middleware The Host CPU SW component that enables communication between the host and WSI. Printed Wireboard Assembly PCB with components assembled, tested and calibrated Radio Equipment Directive The EU directive 2014/53/EU (RED) regulates radio devices used and marketed in the European Union member countries. Widely accepted also in other countries in Europe. Reserved for Future Use HW or SW component which is included in design but is not used in current design. May be used in some future release of the product. Receiver or Reception Specific Absorption Rate Measures the rate (W/kg) at which a human body absorbs RF energy radiated by the tested radio device. The SAR limit ensures that exposure stays within safe limits. Superset Calibration file WSI module specific calibration file that enables accurate MBAN TX power control for different type of host device antennas. The SCAL generated based RF measurement during the WSI PWA manufacturing. The SCAL fie is generated based RF measurement during the WSI PWA manufacturing.

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SMBUS
SW TX UART
UK USB
VSWR
WSI
42

System Management Bus Two-wire communication protocol, derivative of the I2C Software Transmitter or Transmission Universal Asynchronous Receiver/Transmitter Main communication interface between the WSI and host device United Kingdom Universal Serial Bus Standard interface for connecting peripheral to PCs and other devices Voltage Standing Wave Ratio Indicates the quality of the RF matching. Wireless Sensor Interface GEHC radio module that enables wearables sensors in the GEHC monitoring products.

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43 References
GEHC documents [1] Title: Carescape ONE v2 RED (EU) technical file
MWS: DOC3164515 Description: The RED technical file includes the material relating to the CSONE V2 EU radio certification. [2] Title: WSI01 FCC (US) Technical File MWS: DOC3181238 Description: The FCC technical file includes the material relating to the WSI01 US radio module certification. [3] Title: WSI01 ISED (Canada) Technical File MWS: DOC3181243 Description: The ISED technical file includes the material relating to the WSI01 Canada radio module certification External datasheets [4] Title: I-PEX MHF4L datasheet Internet: https://www.i-pex.com/product/mhf-4l Description: WSI MBAN RF (antenna) connector I-PEX MHF4L datasheet which is used as the [5] Title: DF57H-2P-1.2V(21) datasheet Internet: https://www.hirose.com/product/p/CL0666-0104-7-21 Description: WSI NFC RF (antenna) connector Hirose DF57H-2P-1.2V(21) datasheet [6] Title: MBAN W3494_TDS (without dock) MWS: DOC3167940 Description: CSONE MBAN antenna Pulse W3494 datasheet [7] Title: NFC W3965_TDS_V02_20240429 MWS: DOC3167940 Description: CSONE NFC antenna Pulse W3965 datasheet Miscellaneous external documents and specifications [8] Title: PCI Express M.2 Specification, Revision 5.1 Internet: https://pcisig.com/specifications Description: PCI-SIG M.2 specification, which defines M.2 interface used between WSI module and the host device. The document is available only for the PCI-SIG members. GEHC is a PC-SIG member which enables free access to the document after registration. [9] Title: FCC KDB 996369 – D04 Module Integration Guide V02 Internet: https://apps.fcc.gov/oetcf/kdb KDB publication number 996369 D04 Description: The FCC document explains how modules are certified and used in host products. [10] Title: Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz band; Harmonised Standard for access to radio spectrum Internet: https://www.etsi.org/deliver/etsi_en/300300_300399/300328/02.02.02_60/en_300328v020202p.pdf Description: The ETSI standard which covers radio devices using the 2.4 GHz ISM band. [11] Title: Code of Federal Regulations – Title 47 Internet: https://www.ecfr.gov/current/title-47 Description: The collection of the FCC parts (CFR Title 47) which regulate the radio communication in the US. [12] Title: ISED Radio Standards Specifications (RSS) Internet: https://ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-andequipment/radio-equipment-standards/radio-standards-specifications-rss Description: The collection of the ISED radio standards (RSS) which regulate the radio communication in Canada.
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WSI01 User Manual
44 1 Introduction
45 This document provides instructions how to integrate the Wireless Sensor Interface (WSI) module into host 46 products. The target audience is system and design engineers working on the host device development. 47 The WSI module (Figure 1) enables the wireless sensors to connect to the host device (typically a patient 48 monitor). The WSI is used exclusively in GEHC’s internal products. The WSI is not a standalone device and 49 requires a compatible host CPU. The WSI is an M.2 module, which is the industry standard for enabling radio 50 (e.g. WLAN, Bluetooth or cellular) functionality in laptop and desktop PCs. 51 The module is powered by the host device. The UART interface enables communication between the WSI and 52 host device. The OTA communication utilizes GEHC’s proprietary MBAN radio technology. The standard NFC 53 technology is used to pair the wireless sensors with the host device. The MBAN and NFC antennas are not 54 integrated into the WSI module and are instead part of the host device assembly.
55
Figure 1: WSI module (top view with and without RF shield and antennas)
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56 2 WSI HW Description

