Medtronic MDTCSG2V5B Instructions for Use

Mainspring® Data Express

MDTCSG2 Version 5.0

CareLink EHR Integration Specification

Caution: Federal law (USA) restricts this device to sale by or on

the order of a physician (or a properly licensed practitioner).

Trademarks in this manual

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. Medtronic, Paceart Optima, CareLink, Mainspring, Medtronic CareLink

Mainspring Data Express

Mainspring – like the inner workings of a clock – it is the power source that facilitates the movement of cardiac data within your clinic, and between various departments within your organization.

Mainspring Data Express is a comprehensive solution for your cardiac patients, bringing together device and patient data from the Paceart System, the Medtronic CareLink Network, the CareLink Programmer, the Boston Scientific LATITUDE® Patient Management system, the St. Jude Medical Merlin.net® Patient Care Network, your EHR System, and local network.

In order to simplify the process of connecting and sharing demographic, scheduling, and device data between Medtronic applications and electronic health record systems (EHRs), Medtronic has developed Mainspring Data Express.This software application serves as the primary tool to move and share data for device patients. Mainspring Data Express helps to streamline the implementation and on-going maintenance of data movement between applications.

This manual explains how information is can be mapped using the CareLink EHR feature in Mainspring Data Express.You will need this information to integrate with your EHR System.

Explanation of symbols

Symbol definitionSymbol

Consult instructions for use

For US audiences only

Authorized Representative in the European Community

Manufacturer

Lot number

Re-order number

Date of Manufacture

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product.

Temperature Limitation

Humidity Limitation

CareLink EHR Integration Specification | Mainspring Data Express | 5

Symbol definitionSymbol

Software

Indications

Mainspring Data Express is an optional component of the Medtronic CareLink Network and Paceart Optima System.

Mainspring Data Express can be used to perform the following tasks:

• Save CareLink reports to a network location.

• Exchange scheduling data between CareLink and Paceart.

• Bring in demographic and scheduling information from electronic medical record systems or practice management systems via HL7.

• Export device data to electronic medical record systems via HL7.

• Import device data via SessionSync

• Import device data to Paceart via HL7 (for properly formatted IDCO messages)

• Import device data to Paceart from Merlin.Net integration

• Import device data to Paceart from Latitude integration

For more information on the Medtronic CareLink Network, refer to the CareLink Network Online Help. For more information on the Paceart Optima System, refer to the Paceart Optima System Software User

Manual or the Paceart Optima System Online Help.

Precautions

Mainspring Data Express USBs must be stored within the following conditions:

Storage Environment

-20°C (-4°F) to +45°C (113°F)Temperature

20% to 90%Relative Humidity

Mainspring Data Express USBs must be operating in an environment within the following conditions:

Operating Environment

0°C (32°F) to +35°C (95°F)Temperature

20% to 90%Relative Humidity

Call customer service or your biomedical department for service and repairs.

Contraindications

No known contraindications.

6 | CareLink EHR Integration Specification | Mainspring Data Express

Mainspring Data Express Authorized Users

Medtronic representatives provide the Mainspring Data Express orientation and training materials at the time of the installation. Users should be familiar with the Mainspring Data Express documents before using Mainspring Data Express.

Technical Support

In the US and Canada, call 1-800-929-4043 and select option 3. For all other countries contact your local Medtronic representative.

Outbound Messages

Paceart and CareLink integrate with the HL7 protocol for outgoing messages from Paceart and CareLink to an external system by mapping a parameter and a parameter type to HL7 values. This section describes outbound message mapping.

Outbound MSH Message Segments

The HL7 MSH (Message Header) segment is present in every HL7 message type and defines the message's source, purpose, destination, and certain syntax specifics like delimiters (separator characters) and character sets.

