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QHQ-20-10468CPRcard

Laerdal Medical AS
CPRcard - FCC ID QHQ-20-10468 - Laerdal Medical AS
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
May 19, 2021
Application Purpose
Original Equipment
Date of Application
May 19, 2021
Equipment Note
CPRcard
Frequency Range
2402.00000000 - 2480.00000000
Company
Laerdal Medical AS
Country
Norway

Documents & Files

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Users Manual

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

Check revision before useApproved Record Document Nr: 00072686 Rev: C DA-00083976 THE INFORMATION CONTAINED HEREIN IS PROPRIETARY TO LAERDAL AND SHALL NOT BE USED FOR ANY PURPOSE DETRIMENTAL TO OR BE REPRODUCED WITHOUT PERMISSION OF LAERDAL Page 1 of 2 Document Nr: 00072686 Rev C DA-00083976 Title CPRcard User Guide (IE) Document Type Doc - Print Specification Document Category DMR Description of Change: Revise CPRcard3 User Guide specification to Rev C Approved Record Date: 2021-05-12T13:27:37Z Lifecycle: Production (when released in PLM System) Tool Information: Replaces Document: Site: LMAS (Stavanger) Attachments (Electronic Files) FilenameFile DescriptionFile Type Att 2 to 00072686.pdfCPRcard UG - Webfilepdf Att 5 to 00072686.pdfCPRcard UG - Print Specificationspdf Att 3 to 00072686.zipCPRcard UG - Native Indesign Folderzip Att 1 to 00072686.pdfCPRcard UG - Prepressfilepdf Att 4 to 00072686.pdfCPRcard UG - Folding Instructionspdf Electronic Signatures StatusSignoff UserLocal Client Time Create/update and approve documentFosnes, Camilla Andersen2021-05-12T12:18:19Z Verify and approve documentNguyen, Phuong Helen2021-05-12T13:27:37Z Verify and approve documentRisanger, John Sigve2021-05-12T12:56:29Z Verify and approve documentEilevstjønn, Joar2021-05-12T13:12:41Z Part References Valid at Time of Print (for current status see Agile PLM system) Item NumberDescription 20-18063CPRcard User Guide Check revision before useApproved Record Document Nr: 00072686 Rev: C DA-00083976 THE INFORMATION CONTAINED HEREIN IS PROPRIETARY TO LAERDAL AND SHALL NOT BE USED FOR ANY PURPOSE DETRIMENTAL TO OR BE REPRODUCED WITHOUT PERMISSION OF LAERDAL Page 2 of 2 Additional Info Create User Risanger, John Sigve Create Date 2021-02-02T14:13:49Z Replaces Document Specifics Type 01 User Guide Language 01= English (US) Page Number NA Colour 4+4 CMYK Other Accordian User Guide with print on both sides. See Att 4 to 00072686 for folding instructions and size guidelines. See Att 5 to 00072686 for print specifications Symbol Glossary SymbolDefinition CE mark Single Use. Do not re-use. Follow Instructions for Use WEEE Symbol Manufacturer Date of Manufacture YYYY MM DD Defibrillation-proof type BF applied part. The entire CPRcard is the applied part. Warning/Caution Device catalogue number reference Unique Device Identification Ingress protection rating Temperature limitations Humidity limitations Pressure limitations Machine readable Unique Device Identification (UDI). Datamatrix with UDI numbers (XXX = last three UDI digits) Not to be used in a bed or on soft surfaces Not for patient under 8 years UDI CPRcard User Guide EN www.laerdal.com Specifi cations DimensionsHeight 86 mm x Width 54 mm x Depth 2 mm Weight < 7 g External MaterialPolycarbonate (PC) and self-adhesive medical tape. BatteryNon-rechargeable lithium battery 15 mAh nominal capacity* Typical battery life: >30 minutes of CPR End-of-shelf-life battery life: minimum 10 minutes of CPR Shelf life3 years from the production date Operating/Storage Conditions Temperature: 0 – 40 °C (32 – 104 °F) Humidity: ≤ 90% RH Atmospheric Pressure: 620 – 1060 hPa Shipping ConditionsTemperature: -40 – 40 °C (-40 – 104 °F) Humidity: ≤ 90% RH Atmospheric Pressure: 550 – 1060 hPa Bluetooth® Low energy transmitter Frequency band: 2.400 – 2.4835 GHz Modulation: Gaussian frequency shift modulation Maximum radio-frequency shift modulation: 1 mW Effective radiated power : 0 dBm Ingress protection rating IP67. Dust tight, and protected against water submersion to 1 meter (3.3 feet) for 30 minutes *Battery performance varies with temperature. Caution Do not store your CPRcard above 40 °C as this may reduce the lifetime of the battery. Electromagnetic Conformity The device is intended for use outdoors and indoors except for near HF surgical equipment, and the RF shielded room for magnetic resonance imaging. No particular actions are required to maintain safety and performance with regard to electromagnetic disturbances for the expected service life. Warnings • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the CPRcard. Otherwise, degradation of the performance of this equipment could result. Electromagnetic Emissions Tests Emissions Test Standard or test method Compliance RF emissions CISPR 11Group 1 Class BGroup 1 Class B Harmonic emissionsIEC 61000-3-2Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3Complies Electromagnetic Immunity Tests Immunity Test Standard or test method Compliance Level and Immunity Test Level Electrostatic dischargeIEC 61000-4-2±8 kV contact ±2kV, ±4kV, ±8kV ±15 kV air Radiated RF EM fieldsIEC 61000-4-3 10 V/m 80 MHz – 2.7 GHz 80% AM at 2 Hz Proximity fields from RF wireless communication equipment IEC 61000-4-3 380-390 MHz: 27 V/m 430-470 MHz: 28 V/m 704-787 MHz: 9 V/m 800-960 MHz: 28 V/m 1700-1990 MHz: 28 V/m 2400-2470 MHz: 28 V/m 5100-5800 MHz: 29 V/m Rated power frequencyIEC 61000-4-830 A/m 50 Hz or 60 Hz Electrical fat transients / bursts IEC 61000-4-4±2 kV 100 kHz repetition frequency Surges: Line-to-lineIEC 61000-4-5±0.5 kV. ±1 kV Surges: Line-to-groundIEC 61000-4-5±0.5 kV. ±1 kV. ±2 kV Conducted disturbances induced by RF fields IEC 61000-4-63 V ; 0.15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz Voltage dipsIEC 61000-4-110% U T ; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% U T ; 1 cycle and 70% U T ; 25/30 cycles Single phase: at 0° Voltage interruptionsIEC 61000-4-110% U T ; 250/300 cycle U T is the a.c. mains voltage prior to application of the test level. 20-18063 Rev A Support If you need assistance …

