Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™
Device Facts
| Record ID | K221603 |
|---|---|
| Device Name | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ |
| Applicant | Cardinal Health, LLC |
| Product Code | LZH · General Hospital |
| Decision Date | Dec 20, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory. The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.
Device Story
Kangaroo OMNI™ Enteral Feeding Pump is a rotary peristaltic tension loop pump delivering nutritional fluids/water to GI tract. System includes pump, disposable feeding sets, and accessories. Used in hospital, acute, long-term, and home care settings by clinicians, laypersons, or patients (with caregiver support). Operates in stationary or ambulatory modes (via backpack). Pump incorporates menu-controlled software to set feed rates/volumes. Features include feed/flush capability, thick formula delivery, and auto-prime. Sensors (2 ultrasonic, 1 force) monitor flow and detect occlusions (upstream/downstream). Output is controlled fluid delivery; healthcare providers use pump interface to manage nutrition/hydration therapy. Benefits include reliable enteral nutrition for patients unable to ingest food orally.
Clinical Evidence
No clinical data. Bench testing only, including software verification/validation, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), essential performance (flow rate accuracy, alarm detection), human factors/usability engineering, biocompatibility (ISO 10993), and battery testing (IEC 62133).
Technological Characteristics
Rotary peristaltic tension loop pump. Powered by rechargeable Lithium Ion battery. Features 2 ultrasonic sensors and 1 force sensor. Color TFT display (320x240). IP26 liquid ingress protection. Connectivity: standalone. Software: Major Level of Concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, IEC 62304, IEC 62366, IEC 62133.
Indications for Use
Indicated for delivery of enteral fluids (nutritional/water) to GI tract via nasogastric, orogastric, nasojejunal, gastrostomy, or jejunostomy tubes. Patient population: infants, children/adolescents, and adults unable to eat/swallow or requiring supplemental nutrition. Contraindicated for neonates.
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Predicate Devices
- Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal (K153074)
Reference Devices
- Kendall ePump Enteral Feeding Pump and Enteral Feeding Sets
Submission Summary (Full Text)
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December 20, 2022
Cardinal Health LLC Varela Fredy Manager, Regulatory Affairs 3651 Birchwood Drive Waukegan. Illinois 60085
## Re: K221603
Trade/Device Name: Kangaroo OMNI™ Enteral Feeding Pump (385400):Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF):Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ ENPlus Spike Set with Flush Bag ( BSPFFF);Kangaroo OMNI™ ENtelliSet ENPlus Spike with Flush Bag (ESPFF);Kangaroo OMNI™ Thick Formula ENtelliSet 500ml (E5FDR);Kangaroo OMNI™ Thick Formula ENtelliSet 500ml with Flush Bag (E5FFR);Kangaroo OMNI™ Thick Formula ENtelliSet 1000ml (E10FDR);Kangaroo OMNI™ Thick Formula ENtelliSet 1000ml with Flush Bag (E10FFR):Kangaroo OMNI™ Burette ENtelliSet (ER100);Kangaroo™ Power Cord with Adapter (384491);Kangaroo™ Adjustable Pole Clamp (384492):
Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZH Dated: December 1, 2022 Received: December 2, 2022
Dear Varela Fredy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
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product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
#### 510(k) Number (if known) K221603
#### Device Name
Kangaroo™ Omni Enteral Feeding Pump, Kangaroo™ Omni Feeding Sets, and Kangaroo™ Accessories
#### Indications for Use (Describe)
Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.
The Kangaroo OMNI™ Enteral Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.