ComponentFieldSource of Data or Literal Value

N/AMSH-1| N/AMSH-2^~\& 1MSH-3Paceart 1MSH-4Medtronic N/AMSH-7Local date and time in the format YYYMMDDhhmmss 1MSH-9ORU 2MSH-9R01 3MSH-9ORU_R01 N/AMSH-10Message ID in the format YYYYMMDDhhmmss###### 1MSH-11P 1MSH-122.6 N/AMSH-15AL N/AMSH-16NE 1MSH-21IHE_PCD_ORU_R01 2MSH-21IHE PCD 3MSH-211.3.6.1.4.1.19376.1.6.1.9.1

CareLink EHR Integration Specification | Mainspring Data Express | 7

ComponentFieldSource of Data or Literal Value

4MSH-21ISO

Outbound PID Message Segments

The PID (Patient Identification) segment provides important identification information about the patient and is used as the primary means of communicating the identifying and demographic information about a patient between systems.

OccurrenceComponentFieldParameter TypeParameter

2..211PID-3String 50Patient ID Value 11PID-5String 50Patient Last Name 12PID-5String 50Patient First Name 13PID-5String 1Patient Middle Initial 1N/APID-7DateTimePatient Birth Date 1N/APID-8ENUMPatient Gender

Outbound PV1 Message Segments

The PV1 (Patient Visit) segment is used by registration applications to communicate information on a visit-specific basis.

11PID-11String 50Patient Address Line 1 12PID-11String 50Patient Address Line 2 13PID-11String 50Patient Address City 14PID-11String 10Patient Address State 15PID-11String 10Patient Address Postal Code 16PID-11String 50Patient Address Country 11PID-13String 20Patient Phone Number 14PID-13String 100Patient Email Address 11PID-14String 20Patient Fax Number 11PID-29DateTimePatient Date of Death 11PID-30BooleanDeath Indicator

OccurrenceSub-ComponentComponentFieldParameter TypeParameter

ID

N/AN/A1PV1-2String 1Patient Status N/AN/A1PV1-19String 50Encounter Visit

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Outbound PV2 Message Segments

The PV2 (Patient Visit) segment is a continuation of visit-specific information contained in the PV1 segment.

Value (Paceart) Custom Patient

Field(s) (CareLink)

Outbound OBR Message Segments

The OBR (Observation Request) segment transmits information about an exam, diagnostic study/observation, or assessment that is specific to an order or result.

OccurrenceSub-ComponentComponentFieldParameter TypeParameter

mN/A1PV2-7String 6Patient Code

Parameter

and Time

OccurrenceSub-ComponentComponentFieldParameter

Type

N/AN/A1OBR-3String 32Encounter Key N/AN/A1OBR-4ENUMEncounter Type N/AN/A4OBR-4String 20Encounter Type N/AN/A5OBR-4String 20Encounter Type N/AN/A6OBR-4String 20Encounter Type N/AN/A1OBR-7DateTimeEncounter Date and Time N/AN/A1OBR-8DateTimeEncounter Signature Date

N/AN/A1OBR-16String 6Provider Code N/AN/A2OBR-16String 50Provider Last Name N/AN/A3OBR-16String 50Provider First Name N/AN/A4OBR-16String 1Provider Middle Initial N/AN/A5OBR-16String 20Provider Credentials

1

N/AN/A1OBR-25String 1Encounter Lock N/AN/A1OBR-26String 32Encounter Parent Key N/AN/A1OBR-28String 6Provider Code N/AN/A2OBR-28String 50Provider Last Name N/AN/A3OBR-28String 50Provider First Name N/AN/A4OBR-28String 1Provider Middle Initial N/AN/A5OBR-28String 20Provider Credentials N/A11OBR-32String 6Provider Code

1

In Paceart, if Encounter Lock is false, then the value is "P" for preliminary. If Encounter Lock is true, then the value is "F" for final. In CareLink, when an encounter is first sent to the EHR the Encounter Lock value is "F" for final. If subsequent values are sent then the Encounter Lock value is "C" for corrected.

CareLink EHR Integration Specification | Mainspring Data Express | 9

Parameter

Type

OBR:4 Coded Elements

The OBR:4 segment maps the following values to the IDCO Profile values.The items below identify the referenced Universal Service Identifiers.

