mmt FU8002-915 Modal Conaltraidh Rèidio

TUAIRISGE GHAIRM

Tha modal conaltraidh rèidio FU8002-915 air a dhealbhadh gus innealan meidigeach aonaichte airson ceangal uèirleas de choimpiutairean le bathar-bog UDMvision a chaidh a chuir a-steach mar phàirt de dh’ innealan meidigeach bho theaghlach innealan meidigeach Urodynamics 3rd ginealach air an dèanamh le teicneòlas meidigeach MEDKONSULT sro, Pasteurova 67/15, 779 00 OLOMOUC, Poblachd nan Seiceach.
Chan urrainnear an toradh a reic air leth agus tha e an dùil a-mhàin airson cleachdadh an neach-dèanamh fhèin ann a bhith a’ dèanamh innealan meidigeach, no seirbheis ùghdarraichte innealan meidigeach. Chan e inneal rèidio fèin-chumanta a th’ anns an toradh.
Tha an ceanglaiche taobh a-staigh cuairteachadh an uidheim agus chan fhaighear thuige ach le bhith a’ disassembly an inneal nach eil feum air mar as trice.

Aithneachadh

FCC ID 2A8XBFU8002-915V1

A' comharrachadh

RIAGHAILTEAN COITCHEANN

Installation of the FU8002-915 radio module should only be performed by qualified personnel following detailed guidelines provided in this manual to ensure FCC compliance. Any modification to the module or its antenna could lead to the device operating outside of FCC-approved conditions, potentially necessitating a new authorization.
Chan eil stàladh agus seirbheiseachadh modal conaltraidh rèidio FU8002-915 ach air a dhèanamh leis an neach-dèanamh no ionad seirbheis ùghdarraichte. Feumar smachd a chumail air an stàladh agus feumar trèanadh sònraichte.
This module is not a stand-alone product and can be commissioned by an authorized medical device service for urodynamic systems of the manufacturer MEDKONSULT Medical Technology s.r.o. Please contact your distributor for this purpose.

INTEGRATION INSTRUCTIONS (ACCORDING TO KDB996369 D03 2.0)