Type of Use *(Select one or both, as applicable)*
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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#### K221603 510(K) SUMMARY
| Manufacturer's Name: | Cardinal Health LLC<br>3651 Birchwood Drive<br>Waukegan, IL 60085 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Fredy Varela<br>Manager, Regulatory Affairs |
| Telephone Number:<br>E-mail: | 847.887.5781<br>fred.varela@cardinalhealth.com |
| Preparation Date: | December 19, 2022 |
| Trade Name: | Kangaroo OMNITM Enteral Feeding Pump, Kangaroo OMNITM Feeding<br>Sets and KangarooTM Accessories |
| Common or Usual<br>Name: | Enteral Feeding pump, Infusion pump |
| Classification Name and<br>Number: | Infusion Pump<br>21 CFR 880.5725<br>Class II<br>Product Code: LZH |
| Primary Predicate<br>Device: | KangarooTM Connect Enteral Feeding Pump with KangarooTM<br>Connect Feeding Sets and KangarooTM Connect Portal |
| Reference Device: | Kendall ePump Enteral Feeding Pump and Enteral Feeding Sets |
#### Device Description
The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.
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#### Intended Use/Indications for Use
Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.
The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.
| Feature | Predicate Device<br>Kangaroo™<br>Connect<br>K153074 | Subject Device<br>Kangaroo™ OMNI<br>K221603 (current submission) | Subject vs. Predicate Device Differences<br>Substantial Equivalence |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications<br>for Use | Intended to<br>deliver nutritional<br>formula at a<br>controlled rate to<br>the<br>gastrointestinal<br>system of a<br>patient who is<br>physically unable<br>to eat and<br>swallow. Not for<br>use with neonates.<br>The feeding pump<br>and feeding sets<br>are intended to be<br>used in clinical or<br>home care<br>settings by users<br>ranging from<br>laypersons to<br>physicians. | Intended for delivery of enteral fluids,<br>including nutritional fluids and/or water to<br>the gastrointestinal system via nasogastric,<br>orogastric, nasojejunal, gastrostomy, and<br>jejunostomy tubes. Not for use with<br>neonates. Intended for any patients ages<br>infant, child/adolescent and adult who are<br>physically unable to eat and swallow or who<br>are unable to get sufficient nutrition<br>through eating and swallowing. Intended to<br>be used in hospital and acute care settings,<br>as well as long term and home care settings<br>by users ranging from clinicians to<br>laypersons and patients. Some patients may<br>need a caregiver to support using the<br>device. It is intended to be used in both<br>stationary and ambulatory conditions<br>including ground and air transport while<br>using backpack accessory.<br>The Kangaroo OMNI™ Enteral Feeding Pump<br>and Feeding Set are intended to be used<br>together as a system. Kangaroo OMNI™<br>Enteral Feeding Sets for administration of<br>standard formula are able to be connected<br>to access devices of all sizes that are ENFit™<br>compatible. The Kangaroo OMNI™ Thick<br>Formula Feeding Sets for administration of<br>thick formula can be used with access<br>devices 8 Fr size or greater that are ENFit™<br>compatible. | General purpose of the subject device or its<br>function, condition and patient population are<br>the same as predicate device. Subject device<br>feature is substantially equivalent to that of<br>the predicate device |
| Technological<br>Characteristics | Peristaltic<br>pumping action | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Design (Pump) | The pump<br>incorporates a<br>menu-controlled,<br>operating system<br>which contains on<br>board custom<br>software designed<br>to allow the user | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Feature | Predicate Device<br>Kangaroo™<br>Connect<br>K153074 | Subject Device<br>Kangaroo™ OMNI<br>K221603 (current submission) | Subject vs. Predicate Device Differences<br>Substantial Equivalence |
| | to set feed rates<br>and volumes as<br>well as other<br>feeding options | | |
| Free Flow<br>Mechanism | Anti-Free Flow<br>Valve | Stopcock Valve | Difference does not introduce or raise concerns<br>regarding the safe and effective use of the<br>subject device. |
| Feed<br>Capability | Yes | Same | Subject device feature is substantially<br>equivalent to that of the predicate device |