CareLink integrations will only export the "REMOTE" value.

OBR:4.2OBR:4.1Value

MDC_IDC_ENUM_SESS_TYPE_InClinic754050INCLINIC

MDC_IDC_ENUM_SESS_TYPE_Other754055PROGRAMMING

MDC_IDC_ENUM_SESS_TYPE_Remote754051REMOTE

MDC_IDC_ENUM_SESS_TYPE_Other754055TTM

MDC_IDC_ENUM_SESS_TYPE_Implant754049IMPLANT

OccurrenceSub-ComponentComponentFieldParameter

N/A21OBR-32String 50Provider Last Name N/A31OBR-32String 50Provider First Name N/A41OBR-32String 1Provider Middle Initial N/A51OBR-32String 20Provider Credentials

MDC_IDC_ENUM_SESS_TYPE_Other754055PHONENOTE

MDC_IDC_ENUM_SESS_TYPE_ Other754055MISC

Outbound NTE Message Segments

The NTE segment is an optional segment following the OBR and is used to provide notes and comments.

Parameter

Type

Comment

NTE-3Parameter

/PaceartXML/PatientRecord/Encounters/Encounter[1]/CommentString 65000Encounter

Outbound OBX Messages

The OBX segment is primarily used to carry key clinical observation and result reporting information within report messages.

Nonconforming and discriminator OBX values

Each OBX message segment has a value to specify nonconforming values. An OBX-8 value of "NC-PA" means that the data was nonconforming in Paceart or CareLink. An OBX-8 value of "NC-IDCO" means that the data does not conform to the IDCO profile definition for the data.

The OBX-8 value is also used to specify a discriminator value for numerical data. For example, a numerical message segment allows the less-than (<) and greater-than (>) symbols, but not the less-than or equal to (<=) and greater-than or equal to (>=) symbols.The following segment is for valid values of the number:

10 | CareLink EHR Integration Specification | Mainspring Data Express

Parameter

type

NMNumericEncounter Programmed Bradycardia Automatic

731456^MDC_IDC_ SET_BRADY_AT_ MODE_SWITCH_ RATE^MDC

heartbeats per minute^MDC

Mode Switch Therapy Pacing Rate

While the following segment is for nonconforming values of the number:

Parameter

type

{beats}/min^ heartbeats per minute^MDC

Programmed Bradycardia Automatic

NMNumericEncounter

731456^MDC_IDC_ SET_BRADY_AT_ MODE_SWITCH_

RATE^MDC Mode Switch Therapy Pacing Rate

Enumerations

OBX-8OBX-6OBX-3OBX-2Parameter

>, <{beats}/min^

OBX-8OBX-6OBX-3OBX-2Parameter

>=^NC-IDCO, <=^NC-IDCO

For OBX message segments that have a Parameter Type of ENUM, there are multiple OBX-5 values for each possible value of the enumeration.These values are not listed in the OBX message segment tables.

Outbound OBX Session Message Segments

OBX-6OBX-3OBX-2Parameter typeParameter

721025^MDC_IDC_SESS_DTM^MDCDTMDateTimeEncounter Session Timestamp

721026^MDC_IDC_SESS_TYPE^MDCCWEENUMEncounter Type

CWEENUMEncounter Session Reprogrammed

721027^MDC_IDC_SESS_ REPROGRAMMED^MDC

720897^MDC_IDC_DEV_TYPE^MDCCWEENUMEncounter Session Device Type

720900^MDC_IDC_DEV_MFG^MDCCWEENUMEncounter Session Device Manufacturer

720898^MDC_IDC_DEV_MODEL^MDCSTString 50Encounter Session Device Model

720899^MDC_IDC_DEV_SERIAL^MDCSTString 50Encounter Session Device Serial Number

720901^MDC_IDC_DEV_IMPLANT_DT^MDCDTMDateTimeEncounter Session Active Device Implant Date