57 The WSI key operation parameters are listed in Table 1.

58
59 Table 1: WSI operating conditions, connectors and interfaces

Operating conditions

Supply voltage (VDD)

3.3 V ± 5 %

Power consumption

Active mode average < 100 mW

Active mode peak < 1 W (recommended that the host

device power supply can deliver peak currents up to 1 A)

Operating temperature 1

0 – 65 °C

Operating humidity range 1

10 % to 90 % (relative humidity non-condensing)

Atmospheric pressure 1

616 – 1075 hPa

Physical connectors and size

Digital interface to the host device

PCI-SIG M.2 E key connector on the host device PCB

NFC RF interface to the external antenna

Hirose DF57H-2P-1.2V(21) connector on the WSI PCB

MBAN RF interface to the external antennas 2x I-PEX MHF4L receptable RF connector on the WSI PCB

M.2 formfactor

2230 (WSI PCB is 22 mm wide and 30 mm long)

Logical and electrical interfaces

UART

1 Mbaud, HW flow control enabled, 1.8 V IO (excluding

open drain wake up signal output)

I2C

100 kHz or 400 kHz clock (standard or fast mode), 1.8 V IO

GPIO

5x 1.8 V GPIO pins for the RF disable and RF COEX signals

MBAN

2360 2500 MHz (GEHC proprietary radio protocol) 50 , max TX power 12 dBm (conducted)

NFC

13.56 MHz (standard IEC/ISO 14443)

Reading distance 10 mm

60 1 The WSI ambient condition inside the host device mechanics

61 A typical connection diagram between the WSI module and the host device is presented in Figure 2. The
62 mandatory signals are: VDD, GND, UART and RF disable signals. Two LED signals are optional, if there is a 63 need to visually monitor the WSI’s state and activity. The RFU signals are internally connected in the WSI 64 module but not currently used in the normal WSI operation. The WSI antennas (NFC and 2x MBAN) are
65 external components and thus part of the host device HLA.

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67
68 Figure 2: Typical WSI integration diagram
69
70 2.1 WSI M.2 Interface

71 The WSI module is connected to a host device via the PCI-SIG M.2 E-key interface. The M.2 details are defined

72 in the PCI Express M.2 Specification [8]. The WSI M.2 pins used and their functions are listed in Table 2. The

73 color coding in the table is:

· green = GND

· red = VDD

· blue = signal used in the current WSI operation

· white = signal connected in the WSI, but not used in the current operations (RFU)

o COEX pins must be connected

o Other pins should be connected if the interface is available in the host device

· grey = signal not used nor connected in the WSI

81 Table 2: M.2 key E pin numbering and WSI01 pin functions

Pin M.2 pin name
1 GND 2 PWR_3V3 3 USB_P 4 PWR_3V3 5 USB_N
6 LED_1_OUT#
7 GND 8 PCM_CLK/I2S_SCK 9 SDIO_CLK/SYSCLK_OUT

I/O Functions in the WSI module

Module ground

I Supply voltage for the module

I/O USB 2.0 data+. Not used in the current WSI operation (RFU).

I Input power to the module

I/O USB 2.0 data-. Not used in the current WSI operation (RFU).

Active low open drain LED control. WSI controls module status LED1 on the host side via this pin.

Module ground

I/O Not used

O Not used

Rated voltage
0 V 3.3 V 3.3 V 3.3 V 3.3 V
3.3 V
0 V –

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10 PCM_SYNC/I2S_WS

I/O Not used

–

11 SDIO_CMD

I/O Not used

–

12 PCM_IN/I2S_SD_IN

I Not used

–

13 SDIO_DATA0

I/O Not used

–

14 PCM_OUT/I2S_SD_OUT

O Not used

–

15 SDIO_DATA1

I/O Not used

–

16 LED_2_OUT#

Active low open drain LED control. WSI controls module status LED2 on the host side via this pin.