| Feed and Flush<br>Capability | No | Yes | Difference is considered an added<br>benefit/option for the user, and does not<br>introduce or raise concern regarding the safe<br>and effective use of the subject device |
| Thick Formula<br>Capability | No | Yes | Difference is considered an added<br>benefit/option for the user, and a design<br>improvement that does not introduce or raise<br>concern regarding the safe and effective use of<br>the subject device. Clinical benefits offered by<br>thick formula feeding option outweigh the risks<br>associated with it. |
| Flow<br>Monitoring | Yes, 2 Ultrasonic<br>sensors | Same 2 ultrasonic sensors and 1 new force<br>sensor | Difference is considered a design improvement<br>that does not introduce or raise concerns<br>regarding the safe and effective use of the<br>subject device. |
| Occlusion<br>Detection | Yes, Upstream and<br>Downstream | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Accuracy<br>(Standard<br>Formula<br>Feeding Sets) | $\pm$ 5% | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Accuracy<br>(Thick Formula<br>Feeding Sets) | N/A | ±10% | Difference is considered a design improvement<br>that does not introduce or raise concern<br>regarding the safe and effective use of the<br>subject device |
| Delivery Rate<br>Range | 1-600ml in 1ml<br>increments | 1 to 400mL per hour in 1mL increments<br>(Standard Formula Feeding Sets)<br>1 to 200mL per hour in 1mL increments<br>(Thick Formula Feeding Sets) | Difference is considered a design improvement<br>that does not introduce or raise concern<br>regarding the safe and effective use of the<br>subject device |
| Dose Range | 1-3000ml in 1ml<br>increments | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Power<br>requirements | 120V, 60Hz, 1Amp | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Autoprime | Yes | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Display | Color TFT<br>(320x240<br>pixels) | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Maximum<br>Occlusion<br>Pressure | 20 psi | 16 psi | Difference is considered a design improvement<br>that does not introduce or raise concerns<br>regarding the safe and effective use of the<br>subject device. |
| Feature | Predicate Device<br>Kangaroo™<br>Connect<br>K153074 | Subject Device<br>Kangaroo™ OMNI<br>K221603 (current submission) | Subject vs. Predicate Device Differences<br>Substantial Equivalence |
| Size | 3.9" x 6.1" x 1.6" | 5.5" x 6.8" x 2.6" | Differences do not introduce or raise concern<br>regarding the safe and effective use of the<br>subject device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Weight | 0.73 lbs (0.33 kg) | 1.7 lbs (770 grams) | Differences do not introduce or raise concern<br>regarding the safe and effective use of the<br>subject device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Pole Clamp<br>Mountable | Yes | same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Battery Life | 24 hours | 20 hours | Difference is considered a design improvement<br>that does not introduce or raise concern<br>regarding the safe and effective use of the<br>subject device |
| Battery<br>Recharge Time | 7 hours | 12 hours | Difference is considered a design improvement<br>that does not introduce or raise concern<br>regarding the safe and effective use of the<br>subject device |
| Battery<br>Operation<br>Indicator | Yes | same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Operating<br>Temperature<br>Range | 5°-40°C (41°-<br>104ºF) at 93% R.H.<br>(non-condensing) | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Storage<br>Temperature<br>Range | 0°-50°C (32°-<br>122°F) at 93% R.H.<br>(non-condensing) | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Medical and<br>Electrical<br>Safety<br>Standards | IEC 60601-1<br>ANSI/AAMI ES<br>60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-8<br>IEC 60601-1-11<br>IEC 60601-2-24<br>IEC 62304<br>IEC 62366 | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Degree of<br>Protection<br>Against<br>Electrical<br>Shock | Class 2 Type BH<br>per IEC Standards<br>Pass | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| Degree of<br>Protection for<br>liquid ingress | IP26 = Water Jet<br>proof per IEC<br>60529<br>Pass | Same | Subject device feature is the same as the<br>predicate device. Subject device feature is<br>substantially equivalent to that of the<br>predicate device |
| EMC/ EMI and<br>ESD standards | IEC 60601-1-2<br>Parts 1 and 2 | Same…