Outbound OBX Programming Bradycardia Message Segments

OBX-6OBX-3OBX-2Parameter typeParameter

Programmed Bradycardia Pacing Mode

Programmed Bradycardia Lower Rate

Programmed

730752^MDC_IDC_SET_BRADY_MODE^MDCCWEENUMEncounter

730880^MDC_IDC_SET_BRADY_LOWRATE^MDCNMNumericEncounter

731136^MDC_IDC_SET_BRADY_MAX_TRACKING_RATE^MDCNMNumericEncounter

{beats}/min^ heartbeats per minute^UCUM

Bradycardia Maximum Tracking Rate

Programmed Bradycardia Maximum Sensor Rate

Programmed Bradycardia Hysteresis Rate

Programmed Bradycardia Sleep Rate

Programmed Bradycardia Pacemaker Mediated Tachycardia Intervention

Programmed Bradycardia Premature Ventricular Contraction Intervention

Programmed Bradycardia Rate Modulation Threshold

Programmed Bradycardia Rate Modulation Slope

Programmed Bradycardia Rate Modulation Slope Exertion

Programmed Bradycardia Rate Modulation Acceleration Reaction

Programmed Bradycardia Rate Modulation Deceleration Recovery

Programmed Bradycardia Rate Modulation Activities of Daily Living Rate

Programmed Bradycardia AV Delay Sensed

CareLink EHR Integration Specification | Mainspring Data Express | 11

OBX-6OBX-3OBX-2Parameter typeParameter

731200^MDC_IDC_SET_BRADY_MAX_SENSOR_RATE^MDCNMNumericEncounter

730944^MDC_IDC_SET_BRADY_HYSTRATE^MDCNMNumericEncounter

731008^MDC_IDC_SET_BRADY_NIGHT_RATE^MDCNMNumericEncounter

100001^MDT_PROG_BRADY_PMT_INTERVENTION^MDTSTString 50Encounter

100002^MDT_PROG_BRADY_PVC_RESPONSE^MDTSTString 50Encounter

STString 50Encounter

NMNumericEncounter

100003^MDT_PROG_BRADY_RATEMODULATION_ THRESHOLD^MDT

100004^MDT_PROG_BRADY_RATEMODULATION_SLOPE^MDTSTString 50Encounter

100005^MDT_PROG_BRADY_RATEMODULATION_SLOPE_ EXERTION^MDT

ACCELERATIONREACTION^MDT

DECELERATIONRECOVERY^MDT

100008^MDT_PROG_BRADY_RATEMODULATION_ ADLRATE^MDT

{beats}/min^ heartbeats per minute^UCUM

s^seconds^UCUM100006^MDT_PROG_BRADY_RATEMODULATION_

m^minutes^UCUM100007^MDT_PROG_BRADY_RATEMODULATION_

{beats}/min^ heartbeats per minute^UCUM

ms^milliseconds^UCUM731265^MDC_IDC_SET_BRADY_SAV_DELAY_HIGH^MDCNMNumericEncounter

12 | CareLink EHR Integration Specification | Mainspring Data Express

Programmed Bradycardia AV Delay Paced

Programmed

STENUMEncounter

Bradycardia AV Delay Adaptive Status

Programmed Bradycardia AV Delay Adaptive Paced Minimum

Programmed Bradycardia AV Delay Adaptive Sensed Minimum

NMNumericEncounter Programmed Bradycardia AV Delay Adaptive Start Rate

NMNumericEncounter Programmed Bradycardia AV Delay Adaptive Stop Rate

STString 50Encounter Programmed Bradycardia AV Delay Adaptive Curve Description

STENUMEncounter Programmed Bradycardia Automatic Mode Switch Status

NMNumericEncounter Programmed Bradycardia Automatic Mode Switch Detection Criteria Rate

NMNumericEncounter Programmed Bradycardia Automatic Mode Switch Detection Duration Fixed

NMNumericEncounter Programmed Bradycardia Automatic Mode Switch Detection Duration Beat Ratio Numerator

NMNumericEncounter Programmed Bradycardia Automatic Mode Switch Detection Duration Beat Ratio Denominator