3.3 V

17 SDIO_DATA2

I/O Not used

–

18 GND

Module ground

0 V

19 SDIO_DATA3

I/O Not used

–

20 UART_WAKE_OUT#

Active low open drain UART wake up for the host. Requires pull up on the host side (recommended 15 k to 100 k).

3.3 V

21 SDIO_WAKE_IN#

I Not used

–

22 UART_TX_O

O UART Transmit Data connected to RXD on the Host.

1.8 V

23 SDIO_RST#/TX_BLNK_OUT O Not used

–

24-31 M.2_E_KEY_SLOT

–

A physical empty slot in the module PCB specifies the E key version of the M.2 standard.

–

32 UART_RXD_IN

I UART Receive Data connected to TXD on the Host.

1.8 V

33 GND

Module ground

0 V

34 UART_RTS_O

O UART Ready to Send connected to CTS on the Host.

1.8 V

35 PETp0

I/O Not used

–

36 UART_CTS_I

I UART Clear to Send connected to RTS on the Host.

1.8 V

37 PETn0

I/O Not used

–

38 VENDOR2

SMBUS I2C Interrupt. Pull up resistor on the WSI module. The

interface is internally used by the WSI (controls e.g. NFC and PMU ICs). Communication from the host is not needed nor allowed.

1.8 V

(RFU)

39 GND

Module ground

N/A

40 VENDOR1

SMBUS I2C SDA. Pull up resistor on the WSI module. The interface

is internally used by the WSI. Communication from the host is not

1.8 V

needed nor allowed. (RFU, but must be connected)

41 PERp0

I/O Not used

–

42 VENDOR0

SMBUS I2C SCL. Pull up resistor on the WSI module. The interface is

internally used by the WSI. Communication from the host is not

1.8 V

needed nor allowed. (RFU, but must be connected)

43 PERn0

I/O Not used

–

44 COEX3_IO

Radio coexistence signal from the host informs the WSI when the I WLAN RX is active. Not used in the current WSI operation (RFU but 1.8 V
must be connected).

45 GND

Module ground

N/A

46 COEX_RXD_IN

Radio coexistence signal from the host informs the WSI when the I WLAN TX is active. Not used in the current WSI operation (RFU but 1.8 V
must be connected).

47 REFCLKp0

I Not used

–

48 COEX_TXD_OUT

Radio coexistence signal requests the host to interrupt the WLAN O TX while the signal is active. Not used in the current WSI operation 1.8 V
(RFU but must be connected).

49 REFCLKn0

I Not used

–

50 SUSCLK32k_IN_3v3

32.768 kHz clock from the host device. Not used in the current WSI operation (RFU).

3.3 V

51 GND

Module ground

0 V

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52 PERST0_3v3#

I Not used

–

53 CLKREQ0#_3v3

I/O Not used

–

54 W_DIS2_IN_3v3#

Active low, debounced signal when applied by the system it will disable radio operation on the Module.

1.8 V

55 PEWAKE0#_3v3

I/O Not used

–

56 W_DIS1_IN_3v3#

Active low, debounced signal when applied by the system it will disable radio operation on the Module.

1.8 V

57 GND

Module ground (PCB)

N/A

58 I2C_DATA

I/O

I2C data to Module MCU. Open Drain with pull up on the host device. Not used in the current WSI operation (RFU).

1.8 V

59 RES/PETp1

I/O Not used

–

60 I2C_CLK

I2C clock input from Host to Module MCU. Open Drain with pull up on the host device. Not used in the current WSI operation (RFU).

1.8 V

61 RES/PETn1

I/O Not used

–

62 I2C_ALERT#

IRQ line to the host processor. Open Drain with pull up on the host device. Not used in the current WSI operation (RFU).

1.8 V

63 GND

Module ground

0 V

64 RES/VIO 1.8 V

I Not used

–

65 RES/PERp1

I/O Not used

–

66 UIM_SWP/PERST1#

I/O Not used

–

67 RES/PERn1

I/O Not used

–

68 UIM_PWR_SNK/CLKREQ1# O Not used

–

69 GND

Module ground

0 V

UIM_PWR_SRC/GPIO_1/PE WAKE1#

I Not used

–

71 RES/REFCLKp1

Not used

–

72 PWR_3V3

I Supply voltage for the module

3.3 V

73 RES/REFCLKn1

Not used

–

74 PWR_3V3

I Supply voltage for the module

3.3 V

75 GND

Module ground

0 V

82
83 The standard M.2 E key module PCB pin numbering and the pin allocation in the WSI are shown in Figure 3.