• Caibideil 2.2
  Chaidh an FU8002-915 a thoirt seachad le Coimisean Conaltraidh Feadarail (FCC) CFR47 Tele-chonaltradh, Pàirt 15 Fo-roinn C “Rèididheatoran a dh’aona ghnothach” fo earrannan 15.247, còmhla ri cead modular a rèir stiùiridhean ceadachaidh Transmitter Modular Pàirt 15.212.
• Caibideil 2.3
  The antenna must not be changed for a different type than specified in the technical parameters stated in the FU8002-915 Datasheet. Replacement may only be carried out by an authorized service of the manufacturer. The antenna should be installed so that the end user cannot change or modify the antenna.
  Chan urrainnear na paramadairean rèidio atharrachadh agus tha iad air an còdadh gu cruaidh sa mhodal.
  Tha conaltradh gnìomhach a’ mhodal conaltraidh Rèidio FU8002-915 air a làn smachd leis a’ bhathar-bog smachd airson UDMvision de na siostaman urodynamic. Tha am protocol conaltraidh seilbh agus air a chleachdadh airson eadar-chonaltradh a-mhàin airson teaghlach MMT de innealan meidigeach 3mh ginealach Urodynamics.
• Caibideil 2.4
  Gun a bhith a’ buntainn
• Caibideil 2.5
  Dealbhaidhean antenna lorg: Neo-iomchaidh.
  Chan fhaodar an antenna atharrachadh airson seòrsa eadar-dhealaichte na tha air a shònrachadh anns na paramadairean teignigeach.
  Tha gluasad sam bith bho pharaimearan sònraichte an antenna den t-seòrsa ainmichte ag iarraidh gum feum neach-dèanamh an toraidh aoigheachd fios a thoirt do neach-tabhartais a’ mhodal gu bheil iad airson an seòrsa antenna no na paramadairean atharrachadh.
  Anns a 'chùis seo, feumar tagradh atharrachadh ceadaichte Clas II filed leis an neach-tabhartais, no faodaidh an neach-dèanamh aoigheachd uallach a ghabhail tro atharrachadh ann am modh-obrach FCC ID (tagradh ùr) agus an uairsin tagradh atharrachadh ceadaichte Clas II.
• Caibideil 2.6
  Gus dèanamh cinnteach gu bheilear a’ cumail ri riaghailtean nochdaidh FCC RF, feumaidh modal rèidio FU8002-915 astar dealachaidh as ìsle de 20 cm a chumail bho gach neach rè obrachadh agus chan fhaodar a cho-shuidheachadh no obrachadh ann an co-bhonn ri antenna no inneal-sgaoilidh sam bith eile ach a-mhàin a rèir modhan toraidh ioma-sgaoilidh FCC. Chaidh am modal seo a dhealbhadh gus obrachadh le antennas sònraichte. Le bhith a’ cleachdadh antennas gun chead, ag atharrachadh dealbhadh an antenna, no ag obrachadh a’ mhodail taobh a-muigh nan cumhachan ainmichte, dh’ fhaodadh sin a dhol an aghaidh riaghailtean FCC agus ùghdarras an neach-cleachdaidh airson an uidheamachd obrachadh a chuir dheth.
  Ma thèid am modal rèidio FU8002-915 a chleachdadh ann an tagradh so-ghiùlain (tha antenna nas lugha na 20 cm bho dhaoine rè obrachadh), tha e an urra ris an integrator deuchainn Ìre Absorption Sònraichte (SAR) a dhèanamh a rèir riaghailtean FCC 2.1091. Airson tuilleadh fiosrachaidh, thoir sùil air an ann an Leabhar-làimhe KDB 996369 D03 OEM v01 agus KDB 996369 D04 Module Integration Guide v02.
  Bidh an leabhar-làimhe cleachdaiche deireannach a’ toirt seachad teacsa a bharrachd bhon neach-dèanamh toraidh aoigheachd gu luchd-cleachdaidh deireannach, Bidh e a’ toirt a-steach aithrisean gèillidh FCC co-cheangailte ri riatanasan sgaoilidh no bileagan. Mura h-eil aithrisean nochdaidh RF agus cumhachan cleachdaidh air an toirt seachad, feumaidh an neach-dèanamh toraidh aoigheachd uallach a ghabhail airson a ’mhodal tro atharrachadh ann an ID FCC (tagradh ùr).
• Caibideil 2.7
  The antenna must not be changed for a different type than specified in the technical parameters stated in the FU8002-915 Datasheet. Replacement may only be carried out by an authorized service of the manufacturer. The antenna should be installed so that the end user cannot change or modify the antenna.
• Caibideil 2.8
  Tha am modal FU8002-915 air a bhith air a chomharrachadh leis an àireamh ID FCC aige fhèin, agus mura h-eil an ID FCC ri fhaicinn nuair a thèid am modal a chuir a-steach taobh a-staigh inneal eile, feumaidh taobh a-muigh an toraidh chrìochnaichte anns a bheil am modal a bhith air a chuir a-steach bileag a thaisbeanadh a’ toirt iomradh air a ’mhodal dùinte. Faodaidh an leubail taobh a-muigh seo briathrachas a chleachdadh mar a leanas:
  Contains Transmitter Module FCC ID: 2A8XBFU8002-915V1
  -or
  A’ toirt a-steach ID FCC: 2A8XBFU8002-915V1
• Caibideil 2.9
  Thathas a’ moladh deuchainn a dhèanamh air an toradh aoigheachd leis a h-uile inneal-sgaoilidh a chaidh a chuir a-steach - ris an canar an deuchainn sgrùdaidh co-dhèanta - gus dearbhadh gu bheil an toradh aoigheachd a ’coinneachadh ri riaghailtean iomchaidh FCC. Tha an speactram rèidio gu bhith air a sgrùdadh leis a h-uile inneal-sgaoilidh anns an toradh aoigheachd deireannach ag obair gus faighinn a-mach nach bi sgaoilidhean sam bith nas àirde na a ’chrìoch as àirde a tha ceadaichte airson aon inneal-sgaoilidh fa leth mar a tha riatanach ann an Earrann 2.947(f). Tha e an urra ris an neach-dèanamh aoigheachd dèanamh cinnteach nuair a bhios an toradh aca ag obair mar a bha dùil, nach eil sgaoilidhean sam bith ann a tha a-mach à gèilleadh nach robh an làthair nuair a chaidh na luchd-sgaoilidh a dhearbhadh leotha fhèin.
  If the modular transmitter has been fully tested by the module grantee on the required number of channels, modulation types, and modes, it should not be necessary for the host installer to re-test all the available transmitter modes or set-tings. It is recommended that the host product manufacturer, installing the modular transmitter, perform some investigative measurements to confirm that the resulting composite system does not exceed the spurious emissions limits or band edge limits (e.g., where a different antenna may be causing additional emissions).
  Bu chòir don deuchainn sgrùdadh a dhèanamh airson sgaoilidhean a dh’ fhaodadh tachairt mar thoradh air a bhith a ’measgachadh sgaoilidhean le luchd-sgaoilidh eile, cuairteachadh didseatach, no air sgàth feartan corporra an toraidh aoigheachd (cuartachadh). Tha an sgrùdadh seo gu sònraichte cudromach nuair a thathar ag aonachadh ioma inneal-sgaoilidh modular far a bheil an teisteanas stèidhichte air deuchainn a dhèanamh air gach fear dhiubh ann an rèiteachadh leis fhèin.