NMNumericEncounter Programmed Bradycardia

100009^MDT_PROG_BRADY_AVDELAY_ADAPTIVE_ STATUS^MDT

100012^MDT_PROG_BRADY_AVDELAY_ADAPTIVE_ STARTRATE^MDT

100013^MDT_PROG_BRADY_AVDELAY_ADAPTIVE_ STOPRATE^MDT

100010^MDT_PROG_BRADY_AVDELAY_ CURVEDESCRIPTION^MDT

100011^MDT_PROG_BRADY_AUTOMATICEMODESWITCH_ STATUS^MDT

100014^MDT_PROG_BRADY_AUTOMATICEMODESWITCH_ DETECTION_CRITERIA_RATE^MDT

DETECTION_CRITERIA_DURATION_FIXED^MDT

DETECTION_CRITERIA_DURATION_BEATRATIO_ NUMERATOR^MDT

DETECTION_CRITERIA_DURATION_BEATRATIO_ DENOMINATOR^MDT

DETECTION_CRITERIA_DURATION_BEATCOUNT^MDT

OBX-6OBX-3OBX-2Parameter typeParameter

ms^milliseconds^UCUM731329^MDC_IDC_SET_BRADY_PAV_DELAY_HIGH^MDCNMNumericEncounter

ms^milliseconds^UCUM731330^MDC_IDC_SET_BRADY_PAV_DELAY_LOW^MDCNMNumericEncounter

ms^milliseconds^UCUM731266^MDC_IDC_SET_BRADY_SAV_DELAY_LOW^MDCNMNumericEncounter

{beats}/min^ heartbeats per minute^UCUM

s^seconds^UCUM100015^MDT_PROG_BRADY_AUTOMATICEMODESWITCH_

{beats}^heartbeats^UCUM100016^MDT_PROG_BRADY_AUTOMATICEMODESWITCH_

{beats}^heartbeats^UCUM100017^MDT_PROG_BRADY_AUTOMATICEMODESWITCH_

{beats}^heartbeats^UCUM100018^MDT_PROG_BRADY_AUTOMATICEMODESWITCH_

Automatic Mode Switch Detection Duration Beat Count

Programmed Bradycardia Automatic Mode Switch Therapy Pacing Rate

Programmed Bradycardia Automatic Mode Switch Therapy Pacing Mode

Programmed Bradycardia Left Ventricle Sensing Polarity

Programmed Bradycardia Left Ventricle Sensing Pathway Location

Programmed Bradycardia Left Ventricle Sensing Pathway Electrode

Programmed Bradycardia Left Ventricle Sensing Pathway Location

Programmed Bradycardia Left Ventricle Sensing Pathway Electrode

Programmed Bradycardia Left Ventricle Sensing Pathway Location

Programmed Bradycardia Left Ventricle Sensing Pathway Electrode

Programmed Bradycardia Left Ventricle Sensing Pathway Location

Programmed Bradycardia Left Ventricle Sensing Pathway Electrode

Programmed Bradycardia Left Ventricle Sensing Pathway Location

CareLink EHR Integration Specification | Mainspring Data Express | 13

OBX-6OBX-3OBX-2Parameter typeParameter

NMNumericEncounter

CWEENUMEncounter

731456^MDC_IDC_SET_BRADY_AT_MODE_SWITCH_ RATE^MDC

731392^MDC_IDC_SET_BRADY_AT_MODE_SWITCH_ MODE^MDC

729603^MDC_IDC_SET_LEADCHNL_LV_SENSING_ POLARITY^MDC

729677^MDC_IDC_SET_LEADCHNL_LV_SENSING_ANODE_ LOCATION_1^MDC

729741^MDC_IDC_SET_LEADCHNL_LV_SENSING_ANODE_ ELECTRODE_1^MDC

729678^MDC_IDC_SET_LEADCHNL_LV_SENSING_ANODE_ LOCATION_2^MDC

729742^MDC_IDC_SET_LEADCHNL_LV_SENSING_ANODE_ ELECTRODE_2^MDC