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84
85 Figure 3: M.2 E key module PCB pin numbering and WSI pin allocation
86
87 2.2 NFC Antenna
88 The NFC antenna is an external component outside the WSI module and thus part of the host device HLA. 89 The antenna is connected to the WSI using the Hirose DF57H-2P-1.2V(21) connector on the WSI PCB. The 90 connector datasheet is provided the reference [5]. The current WSI NFC antenna matching is optimized for 91 the Pulse W3965 antenna (Figure 4) which is used in CSONE V2. For any other NFC antenna, the reading 92 distance may be degraded. In addition, all WSI radio certifications have been performed using the Pulse 93 W3965 antenna. Thus, it is strongly recommended to reuse the same antenna in other WSI host devices, if the 94 FPC antenna size (19 mm x 32 mm) is applicable for the host device. Changing the antenna (type or gain) 95 requires update to the WSI FCC and ISED module certifications via the CxPC process. The antenna cable (65 96 mm in CSONE) can be lengthened if needed. The reading range should be 10 mm when measured from the 97 outer surface of the host device against the GEHC Sensor Battery. This enables easy device pairing and good 98 user experience.
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Hirose DF57H 2-pin

99
100 Figure 4: Pulse W3965 NFC antenna used in the CSONE
101
102
103 2.3 MBAN Antennas

104 Like the NFC antenna, also the MBAN antennas are external components and thus are part of the host device
105 HLA. The MBAN operation requires two antennas to enable spatial TX and RX diversity. The MBAN antenna 106 requirements are listed in Table 3. “Shall” indicates the minimum acceptable antenna performance, while 107 “should” means a feasible performance target for a good antenna design. The same requirements are valid 108 for both antennas. All parameters are defined in free space over the full MBAN frequency range. The antenna
109 connector is the refence point for all values.

110 Table 3: MBAN antenna requirements

parameter frequency range
impedance return loss
total antenna efficiency peak gain

should be
N/A
N/A 10 dB (VSWR 1.9)
-3 dB ( 50%) 3 dBi

shall be
2360-2500 MHz 50 6 dB
(VSWR 3.0) -5 dB ( 32%) 5 dBi

ECC antenna connector RX desense due to the host device

0.2 N/A
3 dB

0.1 MFH4L or MHF4 plug
6 dB

comments Includes all MBAN bands (US, ISM and EU). Standard 50 RF impedance Inverted S11 values.
Includes all losses after the antenna connector (mismatch, conductive and radiated). The highest gain in the 3D radiation pattern. Defines the maximum allowed conducted TX power. The correlation between the antennas I-PEX MHF4(L) is the standard M.2 RF connector. MHF4L and MHF4 are intermateable. The RX degradation is the radiated MBAN sensitivity delta between the unpowered host device (only MBAN active) vs. the host device operation under heavy load. The heavy load means high CPU activity, a lot of data traffic in memory lines, high PMU activity (e.g. battery charging), continuously changing image on display and potentially noisy accessories connected to the host.

Any TX signals from other radios are excluded from the requirement. The desense is minimized by shielding the noisy components (CPU, PMU etc.) in the host device and locating the antennas as far as possible from those. The WSI design team can help with the desense measurements.
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111

112 The lead host device CSONE uses the Pulse W3494 [6] (size 59 mm x 22 mm) as the WSI MBAN antenna. The

113 W3494 FPC includes two radiators with their own coaxial cables. The connection between the antenna and

114 the WSI are:

115

· W3494 Port 1 (P1) WSI ANT0

116

· W3494 Port 2 (P2) WSI ANT1

117 All WSI radio certifications are made by using the Pulse W3494 antenna. It is strongly recommended to use 118 the same antenna in the other WSI host devices. Changing the antenna (type or gain) requires update to the 119 WSI FCC and ISED module certifications via the CxPC process. If reusing W3494 is not possible then the new 120 antenna should be selected collaboratively by host device and WSI design teams.