Caibideil 2.10
The host product manufacturer should perform the test of radiated & conducted emission and spurious emission etc. according to FCC Part 15C: 15.247 and 15.209 & 15.207, 15B class B requirement, only if the test result complies with FCC part 15C: 15.247 and 15.209 & 15.207, 15B class B requirement.
Leis gu bheil am modal an dùil a chleachdadh ann an innealan meidigeach, feumar deuchainnean EMC a dhèanamh air an ionnstramaid iomlan a ’toirt a-steach am modal a rèir IEC EN 60601-1-2.
Thathas a’ moladh gu làidir an neach-dèanamh toraidh aoigheachd dearbhadh gèilleadh ri riatanasan FCC airson an inneal-sgaoilidh nuair a thèid am modal a chuir a-steach san òstair.
Tha uallach air an neach-dèanamh toraidh aoigheachd airson gèilleadh ri riaghailtean FCC sam bith eile a tha a’ buntainn ris an aoigh nach eil air a chòmhdach le tabhartas teisteanais inneal-sgaoilidh modular. Ma tha an neach-tabhartais a’ margaidheachd an toraidh aca mar a bhith a’ gèilleadh ri Pàirt 15 Fo-roinn B (nuair a tha cuairteachadh didseatach rèididheachd gun dùil ann cuideachd), bheir an neach-tabhartais fios seachad ag innse gu bheil feum fhathast air an toradh aoigheachd deireannach pàirt 15 fo-roinn B deuchainn gèillidh leis an inneal-sgaoilidh modular a chaidh a chuir a-steach. .

TESTPLAN – TESTING REQUIREMENTS AND METHODOLOGY

Thairisview de dhòigh-obrach deuchainn
Chan eil sgiath anns a’ mhodal seo agus chan eil cuir a-steach modaladh / dàta bufair ann agus mar sin tha e cuibhrichte. Bidh feum air an integrator aoigheachd file a Class II Permissive Change for each host-specific installation. The following testing should be performed to demonstrate continued compliance.
The following testing methodology ensures compliance with regulatory requirements and verifies the correct functionality of the module within host devices by MEDKONSULT medical technology s.r.o..

Testing includes:

• Measurement of radiated unwanted emissions (15.209(a))
• Testing of band edge frequencies (15.247(d))
• Measurement of emissions in idle mode (15.109(a))
• Compatibility testing with urodynamic systems (4.2.4)
• Verification of buffered data transmission handling (4.2.5)
• EMC and EMI compatibility testing (4.2.6)

Test Scenarios and Measurement Methodology

Measurement of Radiated Emissions (FCC 15.209(a))
Amas deuchainn:
Verify that emissions from the FU8002-915 module in the range of 30 MHz – 9.2 GHz do not exceed permitted limits.

Modh-obrach:

1. The FU8002-915 module is installed in the test environment according to the installation manual.
2. A spectrum analyzer is used to measure emissions at harmonic frequencies.
3. The results are compared with FCC Part 15.209(a) limits.
   Slatan-tomhais Glacaidh: Chan fhaod sgaoilidhean a bhith nas àirde na na luachan stairsnich a tha air an comharrachadh le FCC.

Testing of Band Edge Frequencies (FCC 15.247(d))

Amas deuchainn:
Ensure that the module does not exceed emission limits at the edge frequencies of its operating band (902–928 MHz).
Modh-obrach:

1. The module is tested at a 915.1 MHz frequency in full operational mode.
2. The spectral power density at band edges is measured.
3. Results are compared against FCC requirements.

Slatan-tomhais gabhail:
Feumaidh sgaoilidhean taobh a-muigh a’ chòmhlain obrachaidh coinneachadh ris na crìochan a shuidhich FCC 15.247(d).

Measurement of Emissions in Idle Mode (FCC 15.109(a)
Amas deuchainn:
Dèan cinnteach nach cruthaich am modal bacadh ann am modh leisg nas fhaide na crìochan sònraichte.

Modh-obrach:

1. The module is placed in receive or idle mode.
2. Emissions in the range of 30 MHz – 5 GHz are measured.
3. Results are compared with FCC Part 15.109(a) limits.

