Healthdot Wearable Biosensor, 30u./Pack

Healthdot

Wearable Biosensor, 30u./Pack

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Philips Healthdot is a medical device. It is a wearable biosensor, allowing health care professionals to monitor patients in hospital, but especially for out-of-hospital and during transitional care. It is a single use medical device which is placed on the lower left rib of a patient and continuously captures the patient´s heart rate, respiratory rate, posture and activity, all of which are transmitted to the hospital in a secure way. Philips Healthdot is one of the world´s first biosensors sending heart and respiratory rates to the hospital without the patient requiring a hub or mobile phone (it uses a built-in LoRa transmitter directly sending data to the cloud). This makes the system easy to use and the sent data reliable.

Kenmerken
Monitor in and out of hospital
Monitor in and out of hospital

Monitor in and out of hospital

CE-marked (EU MDR 2017/45).
Built-in connectivity (LoRa)
Built-in connectivity (LoRa)

Built-in connectivity (LoRa)

No need for hub, phone or installation.
Up to 14 days of wear time
Up to 14 days of wear time

Up to 14 days of wear time

Measures heart rate, respiration rate, activity, and posture. Accurate: Respiration rate ±1 rpm, heart rate ±3% of range. Showerproof.
IntelliVue Guardian software integration
IntelliVue Guardian software integration

IntelliVue Guardian software integration

With information from the Healthdot, Guardian might aid health care professionals in identifying subtle signs of patient deterioration hours before a potential adverse event. Healthdot data enters Guardian via the Philips HSDP cloud platform. This way, patient data reaches the health care professional in a secure and continuous manner, no matter where the patient maybe located inside the Netherlands.*
VitalHealth Engage platform integration
VitalHealth Engage platform integration

VitalHealth Engage platform integration

Healthdot can be connected to the Philips VitalHealth Engage platform (‘Engage’) to enrich the data a patient can share with their care providers. In addition to the Healthdot data on respiratory rate, heart rate, activity and posture, Engage can collect and show data from other connected measurement devices, like SpO2, weight, and blood pressure. The questionnaire, chat and video features of Engage enables clinicians and other care providers to make direct contact with their patients also out of hospital.
  • Monitor in and out of hospital
  • Built-in connectivity (LoRa)
  • Up to 14 days of wear time
  • IntelliVue Guardian software integration
See all features
Monitor in and out of hospital
Monitor in and out of hospital

Monitor in and out of hospital

CE-marked (EU MDR 2017/45).
Built-in connectivity (LoRa)
Built-in connectivity (LoRa)

Built-in connectivity (LoRa)

No need for hub, phone or installation.
Up to 14 days of wear time
Up to 14 days of wear time

Up to 14 days of wear time

Measures heart rate, respiration rate, activity, and posture. Accurate: Respiration rate ±1 rpm, heart rate ±3% of range. Showerproof.
IntelliVue Guardian software integration
IntelliVue Guardian software integration

IntelliVue Guardian software integration

With information from the Healthdot, Guardian might aid health care professionals in identifying subtle signs of patient deterioration hours before a potential adverse event. Healthdot data enters Guardian via the Philips HSDP cloud platform. This way, patient data reaches the health care professional in a secure and continuous manner, no matter where the patient maybe located inside the Netherlands.*
VitalHealth Engage platform integration
VitalHealth Engage platform integration

VitalHealth Engage platform integration

Healthdot can be connected to the Philips VitalHealth Engage platform (‘Engage’) to enrich the data a patient can share with their care providers. In addition to the Healthdot data on respiratory rate, heart rate, activity and posture, Engage can collect and show data from other connected measurement devices, like SpO2, weight, and blood pressure. The questionnaire, chat and video features of Engage enables clinicians and other care providers to make direct contact with their patients also out of hospital.