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Cover Letter(s)

______________________________________________________________________________________________ Mail address Laerdal Medical AS P.O. Box 377 4002 Stavanger, Norway E-mail and Website [email protected] www.laerdal.com Office address Tanke Svilandsgate 30 4007, Stavanger, Norway Telephone +47 51 51 17 00 Telefax +47 51 52 35 57 Org.no. 979 484 488 Date Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request FCC ID: QHQ-20-10468 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, Laerdal Medical AS hereby requests permanent confidential treatment of information accompanying this application as outlined below:  Schematics  Bill of Materials/Parts List  Block Diagrams  Theory of Operation Laerdal Medical AS also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of period of 90 days:  Internal Photos  External Photos  User Manual The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Name: Mari Kaada Title: Corporate Director Q&R, Laerdal Medical AS DocuSign Envelope ID: 1F2D6C75-4DBF-4703-B526-78B1FA2F4C15 07.04.2021 Certificate Of Completion Envelope Id: 1F2D6C754DBF4703B52678B1FA2F4C15Status: Completed Subject: Please DocuSign This Document Source Envelope: Document Pages: 1Signatures: 1Envelope Originator: Certificate Pages: 1Initials: 0Mari Kaada AutoNav: Enabled EnvelopeId Stamping: Enabled Time Zone: (UTC+01:00) Amsterdam, Berlin, Bern, Rome, Stockholm, Vienna Tanke Svilandsgate 30 Stavanger, Stavanger 4002 [email protected] IP Address: 185.81.101.11 Record Tracking Status: Original 2021-04-07 | 13:21 Holder: Mari Kaada [email protected] Location: DocuSign Signer EventsSignatureTimestamp Mari Kaada [email protected] Corporate Director Q&R Laerdal Medical AS Security Level: Email, Account Authentication (None) Signature Adoption: Pre-selected Style Using IP Address: 92.221.21.8 Sent: 2021-04-07 | 13:21 Viewed: 2021-04-07 | 13:21 Signed: 2021-04-07 | 13:22 Electronic Record and Signature Disclosure: Not Offered via DocuSign In Person Signer EventsSignatureTimestamp Editor Delivery EventsStatusTimestamp Agent Delivery EventsStatusTimestamp Intermediary Delivery EventsStatusTimestamp Certified Delivery EventsStatusTimestamp Carbon Copy EventsStatusTimestamp Witness EventsSignatureTimestamp Notary EventsSignatureTimestamp Envelope Summary EventsStatusTimestamps Envelope SentHashed/Encrypted2021-04-07 | 13:21 Certified DeliveredSecurity Checked2021-04-07 | 13:21 Signing CompleteSecurity Checked2021-04-07 | 13:22 CompletedSecurity Checked2021-04-07 | 13:22 Payment EventsStatusTimestamps