Slatan-tomhais gabhail:
Feumaidh sgaoilidhean a bhith nas ìsle na na stairsnich a chaidh a shuidheachadh le FCC 15.109(a).

Compatibility Testing with the Host Device
Amas deuchainn:
Dèan cinnteach gu bheil am modal ag obair gu ceart taobh a-staigh an t-siostam urodynamic gun a bhith ag adhbhrachadh bacadh gun iarraidh.

Modh-obrach:

1. The module is integrated into the test urodynamic system.
2. Common operational scenarios, including data transmission, are simulated.
3. Transmission errors, system response, and potential interference effects are mon

Slatan-tomhais gabhail:
Chan fhaod am modal dragh a chuir air gnìomhachd àbhaisteach an inneal aoigheachd.

Verification of Buffered Data Transmission Handling

Amas deuchainn:

Assess how the module handles data buffering limitations during communication and ensure that any data buffering mechanism does not result in non-compliance with FCC transmission rules.

Co-cheangailte ri Gèilleadh FCC:

• FCC Part 15 regulations require that transmission characteristics (such as duty cycle, burst duration, and occupied bandwidth) remain within permitted limits.
• Data buffering mechanisms must not introduce unintended continuous or prolonged transmissions that could violate these rules.

Modh-obrach:

1. The module is configured for continuous and intermittent data transmission scenarios to observe any impact on emission charactristics.
2. Spectrum measurements are taken before, during, and after buffer-induced transmissions to detect any deviations in duty cycle, emission bandwidth, or transmission power levels.
3. Transmission logs are analyzed for instances where buffering might cause extended transmission durations or spurious emissions.

Slatan-tomhais gabhail:
Feumaidh feartan tar-chuir fuireach taobh a-staigh crìochan aontaichte FCC, a’ toirt a-steach ìrean cumhachd, cearcall dleastanais, agus stairsnich sgaoilidhean spùtach.
Cha bu chòir tar-chuir leantainneach gun dùil tachairt mar thoradh air uidheamachdan buffering.
Feumaidh sgaoilidhean rè tar-chuir bufair fuireach taobh a-staigh crìochan speactram riaghlaidh.

Amas deuchainn:
Assess how the module handles data buffering limitations during communication.

Modh-obrach:

1. The module is configured for continuous data transmission scenarios.
2. Transmission logs are analyzed for dropped packets, delays, and system performance.
3. Any inconsistencies in data buffering behavior are documented and tested for potential optimizations.

Slatan-tomhais gabhail:
Data buffering should not introduce significant latency or data loss beyond defined thresholds.

EMC and EMI Compatibility Testing

Amas deuchainn:
Ensure the module does not introduce electromagnetic interference and is resistant to external EMI.

Modh-obrach:

1. The module is tested for EMC compliance under IEC 60601-1-2 conditions.
2. Measurements of susceptibility to external RF fields are performed.
3. Interference effects on other components in the host device are analyzed.

Slatan-tomhais gabhail:

• The module must comply with IEC 60601-1-2 for EMC.
• No significant degradation in performance due to EMI.

Uidheam deuchainn 

Nì	Cleachdadh
Mion-sgrùdaire speactram	Measurement of emissions
Shielded communication environment	Deuchainn eadar-theachd
Urodynamic device	Deuchainn co-chòrdalachd
Data transmission monitor	Buffered data handling assessment
EMI/EMC test chamber	Compliance with IEC 60601-1-2

Suidheachaidhean Àrainneachdail

• Teòthachd: 20–25 ° C.
• Humidity: 30–60%
• Test Chamber Type: Semi-anechoic chamber (for EMI/EMC tests)

Summary of Testing Requirements
Tha a’ chaibideil seo a’ dèanamh cinnteach gu bheilear a’ cumail ris a’ phlana deuchainn agus a’ mìneachadh dòigh-obrach dearbhaidh soilleir gus coinneachadh ri riatanasan FCC. Feumaidh toraidhean deuchainn a bhith air an clàradh agus air an tasgadh airson adhbharan teisteanais.

Notaichean Gèillidh Riaghlaidh
Class II Permissive Change: If the module is integrated into a new host system, the integrator must file Atharrachadh Ceadaichte Clas II leis an FCC.
Integration Guidance: The host device manufacturer is responsible for ensuring continued compliance with FCC regulations

Ceistean Cumanta

• An urrainnear an antenna atharrachadh?
  No, the antenna specified in the technical parameters should not be changed. Any modifications require notification to the module grantee.
• Cò a bu chòir a bhith a’ stàladh a’ mhodal rèidio?
  Installation should only be done by qualified personnel or authorized service centers to ensure compliance and proper functioning.

Sgrìobhainnean/Goireasan

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