I-PEX MHF4L plug
121
122 Figure 5: Pulse W3494 MBAN antennas used in the CSONE
123
124 3 WSI SW Description
125 The WSI SW functions are divided between the WSI module and host device CPUs as shown in Figure 6. In 126 normal operation the host device interacts only with the WSI Data MCU and all communication goes through 127 the PPM SW.
128

OTA

SPI

UART

129
130 Figure 6: CPUs (green boxes) executing the WSI related SW
131

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132 3.1 WSI.conf file

133 The WSI.conf file includes radio regulatory configuration which defines the rules for how the MBAN radio is 134 used during the normal clinical operation. The radio parameters include the allowed MBAN channels (i.e. 135 used frequencies) and maximum power used by the MBAN TX. These parameters are typically controlled by 136 the local radio regulators like the FCC in the US and RED in the EU. The default conf file is the same for every 137 host device but the file content shall be modified according to the regulatory domain before customers can 138 use the host device. In practice this means that during the initial field installation process in the conf file shall 139 be updated with the valid parameters in that specific target country. The conf parameters shall not be 140 accessible for the end user via any type of UI. The conf file modification shall be made either by a GEHC field 141 engineer or trained hospital biomedical engineer. The WSI radio certification is valid only with the correct 142 configuration parameters. Thus, it is a mandatory and critical step to define the correct parameters for every 143 customer device. The WSI.conf file parameters are listed in Table 4.

144

145 Table 4: WSI.conf file parameters

parameter

value

version

(other integers are RFU)

bandSelection_US_MBAN_indoor

(1 is RFU)

bandSelection_US_MBAN_anywhere 0 or 1

bandSelection_ISM bandSelection_EU_MBAN

1 (0 is RFU)
0 (1 is RFU)

regulatoryDomain

WORLD ETSI FCC

description
Config file format number. The default value is 1. Increase for incompatible format changes.
Enables (=1) or disables (=0) the US MBAN indoors frequency band 2360-2390 MHz (MBAN channels 0-11). The default value 0 shall not be changed. The band can be enabled only in the US and only when the host device is connected to the Axone network. Thus, the value shall always be 0 and the parameter is RFU.
Enables (=1) or disables (=0) the US MBAN anywhere frequency band 2390-2400 MHz (MBAN channels 12-14). The default value is 0. The band shall be enabled (=1) only in installations in the US.
Enables (=1) or disables (=0) the global ISM frequency band 24002483.5 MHz (MBAN channels 15-46). The default value is 1. The band shall always be enabled as the sensor communication is not possible without the ISM band. The parameter is RFU.
Enables (=1) or disables (=0) the EU MBAN frequency band 2483.52500 MHz (MBAN channels 47-52). The default value 0 shall not be changed. The WSI MBAN radio is not certified to operate on the EU MBAN band. When (and if) the certification will be completed the band can be used in the EU countries. The parameter is RFU.
Defines the radio regulatory rules for the MBAN operation. The default is WORLD, which shall be changed to ETSI or FCC during installation.
WORLD is the superset of all (known) radio regulatory limitations. Thus, the WORLD should not be used in any target country as it unnecessarily degrades the radio performance and reliability.

ETSI defines the radio communication to comply with the RED and European standards (EN 300 328) [10]. The ETSI shall be used in all installations in Europe. In addition, it is also used in some other countries which follow the EU radio regulation.

FCC defines the radio communication to comply with the FCC rules (parts 15 and 95) [11]. The FCC shall be used in installations in the

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enabledChannels

CSV channel list or channel range(s)
(RFU)

146
147 3.2 WSI_antenna.conf file

US and Canada. In addition, it is used in some other countries which follow that the FCC radio regulation.
Enables arbitrary user defined MBAN channels to be used in the MBAN communication. The defined channel list active only when all four bands are disabled (=0). The enabled channels are defined by using CSV channels list (allowed value 0-52) or defining the channel ranges by using dash sign (e.g. 20-30).
The default is 15-45, but the value is ignored in the configuration assuming the ISM band is enabled as instructed. The parameter is RFU.