Cover Letter(s)

______________________________________________________________________________________________ Mail address Laerdal Medical AS P.O. Box 377 4002 Stavanger, Norway E-mail and Website [email protected] www.laerdal.com Office address Tanke Svilandsgate 30 4007, Stavanger, Norway Telephone +47 51 51 17 00 Telefax +47 51 52 35 57 Org.no. 979 484 488 Date TUV SUD America Inc. 10 Centennial Drive Peabody, MA 01960, USA Dear Sir or Madam, We, Laerdal Medical AS, P.O. Box 377, Tanke Svilandsgate 30, 4002 Stavanger, Norway, hereby authorize Benjamin Puls and Stefan Breu of TÜV SÜD Product Service GmbH, Äußere Frühlingstraße 45, 94315 Straubing, Germany to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. Yours sincerely, Name: Mari Kaada Title: Corporate Director Q&R, Laerdal Medical AS DocuSign Envelope ID: 2127C986-71FF-4566-AEB4-73D73B0032C0 27.04.2021 Certificate Of Completion Envelope Id: 2127C98671FF4566AEB473D73B0032C0Status: Completed Subject: Please DocuSign This Document Source Envelope: Document Pages: 1Signatures: 1Envelope Originator: Certificate Pages: 1Initials: 0Mari Kaada AutoNav: Enabled EnvelopeId Stamping: Enabled Time Zone: (UTC+01:00) Amsterdam, Berlin, Bern, Rome, Stockholm, Vienna Tanke Svilandsgate 30 Stavanger, Stavanger 4002 [email protected] IP Address: 185.81.101.11 Record Tracking Status: Original 2021-04-27 | 10:20 Holder: Mari Kaada [email protected] Location: DocuSign Signer EventsSignatureTimestamp Mari Kaada [email protected] Corporate Director Q&R Laerdal Medical AS Security Level: Email, Account Authentication (None) Signature Adoption: Pre-selected Style Using IP Address: 92.221.21.8 Sent: 2021-04-27 | 10:21 Viewed: 2021-04-27 | 10:21 Signed: 2021-04-27 | 10:21 Electronic Record and Signature Disclosure: Not Offered via DocuSign In Person Signer EventsSignatureTimestamp Editor Delivery EventsStatusTimestamp Agent Delivery EventsStatusTimestamp Intermediary Delivery EventsStatusTimestamp Certified Delivery EventsStatusTimestamp Carbon Copy EventsStatusTimestamp Witness EventsSignatureTimestamp Notary EventsSignatureTimestamp Envelope Summary EventsStatusTimestamps Envelope SentHashed/Encrypted2021-04-27 | 10:21 Certified DeliveredSecurity Checked2021-04-27 | 10:21 Signing CompleteSecurity Checked2021-04-27 | 10:21 CompletedSecurity Checked2021-04-27 | 10:21 Payment EventsStatusTimestamps

ID Label/Location Info

132 Att 1 to 00064410 Rev B CPRcard artwork 6, 91, 62,10, 0, 0, 50 0, 0, 0, 0 0, 0, 0, 12 0, 0, 0, 0 100, 69, 24, 7 74, 65, 63, 81 74, 65, 63, 81 CMYK 0, 0, 0, 12 Background color (front and the top of the back side)

