npavni REF: MYO1-000M ive Version 6 1|ICED AAANILIAI WIYILIN IVIF ANOS VLR Cl im timisnmiie Oem wermavitmanmta| Denereiivn hdnweittreu VVMETTCIEIUMUMS VSVITIVALLINCHLat FreooUblo WIMVETTILUE MY01 Inc. lecT REP. 1 CEpartner4U BV SNES ONT EES ONIN ERS ee Montral, QC, Canada H2Y 3V4
+1 (855) 799-6901 R,ONLY Or CONTENTS
| S711) oko) sd ) FLT 0) |
| Taleo [0 (oto): eee eee
| VAVETUIINS)S Gio! IN@WSS.1000000c00000000000000000000o03006a0cae0o000009000nc000G000000000000000000000000000 sr es es Or on Ee Comnonents..
| LU EY-Y toad eres) a1 sy] 218A od CX er 101 (0) | ee
| Device Interface
| Operational Instructions
| Troubleshooting
| Device Interface Error Codes
| Pa Instrument Defects or Product Deficiencies OL ie a VE TTT PTTPEPTETTTTTETTeeTTeeTreerrrerrrerreerrreereerrrerrreereeerree appa tT ey iT ety Pd
| Environmental Conditions....
| Electromagnetic Compatibility YYMVOl CAVIaNdtlOr Oo Caution Read instructions for use before operating the device Caution : Federal law (USA) restricts this device to sale by or on the order of R. ONLY a physician oteriiizea using ethylene oxide STERILE EO) Type BF applied part Do not resterilize Do not use if package is damaged Single patient-use device Q Manufacturer Maximum ana minimum temperature limits Maximum and minimum relative humidity limits Maximum and minimum pressure limits Keep away from sunlight Use-by date Batch code LOT ValalOgue NUllVer ner Authorized representative in the European Community EC |REP Ingress Protection (IP Rating) IP53 Signifies European technical conformity DEVICE INTERFACE SYMBOLS Full battery Warning: low battery level Cg Trend arraqwe alw LAa4l Introduction WARNINGS AND NOTES ae aN MENTING Vv ee a ee NN ENA ER EEE IN RENEE EEE NMEA NEN INES NS IM IN MAE GREY OREM meanings and should be reviewed carefully. A WARNING: The personal safety of the patient may be involved. Disregarding this information could result in iniurv to the natient. NOTE: This provides adaitional important intormation the user should be aware of. INTENDED USE me MTU Continuous COMpartmental Fressure MONITOF Is Intenaed Tor real-time ana CONTINUOUS measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. COMPONENTS Packaging and Device Figure 1 : MYO1 Device Dispenser Figure 2 : Packaged MYO1 Device
+k. oan RL a Tt THe MPU VVTITUUUS VUTNIVATLINOT Lal FEO SSULO MIVUITLUL CUINNEISe Ss LH TUNUWINY MHlajur components: the Introducer and the Pressure Monitor. K_/
\ Needle |
Device Body Lead-Wire Housing Display | Push-Button Figure 3 : Introducer Figure 4 : Pressure Monitor (Applied Part) User & Patient Safety Precautions A WARNING e The device should only be used in a healthcare facility environment by medical professionals who have received the appropriate training. Uo not perform a Glagnosis solely Dased on pressure measurements of the aevice. Always use the device with the current standard of care. e Use aseptic practices during usage - follow healthcare facility guidelines. e Do not ship, store or use the device outside the specified environmental conditions (See Table 3). ee Gta nn nn dauinn de wnt paper Datinnts waft man kn pnamnpeminnd EEE MR MNES MEM EO ARIE DAES Y NNGAY ME MME EMER MM e Do not use the device past the expiration date. e Do not resterilize the device. It is initially ETO sterilized and cannot be reprocessed. e Do not clean the device. e Do not perform any maintenance on the device. e Do not use the same device in multinle patients. e Do not use the device in proximity to MRI equipment and high frequency surgical equipment. e Do not use the device if it is believed to be faulty. Ine user should exercise clinical Juag-
ment when performing measurements. e Do not dispose of dispenser packaging until all devices are used. No known contraindications Device Interface Device Reference ID Unique identifier for the device Battery Level Precciira Measurement Unit of Measurement Trend Arrows Pressure Vent Push-Button Long press (until display illuminates) to turn ON Short press (less than 3 seconds) to rotate screen orientation Long press (more than 3 seconds) to dim display Figure 5 : Device Controls and Display Icons Significance of Trend Arrows ea The decrease in pressure is areater than or equal to 0.5 mmHa/hour. a The decrease in pressure is areater than or equal to 2 mmHa/hour. OA The increase in pressure is greater than or equal to 0.5 mmHg/hour. fay The increase in pressure is greater than or equal to 2 mmHg/hour. A WARNING e Do not tice trend arrowe for diaanonsctic niirnocec Alwave tice nrecctire meacitiremente and clinical judgment along with the current standard of care. g A1A1 Ea me eee NAN em ee ee ao ee uoyng-ysng ssid ee, oie BORMAN MIN MERAREETD MIG RIOD EM TTR aM Operational Instructions Peel the Tyvek lid where indicated. Lift the top cover and remove the device from the packaging. A WARNING e Do not use the device if the Sensor is found unhooked from the Needle after opening the package. Never attempt to re-assemble the device. e Do not use the device if the integrity of the packaging is compromised. step @ = Activate the Pressure Monitor by pressing and holding the Push-Button until the MYO1 logo appears. The Display will subsequently show the MYO1 logo and a pressure value of 0. Press Push-Button to Come ON Display illuminates CIN