148 The WSI_antenna.conf file includes information about the peak gains (dBi) of the host device MBAN 149 antennas. Every WSI module is calibrated during the PWA manufacturing to provide accurate TX power to the 150 MBAN antenna connectors. However, the WSI is a generic module which can be used with different types of 151 host device antennas and thus the correct calibration values should be selected based on the actual host 152 device antenna gains. The PPM SW converts (by using the MCU utility convert_scal command) the generic 153 WSI calibration file (SCAL) to a host device specific calibration file (MCAL) by using the antenna parameters in 154 the WSI_antenna.conf file. The conversion happens automatically if a valid configuration file is stored in the 155 host device. The WSI_antenna.conf file parameters are listed in Table 5. The gain values are given with two 156 digits as plain number (e.g. 2.67 without the unit dBi).

157

158 Table 5: WSI_antenna.conf file parameters

parameter

value description

antenna0_US_MBAN_indoor

number 2360-2390 MHz peak gain (dBi) of the antenna connected to the (e.g. 3.80) WSI ANT0 connector.

antenna0_US_MBAN_anywhere

number 2390-2400 MHz peak gain (dBi) of the antenna connected to the WSI ANT0 connector.

antenna0_ISM

number 2400-2483.5 MHz peak gain (dBi) of the antenna connected to the WSI ANT0 connector.

antenna0_EU_MBAN

number 2483.5-2500 MHz peak gain (dBi) of the antenna connected to the WSI ANT0 connector.

antenna1_US_MBAN_indoor

number 2360-2390 MHz peak gain (dBi) of the antenna connected to the WSI ANT1 connector.

antenna1_US_MBAN_anywhere

number 2390-2400 MHz peak gain (dBi) of the antenna connected to the WSI ANT1 connector.

antenna1_ISM

number 2400-2483.5 MHz peak gain (dBi) of the antenna connected to the WSI ANT1 connector.

antenna1_EU_MBAN

number 2483.5-2500 MHz peak gain (dBi) of the antenna connected to the WSI ANT1 connector.

159
160 3.3 WSI SW

161 The module includes the WSI SW in the Data MCU flash memory which is automatically executed when the 162 WSI is powered on. There are two types WSI SW versions:

163

· WSI manufacturing SW: Enables all R&D functionality including MBAN Test Mode commands

164

· WSI clinical SW: Enables normal clinical use (i.e. using wearable sensors)

165

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WSI01 User Manual

166 4 WSI Radio Certifications

167 The WSI is a radio device, which means it shall comply with the radio standards and regulations defined by 168 the local authorities in every country where it is used and marketed. The compliance with these rules is 169 confirmed through radio certification. The certification process varies from country to country, unfortunately 170 a global radio certification does not exist. Only the EU, US and Canada were in scope for the WSI NPI project. 171 The additional effort and cost of radio certification are significantly smaller if the existing antennas are 172 reused in new host devices. At the moment, this refers to the CSONE V2 antennas. If new antennas are 173 needed, the selection should be made in collaboration with the WSI design team to ensure the new antennas 174 work well with the WSI and can be reused in future host devices.

175 4.1 EU RED

176 The WSI.conf parameters for the EU (RED) operation:

177

version=1

# Current file format is 1

178

bandSelection_US_MBAN_indoor=0

# Disabled

179

bandSelection_US_MBAN_anywhere=0 # Disabled

180

bandSelection_ISM=1

# Enabled

181

bandSelection_EU_MBAN=0

# Disabled

182

regulatoryDomain=ETSI

# Follows ETSI standards

183

enabledChannels=15-45

# Default value (ignored)

184
185 The WSI EU radio certification is based on the requirements defined in the Radio Equipment Directive (RED) 186 2014/53/EU. The RED compliance is shown by adding the CE mark (covers all EU requirements, not only 187 radio) to the host device. Although the RED binding regulation only in the EU member countries, it is widely 188 accepted in other European countries such as the UK, Switzerland and Turkey.

189

190 The RED does not recognize radio module concept. Therefore, certification shall be done at the host device

191 level covering radios in the device under a single certificate. Typically, a RED notified body (NB) is asked to

192 review the technical file (TF) to confirm that the host device meets the RED requirements. The accredited test

193 houses (e.g. SGS, TUV, Intertek etc.) offer NB services. After review a RED NB certificate is issued. The RED

194 certification covers the following areas:

195

· Safety and health of users

196

· Electromagnetic compatibility (EMC)

197

· Efficient use of the radio spectrum

198 The WSI is a used in medical devices for which the general safety and EMC requirements are covered by the 199 EU medical regulation (MDR). Therefore, the WSI RED NB certificate is limited to SAR and radio requirements.