Test Report

Trade Register Munich HRB 85742 VAT ID No. DE129484267 Information pursuant to Section 2(1) DL-InfoV (Germany) at www.tuev-sued.com/imprint Managing Directors: Walter Reithmaier (CEO) Dr. Jens Butenandt Patrick van Welij Phone: +49 (0) 9421 55 22-0 Fax: +49 (0) 9421 55 22-99 www.tuev-sued.de TÜV SÜD Product Service GmbH Äußere Frühlingstraße 45 94315 Straubing Germany TÜV SÜD Product Service RESPONSIBLE FOR NAME DATE SIGNATURE Project Management Alex Fink 2021-04-26 SIGN-ID 498452 Authorised Signatory Matthias Stumpe 2021-04-26 SIGN-ID 499537 Signatures in this approval box have checked this document in line with the requirements of TÜV SÜD Product Service document control rules. ENGINEERING STATEMENT The measurements shown in this report were made in accordance with the procedures described on test pages. All reported testing was carried out on a sample equipment to demonstrate limited compliance with FCC 47 CFR Part 15C and ISED Canada RSS-247 and ISED Canada RSS-GEN. The sample tested was found to comply with the requirements defined in the applied rules. RESPONSIBLE FOR NAME DATE SIGNATURE Testing Alex Fink 2021-04-26 SIGN-ID 498452 Laboratory Accreditation DAkkS Reg. No. D-PL-11321-11-02 DAkkS Reg. No. D-PL-11321-11-03 Laboratory recognition Registration No. BNetzA-CAB-16/21-15 ISED Canada test site registration 3050A-2 EXECUTIVE SUMMARY A sample of this product was tested and found to be compliant with FCC 47 CFR Part 15C, ISED Canada RSS-247, Issue 2 (2017- 02) and ISED Canada RSS-GEN:2016, Issue 5 (2019-03). Report on the FCC and IC Testing of the Laerdal Medical AS Model: CPRcard In accordance with FCC 47 CFR Part 15C, ISED Canada RSS-247 and ISED Canada RSS-GEN Prepared for: Laerdal Medical AS P.O. 377, Tanke Svilandsgate 30 4002 Stavanger Norway FCC ID: QHQ-20-10468 IC: 20263-2010468 COMMERCIAL-IN-CONFIDENCE Date: 2021-04-26 Document Number: TR-11437-04517-01 | Issue: 01 DISCLAIMER AND COPYRIGHT This non-binding report has been prepared by TÜV SÜD Product Service with all reasonable skill and care. The document is confidential to the potential Client and TÜV SÜD Product Service. No part of this document may be reproduced without the prior written approval of TÜV SÜD Product Service. © 2021 TÜV SÜD Product Service. ACCREDITATION Our BNetzA Accreditation does not cover opinions and interpretations and any expressed are outside the scope of our BNetzA Accreditation. Document Number: TR-11437-04517-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE COMMERCIAL-IN-CONFIDENCE Page 1 of 49 Contents 1 Report Summary .........................................................................................................................2 1.1 Report Modification Record ...........................................................................................................2 1.2 Introduction ....................................................................................................................................2 1.3 Brief Summary of Results .............................................................................................................3 1.4 Basic information of EUT ..............................................................................................................4 1.5 EUT Modification Record ..............................................................................................................4 1.6 Test Location .................................................................................................................................5 2 Test Setup ....................................................................................................................................6 2.1 Radiated Emission in Fully or Semi Anechoic Room ....................................................................6 2.2 Radiated Emission at Alternative Test Site ...................................................................................8 3 Test Details ............................................................................................................................... 10 3.1 Spurious Emissions .................................................................................................................... 10 3.2 Restricted Band Edges............................................................................................................... 19 3.3 Authorised Band Edges ............................................................................................................. 22 3.4 Emission Bandwidth ................................................................................................................... 25 3.5 Power Spectral Density .............................................................................................................. 33 3.6 Maximum Conducted Output Power .......................................................................................... 35 3.7 Transmitter frequency stability ................................................................................................... 37 3.8 Exposure of Humans to RF Fields ............................................................................................. 41 4 Photographs ............................................................................................................................. 46 4.1 Test Setup Photos ...................................................................................................................... 46 5 Measurement Uncertainty ....................................................................................................... 47 Annex A: Test Setup Photos 4 pages Document Number: TR-11437-04517-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE COMMERCIAL-IN-CONFIDENCE Page 2 of 49 1 Report Summary 1.1 Report Modification Record Alterations and additions to this report will be issued to the holders of each copy in the form of a complete document. Issue Description of Change Date of Issue 1 First Issue 2021-04-26 Table 1 1…

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Test Setup Photos

Document Number: Annex A to TR-11437-04517-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE COMMERCIAL-IN-CONFIDENCE Page 1 of 4 Annex A to Test Report TR-11437-04517-01 | Issue: 01 1 Photographs Taken During Testing Document Number: Annex A to TR-11437-04517-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE COMMERCIAL-IN-CONFIDENCE Page 2 of 4 Document Number: Annex A to TR-11437-04517-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE COMMERCIAL-IN-CONFIDENCE Page 3 of 4 Document Number: Annex A to TR-11437-04517-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE COMMERCIAL-IN-CONFIDENCE Page 4 of 4

Contact Information

Applicant

Mari Kaada(Corporate Regulatory Affairs Manager)
[email protected]+4751511700Fax: +4751511717

Test Firm

TUV SUD Product Service GmbHMarkus Biberger
[email protected]+49 9421 5682-153Fax: +49 9421 5682-199

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz155.00 µW
Confidentiality
Long Term
Grant Notes
Power listed is conducted.

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