729679^MDC_IDC_SET_LEADCHNL_LV_SENSING_ANODE_ LOCATION_3^MDC

729743^MDC_IDC_SET_LEADCHNL_LV_SENSING_ANODE_ ELECTRODE_3^MDC

729805^MDC_IDC_SET_LEADCHNL_LV_SENSING_CATHODE_ LOCATION_1^MDC

729869^MDC_IDC_SET_LEADCHNL_LV_SENSING_CATHODE_ ELECTRODE_1^MDC

729806^MDC_IDC_SET_LEADCHNL_LV_SENSING_CATHODE_ LOCATION_2^MDC

{beats}/min^ heartbeats per minute^UCUM

14 | CareLink EHR Integration Specification | Mainspring Data Express

Programmed

CWEENUMEncounter

Bradycardia Left Ventricle Sensing Pathway Electrode

CWEENUMEncounter Programmed Bradycardia Left Ventricle Sensing Pathway Location

CWEENUMEncounter Programmed Bradycardia Left Ventricle Sensing Pathway Electrode

STENUMEncounter Programmed Bradycardia Left Ventricle Sensing Blanking Previous Event Chamber

NMNumericEncounter Programmed Bradycardia Left Ventricle Sensing Refractory Period Interval

STENUMEncounter Programmed Bradycardia Left Ventricle Sensing Blanking Previous Event Chamber

STENUMEncounter Programmed Bradycardia Left Ventricle Sensing Blanking Previous Event Type

NMNumericEncounter Programmed Bradycardia Left Ventricle Sensing Blanking Interval

NMNumericEncounter Programmed Bradycardia Left Ventricle Sensing Amplitude

CWEENUMEncounter Programmed Bradycardia Left Ventricle Sensing Amplitude Adaptation Mode

CWEENUMEncounter Programmed Bradycardia Right Atrium Sensing Polarity

CWEENUMEncounter Programmed Bradycardia Right Atrium Sensing Pathway Location

CWEENUMEncounter Programmed Bradycardia Right

729870^MDC_IDC_SET_LEADCHNL_LV_SENSING_CATHODE_ ELECTRODE_2^MDC

729807^MDC_IDC_SET_LEADCHNL_LV_SENSING_CATHODE_ LOCATION_3^MDC

729871^MDC_IDC_SET_LEADCHNL_LV_SENSING_CATHODE_ ELECTRODE_3^MDC

101043^MDT_PROG_BRADY_REFRACTORYPERIOD_ PREVIOUSEVENTCHAMBER_LV^MDT

INTERVAL_LV^MDT

101051^MDT_PROG_BRADY_BLANKINGPERIOD_ PREVIOUSEVENTCHAMBER_LV^MDT

101052^MDT_PROG_BRADY_BLANKINGPERIOD_EVENTTYPE_ LV^MDT

LV^MDT

SENSITIVITY^MDC

729923^MDC_IDC_SET_LEADCHNL_LV_SENSING_ ADAPTATION_MODE^MDC

729600^MDC_IDC_SET_LEADCHNL_RA_SENSING_ POLARITY^MDC

729665^MDC_IDC_SET_LEADCHNL_RA_SENSING_ANODE_ LOCATION_1^MDC

729729^MDC_IDC_SET_LEADCHNL_RA_SENSING_ANODE_ ELECTRODE_1^MDC

OBX-6OBX-3OBX-2Parameter typeParameter

ms^milliseconds^UCUM101044^MDT_PROG_BRADY_REFRACTORYPERIOD_

ms^milliseconds^UCUM101053^MDT_PROG_BRADY_BLANKINGPERIOD_INTERVAL_

mV^millivolts^UCUM729539^MDC_IDC_SET_LEADCHNL_LV_SENSING_

Atrium Sensing Pathway Electrode

Programmed Bradycardia Right Atrium Sensing Pathway Location

Programmed Bradycardia Right Atrium Sensing Pathway Electrode