200 Although a stand-alone WSI module cannot be certified, the most of the existing WSI material can be reused

201 in the TF of a new host device, including:

202

· Design files (schematic, layout, part list etc.)

203

· Conducted RF test reports (assuming existing antennas are reused)

204

· RF exposure evaluation report

205
206 The material is included in the CSONE RED TF [1] can be used as an example.

207 The SAR compliance of a host device is based on limb exposure conditions, assuming only user’s hands are 208 exposed to RF energy. The maximum SAR10g for a limbs is 4.0 W/kg. The RF exposure evaluation report
209 shows that the maximum theoretical SAR10g of the WSI module is 0.60 W/kg (combined MBAN + NFC). This
210 means that the WSI module can be integrated to radio products that are used solely by limbs and have SAR10g 211 contribution 3.40 W/kg from other integrated radios.

212 RED certification always requires radiated emission measurements (according to EN 300 328) using the 213 actual host device HLA. Therefore, RED certification cannot be completed using only the test reports from

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WSI01 User Manual

214 other host devices. At a minimum some radiated measurements need to be performed in an accredited radio 215 laboratory. In case that a host device does not reuse the antennas already tested in another host device also 216 new conducted WSI testing is also required.

217 4.2 US FCC

218 The users of the WSI module must understand that changes or modifications not expressly approved by the 219 party responsible for compliance could void the user’s authority to operate the equipment.

220 The WSI.conf parameters for the US (FCC) operation:

221

version=1

# Current file format is 1

222

bandSelection_US_MBAN_indoor=0

# Disabled

223

bandSelection_US_MBAN_anywhere=1 # Enabled

224

bandSelection_ISM=1

# Enabled

225

bandSelection_EU_MBAN=0

# Disabled

226

regulatoryDomain=FCC

# Follows FCC rules

227

enabledChannels=15-45

# Default value (ignored)

228

229 The FCC in the US allows modular certification for radios. The general FCC guidance regarding radio modules

230 is provided in the FCC KDB 996369 [9]. In practice a certified radio module can be used in new host devices

231 with little or no additional certification effort. The prerequisites for using a certified radio module are:

232

· The module is used as defined in the module’s FCC ID grant (e.g. with approved antennas)

233

· The host device includes applicable FCC ID labeling (e.g. contains FCC ID: 2AO8L-WSI01).

234

o E-labeling on host device’s screen is acceptable.

235

· If the module is integrated in a host device with other radios the manufacturer must ensure that the

236

host product meets the FCC’s co-located transmitters requirements defined in the FCC parts 15 and

237

95 [11].

238

o In practice this means that simultaneous operation of the different radios must not

239

generate emissions (typically intermodulation products) above the allowed limit.

240

o This does not require ID modification or sending test reports to the FCC.

241

242 If the module is used in a way not allowed by the existing ID, the FCC C2PC process is required to enable the 243 new use case.

244
245 The WSI is certified as FCC radio module ID: 2AO8L-WSI01. All related material is included in the WSI01 FCC 246 technical file [2]. The grantee code 2AO8L belongs to GEHC Finland and the contact person for the code is 247 Timo Hakala. Any changes needed to the WSI FCC ID must be agreed with GEHC Finland, after which Timo 248 Hakala updates the module ID via the C2PC process. The initial WSI FCC ID allows use only with the CSONE 249 antennas.

250

251 The WSI is intended for use in portable devices operating within 20 cm of the body of the user. The FCC SAR

252 compliance is based on the RF exposure evaluation report [2] which shows the following WSI module SAR

253 values (combined MBAN + NFC):

254

· Extremities (limbs) only use cases: SAR10g is 0.14 W/kg

255

o The FCC limit for extremity configuration is SAR10g 4.0 W/kg

256

o This is the normal use case for WSI hosts which are used solely by extremities (i.e. hands).

257

· Head and body worn use cases: SAR1g is 0.35 W/kg

258

o The FCC limit for head and body-worn configuration is SAR1g 1.6 W/kg

259

o These use cases are allowed for the WSI, but they are not typical for patient monitors.

260 This means that the compliance is shown through calculations, and therefore no SAR measurements were

261 made. The WSI module can be integrated in a host device with other radios if the SAR contribution from

262 other radios is:

263

· In extremity use cases: SAR10g 3.86 W/kg

264

· In head and body-worn use cases: SAR1g 1.25 W/kg

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265 The FCC labeling requires the following texts and warnings to be included in WSI host device’s user manual:

266

· §15.19(a) requires the text:

267

o “This device complies with part 15 of the FCC Rules. Operation is subject to the following two

268

conditions: (1) This device may not cause harmful interference, and (2) this device must

269

accept any interference received, including interference that may cause undesired

270

operation.”