: 0.0 MY01 ma creek Pad eh Mew a eg Preis &
EMER MIN OSES TEs DEMATTEIS 10
&4 WARNING e Always turn ON device BEFORE introducing into patient. e Do not use the device if pressure measurements are not within O- 9 mmHg prior to inser-
tion. A B Figure 8 : Recommended Device Grips Step 3. : While holding the Introducer (see Figure 8), ensure that the information on the Display is visible. Remove Weedle Lap. Without applying excessive force on the visplay, insert tne Needle gently into the muscle compartment in a controlled linear motion. Markings on the Needle should be used to estimate the depth of the insertion. ee a PIygyle J. MILIUUULTTY tie MeVvIte NOTE e The Display can be rotated to the desired orientation to ensure visibility during the insertion
(see Figure 6). e Single marks are spaced along the needle at 1 cm intervals with the first located 2 cm from the Needle tip. Double marks are placed at 5 cm intervals as measured from the Needle tip. e Consider applying local anesthetic before insertion. Ensure there are no allergies to anesthet-
ic use. 11 e The Introducer can be retracted and re-inserted to perform additional single-point measure-
mente withoit electing the Precciire Monitor 3 WARNING e Always keep the Pressure Vent on the bottom-right of the screen unobstructed (see Figure 5). e Do not use the device if the Sensor unhooks unexpectedly during the insertion (up to 5 sin-
gle-point insertions). Never attempt to re-assemble the device. e Do not rotate the Introducer durina insertion to prevent premature Sensor unhookina. ae Pee er Na Se eee Tee SIN EO FD Oe EEE REE BETO ED EEE REE MS SEEM BPM SERIE ARIMA ES AMATTT ISD TIGNES VALGN ESM SIE RIN Pressure Monitor from the Introducer by pressing gently through the back opening of the Intro-
ducer. An adhesive strip will be exposed on the back of the Device Body when ejected.
= kh Figure 10 : Ejecting the Pressure Monitor 12 Step 5 : While holding the Introducer in one hand, use the other hand to adhere the Device So ke kL 2 kt ee ee DUUY bY LN PAIS oS ORITE USI LIS CAPUSEU AUIS SIVE Stil Ul LIS Math UT LIT VEeVIte DUUY. Fur sition the Device Body face-up on the patients skin near the insertion point, ensuring sufficient slack in the Lead-Wire. The Lead-Wire should extend straight out from the insertion site indicat-
ing the insertion angle of the Sensor. rm Figure 11: Placing the Device Body on Patient Skin NOTE e Care should be taken when moving the Device Body to not pull the Lead-Wire which can dis-
place the Sensor within the muscle compartment. e The Device Body should be installed in a location which wont interfere with adhesion during tha mnnitarinn naoarinnd EE SOE EE EEE Dee e It is recommended to prepare the skin appropriately to improve adhesion, especially on hairy or oily skin. Z\ WARNING e Do not re-apply the adhesive. Additional medical tape should be used if the location of the Device Body is changed after the first application. Ensure that the Pressure Vent (see Fig-
ure o) Is not covered Dy the meaical Cape. 13 Step 6 : Disengage the Sensor by rotating the Introducer by 180 degrees. Slowly remove the Introducer trom the patient and dispose of It In a Diohazard-sharps receptacle, as per facility guidelines. NOTE e |t is recommended to apply a dressing to the insertion site to fix the Lead-Wire in place. A WARNING e Sharps biohazard - dispose as per facility guidelines and/or local regulations. A B Figure 12 : Removing the Introducer co OE 8 METER PERS SUIE PEGI TUE GA PENI GE EM LM GUT GUE Se TTR PERE SS UT RS MMT AGT STIS be routinely checked to ensure that it is secured to the patient throughout the monitoring period and that the Lead-Wire does not pull on the Sensor and displace it. A WARNING e No not leave the Sancor incide the natient for a nerind Innoaer than 24 hore EE EE 14 Step 8 : When monitoring is complete, remove the dressing and gently pull on the Lead-Wire by hand to remove the Sensor from the patient. Dispose the Pressure Monitor in a biohazard cCoantainer ac ner farilitv aqnidelinec ro TF eee NOTE e The Lead-Wire should be pulled out at the same angle used for insertion of the Sensor to minimize removal forces. A WARNING Se The Gevice tis FOr SIIgle PdllENl-USe OMY. VO MOU aALLEMIPl CLO FeassMnie Che GEvice OF Fepide the batteries after use. e Always remove the Pressure Monitor from the patient before performing a corrective proce-