Technische specificaties

Physical
Physical
Size of sensor including adhesive (W x H x D)
  • 55 mm x 45 mm x 11 mm (without release liners)
Weight
  • 11.8 g
Durability
  • Survives free fall (1 m drop) per IEC 60601-1
Manufactured with natural rubber latex
  • No
Water ingress protection
  • IP 55 (IEC 60529:2013), Shower proof
Battery
  • 2 * Zinc Air PR44 1.45V, non-replaceable
Size (W x H x D)
  • 40 mm x 33 mm x 11 mm
HSDP Cloud Infrastructure
HSDP Cloud Infrastructure
Location
  • Within the EU (Ireland)
Security
  • ISO 27001, 27018, SOC II Type 2 and HiTRUST certification
Name
  • Philips Health Suite Digital Platform (HSDP)
Pairing Website
Pairing Website
Dedicated mobile web app
  • Accessible with connected devices like mobile phone, tablet or PC
Minimal system requirements
  • Android 10 with Chrome web browser (version 81 and higher)
  • Screen size 5 inch or larger, resolution minimum 720 x 1280, with a camera of 10 megapixel or more
  • Access to camera allowed (e.g. build in for mobile, or accessory for PC)
Environmental
Environmental
Storage atmospheric pressure range
  • 700 – 1060 hPa
Operating atmospheric pressure range
  • 700 – 1060 hPa
Storage humidity range
  • 5 – 95% relative humidity (non-condensing)
Operating humidity range
  • 15 – 90% relative humidity limit (non-condensing)
Shipping atmospheric pressure range
  • 700 – 1060 hPa
Storage temperature range
  • +5°C – +40°C
Shelf life
  • 12 months in individually sealed pouch
Shipping relative humidity range
  • 5 – 95% relative humidity (non-condensing)
Operating ambient temperature range
  • +5°C – +40°C
Shipping temperature range
  • -20°C – +60°C
Wireless/Security
Wireless/Security
Indoor coverage
  • Any room with a window
Radio
  • LoRa
Security
  • Data in rest: AES 128-bit (ECB mode); Data in transit: AES 128-bit (CCM mode), E2E data encryption
RF radiated power output
  • Maximum 14 dBm (Europe)
Frequency band
  • 868 (band) MHz
Coverage
  • Anywhere in the Netherlands (without any additional hub or mobile phone needed)
Coverage in practice
  • In more than 99% of the cases at least one valid data point comes in within two hours
Performance
Performance
Respiration rate measurement range
  • 5 – 60 respirations per minute (rpm)
Heart rate calculation
  • 5-minute average
Posture
  • Supine; Reclined; Upright; Forward leaning; Prone; Upside down; Lying on left side and right side
Activity level
  • 0 = at rest, 1 = minimal activity and 10 = maximum activity
Respiration rate calculation
  • 5-minute average
Data transmission interval
  • Typically, every 5 minutes
Heart rate accuracy
  • 3% of range or ±1 bpm (whichever is greater)
Respiration rate accuracy
  • ±1 rpm
Respiration rate resolution
  • 1 rpm
Heart rate measurement range
  • 30 – 220 beats per minute (bpm)
Heart rate resolution
  • 1 bpm
Use
Use
MRI Safe
  • No
Single use
  • Yes, single use only
Required patient actions
  • Only removal of the device from the skin
Serviceable
  • No
Operational life,data transmission period
  • Healthdot can be worn up to 14 days
Disposable
  • Yes, as small electronic waste (WEEE)
Compliance
Compliance
Release country
  • The Netherlands
Class
  • Class IIa medical device
More information
  • See instructions for use
In compliance with
  • IEC 60601-1:2012
  • IEC 60601-1-11:2015
  • Regulation EU MDR 2017/745
  • ISO 10993-1:2018 (Biocompatibility)
Certification
  • CE-marked – EU MDR 2017/745
Applied Part
  • BF
LoRa Gateway
LoRa Gateway
Range
  • Actual range will vary depending on the layout of the building the gateway is used in.
Connection
  • LoRa to 4G
Ownership
  • KPN (return when no longer used)
Connected to hospital LAN
  • No (4G)
Installation requirements
  • Standard power socket, screw to wall/ceiling
Physical
Physical
Size of sensor including adhesive (W x H x D)
  • 55 mm x 45 mm x 11 mm (without release liners)
Weight
  • 11.8 g
HSDP Cloud Infrastructure
HSDP Cloud Infrastructure
Location
  • Within the EU (Ireland)
Security
  • ISO 27001, 27018, SOC II Type 2 and HiTRUST certification
See all specifications
Physical
Physical
Size of sensor including adhesive (W x H x D)
  • 55 mm x 45 mm x 11 mm (without release liners)
Weight
  • 11.8 g
Durability
  • Survives free fall (1 m drop) per IEC 60601-1
Manufactured with natural rubber latex
  • No