271

· §95.2593(c) requires the text:

272

o “This device may not interfere with stations authorized to operate on a primary basis in the

273

2360-2400 MHz band, and must accept any interference received, including interference that

274

may cause undesired operation.”

275

· §95.2595(c) requires the text:

276

o “This transmitter is authorized by rule under the MedRadio Service (47 CFR part 95). This

277

transmitter must not cause harmful interference to stations authorized to operate on a

278

primary basis in the 2360-2400 MHz band, and must accept interference that may be caused

279

by such stations, including interference that may cause undesired operation. This transmitter

280

shall be used only in accordance with the FCC Rules governing the MedRadio Service. Analog

281

and digital voice communications are prohibited. Although this transmitter has been

282

approved by the Federal Communications Commission, there is no guarantee that it will not

283

receive interference or that any particular transmission from this transmitter will be free from

284

interference.”

285 4.3 Canada ISED

286 The WSI.conf parameters for the Canada (ISED) operation:

287

version=1

# Current file format is 1

288

bandSelection_US_MBAN_indoor=0

# Disabled

289

bandSelection_US_MBAN_anywhere=0 # Disabled

290

bandSelection_ISM=1

# Enabled

291

bandSelection_EU_MBAN=0

# Disabled

292

regulatoryDomain=FCC

# FCC rules are valid also for ISED

293

enabledChannels=15-45

# Default value (ignored)

294

295 The ISED radio standards are available in reference [12]. The WSI is certified as the ISED radio module IC: 296 25821-WSI01. The ISED radio regulation requirements and certification process in Canada are quite similar to 297 the US FCC system. However, the process is independent, and the FCC approval is not valid in Canada. 298 Nevertheless, much of the material in the ISED technical file [3] is the same as in the FCC technical file [2]. 299 The company code 25821 is owned by GEHC Finland and the contact person is Timo Hakala. This means that 300 if IC changes are needed, only Timo Hakala can request them.

301 The ISED SAR exemption calculation differs from the FCC requirements. Therefore, the ISED SAR compliance 302 is based on actual SAR measurement performed inside the CSONE host device. This means that the new SAR 303 measurements are needed for every new host device and based on the new test reports the module 304 certification must be be updated via the ISED C4PC process.
305 Valid ISED labeling is required (contains IC: 25821-WSI01). E-labeling on host device’s screen is accepted.

306 4.4 Other Countries

307 Countries other than the US, EU and Canada were not in scope of the WSI NPI program. It will be agreed later 308 who is responsible for the certifications in other countries and how that work will be organized between the 309 WSI team and host device programs.

310 The existing EU and US certifications can be leveraged in other countries. FCC and RED rules, standards and 311 test reports are accepted in many countries. In such cases, certification is mainly paperwork, and no new 312 measurements are needed. On the other hand, some countries (e.g. China, Japan and South Korea) require a

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WSI01 User Manual 313 full set of measurements and certification against their own national standards and requirements. The 314 conclusion is that every new country needs to be decided, managed and studied separately. In some cases, 315 required extra work may be negligible while is others, the process can be very laborious.
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Documents / Resources

GE HealthCare WSI01 Wireless Sensor Interface [pdf] User Manual
WSI01, WSI01 Wireless Sensor Interface, Wireless Sensor Interface, Sensor Interface

References

User Manual

GE HealthCare WSI01 Wireless Sensor Interface User Manual

WSI01 Wireless Sensor Interface

Product Information

Specifications

Product Usage Instructions

1. Introduction

2. WSI HW Description

2.1 WSI M.2 Interface

2.2 NFC Antenna

2.3 MBAN Antennas

3. WSI SW Description

3.1 WSI.conf file

3.2 WSI_antenna.conf file

3.3 WSI SW

4. WSI Radio Certifications

4.1 EU RED

4.2 US FCC

4.3 Canada ISED

Frequently Asked Questions (FAQ)

Q: How do I update the firmware of the WSI01 device?

Q: Can I use multiple WSI01 devices together for extended
coverage?

Documents / Resources

References

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