dure (e.g. fasciotomy, amputation, debridement, skin graft). 15 G H Figure 13 : Insertion Procedure Summary 16 Troubleshooting DEVICE INTERFACE ERROR CODES Tdblie tf Error LOGE List eonaAn CODE ERROR NAME DESCRIPTION CORRECTIVE ACTION NON-CRITICAL ERRORS A oo 8 ak ot nw ee ne eee ee IT CTI GAINES 1 BLE Security Error mobile phone is trying to pair with the N/A*
device 2 Other BLE Error Bluetooth communication problem N/A*
VeVIce OPeldtiOr Is NOt rECOMImMena-
Device has been running for longer ed beyond this time, if device is cur-
than intended operating time rently being used cease operations 3 Lifetime Exceeded DO NOT use the device. Call cus-
tamar cunnnrt far inetrirtiaAnnan cpp 1n_ Sensor Integrity System has detected a critical mal-
aS EE ESE ANODE Compromised function in th nsing element . PI Sensing eleme! how to discard the device DO NOT use the device. Call cus-
ERR 11 Software Error Software malfunction tomer support for instruction on how to discard the device
* Future feature to be implemented at a later date 17
/Non-Critical Error NTN oe Error Code Figure 14 : Error Code Display INSTRUMENT DEFECTS OR PRODUCT DEFICIENCIES e For defective device concerns, or any related quality issues, please contact help@MYO1.io or call +1 (855) 292-6901. ea AWMYON1 ronracantativea will daal with anv nnalityv icetnac roalatoad tn hardware ar cranftware finc. I DIE IE IEE IEEE EE SEEDS eee ee DE OEE EE IE EE tionality in a timely manner. 18 Specifications DEVICE Table 2: Device Specifications Model MYO1-0001 Pressure range 0 - 99.9 mmHg Power Two (2) 3 V batteries (non replaceable) Display resolution 0.1 mmHg Battery life 24 hours IP Rating IP53 Weight 85 g (+/- 5g)
[Dimensions 20 cm x 6.5 cm x 3 cm (4+/- 1cm) NEEAIE Gauge I f-Qaluge 19 ENVIRONMENTAL CONDITIONS Table 3: Environmental Conditions Operation Storage Transportation 40C 40C 55C Temperature V V V ZO
-20C
| nd@ | 0t 75%
75%
75%
| Humidity 106 kPa 106 kPa 106 kPa
| Pressure | fy) 90 KPa 50 Pa 50 Pa 20 ELECTROMAGNETIC COMPATIBILITY A WARNING:
e Use of MYO1 device adjacent to or stacked with other electrical equipment should be avoided as it could result in improper operation. If such use is necessary, the MYO1 device and other electrical equipment should be observed to verify that they are op-
erating normally. e Portable RF communications equioment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part ortne Mrul aevice, inciuaing Cabies specified Dy the manufacturer. UTNEerwise, Geg-
radation of the performance of this equipment could result. Note e MYO1 has no cables or accessories. Do not attempt to add any cables or accessories tn thn Anvinn AMAT MM NIMS e MYO1 can communicate over a frequency band of 2.402MHz-2.4835MHz with GFSK modulation and effective radiated power of 1mWatts]
21 Table 4: Electromagnetic Emissions Group and Classification Attribute Compliance/ Class Group RF Emissions Group per CISPR 11 Group 1 Class B (although the device is not RF Emissions Class per CISPR 11 for residential environment use) table o: Electromagnetic Immunity Levels ACLTIDULTE LOMPHanCes ULldss GlOUD
+ 8 kV contact Electrostatic Discharge (ESD) +2 kV,+4kV, +8 kV, +15 KV air Per IEC 61000-4-2 3 V/m 80 MHz - 2.7 GHz Radiated RF EM fields 80 % AM at 1 kHz Der ler cinnna 2 L jit YY EYES Proximity fields from RF wireless com-
As indicated in IEC 60601-1-2
[munications equipment |
[Immunity to Rated Power frequency mag- [30A/m at 60Hz, 50Hz netic field Per IEC/EN 61000-4-8 22 Vate or release : 1a Vec cUI9 Oo REF # : MYO-00119-M ical Saf C i S The MYO1 compartmental pressure monitor complies to IEC 60601-1 and IEC 60601-1-2 ECC Compliance Statement This device complies with FCC Subpart 15C rules 15.247. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) UMis GQevice MuUSt dACCe pl dny Mterrerence freceived, MCMuaing iMterrerence nat May cause undesired operation. Changes or modifications to this product not authorized by MYO1 Inc. could void the electromagnetic compatibility and negate your authority to operate the product. Canadian Regulatory Statement / Dclaration rglementaire Canadienne This device complies with Industry Canada licence-exempt RSS standard(s). Operation ee AhtARnt tn thn fallausinn fan randitinne: (1)\ thie dnvinn may nant panier intarfar. PO VMN ME RM REE EEN SM EEA RE MAE ED ONE PRETEEN TEAM AMON OTTER EET ence, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exemnts de licence. Lexnloitation est autorise aux deux conditions suivantes:
(1) appareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage raaioelectrique subi, meme SI 'e broulillage est susceptible den compromettre le fonctionnement. 23