Water ingress protection
  • IP 55 (IEC 60529:2013), Shower proof
Battery
  • 2 * Zinc Air PR44 1.45V, non-replaceable
Size (W x H x D)
  • 40 mm x 33 mm x 11 mm
HSDP Cloud Infrastructure
HSDP Cloud Infrastructure
Location
  • Within the EU (Ireland)
Security
  • ISO 27001, 27018, SOC II Type 2 and HiTRUST certification
Name
  • Philips Health Suite Digital Platform (HSDP)
Pairing Website
Pairing Website
Dedicated mobile web app
  • Accessible with connected devices like mobile phone, tablet or PC
Minimal system requirements
  • Android 10 with Chrome web browser (version 81 and higher)
  • Screen size 5 inch or larger, resolution minimum 720 x 1280, with a camera of 10 megapixel or more
  • Access to camera allowed (e.g. build in for mobile, or accessory for PC)
Environmental
Environmental
Storage atmospheric pressure range
  • 700 – 1060 hPa
Operating atmospheric pressure range
  • 700 – 1060 hPa
Storage humidity range
  • 5 – 95% relative humidity (non-condensing)
Operating humidity range
  • 15 – 90% relative humidity limit (non-condensing)
Shipping atmospheric pressure range
  • 700 – 1060 hPa
Storage temperature range
  • +5°C – +40°C
Shelf life
  • 12 months in individually sealed pouch
Shipping relative humidity range
  • 5 – 95% relative humidity (non-condensing)
Operating ambient temperature range
  • +5°C – +40°C
Shipping temperature range
  • -20°C – +60°C
Wireless/Security
Wireless/Security
Indoor coverage
  • Any room with a window
Radio
  • LoRa
Security
  • Data in rest: AES 128-bit (ECB mode); Data in transit: AES 128-bit (CCM mode), E2E data encryption
RF radiated power output
  • Maximum 14 dBm (Europe)
Frequency band
  • 868 (band) MHz
Coverage
  • Anywhere in the Netherlands (without any additional hub or mobile phone needed)
Coverage in practice
  • In more than 99% of the cases at least one valid data point comes in within two hours
Performance
Performance
Respiration rate measurement range
  • 5 – 60 respirations per minute (rpm)
Heart rate calculation
  • 5-minute average
Posture
  • Supine; Reclined; Upright; Forward leaning; Prone; Upside down; Lying on left side and right side
Activity level
  • 0 = at rest, 1 = minimal activity and 10 = maximum activity
Respiration rate calculation
  • 5-minute average
Data transmission interval
  • Typically, every 5 minutes
Heart rate accuracy
  • 3% of range or ±1 bpm (whichever is greater)
Respiration rate accuracy
  • ±1 rpm
Respiration rate resolution
  • 1 rpm
Heart rate measurement range
  • 30 – 220 beats per minute (bpm)
Heart rate resolution
  • 1 bpm
Use
Use
MRI Safe
  • No
Single use
  • Yes, single use only
Required patient actions
  • Only removal of the device from the skin
Serviceable
  • No
Operational life,data transmission period
  • Healthdot can be worn up to 14 days
Disposable
  • Yes, as small electronic waste (WEEE)
Compliance
Compliance
Release country
  • The Netherlands
Class
  • Class IIa medical device
More information
  • See instructions for use
In compliance with
  • IEC 60601-1:2012
  • IEC 60601-1-11:2015
  • Regulation EU MDR 2017/745
  • ISO 10993-1:2018 (Biocompatibility)
Certification
  • CE-marked – EU MDR 2017/745
Applied Part
  • BF
LoRa Gateway
LoRa Gateway
Range
  • Actual range will vary depending on the layout of the building the gateway is used in.
Connection
  • LoRa to 4G
Ownership
  • KPN (return when no longer used)
Connected to hospital LAN
  • No (4G)
Installation requirements
  • Standard power socket, screw to wall/ceiling
  • * Provided the patient remains in the range of the LoRa network, in rooms with a window and avoids high activity (such as strong exercising).
  • Philips Healthdot is only available in the Dutch market.
  • Philips Healthdot (“Healthdot”) is not intended for use on patients for which the nature of variations of the measured parameters respiratory and heart rate is such that it could result in immediate danger to the patients.
  • The Healthdot wearable is intended for use by healthcare professionals inside of care facilities. The data collection of the patient parameters may continue outside the care facility. Healthdot is not indicated for use in hospitals areas in which continuous monitoring of acutely ill patients is needed, such as intensive care units or operating rooms.

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